New Risk • May 13
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 South Korean 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 Risk Revenue is less than US$1m (₩95m revenue, or US$64k). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (₩56.0b market cap, or US$37.5m). Tillkännagivande • Mar 12
NeoImmuneTech, Inc., Annual General Meeting, Mar 27, 2026 NeoImmuneTech, Inc., Annual General Meeting, Mar 27, 2026, at 10:00 Tokyo Standard Time. Location: conference room, 131, bundangnaegok-ro, bundang-gu, gyeonggi-do, seongnam South Korea New Risk • Dec 09
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of South Korean stocks, typically moving 12% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Revenue is less than US$1m (₩94m revenue, or US$64k). Minor Risk Market cap is less than US$100m (₩78.9b market cap, or US$53.7m). New Risk • Oct 12
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of South Korean stocks, typically moving 10% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings have declined by 3.7% per year over the past 5 years. Revenue is less than US$1m (₩208m revenue, or US$146k). Minor Risk Market cap is less than US$100m (₩75.7b market cap, or US$53.0m). Tillkännagivande • Sep 10
NeoImmuneTech, Inc. has completed a Follow-on Equity Offering in the amount of KRW 42.310948 billion. NeoImmuneTech, Inc. has completed a Follow-on Equity Offering in the amount of KRW 42.310948 billion.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 50,349,277
Price\Range: KRW 721
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 8,334,423
Price\Range: KRW 721
Transaction Features: Rights Offering New Risk • Aug 31
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: -₩35b 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 (-₩35b free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Revenue is less than US$1m (₩208m revenue, or US$150k). Minor Risk Market cap is less than US$100m (₩101.5b market cap, or US$73.2m). New Risk • May 19
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 South Korean stocks, typically moving 8.9% 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 (-₩44b free cash flow). Earnings have declined by 14% per year over the past 5 years. Revenue is less than US$1m (₩170m revenue, or US$123k). Minor Risks Share price has been volatile over the past 3 months (8.9% average weekly change). Market cap is less than US$100m (₩30.2b market cap, or US$21.7m). Tillkännagivande • Mar 18
NeoImmuneTech, Inc., Annual General Meeting, Mar 31, 2025 NeoImmuneTech, Inc., Annual General Meeting, Mar 31, 2025, at 10:00 Tokyo Standard Time. Location: conference room, 253, pangyo-ro, bundang-gu, gyeonggi-do, seongnam South Korea New Risk • Dec 16
New major risk - Financial data availability The company has not reported any financial data. This is considered a major risk. With no or incomplete audited reported financial data, it is virtually impossible to assess the company's investment potential. Currently, the following risks have been identified for the company: Major Risk No financial data reported. Minor Risk Market cap is less than US$100m (₩23.8b market cap, or US$16.5m). New Risk • Nov 28
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: -₩42b 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 (-₩42b free cash flow). Earnings have declined by 16% per year over the past 5 years. Revenue is less than US$1m (₩1.1b revenue, or US$782k). Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (₩24.2b market cap, or US$17.3m). New Risk • Sep 09
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 South Korean stocks, typically moving 10% 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 Earnings have declined by 19% 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 (10% average weekly change). Market cap is less than US$100m (₩34.5b market cap, or US$25.6m). Tillkännagivande • Jun 05
NeoImmuneTech's New Data at ASCO 2024 Highlights Enhanced Benefits of Combining NT-I7 with Checkpoint Inhibitors (CPI) in Immuno-Oncology NeoImmuneTech, Inc. announced promising interim results of its major clinical trial NIT-110 of NT-I7 (efineptakin alfa), at the 2024 American Society of Clinical Oncology (ASCO) global meeting held in Chicago, from May 31 to June 4. The company also presented two additional posters at the conference. NIT-110 is a foundational clinical trial for NT-I7 that aims to confirm the safety and efficacy of combining NT-I7 with pembrolizumab (Keytruda®) in solid tumors. The data presented at ASCO 2024 confirmed that the combination is safe and well-tolerated. Key findings from NIT-110 include: Pancreatic cancer - Data showed a median overall survival (mOS) of 11.1 months among the 48 pancreatic cancer patients included in the study. The mOS for pancreatic cancer patients who have received a second-line standard of care treatment is currently known to be 6.1 months. This mOS improvement is particularly noteworthy considering that 93.75% of the patients are receiving the combination treatment as third-line or beyond. MSS colorectal cancer -The mOS for the 50 microsatellite-stable (MSS) colorectal cancer patients was 13.2 months. The mOS for the current standard of care treatment is 10.8 months. These results underscore the improved efficacy of the NT-I7 and Keytruda combination over existing standard of care treatments. separate poster from trial NIT-110 revealed a correlative analysis identifying a potentially predictive biomarker. These biomarkers may help identify patient populations more likely to benefit clinically from the NT-I7 and Keytruda combination. NeoImmuneTech is committed to further biomarker validation to enhance clinical outcomes. Additionally, a preclinical study presented at ASCO 2024 highlighted the combination of NT-I7 with an oncolytic virus (ZIKV) in a glioblastoma animal model. Results demonstrated a significant increase in tumor specific CD8 T cells in the tumor microenvironment, leading to improved survival rates. Furthermore, 80% of cases in the experimental group combining NT-I7 with immune checkpoint inhibitors resulted in complete tumor eradication. NT-I7 continues to show clinical benefits driven by T cell amplification when combined with immune therapies. NIT-110 is an open label Phase 2a clinical trial supported by Merck that aims to confirm the efficacy of combining NT-I7 with Keytruda in two solid tumors. Early results in 2022 had confirmed the efficacy of the combination in pancreatic cancer and MSS colorectal cancer patients, who are known to be unresponsive to immune checkpoint inhibitors alone. Consequently, 24 and 25 additional patients were recruited for each group, respectively, bringing the total to 48 pancreatic cancer patients and 50 MSS colorectal cancer patients currently undergoing clinical trials. Results presented at ASCO 2024 provide an updated analysis including the original and expansion cohorts. NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. Tillkännagivande • Apr 03
NeoImmuneTech, Inc. Announces Chief Executive Officer Changes NeoImmuneTech, Inc. announced that Luke Oh, Ph.D. has been appointed as Chief Executive Officer (CEO) of the company, effective from March 29, 2024. Having joined the company as President in January 2024, Dr. Oh now succeeds Dr. Se Hwan Yang, Ph.D., as Chief Executive Officer of the company. In his new role, Dr. Oh will lead NeoImmuneTech from its Rockville headquarters and overview all the operations in Korea. Dr. Oh is an expert in regulatory policies and drug development, encompassing both biologics and small molecules. He brings over six years of regulatory experience at the U.S. FDA. His recent tenure at Samsung Bioepis as Vice-President in charge of Regulatory Development was marked by a number of successful preparation and submission of biosimilar applications to regulatory agencies in the US, EU, UK, and Canada. Prior to this position, he has worked as Senior Staff Fellow at the U.S. FDA Division of Clinical Pharmacology III and Division of Inflammation and Immune Pharmacology, and he has held various roles in research and development for leading organizations such as Mallinckrodt Pharmaceuticals, Human Genome Sciences, and Vertex Pharmaceuticals. Dr. Oh has a Ph.D. in Neuroimmunology from the McGill University (Montreal, Canada). New Risk • Jan 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 South Korean stocks, typically moving 8.4% 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 Earnings have declined by 20% 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 (8.4% average weekly change). Market cap is less than US$100m (₩36.1b market cap, or US$27.0m). Tillkännagivande • Jan 15
NeoImmuneTech, Inc. Appoints Luke Oh as President NeoImmuneTech, Inc. announced the appointment of Luke Oh, Ph.D., as President, effective immediately. Dr. Oh is an expert in regulatory policies and drug development, encompassing both biologics and small molecules. He brings over six years of regulatory experience at the U.S. FDA. His recent tenure at Samsung Bioepis as Vice-President in charge of Regulatory Development was marked by the successful preparation and submission of seven biosimilar applications to regulatory agencies in the US, EU, UK, and Canada. Prior to this position, he has worked as Senior Staff Fellow at the U.S. FDA Division of Clinical Pharmacology III and Division of Inflammation and Immune Pharmacology, and he has held various roles in research and development for leading organizations such as Mallinckrodt Pharmaceuticals, Human Genome Sciences, and Vertex Pharmaceuticals. Dr. Oh has a Ph.D. in Neuroimmunology from the McGill University (Montreal, Canada). In his new role, Dr. Oh will spearhead NIT's local team from its Rockville headquarters. His primary focus will be on accelerating the clinical development of NT-I7, NeoImmuneTech's long-acting human IL-7, and strategizing the regulatory path for its potential inaugural approval for the treatment of Acute Radiation Syndrome (ARS). Dr. Oh's commitment to fostering international collaboration is evident from his founding and leadership of the Korean-American Professional Association in Life Sciences (KAPAL), a testament to his belief in the power of cross-cultural collaborations. This experience is particularly relevant as NeoImmuneTech continues to build on its global footprint and seeks to leverage diverse perspectives in advancing biopharmaceutical innovation. Tillkännagivande • Nov 21
Fda Grants Orphan Drug Designation to Neoimmunetech's Nt-I7 for the Treatment of Acute Radiation Syndrome NeoImmuneTech, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for their investigational drug NT-I7 (efineptakin alfa) (rhIL-7-hyFc) for the treatment of Acute Radiation Syndrome (ARS). ARS is an illness that occurs following a high dose of radiation exposure, leading to severe damage to the bone marrow and the immune system. Currently, there are no treatments available that effectively promote T cell recovery after such exposure. NT-I7, a novel long-acting human interleukin-7 (IL-7), is expected to address this unmet medical need, with the potential to rapidly recover and improve the immune response. In the clinical setting, NT-I7 has demonstrated impressive results by effectively and consistently boosting T cell counts, all while maintaining a remarkable level of safety and tolerance. The FDA's ODD for NT-I7 reflects progress in the company's efforts. A contract research organization (CRO) under contract to National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is conducting a study that employs well-developed NIAID ARS rodent models to investigate NT-I7's efficacy as a potential treatment for the serious health implications of ARS. NIAID is supporting this research through product development funding to the CRO. ODD is a status assigned to a medicine intended for use against a rare disease or condition that affects fewer than 200,000 people in the United States. The designation provides incentives to advance the development of treatments for rare diseases, including protection from competition once the drug is on the market, tax credits for clinical research costs, and exemption from prescription drug user fees. New Risk • Aug 09
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 South Korean stocks, typically moving 9.1% 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 Risk Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (9.1% average weekly change). Market cap is less than US$100m (₩45.1b market cap, or US$34.3m). Tillkännagivande • Jul 26
Neoimmunetech, Inc. Appoints Benny J. Chen and Su-Hyung Park to Its Scientific Advisory Board NeoImmuneTech, Inc. announced the addition of two distinguished experts to its Scientific Advisory Board (SAB). The SAB is organized along clear lines of expertise related to NIT's mission: to expand the horizon of immuno-oncology by providing scientific insights into the mechanism of T cell amplification and strategies for novel drug development. NIT believes the SAB will benefit from the valuable insights brought by these newly appointed members. Dr. Benny J. Chen, M.D., is a Professor of Medicine at the Duke University School of Medicine, is a member of the Duke Cancer Institute, Duke Regeneration Center, and Duke Fitzpatrick Institute for Photonics. Board Change • Nov 16
No independent directors There are 7 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 7 new directors. 3 experienced directors. No highly experienced directors. No independent directors (5 non-independent directors). Member of Scientific Advisory Board Rafi Ahmed is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of board continuity. Lack of experienced directors. Tillkännagivande • Nov 12
New Evidence of NeoImmuneTech's NT-I7 Clinical Efficacy in Combination with Pembrolizumab in Relapsed/Refractory (R/R) Gastrointestinal Tumors NeoImmuneTech, Inc. presented new data from its phase 2a clinical study NIT-110, at the Society for Immunotherapy of Cancer (SITC) 2022 annual meeting. Results showed the clinical efficacy of NT-I7 (efineptakin alfa) when combined with pembrolizumab in checkpoint-inhibitor-naïve microsatellite stable colorectal cancer (CPI-naïve MSS-CRC) and pancreatic cancer (CPI-naïve PaC). The oral presentation from Dr. A. Naing (University of Texas MD Anderson Cancer Center) has been focused on the follow-up of two cohorts of patients with relapsed/refractory (r/r) gastrointestinal indications: 25 patients with CPI-naïve MSS-CRC and 25 patients with CPI-naïve PaC. The presentation highlighted results of patients who did not have liver metastasis, which is usually associated with a worse prognosis and is known to be a predictable marker. While historically anti-PD(L) monotherapies have shown no response in these indications, results presented at SITC showed an ORR of 30.8% and a DCR of 69.2% per iRECIST across the groups in patients without liver metastasis (n=13/50). Among the patients without liver metastasis, the probability of survival rate through 60 weeks was 100%, which is significantly higher than in those with liver metastasis. However, in patients with liver metastasis, the combination of NT-I7 plus pembrolizumab also showed clinical benefit. One patient had a partial response with 46% tumor reduction (per iRECIST) even though the patient had 3 liver lesions at baseline. Immunohistochemistry (IHC) staining confirmed that the combination of NT-I7 plus pembrolizumab boosts CD8+ T cell infiltration in patients regardless of liver metastasis. Data also suggested that increased CD8+ T cell infiltration correlates with higher OS and favors a tumor microenvironment that contributes to the overall high DCR observed in these hard-to-treat CPI-resistant indications. NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. Tillkännagivande • Aug 09
NeoImmuneTech, Inc. Appoints New Members to its Scientific Advisory Board NeoImmuneTech, Inc. announced the appointment of new members of its Scientific Advisory Board. Dr. Keith Watson (Owner & Managing Director, KRW BioReg Solutions, UK), Prof. Richard Kim (University of South Florida College of Medicine, US), Associate Prof. Hyunseok Kang (University of California, San Francisco, US), and Associate Prof. Young Kwang Chae (Northwestern University Feinberg School of Medicine, US) are joining Prof. Ahmed Rafi (Emory University School of Medicine, US) on the SAB. Dr. Keith Watson is a quality and regulatory expert who served as a Senior biological quality assessor at the MHRA, UK as well as being a regular participant and contributor to the biologics working party (BWP) and member of various CHMP scientific guideline drafting groups at the EMA. Through his long career spanning manufacturing, development, regulatory affairs and policy within CMDO, CRO and the Biotech industry including Lonza, Parexel, Abbvie and Celltrion, Dr. Watson has developed a deep knowledge and expertise of the regulatory approval processes, more specifically with the EMA in Europe. Dr. Watson has a Ph.D. in biochemistry from the Imperial College of London (UK). Dr. Richard Kim is a Service Chief of Medical Gastrointestinal Oncology and Senior Member in the Gastrointestinal Oncology Department at Moffitt Cancer Center (Florida, US). He is a Professor of Oncology at the University of South Florida College of Medicine. Dr. Kim's clinical and research interests focus on gastrointestinal tumors, in particular hepatobiliary and colon cancer. He is a principal investigator in multiple investigator-initiated and pharmaceutical phase 1, 2, 3 trials using immunotherapy and novel targeted agents. He is the principal investigator of the phase 1-2 study NIT-110 that explores the safety and efficacy of NT-I7 in combination with pembrolizumab in multiple solid tumors. Dr. Hyunseok Kang is Associate Professor of Clinical Medicine at University of California, San Francisco. As a specialist of head and neck cancers, his expertise encompasses conventional chemotherapy, targeted and immunotherapy. In his research, Dr. Kang studies how to improve the efficacy of immune checkpoint inhibitors with combination approaches. He is the principal investigator of the phase 1 study NIT-115 evaluating NT-I7 in head and neck squamous cell carcinomas. Dr. Kang earned his medical degree at Yonsei University College of Medicine in Seoul (Korea). After graduating from the Seoul National University (Korea) as a medical doctor, Dr. Young Kwang Chae pursued his scholarship at the Johns Hopkins University where he passed an MBA and MPH. He is an Associate Professor at the Northwestern University Feinberg School of Medicine (Illinois, US). His clinical and research interests focus on lung cancer. He has led several research projects in Immuno-oncology. Dr. Rafi Ahmed, Ph.D., is Professor of Microbiology and Immunology at Emory University School of Medicine, where he is also the director of the Emory Vaccine Center. His work has uncovered the primary role of the PD-1 inhibitory receptor in the promotion of T cell dysfunction during chronic infection which directly led to the successful use of PD-1 checkpoint blockade therapy in cancer patients. He has been a member of Scientific Advisory Board for the last three years, and he will continue to collaborate with NIT. Tillkännagivande • Jun 15
NeoImmuneTech's NT-I7 Enhances CAR-T Cell Expansion, Persistence and Anti-tumor Activity NeoImmuneTech, Inc. reported that Nature Communications published the results of an in vivo study combining the long-acting human IL-7, NT-I7, with chimeric antigen receptor (CAR) T cells directed against CD19+ B cell lymphoma and acute myeloid leukemia. The study led by Dr. DiPersio and his team at Washington University investigated the impact of NT-I7 on in vivo CAR-T cell expansion and anti-tumor response employing sophisticated models of B cell lymphoma or acute myeloid leukemia and an immune competent syngeneic model of acute promyelocytic leukemia. Utilizing these tools, the group tested whether NT-I7 could expand a less differentiated CAR-T product with improved durability and tumor killing abilities in multiple models of hematological cancer. Over the past 10 years, CAR-T cell therapy has become routinely used to treat patients with refractory hematologic malignancies. Despite progress, long-lived memory responses and long-term in vivo persistence of CAR-T cells have yet to be consistently achieved to prevent tumor cell escape and clinical relapse. In the study reported in Nature Communications, NT-I7 protected CD19-targeting CAR-T cells from cell death, enhancing their viability while promoting their expansion in the presence of CD19+ tumor cells. CAR-T cells expanded in the presence of NT-I7 were less differentiated but with equivalent effector cytokine secreting abilities. Treatment of tumor bearing mice with NT-I7 enhanced in vivo expansion and subsequent anti-tumor effects of CAR-T cells targeting CD19+ B cell lymphoma or CD33+ acute-myeloid leukemia. The combination of NT-I7 and CAR-T cells dramatically extended survival. Impressively, co-treatment of tumor bearing mice with NT-I7 reduced the minimum number of CAR-T cells needed to achieve a survival benefit by imparting increased tumor killing abilities to CAR-T cells on a per cell basis and expanding CAR-T cells in vivo. These studies provide compelling evidence that NT-I7 has the potential to enhance CAR-T therapy for the treatment of hematological diseases by promoting CAR-T anti-tumor activity, expansion and persistence. This study presented in Nature Communications demonstrates the potential for NT-I7 to support impactful clinical use of multiple CAR-T therapies with improved safety and tolerability. Strategic combination of NT-I7 with CD19-targeting CAR-T cells is currently being tested as part of a multi-site clinical trial (NCT05075603) for the treatment of relapsed/refractory large B-cell lymphoma. Tillkännagivande • Jun 07
NeoImmuneTech, Inc.'s Lead Asset NT-I7 (efineptakin alfa) Shows Preliminary Anticancer Activity in Combination with Check-Point Inhibitors NeoImmuneTech, Inc. presented new data from two on-going clinical studies at the American Society of Clinical Oncology Annual Meeting, 3-7 June 2022. The data, presented in poster discussion and poster display sessions, combine its lead asset NT-I7 (efineptakin alfa), a long-acting human IL-7, with check-point inhibitors pembrolizumab and atezolizumab, and showed that anti-cancer and safety results associated with NT-I7 were consistent with previously communicated results. In the phase 2a study NIT-11o, NT-I7 combined with pembrolizumab showed preliminary anticancer activity and a manageable toxicity profile in heavily pretreated patients with immunologically cold microsatellite stable tumors, colorectal cancers (CRC), and pancreatic ductal adenocarcinoma cancers not previously treated with CPIs, as well as in CPI-treated patients with triple negative breast cancers, non-small cell lung cancers, and small-cell lung cancers (SCLC). CPIs are usually ineffective in patients with immunologically cold tumors, such as MSS-CRC or PDAC, and in patients progressing despite prior PD-1/PD-L1 inhibition. ORR for the MSS-CRC cohort was 11.1% with 40.7% DCR; and the PDAC cohort had an ORR of 7.7% with 34.6% DCR. Two patients out of 26 in the PDAC cohort showed significant target lesion reduction (- 100% and -72% respectively). In all cohorts, including CPI-treated and CPI-naïve subjects, NT-I7 plus pembrolizumab led to an increase in change of mean absolute lymphocyte count from baseline. In the phase 1b/2a study NIT-106, the combination of NT-I7 with atezolizumab showed favorable safety and anticancer activity in CPI-relapsed/refractory high-risk skin cancer patients. The recommended phase 2 dose was determined so that phase 2a dose expansion is now enrolling. The combination increased by 30-fold the stem-cell memory T cells (Tscm), which may be associated to better anti-tumor activity. NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. Board Change • Apr 27
No independent directors There are 7 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 7 new directors. 2 experienced directors. No highly experienced directors. No independent directors (5 non-independent directors). Member of Scientific Advisory Board David Lebwohl is the most experienced director on the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of board continuity. Lack of experienced directors. Tillkännagivande • Apr 14
Neoimmunetech Demonstrates Nt-I7’S Broad Combination Potential with Immune Checkpoint Inhibitors and Immunocytokine At Aacr 2022 NeoImmuneTech, Inc. (NIT), presented the broad combination potential of its long-acting IL-7 candidate - NT-I7 (efineptakin alfa) (rhIL-7-hyFc) - at the American Association for Cancer Research (AACR) Annual Meeting taking place in New Orleans, Louisiana, United States, April 8-13 2022. In the two pre-clinical studies presented as posters, NT-I7, a novel long-acting human IL-7, was evaluated in combination with IL-2 (hIL-2/TCB2c), and in combination with anti-TIGIT or anti-VEGF therapies. NT-I7 has demonstrated in previous studies that it can increase the number of memory T cells with prolonged effect, whereas IL-2 activates the effector T cell for a limited period. The results of the pre-clinical study showed that the combination of their different mechanisms of action (MoAs) created a heightened anti-tumor response. Additionally, data from the second pre-clinical study showed that NT-I7, in combination with anti-TIGIT or anti-VEGF, enhanced the anti-tumor responses and this effect was further increased when NT-I7 was combined with anti-TIGIT and anti-PD-1 in triple combination. NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. Tillkännagivande • Feb 08
NeoImmuneTech, Inc. Announces First Patient Dosed in Phase 2 Study of NT-I7 (efineptakin alfa) with PD-L1 Checkpoint Inhibitor in High-Risk Skin Cancers NeoImmuneTech, Inc. announced that the first patient has been dosed in the Phase 2a portion of a study evaluating NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with the PD-L1 targeting drug atezolizumab (Tecentriq®), in patients with advanced high-risk skin cancers including melanoma, merkel cell carcinoma (MCC), and cutaneous squamous cell carcinoma (cSCC). All three of these skin cancers can grow rapidly and have the potential to be fatal if left untreated. While cSCC is considered a more treatable form of skin cancer, it affects millions of patients per year in the U.S. alone and represents up to 50% of all skin cancer cases. Melanoma and MCC are less common forms of skin cancer, but they are notable for spreading rapidly and carrying a high risk for recurrence. Skin cancer is the most common form of cancer in the U.S., accounting for more diagnoses than all other cancers combined. This open-label, multicenter Phase 2a study will evaluate the safety, tolerability and anti-tumor effect of the combination therapy. Roche will supply NeoImmuneTech with atezolizumab for the clinical trial. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. Tillkännagivande • Jan 25
NeoImmuneTech, Inc. Announces the Publication of Preclinical Data Evaluating Lead Asset NT-I7 NeoImmuneTech, Inc. announced the publication of preclinical data evaluating the company’s lead asset NT-I7 (efineptakin alfa), a novel T cell amplifier, in mouse models of glioblastoma (GBM). The data come from a publication titled “Long-acting recombinant human interleukin-7, NT-I7, increases cytotoxic CD8 T cells and enhances survival in mouse glioma models,” in the Clinical Cancer Research journal. The paper waspublished in collaboration with lead author Dr. Jian Li Campian, M.D., Ph.D., of the Mayo Clinic and Principal Investigator of this study, along with additional authors from NeoImmuneTech. These data show that NT-I7, in combination with radiation therapy, significantly prolonged survival in two glioma models dependent on the NT-I7-driven increase of CD8 T cells. This study utilized a murine model of glioblastoma, in which one dose of NT-I7 significantly boosted lymphocyte levels in the blood, lymphoid organs and tumor and enhanced the anti-tumor response in animal. When NT-I7 was combined with radiation therapy, this translated to a significant improvement in mouse survival; the addition of temozolomide (TMZ) offered no additional survival improvement. In addition, data showed that NT-I7promoted an inflamed tumor microenvironment by significantly increasing the CD8 to Treg ratio, and enhanced the anti-tumor response by increasing the infiltration of IFN?-expressing T cells in the tumor. While chemoradiation caused a notable decrease in the number of CD4 and CD8 T cells in the lymph nodes, the addition of NT-I7 not only restored these numbers but in some cases surpassed the levels seen in untreated controls. NT-I7 is currently under evaluation for the treatment of glioblastoma in an ongoing Phase 1/2 trial (NCT03687957). Tillkännagivande • Nov 27
NeoImmuneTech, Inc. announced that it has received $4.7 million in funding from Hefei SPARK Venture Capital Management Co., Ltd., Kindstar Global (Beijing) Technology, Inc. NeoImmuneTech, Inc. (KOSDAQ:A950220) announced that it has received $4,700,000 in funding led by Kindstar Global (Beijing) Technology, Inc. on November 25, 2021. The transaction included participation from Hefei SPARK Venture Capital Management Co., Ltd. Tillkännagivande • Nov 24
NeoImmuneTech, Inc. Presents Phase 1 Study Data at Society for Neuro-Oncology Annual Meeting NeoImmuneTech, Inc. presented data from Phase 1 of an ongoing study at the Society for Neuro-Oncology (SNO) annual meeting. The data show that NT-I7, a novel long-acting human IL-7, was well tolerated following chemoradiation in patients with high-grade gliomas (HGG), supporting continued evaluation in the Phase 2 portion of the study. The data were presented as an oral presentaion, titled “A phase I/II study evaluating the safety and efficacy of a novel long-acting interleukin-7, NT-I7, for patients with newly diagnosed high-grade gliomas after chemoradiotherapy,” by lead author Jian Li Campian, M.D., Ph.D., of Mayo Clinic. The data show that NT-I7’s maximum tolerated dose in this cohort was 720 µg/kg. Despite the concomitant administration of chemotherapy (temozolomide, TMZ), the absolute lymphocyte count (ALC) persistently increased 1.3–4.1 fold at week 4 after NT-I7 injection, suggesting that NT-I7 as a single agent could be an effective approach to counteract the treatment-related lymphopenia associated with shorter survival that is commonly observed in HGG patients after chemoradiation. The median progression-free survival for MGMTp unmethylated GBM was 11.6 months, compared to 5.3 months commonly reported in chemoradiation studies. Strikingly, NT-I7 single agent preferentially expanded memory stem T cells (Tscm), a self-renewing T cell subset that has shown better antitumor activity compared with other memory T cell subsets. Thus, although further studies are necessary to determine the clinical benefit, NT-I7 as a single agent added to neoadjuvant chemotherapy has shown encouraging efficacy signals in this aggressive indication. NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. Tillkännagivande • Sep 14
Neoimmunetech to Present At Society for Neuro-Oncology NeoImmuneTech, Inc. announced that new data from a Phase 1/2 study evaluating the company’s lead asset NT-I7 (efineptakin alfa) will be presented during oral abstract sessions at the Society for Neuro-Oncology
(SNO) annual meeting, to be held in Boston, Massachusetts on November 18-21, 2021. The study evaluates the safety and efficacy of NT-I7, a novel long-acting human IL-7, given concurrently with adjuvant chemotherapy in patients with high-grade gliomas. A phase I/II study evaluating the safety and efficacy of a novel long-acting interleukin-7, NT-I7, for patients with newly diagnosed high-grade gliomas after chemoradiotherapy. NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. Tillkännagivande • Jul 28
NeoImmuneTech Receives U.S. FDA IND Clearance for Phase 1 Study of NT-I7 (efineptakin alfa) for the Treatment of Kaposi Sarcoma in Patients With or Without HIV Infection NeoImmuneTech, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase 1 study evaluating the company’s lead asset, NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), for the treatment of Kaposi Sarcoma in patients with or without infection with HIV. This investigator-initiated trial will be conducted by the Cancer Immunotherapy Trials Network (CITN), a program funded by the National Cancer Institute, part of the National Institutes of Health, that is managed by Fred Hutchinson Cancer Research Center in its role as the CITN Central Operations and Statistical Center. Kaposi Sarcoma (KS) is an angioproliferative tumor associated with infection by Kaposi sarcoma-associated herpes virus (KSHV). The identification of a viral etiology of KS helped explain the long-observed association between KS and immunosuppression, specifically CD4+ T cell lymphopenia, commonly seen with HIV infection. IL-7 plays an important role in T cell development and proliferation. In chronic uncontrolled HIV infection, physiologic doses of IL-7 are unable to prevent CD4+ lymphopenia. Furthermore, lymphopenia-inducing insults that may occur in the treatment of KS with anti-neoplastic or radiation treatment could result in a prolonged CD4+ T cell depletion. HIV-related KS accounts for greater than 80% of KS in the United States and increases the risk of death by at least two-fold in these patients. Tillkännagivande • Jun 09
NeoImmuneTech, Inc. Announces First Clinical Trial Application Authorization Received in the EU for its Phase 2 Study of NT-I7 (efineptakin alfa) and Opdivo® (nivolumab) NeoImmuneTech, Inc. announced the first Clinical Trial Application (CTA) authorization in the European Union (EU). This authorization comes from Italy’s Agenzia Italiana Del Farmaco (AIFA) for the company’s ongoing Phase 2 study of NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with Bristol-Myers Squibb Company’s Opdivo® (nivolumab), a PD-1 blocking antibody, versus nivolumab monotherapy. This ongoing Phase 2, randomized, proof-of-principle study is to evaluate preliminary anti-tumor activity of NT-I7 and nivolumab, compared with nivolumab alone, in patients with previously treated advanced or metastatic gastric or gastro-esophageal junction (GEJ) cancer, or esophageal adenocarcinoma, and to assess safety and tolerability of the combination in these patients. AIFA’s CTA authorization is for the phase 2 part of the study, upon successful completion of the dose escalation phase. The results of this study will be used to further clinical development of this combination in selected clinical settings and tumor types. Tillkännagivande • May 25
NeoImmuneTech, Inc. Announces First Patient Dosed in the Pilot Study of NT-I7 (efineptakin alfa) in Progressive Multifocal Leukoencephalopathy NeoImmuneTech, Inc. announced that the first patient has been dosed in the pilot study evaluating NT-I7 (efineptakin alfa), a novel long-acting human IL-7, in progressive multifocal leukoencephalopathy (PML), a rare but very aggressive, opportunistic brain infection. PML is caused by the reactivation of John Cunningham virus (JCV) in immunocompromised individuals, and there are currently no approved therapies for this illness. This investigator-initiated study is being led by Irene Cortese, M.D., of the National Institute of Neurological Disorders and Stroke (NINDS)/National Institute of Health (NIH). PML is characterized by progressive damage of the white matter of the brain at multiple locations resulting from lytic infection of glia cells, leading to permanent damage of the affected nervous system, and in some cases can be fatal. Common conditions predisposing PML are hematologic and solid malignancies, rheumatologic disorders, primary immune deficiencies, and HIV infection. The primary outcome measure of this pilot study is longitudinal change in absolute lymphocyte count following NT-I7 administration. More information can be found at www.neoimmunetech.com or www.clinicaltrials.gov, identifier: NCT04781309. NT-I7: NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications. 