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- Agenus published clinical results showing botensilimab plus balstilimab achieved a 23% overall response rate and 31% clinical benefit rate in heavily pretreated, treatment-refractory ovarian cancer patients. - The combination demonstrated durable responses with a median duration of 9.7 months and median overall survival of 14.8 months in a population historically resistant to immunotherapy. - The study enrolled 44 women with treatment-refractory ovarian cancer, with nearly three-quarters being platinum-resistant or platinum-refractory patients. - The treatment showed a manageable safety profile with most common adverse events being diarrhea/colitis (43%), fatigue and nausea (36%), and no treatment-related deaths reported.
- Agenus and Noetik announced a research collaboration to develop predictive biomarkers for the BOT/BAL immunotherapy combination using AI-powered virtual cell models. - The partnership leverages Noetik's OCTO foundation model, trained on data from nearly 200 million tumor and immune cells across thousands of patients with various cancer types. - The collaboration aims to identify which patients are most likely to respond to botensilimab and balstilimab treatment, potentially improving clinical trial outcomes and patient care. - Botensilimab has been evaluated in over 1,200 patients across nine tumor types and has shown responses even in immunotherapy-resistant "cold" tumors.
- Agenus' botensilimab and balstilimab combination achieved 100% pathological complete response rates in dMMR colorectal cancer patients at higher doses, demonstrating breakthrough activity in microsatellite stable "cold tumors." - New data from the pan-cancer NEOASIS study showed the combination can induce pathological responses across multiple solid tumor types including triple-negative breast cancer and sarcomas, with no dose-limiting toxicities observed. - The company appointed Dr. Richard Goldberg as Chief Development Officer to advance regulatory engagement for the BOT/BAL program while reducing operating cash burn below $50 million annually. - Agenus reported Q1 2025 revenue of $24.1 million with a net loss of $26.4 million, ending the quarter with $18.5 million in cash as it prepares for a near-term capital transaction.
- ImmunoGenesis has dosed the first subject in a Phase I/II trial evaluating IMGS-101 (evofosfamide) in combination with checkpoint inhibitors balstilimab and zalifrelimab at MD Anderson Cancer Center. - The open-label trial targets patients with advanced castration-resistant prostate cancer, HPV-negative head and neck squamous cell carcinoma, and pancreatic cancer—malignancies typically resistant to immunotherapy. - IMGS-101 works as a hypoxia reversal agent that may overcome a key immunosuppressive barrier in tumors, potentially enhancing T-cell infiltration and improving checkpoint inhibitor efficacy in hard-to-treat cancers.
- Agenus will showcase interim data from a Phase 2 study combining BOT/BAL with iNKT cell therapy AgenT-797 in refractory gastric cancer patients at the AACR IO Annual Meeting. - A Trial-in-Progress poster will present findings from an ongoing Phase 1/2 study evaluating BOT/BAL as a first-line treatment for microsatellite stable colorectal cancer. - The presentations highlight Agenus's innovative approach using botensilimab, an Fc-enhanced CTLA-4 inhibitor, designed to extend immunotherapy benefits to traditionally unresponsive "cold" tumors.
- Agenus's botensilimab/balstilimab combination therapy demonstrated strong efficacy in colorectal cancer treatment, achieving a 65% pathologic response rate and 38% complete response rate across all patients. - The NEST clinical studies showed remarkable progression-free survival outcomes, with all patients remaining alive and progression-free at median follow-up periods of 18 months (NEST-1) and 9 months (NEST-2). - While dose-dependent adverse events were observed in NEST-2 compared to NEST-1, the safety profile remained manageable with Grade 3 events limited to colitis, a known side effect of the treatment.
- MiNK Therapeutics' agenT-797, combined with botensilimab and balstilimab, demonstrates robust immune activation in refractory gastroesophageal cancer. - The Phase 2 study reveals increased interferon-gamma levels and enhanced T-cell infiltration, suggesting improved clinical outcomes. - Early administration of agenT-797 alongside checkpoint inhibitors before chemotherapy amplifies immune responses, optimizing T-cell priming. - The off-the-shelf allogeneic iNKT platform offers a scalable and accessible treatment option for patients with hard-to-treat cancers.
- Preliminary phase 2 data shows balstilimab combined with botensilimab yields a higher objective response rate in MSS mCRC patients without liver metastases. - The combination of botensilimab 75 mg Q6W plus balstilimab showed a confirmed ORR of 19% and a disease control rate of 55%. - The median duration of response has not been reached, with 70% of responses ongoing, indicating durable efficacy of the combination therapy. - A phase 3 trial is planned using botensilimab 75 mg with balstilimab 240 mg, based on the favorable safety and efficacy profile observed.
- Japan's MHLW has approved GSK's Arexvy vaccine for adults aged 50-59 at increased risk of RSV, expanding its previous authorization for those 60 and older. - The approval was based on Phase III trial data demonstrating non-inferior immunogenicity in the 50-59 age group compared to the older population. - Arexvy is the first RSV vaccine approved in Japan for this younger age demographic, already authorized in the US and 35 other countries. - This expansion aims to protect a broader population at risk from severe RSV consequences, especially those with underlying medical conditions.
- Agenus executives are being sued for allegedly misleading the public about clinical trial results for a metastatic colorectal cancer treatment. - The lawsuit claims the executives breached their fiduciary duties by touting the combination therapy's prospects despite FDA concerns. - The FDA advised Agenus against submitting trial results for its botensilimab combination, impacting the drug's regulatory pathway.
