Duyuru • Oct 08
Defence Therapeutics Inc., Annual General Meeting, Dec 10, 2025 Defence Therapeutics Inc., Annual General Meeting, Dec 10, 2025. Location: quebec, montreal Canada Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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 Duyuru • 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 Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • Oct 07
Defence Therapeutics Inc., Annual General Meeting, Dec 07, 2023 Defence Therapeutics Inc., Annual General Meeting, Dec 07, 2023. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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.