Core Insights - IMUNON, Inc. announced promising Overall Survival data from the Phase 2 OVATION 2 Study of IMNN-001 for treating newly diagnosed advanced ovarian cancer, which will be presented at the 2025 ASCO Annual Meeting [1][3] - The company has aligned with the FDA on the Phase 3 OVATION 3 clinical trial protocol for IMNN-001 and has begun activating trial sites [1][3] Company Overview - IMUNON is a clinical-stage biotechnology company focused on developing innovative treatments using its proprietary TheraPlas technology platform, which enables gene-based delivery of cytokines for cancer treatment [9][10] - The lead clinical program, IMNN-001, is a DNA-based immunotherapy designed to produce interleukin-12 and interferon gamma at the tumor site, targeting advanced ovarian cancer [10] Study Details - The OVATION 2 Study evaluated the safety and efficacy of intraperitoneal IMNN-001 combined with neoadjuvant chemotherapy in patients with advanced epithelial ovarian cancer, enrolling 112 patients [5][6] - The study was not powered for statistical significance but included endpoints such as objective response rate and surgical response [6] Treatment Context - Epithelial ovarian cancer is a significant health concern, with approximately 20,000 new cases annually in the U.S., and about 70% diagnosed at advanced stages [8] - The five-year survival rates for patients with Stage III/IV ovarian cancer are low, highlighting the need for innovative therapies that improve overall survival and reduce recurrence rates [8]

Industry Overview - The cancer market is experiencing significant growth due to rising demand for targeted and less toxic cancer medicines, with new cancer cases in the U.S. expected to exceed 2 million for the first time in 2024, leading to increased global spending on cancer treatments [1][3] - Innovative cancer treatments such as immunotherapy, targeted therapies, and personalized vaccines are emerging, utilizing the body's immune system and focusing on specific genetic mutations to provide more effective and less harmful alternatives to traditional chemotherapy [2][3] Company Developments - Major pharmaceutical companies like Novartis, AstraZeneca, Pfizer, AbbVie, and Eli Lilly are actively developing new cancer therapies, including antibody-drug conjugates and immune-oncology agents, while smaller biotech firms are also making significant advancements [4] - Verastem Oncology is seeking FDA approval for its combination regimen of avutometinib and defactinib for treating KRAS mutant recurrent low-grade serous ovarian cancer, with a decision expected by June 30, 2025 [6][7] - Relay Therapeutics has reported positive interim data for its RLY-2608 breast cancer program, leading to plans for a pivotal study in mid-2025 [9][10] - Pyxis Oncology is focused on developing next-generation therapeutics, with its lead candidate showing significant tumor regression in patients with recurrent and metastatic head and neck squamous cell carcinoma, and has received Fast Track Designation from the FDA [12][13][14]

Update on American Association for Cancer Research Annual Meeting 2025 presentation PRINCETON, N.J., April 16, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that preclinical immune response data with a novel Infectimune based flu vaccine will be featured in a symposium on universal influenza vaccines at the American Association ...

Median overall survival of 17.3 months in Bria-IMT™ treated patients with hormone receptor positive (HR+) metastatic breast cancer markedly exceeds historical data of 14.4 months in TRODELVY® (sacituzumab govitecan-hziy) in similar heavily pre-treated patientsSurvival data in triple negative breast cancer patients treated with the BriaCell regimen was comparable to TRODELVY® No Bria-IMT related discontinuations reported to date PHILADELPHIA and VANCOUVER, British Columbia, April 16, 2025 (GLOBE NEWSWIRE) -- ...

Core Viewpoint - BriaCell Therapeutics Corp. and its subsidiary BriaPro are advancing the development of novel high-affinity antibodies targeting B7-H3, a significant player in cancer progression, with plans for patent applications and multiple cancer indications [1][2][8]. Group 1: Company Overview - BriaCell is a clinical-stage biotechnology company focused on developing innovative immunotherapies to transform cancer care [5]. - BriaPro is a pre-clinical stage immunotherapy company aiming to enhance the body's cancer-fighting capabilities [6]. Group 2: Technology Development - BriaPro is utilizing molecular modeling techniques to develop anti-B7-H3 antibodies, which are expected to be incorporated into the Bria-TILsRx™ platform designed to activate T cells in the tumor microenvironment [2][8]. - The B7-H3 target is overexpressed in various solid tumors, including prostate, lung, breast, pancreatic, and ovarian cancers, while showing limited expression in normal tissues, making it an ideal target for selective activation of tumor infiltrating lymphocytes [3][8]. Group 3: Market Potential - Antibodies targeting B7-H3 are in high demand among pharmaceutical and biotechnology companies, indicating a strong market interest [5]. - The development of anti-B7-H3 antibodies is expected to synergize with BriaCell's existing cell-based immuno-oncology platform, which includes novel cell-based immunotherapy approaches [5].

Core Viewpoint - OS Therapies has announced positive data for its treatment OST-HER2 in dogs with unresected osteosarcoma, indicating potential for use as a frontline therapy in humans, aiming to prevent or delay limb amputation and reduce the need for chemotherapy [2][4][8] Group 1: Treatment Efficacy - OST-HER2 combined with palliative radiation showed clinical and radiographic arrest of primary tumors in dogs, leading to prolonged time to metastasis without surgery or chemotherapy [2][4] - The treatment demonstrated a significant improvement in overall survival, with 5 out of 15 dogs surviving over 500 days [6] - Positive data published in "Molecular Therapy" correlates immune responses to OST-HER2 with prevention of metastasis and long-term survival benefits [3][6] Group 2: Safety and Tolerability - Treatment with OST-HER2 was found to be safe and well tolerated in both studies conducted [4][6] Group 3: Future Plans and Approvals - The company plans to submit data to the USDA for conditional approval of the new manufacturing process for OST-HER2, aiming for sales to begin in 2025 [7] - A pivotal clinical study is planned to gain full approval by 2026 [7] - The company is focused on obtaining Accelerated Approval for OST-HER2 in recurrent, fully resected, lung metastatic human osteosarcoma by the end of 2025 [8] Group 4: Company Background - OS Therapies is a clinical-stage oncology company specializing in treatments for osteosarcoma and other solid tumors, with OST-HER2 as its lead asset [9] - The company has received various designations from the FDA, including Rare Pediatric Disease Designation and Fast-Track status [9] - OST-HER2 has shown statistically significant benefits in previous clinical trials for lung metastatic osteosarcoma [9]

Core Insights - Tevogen Bio Holdings Inc. is focused on immunotherapy and artificial intelligence, with recent presentations highlighting its AI-driven technology for T cell therapies [1][3] - The company aims to develop off-the-shelf, genetically unmodified precision T cell therapies to address significant unmet medical needs in infectious diseases and cancers [4][5] Company Overview - Tevogen Bio is a clinical-stage specialty immunotherapy company utilizing CD8+ cytotoxic T lymphocytes for therapeutic development [4] - The company has reported positive safety data from its proof-of-concept clinical trial and owns key intellectual property assets, including three granted patents and multiple pending patents related to artificial intelligence [4] Recent Events - Mittul Mehta, the Chief Information Officer, presented at the AI x Bio Philly event, discussing Tevogen.AI's proprietary technology that accelerates the discovery and development of precision T cell therapies [1][3][2] - The event gathered innovators and investors to explore the impact of AI on biotechnology, showcasing the convergence of these fields [2]

TAMPA, Fla., April 8, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that an abstract highlighting Kineta Inc.'s novel KVA12123 antibody and an abstract from Moffitt Cancer Center scientists examining the mechanisms of Company's IFx-Hu2.0 therapy in advanced melanoma have been selected for poster presentation at the American Association for Cancer Research ...

Core Insights - TuHURA Biosciences, Inc. has appointed Dr. Bertrand Le Bourdonnec as Executive Vice President, Head of Drug Discovery, Early Development, and Program Management, bringing extensive experience in drug discovery and development [1][3][4] Company Overview - TuHURA is a Phase 3 registration-stage immuno-oncology company focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing a significant challenge in cancer treatment [6][8] - The company is preparing to initiate a Phase 3 trial for its lead candidate, IFx-2.0, as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [7] Leadership and Expertise - Dr. Le Bourdonnec has a proven track record in leading R&D programs across various therapeutic areas, including oncology and pain management, and is an expert in the biochemistry and pharmacology of the Delta Opioid Receptor (DOR) [2][4] - His previous roles include Chief Scientific Officer at HDAX Therapeutics and VP at Deciphera Pharmaceuticals, where he managed significant teams and contributed to the development of novel therapeutics [4][5] Technology and Innovation - TuHURA is leveraging its DOR technology to develop first-in-class bi-specific Antibody Drug Conjugates (ADCs) and Antibody Peptide Conjugates (APCs) targeting Myeloid Derived Suppressor Cells (MDSCs) to enhance the immune response in the tumor microenvironment [8] - The company aims to address unmet medical needs and transform treatment paradigms for cancer patients through innovative drug development [4][6]

Core Insights - The SB221 study demonstrates positive safety results for SON-1010 in combination with atezolizumab for patients with platinum-resistant ovarian cancer (PROC) [1][5] - The maximum tolerated dose (MTD) of SON-1010 was established at 1200 ng/kg without dose-limiting toxicity or cytokine release syndrome [1][3] - The study showed a partial response (PR) in one patient and stable disease (SD) in 33% of evaluable patients at four months [1][5] Study Design and Results - The SB221 study aimed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 with atezolizumab, focusing on establishing the MTD [2][8] - A total of 19 subjects were treated, with one patient achieving a PR at the highest dose [2] - Common adverse effects included fatigue, fevers, and gastrointestinal symptoms, with no significant toxicity observed [3][5] Clinical Implications - The results indicate that SON-1010 may enhance the efficacy of immune checkpoint inhibitors (ICIs) in treating 'cold' tumors like ovarian cancer [4][5] - The study's findings are encouraging given the historical safety concerns associated with rhIL-12, suggesting a potential for improved tumor control [5][6] - The ongoing trial will assess longer-term safety and tumor responses, with a focus on expanding the dataset for efficacy evaluation [6][8] Company Overview - Sonnet BioTherapeutics is focused on developing targeted biologic drugs using its Fully Human Albumin-Binding (FHAB) platform [10][11] - SON-1010 is designed to deliver IL-12 to tumor tissues, potentially improving the safety and efficacy profile of immunomodulators [7][10] - The company is also exploring partnerships to support the later stages of SON-1010's development [6][11]