Clinical Trials
46
13 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
13
28.3%
Available
2
4.3%
Completed
15
32.6%
Recruiting
6
13.0%
Terminated
7
15.2%
Withdrawn
3
6.5%
No approval data available
- Agenus announced an oversubscribed private placement of up to $340 million, with $85 million upfront and up to $255 million upon full warrant exercise, to fund the registrational Phase 3 ROBBIN trial. - The ROBBIN trial will evaluate neoadjuvant botensilimab plus balstilimab (BOT+BAL) in high-risk Stage II/III microsatellite-stable (MSS) colon cancer, a population with no new curative-intent therapies approved in over 20 years. - Phase 2 data from NEST and UNICORN trials showed pathologic complete response rates of approximately 30% and major pathologic response rates of 35-40%, with all treated patients remaining disease free at median follow-up of 9 to 18 months. - Agenus is discontinuing financial support for the BATTMAN Phase 3 trial in late-line metastatic MSS colorectal cancer to focus resources on the neoadjuvant opportunity.
- The checkpoint inhibitor refractory cancer market is expected to grow significantly by 2036, driven by rising resistance to immune checkpoint inhibitors and demand for next-generation therapies. - Approximately 40–60% of patients with melanoma, NSCLC, renal cell carcinoma, urothelial carcinoma, and head and neck cancers experience primary resistance to PD-1/PD-L1 inhibitor therapy. - Promising investigational therapies include Sitravatinib + Nivolumab, TAVO + Pembrolizumab, Botensilimab + Balstilimab, and ICT01, which aim to overcome resistance and restore antitumor immunity. - The United States accounted for the largest checkpoint inhibitor refractory cancer treatment market size in the 7MM in 2025.
- 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.
- France's National Agency for Medicines and Health Products Safety (ANSM) has approved compassionate access for Agenus' botensilimab plus balstilimab combination in patients with refractory microsatellite-stable metastatic colorectal cancer. - The treatment is fully reimbursed by France's Assurance Maladie for eligible patients meeting specific criteria, including MSS status and no active liver metastases. - Clinical data from Phase 1b trials demonstrate a 20% objective response rate and median overall survival of 20.9 months in heavily pretreated MSS colorectal cancer patients. - The global Phase 3 BATTMAN trial is set to launch in November 2025, enrolling 834 patients to evaluate the combination against best supportive care.
- 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.
