New Risk • Mar 10
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 38% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$1.2m). Earnings have declined by 9.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (38% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (CA$45.4m market cap, or US$33.4m). Board Change • Jan 02
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 2 experienced directors. No highly experienced directors. CEO, President & Director Sebastien Plouffe is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. New Risk • Dec 04
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 20% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$4.2m free cash flow). Negative equity (-CA$1.4m). Earnings have declined by 16% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (CA$52.7m market cap, or US$37.8m). New Risk • Nov 30
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$4.2m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$4.2m free cash flow). Negative equity (-CA$1.4m). Earnings have declined by 16% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (CA$46.0m market cap, or US$32.9m). Ankündigung • Oct 08
Defence Therapeutics Inc., Annual General Meeting, Dec 10, 2025 Defence Therapeutics Inc., Annual General Meeting, Dec 10, 2025. Location: quebec, montreal Canada Ankündigung • Aug 23
Defence Therapeutics Inc. announced that it expects to receive CAD 1.2 million in funding Defence Therapeutics Inc. announced a non-brokered private placement to issue 1,200 debentures units at an issue price of CAD 1,000 per unit for gross proceeds of CAD 1,200,000 on August 22, 2025. Each unit will consist of one CAD 1,000 principal amount of 8% convertible debenture and 1,666 common share purchase warrants. The debentures will bear interest at 8% per annum and will mature two years following the issue date. The debentures are unsecured. The principal amount of each debenture will be convertible at the option of the holder into common shares in the capital of the company at the conversion price of CAD 0.60 per common share. Each warrant will be exercisable to acquire one common share at an exercise price of CAD 0.75 per warrant share for a period of two years from the issue date. All securities issued in connection with the offering will be subject to a statutory hold period of four months and one day following the closing date of the offering in accordance with applicable securities legislation. Completion of the offering is subject to a number of conditions, including, but not limited to, the receipt of all regulatory approvals. The company may pay a finder's fee in connection with the offering to eligible arm's length finders in accordance with the policies of the Canadian Securities Exchange. New Risk • May 25
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$4.5m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$4.5m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Negative equity (-CA$220k). Earnings have declined by 30% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (CA$46.5m market cap, or US$33.9m). Ankündigung • Mar 26
Defence Therapeutics Inc. Appoints Elias Theodorou as Chief Operating Officer, Effective April 2025 Defence Therapeutics Inc. announced that Dr. Elias Theodorou is joining the management team as the chief operating officer "COO", effective in April 2025. Dr. Elias Theodorou, Ph.D., is a molecular biologist with over 25 years of experience in cancer research, stem cell differentiation, and gene delivery. He is the co-founder of Protos Biologics Inc., where he has been developing innovative DNA delivery systems. Previously, he served as the Director of Research at WBC Biosciences LLC, where he co-invented a method to modify innate immune cells for enhanced anticancer properties. Dr. Theodorou earned his Ph.D. from Yale University, focusing on identifying novel drivers of neural differentiation. He has authored numerous publications and holds patents related to gene therapy and protein engineering. New Risk • Mar 19
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 22% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Negative equity (-CA$3.5m). Earnings have declined by 37% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (22% increase in shares outstanding). Market cap is less than US$100m (CA$58.6m market cap, or US$40.9m). New Risk • Jan 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$4.1m). Earnings have declined by 45% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (CA$48.2m market cap, or US$33.5m). Ankündigung • Jan 01
Defence Therapeutics Inc. announced that it expects to receive CAD 4.2 million in funding Defence Therapeutics Inc. announced a non brokered private placement to issue 7,000,000 units at an issue price of CAD 0.60 per unit for gross proceeds of CAD 4,200,000 on December 31, 2024. Each Unit is comprised of one common share and one common share purchase warrant. Each Warrant will entitle the holder thereof to acquire one additional common share at a price of CAD 0.75 per common share for a period of 24 months of the closing date. The Company may pay a finder's fee in connection with the Offering in accordance with the policies of the CSE. The securities issued in connection with the Offering will be subject to a statutory hold period of four months and one day following the closing date in accordance with the CSE. Ankündigung • Nov 27
Defence Therapeutics Inc Announces Executive Changes Defence Therapeutics Inc. announced that Dr. Maxime Parisotto has joined the Company as Chief Scientific Officer, Director of Science and Business Development. Dr. Maxime Parisotto is a seasoned biochemist with over 20 years of experience spanning academic research, drug development, and innovation. He holds a PhD in biochemistry focused on breast cancer and metabolism and has held postdoctoral fellowships at prestigious institutions, including the IGBMC in Strasbourg, France, and the Université de Montréal. As Senior Analyst, he contributed to significant investment decisions at adMare Bioinnovations. He also holds a graduate certificate in life science entrepreneurship development from Concordia university and will be graduating with an MBA from Sherbrooke University in April 2025. The company also mention that Dr. Moutih Rafei is no longer with the Company. The Company would like to thank Dr. Rafei for his contributions. Ankündigung • Nov 15
Defence Therapeutics Inc. announced that it expects to receive CAD 1.57 million in funding Defence Therapeutics Inc. announces a non-brokered private placement of Unsecured Convertible debentures for gross proceeds of CAD 1,570,000 on November 14, 2024. interest at the rate is 8.0% per annum and mature on November 16, 2025. The principal amount of each New Debenture is convertible at the option of the holder into common shares in the capital of the Company at a price of CAD 0.60 per Common Share at any time up to and including the Maturity Date. All securities issued in connection with the Offering are subject to a statutory hold period of four months plus a day in accordance with applicable securities legislation New Risk • Nov 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$3.0m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$3.0m free cash flow). Negative equity (-CA$4.1m). Earnings have declined by 45% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (2.9% increase in shares outstanding). Market cap is less than US$100m (CA$27.3m market cap, or US$19.4m). Ankündigung • Oct 22
Defence Therapeutics Inc., Annual General Meeting, Dec 12, 2024 Defence Therapeutics Inc., Annual General Meeting, Dec 12, 2024. Location: british columbia, vancouver Canada Ankündigung • Sep 27
Defence Therapeutics Inc. announced that it expects to receive CAD 3 million in funding Defence Therapeutics Inc. announced a non-brokered private placement comprising of 6 million units at CAD 0.50 per unit for gross proceeds of CAD 3 million on September 27, 2024. Each unit comprises of one common share in the capital of the Company and one-half share purchase warrant. Each warrant will entitle the holder to acquire one additional share at a price of CAD 1.00 per share for a period of 24 months of the closing date. The Company may pay a finder's fee in connection with the offering in accordance with the policies of the CSE. The securities issued in connection with the offering will be subject to a statutory hold period of four months and one day following the closing date in accordance with the CSE. Board Change • Sep 11
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Director Raimar Lobenberg was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. New Risk • Sep 05
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.6% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$6.1m free cash flow). Negative equity (-CA$2.3m). Earnings have declined by 50% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (3.6% increase in shares outstanding). Market cap is less than US$100m (CA$25.5m market cap, or US$18.9m). Ankündigung • Aug 21
Defence Therapeutics IncInvestigates the Application of the Accum Hydrogel Technology to Deliver GLP-1 in Order to Increase the Treatment Efficacy of Diabetes and Weight Loss Defence Therapeutics Inc. announced a project consisting of investigating the potential benefit of using the Accum® technology to increase the half-life and efficacity of the GLP-1 agonist as a treatment for obesity and related comorbidities (type 2 diabetes). Obesity is one of the most urgent health challenges in the world with extensive comorbidities, such as type 2 diabetes, cardiovascular diseases, steatohepatitis and chronic kidney disease to name a few. Over four billion people - about 50% of the world's population - are estimated to be impacted by obesity or being overweight by 2035. According to WHO, more than one billion people are obese including 650 million adults, 340 million adolescents and 39 million children. The growing number puts an incredible strain on societies and healthcare systems around the world. With the development of revolutionary drugs able to reduce the body weight by 15% to 20% of overweight and obese patients, this could be the biggest opportunity that the pharma industries have ever seen. Native GLP-1 has a very short half-life (2 min) and is rapidly degraded by dipeptidyl peptidase-IV (DPP-4). Modified GLP-1 peptide analogs with improved stability have therefore been developed for therapeutic purposes. The first GLP-1 peptide analog approved as an anti-diabetic agent is exenatide. The half-life of exenatide after subcutaneous injection is 2-3 h, requiring two injections daily. Liraglutide is a human GLP-1 analog with a half-life of 13 h, making it suitable for a single daily administration. In the last few years, dulaglutide and semaglutide have become available; these are long-acting GLP-1 analogs with >100-hour half-lives and require a single weekly injection. Current limitations of GLP-1 peptide analogs include the tolerability of gastrointestinal side effects, challenges with managing injections, as well as costs and scalability of drug manufacturing. Furthermore, there are still patient populations whose glucose levels and body weight cannot be adequately controlled by current therapeutics. Unfortunately, while optimization of GLP-1 drugs has reduced injection frequency from daily to weekly, the treatment burden of weekly injection still led to poor patience compliance and the development of longer acting GLP-1 agonists still to be a need for the patient compliance. Ankündigung • Jun 08
Defence Therapeutics Inc. Announces Publication of A Peer-Reviewed Study on the Anticancer Properties of Its Unconjugated AccuTOX Defence Therapeutics Inc. announced the publication of a peer-reviewed study on the anticancer properties of its unconjugated AccuTOX, one of Defence's lead products engineered to treat established solid tumors. The study, which was published in the prestigious Journal of Translational Medicine, is entitled, "Local delivery of AccuTOX synergises with immune-checkpoint inhibitors at disrupting tumor growth". The Accum®? platform was initially designed to accumulate biomedicines in target cells by inducing endosomal-to-cytosol escape. Interestingly however, the use of unconjugated Accum®? was observed to trigger cell death in a variety of cancer cell lines; a property further exploited in the development of Accum®?-based anti-cancer therapies. Despite the impressive pro-killing abilities of the parent molecule, some cancer cell lines exhibited resistance. This prompted to test additional Accum®? variants, which led to the identification of the AccuTOX®? molecule. From that perspective, AccuTOX®? holds many advantages over the parent Accum®? entity: it exhibits enhanced killing potency while retaining the innate function of endosomal- to-cytosol escape, the molecule can be easily manufactured, it can be linked to antibodies as an in situ cleavable anticancer molecule (to increase its specificity), and iv) it is highly versatile, as it targets multiple intracellular pathways that are highly relevant to cancer growth and progression. The key highlights of the AccuTOX® study are: AccuTOX® is therapeutically superior to parent Accum® (both in vitro and in vivo); The molecule induces cell death of various murine and human cancer cell lines (T-cell lymphoma, colon, melanoma, lung and breast); AccuTOX® triggers the intracellular production of reactive oxygen species and disrupts endosomal membranes; Following contact with AccuTOX®, cancer cells die through a process called immunogenic cell death; The compound leads to similar responses in both male and female animals with no apparent toxicity; AccuTOX® enhances antigen presentation (tumor becomes visible to immune cells) Intratumoral administration of AccuTOX® to lymphoma, melanoma or breast cancer synergises with common immune-checkpoint inhibitors leading to efficient tumor growth control. In summary, unconjugated AccuTOX® could be used as an anti-cancer molecule. The triggered effects are interesting and unexpected as the induction of immunogenic cell death brings an additional immune component to the equation, which may turn a "cold" into a "hot" tumor with increased infiltration of immune cells as shown in the published study. With FDA clearance to initiate a Phase I trial, Defence recently submitted a CTA application to Health Canada to widen the scope of clinical testing. New Risk • Jun 02
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$6.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$6.1m free cash flow). Negative equity (-CA$2.3m). Earnings have declined by 50% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (16% average weekly change). Shareholders have been diluted in the past year (4.2% increase in shares outstanding). Market cap is less than US$100m (CA$50.5m market cap, or US$37.1m). Ankündigung • Jan 10
Defence Therapeutics Inc. Tests a New Formulation of its ACCUM-002TM Dimer CDCA-SV40 Commonly Named AccuTOX® Defence Therapeutics Inc. announced that it successfully tested a new formulation of its ACCUM-002TM Dimer CDCA-SV40 commonly named "AccuTOX®", as an anticancer treatment for lung-established tumors. These results widen the scope of application for AccuTOX® in the treatment of solid cancer tumors. AccuTOX® is an optimization of the Accum® molecule and platform technology developed by Defence Therapeutics. Recent studies demonstrated that AccuTOX® has enhanced therapeutic properties and a broader application in cancer therapeutics as it has successfully killed more than a dozen different murine and human cancer cell lines. When initially delivered intranasally, AccuTOX® had a great impact on blocking tumor growth of pre-established lung nodules in mice. However, the drug was delivered as nasal droplets, which represents an approach difficult to translate to the clinic. Therefore, Defence used a nebulizing device named "Anesthesia Mask Nebulizer Delivery System" of Kent Scientific Corporation to deliver its compound in the least invasive way. Following several preclinical studies to set-up different delivery parameters, a maximum tolerated study revealed that the drug is tolerated by rodents at a dose of 3 mg/kg. When delivered as a monotherapy, AccuTOX® inhibited the growth of lung nodules. AccuTOX® was recently cleared by the FDA to begin a Phase I trial in patients with Stage IIIB to IV melanoma, as released per the Company on December 11, 2023. According to Precedence Research, the global cancer therapeutics market size is expected to be worth around USD 393.61 billion by 2032 from at USD 164 billion in 2022, growing at a CAGR of 9.20% during the forecast period 2023 to 2032. Ankündigung • Dec 12
Defence Therapeutics Inc. Receives FDA Approval for Phase I Clinical Trial Targeting Solid Cancer Tumors with Accutox Defence Therapeutics Inc. announced that the U.S. FDA has cleared "Study May Proceed" its Investigational New Drug (IND) application for a Phase I clinical trial of ACCUM-002TM Dimer CDCA-SV40 commonly named "AccuTOX®?", as an injectable anticancer molecule, for the treatment of solid cancer tumors. The approval granted to AccuTOX®?, the company's first first-in-class therapy, marks another key advancement for Defence in the immune-oncology field. The successful filing and safety review by the U.S. FDA of protocol entitled "Phase 1 trial of ACCum-002TM administered intratumorally as monotherapy and in combination with Opdualag (fixed IV doses), in patients with unresectable, stage IIIB to IV melanoma refractory to or relapse from standard therapy" marks a significant milestone for the company's strategy featuring diverse pipelines. Alongside its cancer vaccine-related therapies, AccuTOX®? will become Defence's asset in the anti-cancer therapeutics field. Defence remains committed to its mission of addressing unmet clinical needs and in pursuing its goals to become a global leader in the development of innovation anti-cancer therapies. AccuTOX®? is a derivative of the initial Accum®? backbone molecule. It was initially designed to various cellular processes including endosomal membranes to impair intracellular transport mechanisms, triggering genotoxic effects, blocking DNA repair mechanisms, and eliciting immunogenic cell death to stimulate the immune system. The use of AccuTOX®? in preclinical animal models with T-cell lymphoma, melanoma or breast cancer, under Dr. Moutih Rafei supervision, Defence's CSO, resulted in impaired tumor growth with 70% of treated animals showing complete responses. The primary objective of this upcoming Phase I clinical trial, is to identify the safest dosing range in order to co-administer AccuTOX®? with Opdulag®?, a BMS product containing both anti-LAG3 and anti-PD-1. Several other secondary parameters including therapeutic efficacy will be monitored in treated patients in preparation for a Phase II clinical trial on a basket of tumors. More details about the beginning of the Phase I will be announced in the near future. According to Data Bridge Market Research, the solid tumors market was valued at USD 209.61 billion in 2021 and is expected to reach USD 901.27 billion by 2029, registering a CAGR of 20.0% during the forecast period of 2022 to 2029. New Risk • Nov 17
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$6.8m free cash flow). Earnings have declined by 64% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (18% increase in shares outstanding). Market cap is less than US$100m (CA$96.5m market cap, or US$70.1m). Recent Insider Transactions Derivative • Oct 29
Chief Technical Science Officer exercised options to buy CA$144k worth of stock. On the 23rd of October, Simon Beaudoin exercised options to buy 50k shares at a strike price of around CA$1.25, costing a total of CA$63k. As of today, Simon currently holds no shares directly. Company insiders have collectively bought CA$182k more than they sold, via options and on-market transactions, in the last 12 months. Ankündigung • Oct 26
Defence Therapeutics Inc. Announces the Discovery of a Novel Function for Its Lead Antigen Injectable Drug AccuTOX Defence Therapeutics Inc. announced the discovery of a novel function for its lead anticancer injectable drug AccuTOX in the context of cell-based cancer vaccine engineering. The objective of the Accum®? technology is to improve the accumulation of biomolecules such as antibodies, proteins or genetic material in target cells. Defence has discovered that the delivery of unconjugated Accum®? exerts powerful and potent anti-cancer properties. This observation led to the engineering of AccuTOX®?, a lead Accum®? variant capable of halting the growth of pre-established lymphoma, melanoma and cervical cancer when co-delivered with different immune-checkpoint blockers. The AccuTOX®? mode of action summarized as follow: disruption of endosomal membranes, ii) production of reactive oxygen species, inducing of genotoxic effect resulting in irreversible DNA damage, and iv) triggering immunogenic cell death, which can activate the immune system leading to the development of anti-tumoral immune responses. As such, AccuTOX®? not only destroys cancer tumor cells from inside-out, but it can also stimulate an immune response to protect the host from subsequent tumor re-growth. Survey Survey Survey conducted on tumor cells treated with AccuTOX®? unveiled yet another therapeutic and positive effect: antigen cross-presentation. This process is very important in the context of cancer immunotherapy as it will lead the team to the future design of cell-based anticancer vaccines, capable of priming CD8 T cells, which in turns can trigger cancer destruction. In fact, the Defence team has recently completed an in vitro study demonstrating how low AccuTOX®? concentrations can indeed reprogram mesenchymal stromal cells to behave like antigen presenting cells akin to Defence's lead ARM vaccine. Once validated, Defence can advance with an optimized second-generation of its ARM vaccine. Additional studies are currently ongoing to further investigate the cross-presenting potency of AccuTOX®®?. The versatility of AccuTO X®? is adaptable to various cancer indications as well as widen the scope of AccuTOX®™? application by providing a line of novel therapeutic products. Ankündigung • Oct 19
Defence Therapeutics Inc. Announces Novel Accutox(Tm) Continues Toprise on Results Against Cancer Defence Therapeutics Inc. announced that the excitement around AccuTOXTM against cancer continues to develop and expand its applications. The AccuTOXTM molecule can eradicate cancer cells via different mechanisms including the initiation of immunogenic cells death, endoplasmic reticulum stress and by causing direct damages to DNA. When tested in three different animal models of solid tumors (lymphoma, melanoma and breast), the compound-controlled tumor growth and synergized with different commercially-used immune-checkpoints (anti-PD-1, anti-CTLA4 and anti-CD47). AccuTOXTM on Lung cancer, a completed pre-clinical study using Defence's intranasal formulation of AccuTOXTM in the context of animals with pre-established lung cancer showed that AccuTOXTM administration as a combination therapy with the immune-checkpoint inhibitor anti-PD1 reduces dramatically the level of lung nodules compared to control non-treated or anti-PD1-treated animals. This 50% reduction of cancer nodules on animals with pre-established lung tumors was achieved in a treatment plan of only 6 administrated doses over 2 weeks with the AccuTOXTM anti-PD1 combination. AccuTOXTM anti -cancer, in preparation of its Phase I clinical trial using AccuTOXTM as an anti-cancer molecule and in recommendation by its collaborators at the City of Hope National Medical Center and Beckman Research Institute where the Phase I will be done, Defence conducted a preclinical study investigating two objectives: i) minimizing AccuTOXTM dosing to twice a week over a period of three weeks (for a total of 6 injections), and ii) combining AccuTOXTM with both anti-PD-1 and anti-LAG3, which is equivalent to the use of Opdualag (a BMS premixed combination of nivolumab and relatlimab) currently administered to cancer patients at City of Hope. The strong results confirm that AccuTOXTM is suitable for any solid tumor, and it can synergise with a variety of immune-checkpoint inhibitors making it a future treatment of choice in immune-oncology. AccuTOXTM manufacturing Phase I, Biopeptek Pharmaceuticals, LLC, a renowned US based CDMO dedicated to the production of high-quality peptides for clinical applications, has optimized formulation and is finalizing manufacturing and packaging of the AccuTOXTM final drug product in vials dedicated for the Phase I clinical trial at City of Hope, CA, USA. Final quality validation and stability studies are being processed to meet with FDA high standards requirements. IND filling for Defence's Phase I clinical trial to treat melanoma patients at City of Hope,CA, USA will be done imminently. AccuTOXTM triggers cancer tumor regression, Defence also recently demonstrated that encapsulated AccuTOXTM with chitosan nanoparticles triggers complete tumor regression in animals with pre-established solid lymphoma. This additional discovery on AccuTOXTM is a simpler and cheaper method compared to the use of antibodies and may represent a key component of Defence's future encapsulation strategies and could revolutionize the future of molecular medicine by increasing the compounds specificity to tumor site while minimizing the needed dosage and thus, associated side effects. AccuTOXTM patent portfolio is growing. Further development and expanding applications on Defence's leading AccuTOXTM therapeutic is. ongoing and further news to be released upon results. Recent Insider Transactions Derivative • Oct 13
Corporate Secretary exercised options to buy CA$145k worth of stock. On the 9th of October, Carrie Cesarone exercised options to buy 50k shares at a strike price of around CA$1.25, costing a total of CA$63k. This transaction amounted to 76% of their direct individual holding at the time of the trade. As of today, Carrie currently holds no shares directly. Company insiders have collectively bought CA$119k more than they sold, via options and on-market transactions, in the last 12 months. Ankündigung • Oct 11
Defence Therapeutics Inc. Announces Peer-Reviewed Publication of its Preclinical Data on Accum as Anti-Cancer Molecule in Journal of Cancer Science Defence Therapeutics Inc. announced the publication of a peer-reviewed study on the anticancer properties of its unconjugated Accum®, one of Defence's product designed notably to treat established T-cell lymphoma. The study, which was published in the prestigious journal of Cancer Science, is entitled, Intratumoral administration of unconjugated Accum® impairs the growth of pre-established solid lymphoma tumors. The urgent need for novel anticancer therapeutics fuels active research in this field. From that perspective, Accum® holds many advantages over molecules discovered by high throughput screening because: it was rationally designed to break down endosomal membranes and hence has a known initial function, the chemical structure of the molecule could be easily modified to generate several Accum® variants, it can be easily linked to antibodies as an in situ cleavable anticancer molecule (to increase its specificity), and it is highly versatile, as it targets a common pathways relevant to any, if not most, cancer indication. The key highlights of the Accum® study are: The molecule induces cell death of various cancer cell lines (T-cell lymphoma, colon, melanoma and breast). Accum® triggers the intracellular production of reactive oxygen species and disrupts endosomal membranes. Following contact with Accum®, cancer cells die through a process called immunogenic cell death. The Accum® effect required both CD4 and CD8 T cells (important in fighting cancer). Intratumoral administration of Accum® synergises with common immune-checkpoint inhibitors leading to efficient tumor growth control. In summary, unconjugated Accum® could be used as an anti-cancer molecule. The triggered effects are very interesting and unexpected as the induction of immunogenic cell death brings an additional immune component to the equation, which may turn a cold into a hot tumor with increased infiltration of immune cells as shown in the published study. Ankündigung • Oct 07
Defence Therapeutics Inc., Annual General Meeting, Dec 07, 2023 Defence Therapeutics Inc., Annual General Meeting, Dec 07, 2023. Ankündigung • Sep 26
Defence Therapeutics Inc. Announces Accum-mRNA Lipid Nanoparticles Elicit Antibody Response 2X Stronger than Standard mRNA Vaccines Defence Therapeutics Inc. announced that its encapsulation strategy used to generate Accum®-mRNA lipid nanoparticles (LNPs) results in an antibody response that is twice as potent as standard mRNA LNPs. These results constitute a strong basis for conducting additional tests to optimize Defence's mRNA vaccine pipeline. This in vivo study had two main objectives: testing multiple LNP formulations and comparing their induced immune responses to standard mRNA. All vaccines were delivered as part of a prime-boost vaccination protocol with animal bleeding performed every two weeks over a total period of 4 weeks and antibody titers quantified by ELISA. Amongst the tested groups, one Accum®-containing LNP formulation stood-up triggering a higher antibody compared to the remaining groups. Defence will design additional studies, currently now being prepared to test different concentrations of the selected LNPs. Once the optimal dosing is identified, a validation study will be conducted in cancer- bearing mice to test their therapeutic potency. In this case, animals will be transplanted with a solid tumor expressing an experimental antigen followed by a prime-boost vaccination administered alone or in combination with immune-checkpoint blockers such as anti-PD-1. Accum® has been tested in various applications including protein and cell-based vaccination modalities and was discovered to significantly boost their therapeutic potency. Defence is therefore convinced that Accum® will increase the stability of mRNA molecules by enhancing structural integrity of the molecule, and augment their bio-accumulation and efficient translation in target cells resulting in a stronger immune-reactivity as shown with its latest LNP vaccination study. Ankündigung • Jun 16
Defence Therapeutics Inc. Announces Reach the Final Stages of Its AccuTOX^TM Chemistry, Manufacturing and Controls Defence Therapeutics Inc. announced that it reached the final stages of its AccuTOX^TM Chemistry, Manufacturing and Controls (CMC) in preparation to IND filling for its Phase I clinical trial to treat melanoma patients at City of Hope, CA, USA. Every experimental drug must undergo rigorous manufacturing and quality control testing prior to IND submission. Biopeptek Pharmaceuticals, LLC using cutting-edge science and technology, was mandated by Defence Therapeutics to complete these final crucial steps. With its state-of-the-art facilities and experienced scientific team, Biopeptek has optimized formulation and is currently manufacturing and packaging the AccuTOX^TM final drug product in vials dedicated for the Phase I clinical trial at City of Hope, CA, USA. Final quality validation and stability studies are being processed to meet with FDA high standards requirements. Biopeptek has already successfully completed a 12-month stability study testing AccuTOX^TM active pharmaceutical ingredient (API). Testing included temperature fluctuations, humidity as well as strong light treatments. The conclusion is that AccuTOX^TM is stable at temperatures ranging from 5 to -20C which is standard for a peptide API approved by Regulatory Agency. AccuTOX^TM API meets all manufacturing/stability criteria as a standard peptide API used for clinical trial. Ankündigung • Jun 08
Defence Therapeutics Inc. Begins Testing Its Arm Vaccine Against Pancreatic Cancer Defence Therapeutics Inc. announced that it mandated Transbiotech Biotechnology Research and Transfer Center to initiate testing its cellular anti-cancer ARM vaccine against deadly pancreatic cancer. Using the AccumTM technology, Defence developed a ground-breaking approach to convert the innate suppressive mesenchymal stromal cells (MSCs) into potent antigen presenting cells capable of mounting an effective anti-tumoral response against solid tumors. Defence tested this vaccine using various in vivo animal models including solid T-cell lymphoma and melanoma. The vaccine was consistently effective against these models and cured 80-100% of treated animals, whereby the tumor completely regressed. Based on these impressive data, Defence contracted Transbiotech Biotechnology Research and Transfer Center, to test the potency of its ARM vaccine in animals with pre-established pancreatic tumors. The study will consist of using the lysate of the Pan02 cell line (serving as a source of tumor antigens) mixed with the A1 dimer prior to in vitro pulsing MSCs. The final ARM vaccine will then be administered to allogeneic animals in combination with the anti-PD-1 immune-checkpoint inhibitor. Ankündigung • May 25
Defence Therapeutics Inc. Announces Successful Completion of Pre-Clinical Study Evaluating the Therapeutic Potency of Second-Generation Arm Vaccine Targeting Solid Tumoma Defence Therapeutics Inc. announced the successful completion of a pre-clinical study evaluating the therapeutic potency of a second-generation ARM vaccine targeting solid tumors. The Accum technology holds a promising future with its versatile application in the development of various products. Accum is acting as an endosomal-damaging agent capable of enhancing bio-drug accumulation in target cells. The Accum molecule can be modulated to generate a series of variants exhibiting novel, and sometimes, unexpected pharmacological properties. For instance, the Accum variant A1, when admixed with antigens, can cause protein aggregation and "turn on" various stress responses in mesenchymal stromal cells (MSCs) converting them to potent antigen presenting cells. The Defence team recently engineered a new dimer form of A1, named the A1-2 variant, which when used to stimulate MSCs, cures all treated mice with pre-established lymphoma. These amazing results were obtained with the use of a dose equivalent to only 40% of the initial A1 dose used to generate the ARM vaccine. Defence has recently initiated the dry runs (establishing the manufacturing protocol) required by Health Canada to validate its GMP manufacturing steps required prior to launch its Phase I trial. With these runs expected to be completed this summer, Defence intends to submit its CTA application in third quarter of 2023. Ankündigung • Feb 04
Defence Therapeutics Inc. Manufacturing Its Arm Vaccine in Preparation for Phase I Clinical Trial Against Solid Tumors Defence Therapeutics Inc. announce the start of its ARM vaccine manufacturing in preparation of its Phase I clinical trial targeting patients with solid cancer tumors. Defence is continuously striving to exploit its AccumTM technology in many verticals. Defence demonstrated that AccumTM has the capacity to enhance biomedicine's accumulation in target cells and the AccumTM molecule can be modified and enhanced to behave as an anti-cancer drug, AccuTOXTM. The most recent discovery of the Defence team is that AccumTM can be engineered to reprogram mesenchymal stromal cells, which are naturally immune-suppressive, into antigen-presenting cells capable of mounting potent anti-cancer responses which lead to the ARM vaccine. The roadmap to Phase I: In collaboration with Allucent, Defence is currently preparing its application to Health Canada to initiate its Phase I clinical trial in 2023. Meanwhile, the final pre-clinical studies, supervised by Dr. Rafei, Defence's VP - Research and Development, are currently being conducted to identify the best dosing regimen (cell dose, timing of administration and routing). In parallel, GMP-grade human cells are currently being expanded in a GLP cell processing facility at the Lady Davis Institute cell processing center, Montreal, Canada, to conduct the dry runs required by Health Canada prior to Phase I clinical trial approval. These studies consist of assessing the expansion potential of cells as well as the time required to generate enough cellular doses to treat all enrolled patients. Various quality control studies related to antigen capture, processing and presentation will be validated to ensure reproducibility of the different ARM vaccine batches generated from various unrelated healthy donors. Once the Master and Working cell banks established via these runs, cancer cell lysates obtained from patients will be prepared, characterized and stored accordingly for ARM vaccine pulsing. The completion of the dry runs along with all required quality control steps is to be expected by mid- spring. Defence will then meet with Health Canada to obtain permission for its Phase I clinical trial, with the objective to beginning it in 2023. Once the Phase I clinical trial will be completed, this universal off- the-shelf ARM vaccine could be adapted to accommodate patients with various cancer tumor types. Ankündigung • Feb 02
Defence Therapeutics Inc. Announces Start of Its GLP Studies on A New Intranasal Accutoxtm Formulation Defence Therapeutics Inc. announced the start of its GLP studies on a new intranasal AccuTOXTM formulation. This milestone is crucial to initiate a Phase I trial for this drug in the context of lung cancer. The AccuTOXTM molecule can eradicate cancer cells via different mechanisms including the initiation of immunogenic cells death, endoplasmic reticulum stress and by causing direct damages to DNA. When tested in three different animal models of solid tumors (lymphoma, melanoma and breast), the compound-controlled tumor growth and synergized with different commercially-used immune- checkpoints (anti-PD-1, anti-CTLA4 and anti-CD47). Building upon this success, Defence designed a new non-invasive formulation allowing the drug to be delivered intranasally to reach lung-established tumors. Lung cancer is the deadliest cancer worldwide, accounting for 1.79 million deaths in 2020. For that purpose, a series of maximum tolerated dose (MTD) studies were conducted to identify the best regimen for intranasal AccuTOXTM delivery. These studies showed that AccuTOXTM is well tolerated up to 3 mg/kg (5-6 times lower than the injectable dose) and could be delivered up to 6 times over a period of 2 weeks. The translation of this dosing regimen to mice with lung cancer decreased by over 50% the number of cancer nodules when delivered as a combo with the anti-PD1 immune-checkpoint inhibitor. The next step is now to test the safety and the tolerability of the intranasal Defence's AccuTOXTM formulation in a series of GLP tox studies prior to its therapeutic use on patients in clinical trial. Defence signed a service agreement with Adgyl Life Sciences, a leading Good Laboratory Practice Drug Development and Toxicology Contract Research Organization, to test its intranasal AccuTOXTM formulation using a medical spray device. The studies will be conduct in both rats and dogs. More specifically, Defence intends to: i) assess the eye irritation potential of AccuTOXTM using reconstructed human cornea-like epithelium, ii) evaluate the skin corrosion potential of AccuTOXTM, iii) determine the plasma PK and bioavailability of AccuTOXTM following a single dose intranasal administration in rats and dogs, iv) determine the toxicity potential and kinetics of AccuTOXTM when administered on alternate days for 7 days (Days 1, 3, 5 and 7) as intranasal drops or intranasal spray (using a spray device) in rats and dogs, and finally v) evaluate multiple parameters such as food consumption, body weight, hematological parameters and histopathology in rats and dogs. Ankündigung • Jan 26
Defence Therapeutics Inc. Announces Melanoma Targeted Vaccine A1- Reprogrammed MSC (ARM) Cell Potency Validated Defence Therapeutics Inc. reported the validation of its ARM vaccine candidate in a melanoma model with a cure rate of 60%. Defence used a variant of the Accum to reprogram innate MSCs into antigen presenting cells. This "off-the-shelf" universal vaccine was able to cure animals with pre-established lymphoma, and also the observed therapeutic effects synergised with the use of the anti-PD-1 immune-checkpoint blocker. The vaccinated animals survived, and the great majority rejected the established tumor and remained tumor free for over 3 months. Based on these strong results, Defence continued to accelerate the progress on the vaccine. These recently completed results add another therapeutic validation using the melanoma cancer model. This program was prepared by the same planned protocol for a potential Phase I clinical cancer trial, where the melanoma cell lysate was used to pulse the ARM vaccine prior to vaccination. Defence is currently working to begin the manufacturing of its ARM vaccine in First Quarter of 2023 with the objective to start treating patients in Phase I clinical cancer trial with solid tumors by Q3/Q4 of 2023. Ankündigung • Jan 11
Defence Therapeutics Inc. Announces the Advancement in the Development of its Accum -mRNA Vaccine Program Defence Therapeutics Inc. announced the advancement in the development of its AccumTM -mRNA vaccine program. This R&D program will not only impact the field of cancer immunotherapy, but it can also be directly applied to the development of new vaccines targeting infectious diseases. The mRNA vaccination approach offers tremendous advantages over the use of peptide- or protein- based vaccines. mRNA like any other biomolecule, is extremely sensitive to harsh conditions such as high acidity and enzymatic reactions, which would directly impede their therapeutic potency. In addition, mRNA molecules need to reach the cytoplasm where they can be efficiently translated into full proteins, this is where AccumTM may add stability and potency. Defence is working with a private European company to synthesize mRNA vaccine coupled with its AccumTM. Defence's has now completed the first phase of its AccumTM-mRNA vaccine development by achieving the synthesis and the Quality Control of the amino-modified polyA tail Ova mRNA. Defence is advancing on the second step, which consists of coupling AccumTM variants to amino-modified mRNA as well as testing and analyzing: i) the effect of AccumTM and linkers on mRNA stability, ii) the linker coupling onto amino-modified mRNA, iii) the AccumTM coupling onto linker-amino modified mRNA, and finally iv) the purification and analysis of the AccumTM-linker-amino-modified mRNA. The third and final step of this Accum-mRNA vaccine development, scheduled at the end of January 2023, will be the production of a small vaccine batch to conduct in vivo studies in animals as a head-to- head comparison between AccumTM-linked and "naked" mRNA vaccines for their potential to generate an immune response capable of eradicating and controlling established tumors. Ankündigung • Dec 22
Defence Therapeutics Inc. Completes Pre-Clinical Study Using Its Intranasal Formulation of AccuTOXTM Defence Therapeutics Inc. just completed a pre-clinical study using its intranasal formulation of AccuTOXTM in the context of animals with pre-established lung cancer. The study shows that AccuTOXTM administration as a combination therapy with the immune-checkpoint inhibitor anti-PD1 reduces dramatically the level of lung nodules compared to control non-treated or anti-PD1-treated animals. This 50% reduction of cancer nodules on animals with pre-established lung tumors was achieved in a treatment plan of only 6 administrated doses over 2 weeks with the AccuTOXTM anti-PD1 combination. AccuTOXTM as a pleiotropic anti-cancer treatment. The AccuTOXTM molecule was originally designed to exhibit enhanced anti-tumoral properties compared to the original AccumTM molecule. In fact, the IC50 of AccuTOXTM is 30-fold lower than that of AccumTM clearly demonstrating improved therapeutic potency as shown using a large set of murine and human tumors. This is also exemplified by the enhanced therapeutic potency of the compound when directly injected in solid tumors in combination with various immune-checkpoints (anti-PD-1, anti-CTLA4 and anti-CD47). The sum of these results paved the path to test the compound in another animal model of pre-established lung cancer delivered via the intranasal route. For that purpose, a series of maximum tolerated dose (MTD) studies was conducted to identify the volume, dosage and tolerance of mice to repetitive administration of AccuTOXTM. These studies show that AccuTOXTM is well tolerated up to 3 mg/kg (5-6 times lower than the injectable dose) with a regimen of 6 administrations over 2 weeks. When tested using this schedule on animals with lung tumors, AccuTOXTM decreased by over 50% the number of cancer nodules especially in the group combined with the anti-PD1 immune-checkpoint inhibitor. Ankündigung • Dec 10
Defence Therapeutics Inc. Appoints Kwin Grauer to Its Board of Directors Defence Therapeutics Inc. announced the appointment of Mr. Kwin Grauer to its board of directors, effective immediately. Mr. Kwin Grauer, CPA, CA, has more than 20 years' experience operating, buying and selling small and medium-size businesses. Kwin is a seasoned professional in financing, financial modeling and corporate restructuring. He has over 10 years of active board work to go along with his business experience and Chartered Professional Accountant Designation. He has served as a Board Member of Langara College, where he was Chair of the Finance and Audit Committee for 5 years and Board Chair for 2 years. Kwin currently serves as the Audit Committee Chair for Uniserve Communications Corp. Ankündigung • Dec 07
Defence Positioned to Begin Its Anti-Cancer AccuTOX(TM) Phase I Trial with Successful Completion of GLP Studies Defence Therapeutics Inc. announced the successful completion of all GLP studies related to its anti-cancer AccuTOXTM molecule. The Company is planning to meet with the FDA in the weeks to come to obtain approval for launching its Phase I trial against solid tumors. In the past 16 months, Defence engineered a large library of AccumTM variants exhibiting differential effects on both immune and cancer cells. One of these lead molecules is AccuTOXTM, a small compound capable of effectively killing a large set of murine and human tumors by inducing the production of reactive oxygen species, causing immunogenic cells death as well as triggering direct DNA damage akin to chemotherapeutic agents. Interestingly, AccuTOXTM administration synergises with different immune-checkpoints (anti-PD-1, anti-CTLA4 and anti-CD47) making it a highly mouldable molecule adaptable to a myriad of solid cancer indications. For instance, AccuTOXTM dosed at 16 mg/kg halts the growth of solid T-cell lymphoma, melanoma as well as breast cancer in mice with a survival rate of more than 90%. These results combined to the molecular characterization of AccuTOXTM's mechanism of action clearly highlight the anti-neoplastic potential of this molecule as a next generation treatment for various cancer types.GLP studies in rodents revealed no adverse effects for AccuTOXTM. Building upon the impressive results obtained in different pre-clinical murine cancer models, a set of GLP studies was then conducted in male and female Sprague-Dawley rats to determine the toxicity potential and toxicokinetic profile of AccuTOXTM when administered through the sub-cutaneous route for 14 days (delivered every 48h for a total of 7 repetitive injections). Besides slight erythema/edema at the injection site, no clinical signs of morbidity or mortality were observed in both sexes using a dose as high as 30 mg/kg, which is twice as high as the therapeutic dose used in pre-clinical studies. Animals body weight, food consumption, coagulation and urine parameters were unaffected at all tested doses in both male and female rates. Hematological changes were considered minimal with no noticeable side effects to report. Furthermore, the time to reach peak plasma concentration (Tmax) was 1h in both genders. In conclusion, AccuTOXTM exhibits no adverse effects in rats and is well tolerated even at repetitive dosing of 30 mg/kg. Upon completing the GLP study in rats, Defence followed up with a second set of GLP studies in Beagle dogs. In this case, higher AccuTOXTM doses were used (up to 100 mg/kg, which is 6.2-fold higher than the therapeutic dose used in mice). Although no clinical signs were observed up to 50 mg/kg, a very slight erythema was observed at the injection site following single dosing. Repetitive dosing, on the other hand, revealed very limited erythema and hardness at injection sites, which were considered of minimal impact. No mortalities were observed in male or female dogs up to 100 mg/kg and body weights of all treated animals were consistent despite a small decrease in food consumption. No apparent changes were noticed in the conducted electrocardiograms in both genders nor in their hematological, coagulation and urinalysis parameters. Chronic inflammation was apparent at the injection sites associated with mild leukocyte infiltration. The Tmax for AccuTOX in dogs varied between 0.25 and 1h in both genders, with a detected T1/2 of 0.553h. In sum, AccuTOXTM is safe and well tolerated by Beagles. Ankündigung • Nov 24
Defence Therapeutics Inc.'s Successfull Study on the AccuVAC- PT007 Vaccine Targeting Cervical Cancer Defence Therapeutics Inc. reported the successful completion of its Good Laboratory Practice studies on the AccuVAC-PT007 vaccine candidate specifically designed to target cervical cancer. GLP studies conducted on rodents demonstrate a full spectrum of safety and tolerability with no signs of complications. Cervical cancer normally occurs when epithelial cells of the cervix are infected with the human papillomavirus (HPV), one of the most common sexually transmitted disease. Although HPV infections can resorb, infections escaping the immune system ultimately led to genital warts leading to advanced cancers that are hardly treated with standard of care. Currently, vaccination targeting HPV directly can protect from cervical cancer. However commercially available vaccines (containing a mix of 9 HPV- derived L1 proteins) are not designed to protect from all HPV subtypes and the vaccine on the market cannot be used to treat pre-established cervical cancer. Defence focused on this "gap" by engineering AccuVAC-PT007, a protein-based vaccine containing a single oncoprotein (E7) linked to AccumTM for enhanced antigen presentation by the immune system. This vaccine can not only be used to protect from HPV (prophylactic use), but it is the only experimental vaccine capable of curing established cervical cancer when combined to immune-checkpoint inhibitors. The AccuVac may be a solution. Using the AccumTM platform, Defence developed the AccuVAC-PT007, a protein-based vaccine targeting the E7 oncoprotein of the HPV virus. AccuVAC-PT007 was previously shown to provide complete protection against cervical cancer (prophylactic vaccination) as shown in its press release dated on May 17, 2022. These ground-breaking observations led to the testing of AccuVAC-PT007 as a treatment with pre-established cervical cancer (therapeutic vaccination). Pre-clinical studies conducted on rodents, as reported in its press release dated on June 27, 2022, showed that the co-delivery of AccuVAC-PT007 with several immune-checkpoint blockers (anti-PD-1, anti-CTLA4 or anti-CD47) lead to potent control of tumor growth with a more pronounced effect observed with anti-CD47, one of the latest immune-checkpoint blockers undergoing clinical development. Besides cervical cancer, HPV can cause cancer of the vulva, vagina, penis, or anus. It can also cause cancer in the back of the throat (called oropharyngeal cancer) and can include the base of the tongue and tonsils. In addition, patients with weak immune systems may be unable to fight off a given HPV infection, which brings forward another important ailment with unmet medical needs. This is an opportunity for the AccuVAC-PT007 that Defence has developed. Cervical cancer has a high mortality rate (nearly 50%), which can be reduced by diagnosis and prevention. A report from 360ResearchReports projected that the global Cervical Cancer Treatment market size is expected to expand at a CAGR of 4.8% during the forecast period, reaching USD 11 Billion by 2027. Ankündigung • Nov 18
Defence Therapeutics Inc. announced that it has received CAD 2.355 million in funding On November 16, 2022, Defence Therapeutics Inc. closed the transaction. The debentures bear interest at a rate of 8.0% per annum and mature on November 16, 2024. The debentures bear interest at a rate of 8.0% per annum and mature on November 16, 2024. Each warrant is exercisable to acquire one common share at an exercise price of $2.50 per warrant share on or before November 16, 2024. The company has paid aggregate cash finders' fee of CAD 188,400 and issued 120,000 finders' warrants in the transaction. Board Change • Nov 16
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. CEO, President & Director Sebastien Plouffe is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Ankündigung • Oct 13
Defence Therapeutics Inc. Initiates Lung Cance Treatment Program with Its Novel AccuTOX(TM) Formulation Via Intranasal Defence Therapeutics Inc. reported the start of a pre-clinical program using its novel patent pending technology AccuTOXTM. The novel AccuTOXTM formulation is designed for the treatment of lung cancer including various types of malignancy of the upper or lower respiratory tracks. The AccuTOXTM will be delivered intranasal to effectively deliver the AccuTOXTM into the transmucosal and will target the lungs. Future programs may expand into targeting various malignancy of the upper and lower respiratory. The AccuTOXTM technology is an AccumTM variant developed by Defence Therapeutics to specifically halt tumor growth when administered intratumorally. The use of this compound in combination with various immune-checkpoints results in a substantial cure rate. At the molecular level, AccuTOXTM impairs several crucial cellular pathways exploited by tumors such as: DNA replication, cell division, nuclear integrity, and various modifications affecting the genome. The net outcome culminates in limited cell repair as well as accumulation of misfolded proteins and generation of free radicals capable of eliciting irreversible DNA damage. AccuTOXTM causes the overall cellular equilibrium to collapse consequently resulting in effective diseased cell death. Ankündigung • Oct 07
Defence Therapeutics Inc., Annual General Meeting, Dec 08, 2022 Defence Therapeutics Inc., Annual General Meeting, Dec 08, 2022. Ankündigung • Sep 22
Defence Therapeutics Inc. Reports Defence's Novel Vaccine Candidate Triggers A Potent Anti-Tumoral Response Capable of Curing Animals with Pre-Established Lymphoma Defence Therapeutics Inc. report that Defence's novel vaccine candidate triggers a potent anti-tumoral response capable of curing animals with pre-established lymphoma. Antigen presentation is a crucial step for the initiation of an immune response against a given cancer cell, foreign agent or pathogen. For cancer, this entails priming cytotoxic T lymphocytes (CTLs), a form of a white blood cell educated to attack a specific target on cancer cell surfaces. Defence's objective is to develop a novel therapeutic and an unlimited supply of antigen presenting cells capable of eliciting potent anti-cancer responses while limiting all manufacturing-associated pitfalls. Studies are currently ongoing to re-challenge cured animals with the same tumor as a means to demonstrate long-lasting anti-tumoral memory response. In parallel, Defence is actively working on its CMC protocol to manufacture its A1-MSC "ARM" vaccine in preparation of a Phase I trial in patients with melanoma. Ankündigung • Aug 18
Defence Therapeutics Inc. Reports the Development of A Novel Anti-Cancer Cellular Vaccine by Reprogramming the Unconventional Suppressive Mesenchymal Stromal Cells Defence Therapeutics Inc. report the development of a novel anti-cancer cellular vaccine by reprogramming the unconventional suppressive mesenchymal stromal cells (MSCs) into potent antigen presenting cells (APCs). The immune system is a structured entity working in tandem to activate specific immune cells as a means to seek and destroy "non-self" antigens. With respect to cancer, the immune system relies on dendritic cells (DCs), a subset of potent endogenous APCs, to prime cytotoxic T lymphocytes (CTLs). CTLs can then attack and eliminate virally-infected or cancerous cells. Unfortunately, however, most cancer cells can acquire strategies to escape DC-elicited immunity resulting in the development of deadly tumors. Although several strategies were developed by other companies and tested to correct this anomality, most of them failed due to limitations related to inefficient CTL priming. To overcome this issue, Defence Therapeutics applied a novel strategy, which consists at reprogramming the immune-suppressive MSCs to convert them into potent APCs. This discovery and the application are not only unconventional, but it has the potential to revolutionise the field of modern medicine as it applies as novel therapeutic cancer vaccines and infectious diseases vaccines. This application discovered that it uses a unique cell type to which tumor cells are not programmed to respond. The advantage is substantial as MSCs are logistically easier to produce and manufacture compared to conventional DCs. Defence's technology platform is AccumTM. The variant A1 is a variant molecule within the AccumTM platform. This molecule A1 has the ability to form aggregates when admixed to a given antigen. Dr. Nehme Hachem is a computational biologist and pharmacogenomics expert specialized in analysing large chemo-genomic datasets. Dr. Hachem has stated that A1 converts MSCs into APCs by stimulating endoplasmic reticulum stress caused by the A1-antigen aggregates captured by treated cells. Furthermore, A1 could enhance antigen presenting properties through regulating several genes involved in lipid homeostasis, which has been reported to play a role in inflammation and immune reprogramming. As a result, A1-Reprogrammed MSCs (ARMs) activate a cellular defense mechanism known as the unfolded protein response, which has a single objective: to get rid-off or destroy these toxic protein aggregates via the cellular proteasomal machinery. As such, antigen-pulsed ARMs elicit powerful anti-tumoral CTLs in response to presented peptide fragments. Defence conducted pre-clinical studies in animals which have recently shown that administration of the ARM vaccine along with the immune-checkpoints anti-PD1 results in a synergistic effect leading to 100% survival of animals with pre-established lymphoma. "This is yet another clear successful example of how versatile and efficient the AccumTM technology is. By optimizing specific components of the AccumTM molecule, Defence can expand and design new entities exhibiting novel pharmacological properties that can be used in the development of new products targeting various cancer indications on a personalized medicine approach", says Mr. Plouffe, the CEO of Defence Therapeutics. Defence is currently preparing the manufacturing of the ARM vaccine in a GLP clean room in Canada in preparation of a Phase I trial in patients with melanoma. The objective is to start this clinical trial in Second Quarter of 2023. Ankündigung • Aug 02
Defence Therapeutics Inc. to Report the Discovery of Novel DNA Damaging Function Triggered by One of Its Lead Compounds AccuTOXTM Defence Therapeutics Inc. to report the discovery of a novel DNA damaging function triggered by one of its lead compounds AccuTOXTM, which effectively elicits cell death in cancer cells. Cancer can be generally described as a state of uncontrolled cell proliferation. This is mainly due to losses in the ability of a given cell to activate its own cell death via a specific set of proteins known to sense unusual activities. Although it is difficult to reactivate these specific pathways to elicit cancer cell death, AccuTOXTM can address this. Defence previously reported the discovery of an AccumTM variant, AccuTOXTM, capable of controlling cancer growth when injected directly in tumors. The use of AccuTOXTM in combination with multiple immune-checkpoints results in a survival rate between 60% and 100%, based on the pre-clinical tumor models studies in mice. The mode of action of AccuTOXTM approached is a non-biased transcriptomic application and revealed that the compound impairs several crucial pathways including DNA replication, cell division, nuclear integrity, and multiple modifications affecting DNA activity. The accumulation of exhaustive cell repair mechanisms triggered by AccuTOXTM combined to the build-up of misfolded proteins and generation of free radicals induce irreversible DNA damages leading to a general collapse in several cellular pathways resulting in effective cancer cell death. Ankündigung • Jun 28
Defence Reports Effective Control of Cervical Cancer Growth in Response to Its AccuVAC-PT007 Therapeutic Vaccination Defence Therapeutics Inc. reported potent pre-clinical results on the use of its AccumTM-linked protein vaccine, AccuVAC-PT007, against cervical cancer. Cervical cancer is a type of cancer affecting the cervix. Various strains of the human papillomavirus (HPV), a sexually transmitted infection, play a major role in causing cervical cancer. When exposed to HPV, epithelial cells of the cervix undergo a series of transformation events eventually leading to tumor development. Although the risk of developing cervical cancer can be significantly reduced by performing regular screening tests, receiving anti-HPV vaccines such as Gardasil, Gardasil-9 or Cervarix, remain currently the most effective strategy to prevent from cervical cancer caused by HPV 16 and 18. However, there is currently no cure besides standard of care for patients who develop cervical cancer, and the clinical trials conducted with other companies with both the E6 and E7 oncoproteins (derived from the HPV genome) were highly unsuccessful. Using the AccumTM platform, Defence developed the AccuVAC-PT007, a protein-based vaccine targeting the E7 oncoprotein of the HPV virus. AccuVAC-PT007 was previously shown to provide complete protection against cervical cancer (prophylactic vaccination) as shown in press release dated on May 18, 2022. These ground-breaking observations led to the testing of AccuVAC-PT007 as a treatment with pre-established cervical cancer (therapeutic vaccination). Pre-clinical studies conducted on rodents show that the co-delivery of AccuVAC-PT007 with several immune-checkpoint blockers (anti-PD-1, anti-CTLA4 or anti-CD47) lead to potent control of tumor growth with a more pronounced effect observed with anti-CD47, one of the latest immune-checkpoint blockers undergoing clinical development. Ankündigung • May 19
Defence Therapeutics Inc.'s Novel AccuVAC-PTE7 Vaccine Shows Complete Protection from Cervical Cancer Defence Therapeutics Inc. announced the development of novel dual-acting AccumTM-linked protein vaccine, AccuVAC-PTE7, dedicated to protect from cervical cancer (prophylactic vaccine) or to treat (therapeutic vaccine) patients with pre-established cervical tumors. The protection from cervical cancer can currently only be achieved with the use of Gardasil-9 or Cervarix, two vaccines directed against the L1 proteins of HPV. However, there is currently no cure for patients with established cervical cancer and the clinical trials conducted previously with other companies with both the E6 and E7 proteins were highly disappointing. Pre-clinical studies conducted on this new vaccine, AccuVAC-PTE7, not only provide a 100% protection from cervical cancer if delivered prophylactically (e.g. before tumor growth), but also show potent anti-tumoral effects against established tumors when combined with various immune-checkpoint blockers such as anti-PD-1, anti-CTLA4 or anti-CD47. According to Fortune Business Insights, the global HPV vaccine market size was valued at $3.80 Billion in 2019 & is projected to reach $12.69 Billion by 2027, with a CAGR of 16.3%. Board Change • Apr 27
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. CEO, President & Director Sebastien Plouffe is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Ankündigung • Jan 28
Defence Therapeutics Inc. Announces the Development of AccuVAC-PT009 Defence Therapeutics Inc. announced the development of AccuVAC-PT009, a new protein-based HPV vaccine, leading to a humoral response bypassing Gardasil-9 (Merck) immunogenicity in animals. ACCUMTM is a platform technology 100% owned by Defence Therapeutics. ACCUMTM is an enabling technology as it can be used to enhance the intracellular accumulation of various proteins of pharmacological interests into any target cells. As such, it is currently used by Defence for the development of several anti-cancer and COVID vaccines, as well as for the improvement of approved or in development antibody-drug conjugates. To further demonstrate the ACCUMTM versatility, the Defence research and development team designed and engineered a HPV vaccine (a mix of the same 9 HPV-derived L1 proteins used in Gardasil-9) and compared its immunogenicity to a group of Gardasil-9-immunized animals. Compared to Gardasil-9, AccuVAC-PT009 triggers an impressive 27- and 36-fold increase in antibody titer at 4- and 6-weeks post-immunization respectively. Ankündigung • Jan 12
Defence Therapeutics Inc. Begins Ind-Enabling Testing of its Accutox Lead Compound Against Breast Cancer Defence Therapeutics Inc. (‘Defence’ or the ‘Company’) announced the start of its final step in GLP studies on its lead anti-cancer AccuTOXTM molecule at Eurofins Advinus Limited prior to initiate its Phase I trial in breast cancer patients. Eurofins Advinus Limited is a leading Drug Discovery and Development Contract Research Organization (CRO) with 30 years of experience testing regulated products under Good Laboratory Practice (GLP). With 400 employees, 80 full Preclinical IND packages completed and over 20,000 GLP Toxicology studies with the full range of required toxicology studies, Eurofins Advinus is one of the most experienced Drug Development Contract Research Organisation. Eurofins has been mandated by Defence to complete all final GLP studies required by the FDA and Health Canada on its lead AccuTOXTM molecule. The studies will be conducted on both rats (rodent) and dogs (non-rodents) to identify the maximum tolerated dose in addition to evaluate the pharmacokinetic and toxicology profile of the lead compound. According to Fortune Business Insights, the Global Breast Cancer Therapeutics Market, which stood at USD 17.8 Billion in 2018, will reach USD 38.5 Billion by the end of 2026, which would represent a CAGR of 10.2% between 2018 and 2026. The pre-clinical studies conducted by the Defence team on mice revealed how potent is the AccumTM molecule at inhibiting tumor cell growth both in vitro and in vivo. In addition, AccumTM was shown to elicit additive effects in animals when used in conjunction with immune-checkpoint inhibitors such as CTLA-4 and PD-1, two antibodies currently being used in the oncology clinic to treat cancer patients. Ankündigung • Oct 01
Defence Therapeutics Inc. to Finalize Its Objectives to Initiate A Phase I Trial Against Breast Cancer Defence Therapeutics Inc. announced that it will be conducting a series of final studies to complete all requirement needed to initiate a Phase I trial for one of its leading AccuTOX candidate against breast cancer. The Accum technology platform was initially designed to enhance the accumulation of specific proteins, antibodies (ADCs) or antigen in target cells. Studies conducted by Defence revealed a strong therapeutic function for Accum when delivered on its own. In other words, the delivery of free "naked" Accum (AccuTOX-001) triggered cell death of a variety of cancer cells, including breast cancer, and was well tolerated by animals under the same treatment regiment. The Defence team is currently working to demonstrate that AccuTOX-001 can trigger the death of pre-establish 4T1 breast cancer in immunocompetent mice alone or in combination with anti-PD1. In parallel, the potency of the leading drug will be demonstrated in previously characterized PDX models to ensure a good translation from mice to human studies. Once completed, this data along with the GLP study scheduled in Fourth Quarter of 2021 will be compiled and presented to the FDA to have clearance for a Phase I trial against breast cancer. Defence continues extensive research and development programs with its AccumTM technology platform including the AccuTOX program. Defence has developed a DC cancer vaccine targeting 4 different indications (AccuVAC-D), two ADCs in late-stage pre-clinical development (AccuADC) and various protein-based vaccines against infectious diseases such as COVID and HPV (AccuVAC-PTs and AccuVAC-INs). In line with the Company's strategy for preparing a Nasdaq listing submission in the beginning of second quarter of 2022, Defence Therapeutics has retained Lifewater Media to introduce Defence and its products to the US investment community. The contract with Lifewater Media begins for a 30-day period, starting at $150,000 USD. Lifewater Media are well known professionals in the media industry with more than 40 years of combined experience. Lifewater Media is a pioneer in US marketing strategy and digital marketing. Ankündigung • Sep 09
Defence Therapeutics Inc Announces Development Program to Engineer New HPV Vaccine Initiated Defence Therapeutics Inc. announced the establishment of a high priority program to develop a novel HPV-targeting vaccine for cervical cancer with it's AccumTM technology. Currently there are more than 40 types of HPV strains capable of affecting the genital areas, mouth and throat of both males and females. This makes HPV one of the most common sexually transmitted disease worldwide. Just in the USA, 79 million Americans are currently infected with the virus, and 14 million will roughly become newly infected each year according to the center for disease control. Although most people with HPV never develop symptoms or health problems, HPV infections will persist resulting in life-threatening health issues such as genital warts, cervical, oropharyngeal, anal, vulvar, vaginal and penile cancer. The global Human Papillomavirus (HPV) Vaccine market size was valued at USD 3.8 billion in 2019 and is projected to reach USD 12.69 billion by 2027, exhibiting a CAGR of 16.3% during the forecast period according to Fortune Business Insights. Ankündigung • Aug 19
Defence Therapeutics Selects the Best 8 Accum Variants to Optimize Its ADC Therapeutic Defence Therapeutics Inc. announced that after a detailed and rigorous selection process, very strong and promising results of its bests AccumTM variants has been identified. Defence's has tested 43 AccumTM variants conjugated to T-DM1 with a low conjugation ratio (1- 4 AccumTM per T-DM1) in order to select the best ones to pursue selection of the optimized Accum-T-DM1 conjugate based on in vitro assessments. These studies highlight the additive effect of the AccumTM technology and guide the selection of the optimal Accum-T-DM1 in vivo testing on breast and gastric cancer models. Defence's AccumTM platform has been developed and tested in vitro to enhance the intracellular drug delivery on multiple ADCs that are FDA approved or under development. In that regard, Defence is also pleased to announce the commencement of a new study project to test the AccumTM variants on the recent ADC Enhertu® (fam-trastuzumab-deruxtecan-nxki) owned by AstraZeneca and Daiichi Sankyo. Defence's scientific team believes the AccumTM will increase the routing and delivery of the deruxtecan to the nucleus and consequently will increase more significantly the potency of ADC from which the drug targets the nucleus protein/process compared to T-DM1 targeting microtubule (a cytoplasmic and non-nucleus protein machinery). Deruxtecan is a small toxic drug inhibitor targeting the nuclear protein named topoisomerase I. Ankündigung • Jun 23
Defence Therapeutics Inc. Announces Major Breakthrough Advances in its Pre-Clinical Research Program on its Accutox Molecules as Potent Anti-Cancer Agents Defence Therapeutics Inc. announced major breakthrough advances in its pre-clinical research program on its AccuTOX (free AccumTM or AccumTM variants) molecules as potent anti-cancer agents. The AccumTM technology platform is very efficient at enhancing intracellular delivery of proteins of pharmacological interests such as ADCs or vaccine antigens. Defence's scientific team recently identified a novel function for the use of "free" AccumTM and its recently developed variants as anti-cancer molecules. The Defence team engineered a large library of AccumTM variants (over 50 so far). They are currently being testing for their therapeutic efficacy against breast, colon, melanoma and lymphoma cancers. In addition, a new strategy is currently being developed to engineer an "intelligent" Poly-AccuTOX molecule (a chain of various AccuTOX molecules) capable of selectively killing a wide range of cancer cells without collateral side effects. Ankündigung • Jun 01
Defence Therapeutics Inc. Advances in Preclinical Testing of Its Infectious Disease Vaccine Program Defence Therapeutics Inc. is developing these transformative medicines for catastrophic illnesses and is please to provide an update on its COVID-19 vaccine program with its first lead candidate AccuVAC-PT001 (study initiated in Fourth Quarter of 2020). Defence's ACCUMTM platform opens a new biotherapeutic modality by ensuring effective and distinct protein (antigen) processing by specialised antigen presenting cells (dendritic cells) consequently resulting in enhanced immune responses. This is exemplified by the long-lasting and potent immune response induced with its AccuVAC-PT001 protein-based vaccine candidate against the SARS-CoV-2 Wuhan strain (additional studies targeting other COVID variants are underway). These observations clearly highlight how the ACCUMTM platform can be applied to any infectious disease antigen as a means to dramatically boost its processing by dendritic cells and effectively stimulate immunity. When tested in immunocompetent mice at an academic laboratory, Defence's AccuVAC-PT001 generated a very high antibody titer with a response lasting more than 18 weeks post-vaccination (the research study for publication is in progress with expected release date in fourth quarter of 2021). This is a breakthrough observation for Defence as most humoral responses induced by current vaccination strategies or natural infections start waning exponentially in less than 8 weeks. Additional studies completed at a private clinical research organization further demonstrate active blocking of human cell infection by the virus when subjected to AccuVAC-PT001- induced antibodies. In addition to completing standard toxicology studies to ensure safety of the vaccine, AccuVAC- PT001 is currently being tested on larger non-rodent animals to validate its potency and immunogenicity. The results of this study will determine the progress towards further clinical studies. 