This section highlights FDA-related milestones and regulatory updates for drugs developed by Agenus (AGEN).
Over the past two years, Agenus has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AgenT-797, BOT/BAL, Botensilimab, and Botensilimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AgenT-797 FDA Regulatory Timeline and Events
AgenT-797 is a drug developed by Agenus for the following indication: Multiple myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AgenT-797
- Announced Date:
- May 12, 2026
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc. announced data being presented at the American Society of Gene and Cell Therapy Annual Meeting (ASGCT 2026) in Boston, Massachusetts.
AI Summary
MiNK Therapeutics said it will present new data at the American Society of Gene and Cell Therapy Annual Meeting in Boston. The poster, scheduled for May 14, 2026, shows that its agenT-797 cell therapy can trigger different immune responses depending on the disease being treated. In 34 patients with solid tumors, the treatment activated a TH1 pro-inflammatory response, which is linked to stronger cancer-fighting activity. In 20 patients with ARDS, the same product led to a TH2 anti-inflammatory response, which may help calm harmful immune activity.
The company said the results were seen across multiple manufacturing batches and donors, suggesting the platform works consistently at scale. MiNK said this supports its goal of using allogeneic invariant natural killer T cell therapies to restore immune balance and produce lasting immune effects in serious diseases.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- April 17, 2026
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, announced data from an investigator-initiated Phase II trial at Memorial Sloan Kettering Cancer Center, evaluating agenT-797, MiNK's allo-iNKT cell therapy, in combination with botensilimab (BOT) and balstilimab (BAL), ramucirumab and paclitaxel in patients with advanced PD-1 refractory gastroesophageal adenocarcinoma.
AI Summary
MiNK Therapeutics reported results from an investigator-initiated Phase II trial (n=17) at Memorial Sloan Kettering Cancer Center testing agenT-797, an allogeneic iNKT cell therapy, given with botensilimab and balstilimab plus ramucirumab and paclitaxel in patients with advanced, PD‑1–refractory gastroesophageal adenocarcinoma.
Correlative analyses indicated the combination drove significant intratumoral T cell and dendritic cell infiltration and, in one patient with prolonged benefit, the formation of organized tertiary lymphoid structures in on‑treatment biopsies. Peripheral immune activation was also seen, with increased CD4 and CD8 T cell activity. These findings suggest the regimen can stimulate local and systemic anti‑tumor immune responses.
The safety profile matched expectations for the component agents. Common treatment‑emergent adverse events included fatigue, fever, diarrhea, anorexia, nausea and mucositis. Immune‑related events reported included dermatitis, colitis, gastritis, enteritis, hepatitis and hypothyroidism. Further analysis of the full biospecimen set is ongoing to clarify mechanisms, optimal sequencing and biomarkers to identify likely responders.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- April 3, 2026
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, announced that data from an investigator-initiated Phase II trial at Memorial Sloan Kettering Cancer Center, evaluating agent-797, MiNK's allo-iNKT cell therapy, in combination with botensilimab (BOT) and balstilimab (BAL), will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego, CA.
AI Summary
MiNK Therapeutics said data from an investigator‑initiated Phase II trial at Memorial Sloan Kettering Cancer Center, evaluating agenT‑797, MiNK’s allo‑iNKT cell therapy in combination with botensilimab (BOT) and balstilimab (BAL), will be presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, April 17–22, 2026. The study tests this multi‑mechanistic immunotherapy in patients with PD‑1‑refractory gastroesophageal cancer (GEC), an area of high unmet need where checkpoint inhibitors have failed.
MiNK expects the results to shed light on immune modulation, treatment sequencing, and the durability of response when re‑engaging immunity after prior checkpoint therapy. Jennifer Buell, Ph.D., MiNK’s President and CEO, said the trial is one of the first to combine an iNKT cell therapy with dual checkpoint modulation in GEC.
Presentation details: Abstract titled “A phase II study of agenT‑797, botensilimab (BOT) and balstilimab (BAL) in PD‑1 refractory gastroesophageal cancer (GEC),” presenter Samuel L. Cytyrn, MD; Session “Phase II and Phase III Clinical Trials”; April 20, 2026, 2:00–5:00 PM PT (5:00–8:00 PM EDT); Poster Section 52; Abstract No. CT166.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- January 8, 2026
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc announced the upcoming initiation of a Phase 1, investigator-sponsored clinical trial evaluating its lead therapy, agenT-797, in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
AI Summary
MiNK Therapeutics announced the upcoming start of a Phase 1 investigator‑sponsored trial testing agenT‑797 in patients receiving allogeneic hematopoietic stem cell transplantation (allo‑HSCT). The study, led by Hongtao Liu, MD, PhD, with co‑investigator Kalyan V. G. Nadiminti at the University of Wisconsin, will assess safety, tolerability, and early signs of benefit in reducing graft‑versus‑host disease (GvHD), relapse, and other post‑transplant complications in people with high‑risk leukemias and blood cancers.
AgenT‑797 is an off‑the‑shelf, donor‑derived invariant natural killer T (iNKT) cell therapy designed to be HLA‑independent and used without lymphodepleting conditioning. iNKT cells may suppress harmful allo‑immune inflammation while preserving anti‑leukemia activity and helping immune recovery, offering a potential way to lower GvHD and relapse risk after transplant.
The trial is funded by two non‑dilutive awards: an NIAID STTR grant supporting preclinical development with UW–Madison and the Mary Gooze Clinical Trial and Translation Award funding enrollment, immune monitoring, and trial operations, enabling parallel translational and clinical research.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- October 30, 2025
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc announced that late-breaking data demonstrating durable clinical activity of AgenT-797, allo-INKTs, in advanced solid tumors will be presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 7–9, 2025, in National Harbor, Maryland..
AI Summary
MiNK Therapeutics announced that late-breaking data on AgenT-797, its off-the-shelf allogeneic invariant natural killer T (iNKT) cell therapy, will be presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Maryland, November 7–9, 2025. The data highlight durable clinical activity and safety in patients with advanced solid tumors from the ongoing Phase 1 study.
The presentation, titled “AgenT-797, an Allogeneic iNKT Cell Therapy, Demonstrates Durable Clinical Activity in Solid Tumors: Updated Phase 1 Findings” (Abstract #1344), will be delivered by Dr. Benjamin Garmezy. Attendees can view the poster on Saturday, November 8, from 12:15–1:45 p.m. ET and 5:10–6:35 p.m. ET in the Prince George ABC Exhibit Halls at the Gaylord National Resort & Convention Center.
AgenT-797 is designed to reprogram the immune system and overcome resistance to standard immunotherapies. These updated findings will inform the therapy’s potential to offer durable responses in hard-to-treat solid tumors.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- July 15, 2025
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc. announced the publication of a peer-reviewed article titled "CAR-iNKT Cells: Redefining the Frontiers of Cellular Immunotherapy" in Frontiers in Immunology.
AI Summary
MiNK Therapeutics, Inc. announced the publication of a peer-reviewed article titled "CAR-iNKT Cells: Redefining the Frontiers of Cellular Immunotherapy" in Frontiers in Immunology. The article focuses on the innovative use of allogeneic invariant natural killer T (iNKT) cells, showing how they can overcome challenges seen with traditional cell therapies for solid tumors. Researchers explain that when iNKT cells are engineered with chimeric antigen receptors (CARs), they offer dual targeting—leveraging both the natural invariant T-cell receptor and the added CAR mechanism. This dual action not only directly kills tumor cells but also helps remodel the tumor microenvironment, which is crucial for overcoming fibrotic barriers. The study highlights MiNK’s unique approach with therapies like MiNK-215, an IL-15–armored, FAP-targeting CAR-iNKT treatment, demonstrating the potential of these cells to provide potent and durable responses without the need for complex conditioning processes.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- July 11, 2025
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc. announced the publication of another landmark case in Nature's Oncogene describing a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer, following treatment with agenT-797, MiNK's allogeneic iNKT cell therapy.
AI Summary
MiNK Therapeutics, Inc. recently announced a major breakthrough in the treatment of metastatic, treatment-refractory testicular cancer. The company published a landmark case in Nature’s Oncogene showing that a patient who had exhausted several therapies, including platinum-based chemotherapy, autologous stem cell transplant, and multiple immune checkpoint inhibitors, achieved a complete and durable remission. This success came after the patient received a single infusion of MiNK’s allogeneic iNKT cell therapy, agenT-797, along with nivolumab. The case demonstrated that the donor iNKT cells remained detectable for up to six months post-infusion, and the treatment was well-tolerated without severe side effects such as cytokine release syndrome or graft-versus-host disease. These promising findings underscore the potential of agenT-797 to offer new hope for patients with difficult-to-treat cancers and support further clinical studies in this area.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- February 12, 2025
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, announced that it has been selected for an oral presentation at the upcoming American Association for Cancer Research (AACR) IO Annual Meeting that will take place on February 23-26 in Los Angeles, California.
AI Summary
MiNK Therapeutics, a clinical-stage biopharmaceutical company, has been chosen for an oral presentation at the upcoming American Association for Cancer Research (AACR) IO Annual Meeting. The event will take place from February 23 to 26 in Los Angeles, California. During the meeting, MiNK will share interim data from its ongoing Phase 2 study. The study is testing their cell therapy AgenT-797 in combination with botensilimab and balstilimab for patients with refractory gastric cancer.
The presentation is scheduled for Tuesday, February 25, from 1:00 to 1:45 p.m. PST and will be part of the Proffered Papers, Session 2. This opportunity highlights MiNK Therapeutics’ work on off-the-shelf invariant natural killer T (iNKT) cell therapies that target cancer and other immune-related diseases. The company is committed to developing innovative therapies and advancing their engineering programs for scalable and reproducible cell therapy solutions.
Read Announcement- Drug:
- AgenT-797
- Announced Date:
- May 22, 2024
- Indication:
- Multiple myeloma
Announcement
MiNK Therapeutics, Inc. announced presentation of clinical data on agenT-797 in a complex case of severe acute respiratory distress (ARDS) at the American Thoracic Society (ATS) Annual Meeting. These translational and mechanistic insights build on an expanding dataset of clinical activity for patients with severe ARDS.
AI Summary
MiNK Therapeutics recently presented clinical data on its investigational treatment, agenT-797, at the American Thoracic Society Annual Meeting. The data focused on a complex case of severe acute respiratory distress syndrome (ARDS) in a patient who had a history of chronic immunosuppression after a renal transplant. The patient, who contracted COVID-19, experienced severe respiratory failure and required advanced life support, including veno-venous extracorporeal membrane oxygenation (VV-ECMO). Following a single dose of 1x10^9 allogeneic invariant natural killer T (iNKT) cells, the patient showed promising improvements, such as a rapid decrease in inflammatory cytokines and eventual recovery. Dr. Terese Hammond of UCLA highlighted the survival benefit and emphasized the potential role of allogeneic iNKT cells in treating severe respiratory distress. This promising case builds on an expanding dataset of clinical activity, suggesting further investigation is needed in acute critical care settings.
Read Announcement
BOT/BAL FDA Regulatory Timeline and Events
BOT/BAL is a drug developed by Agenus for the following indication: In Metastatic MSS Colorectal Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BOT/BAL
- Announced Date:
- April 1, 2026
- Indication:
- In Metastatic MSS Colorectal Cancer
Announcement
Agenus Inc announced that the first patient has been enrolled in the landmark global phase 3 BATTMAN (CO.33) trial (NCT07152821).
AI Summary
Agenus Inc. announced the first patient has been enrolled in the global Phase 3 BATTMAN (CO.33) trial (NCT07152821). This landmark registrational study tests Agenus’ immunotherapy candidates and is designed to change outcomes for patients with microsatellite stable metastatic colorectal cancer (MSS mCRC), which makes up about 95% of metastatic colorectal cancer cases.
The trial is intended for patients who have exhausted other treatment options and could provide a new standard of care if successful. Investigators have shown strong early enthusiasm: leading centers in Canada moved quickly to open the study after a Health Canada submission, helping the global effort to enroll patients and evaluate the treatment combination.
Read Announcement- Drug:
- BOT/BAL
- Announced Date:
- September 9, 2025
- Indication:
- In Metastatic MSS Colorectal Cancer
Announcement
Agenus Inc announced its investigational combination botensilimab plus balstilimab (BOT/BAL) is now available to eligible patients with refractory microsatellite‑stable (MSS) metastatic colorectal cancer (mCRC) under France's compassionate access (Accès compassionnel, or AAC) framework.
AI Summary
Agenus Inc. today announced that its investigational combination of botensilimab plus balstilimab (BOT/BAL) is now available to eligible patients with refractory microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) under France’s compassionate access (Accès compassionnel, AAC) framework. The French National Agency for Medicines and Health Products Safety (ANSM) has published eligibility criteria, including MSS status and no active liver metastases, along with dosing guidelines. BOT/BAL remains investigational and is not approved for commercial use in France or elsewhere.
Under AAC, Assurance Maladie covers 100% of hospital costs, with reimbursements paid “en sus du GHS” at the invoiced purchase price (TTC). During this period, Agenus may provide the drugs free of charge or invoice a company-set indemnity, with the maximum indemnity declared to French authorities as required by law.
Peer-reviewed and congress data show durable activity of BOT/BAL in refractory MSS mCRC, including about 21-month median overall survival, roughly 42% two-year survival, and a 20% objective response rate, especially in patients without active liver metastases.
Patients across the European Union and European Economic Area can access planned care in France under Directive 2011/24/EU, subject to prior authorization and home-system reimbursement. Agenus will support French treatment centers to ensure reliable BOT/BAL supply and high-quality real-world evidence, and plans a global Phase 3 BATTMAN trial in Q4 2025.
Read Announcement- Drug:
- BOT/BAL
- Announced Date:
- July 7, 2025
- Indication:
- In Metastatic MSS Colorectal Cancer
Announcement
Agenus also confirmed that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the design of the global BATTMAN Phase 3 trial.
AI Summary
Agenus has reached a significant step forward in its push to treat metastatic colorectal cancer. The company confirmed that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of its global BATTMAN Phase 3 trial. Under this agreement, the FDA waived the need for a BOT monotherapy arm, allowing the trial to use a simpler two-arm design. This streamlined approach will focus solely on evaluating the BOT/BAL combination therapy, which has shown promising clinical activity in patients with microsatellite-stable colorectal cancer.
The BATTMAN trial is set to launch in the fourth quarter of 2025. By aligning with the FDA's guidance, Agenus aims to accelerate the development of this potential chemo‑free treatment option for patients who have exhausted standard therapies, ultimately addressing an urgent unmet need in this challenging patient population.
Read Announcement- Drug:
- BOT/BAL
- Announced Date:
- January 22, 2025
- Indication:
- In Metastatic MSS Colorectal Cancer
Announcement
Agenus Inc today shared new data on botensilimab (BOT) and balstilimab (BAL) at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco. Data from five presentations underscore the transformative potential of BOT/BAL across multiple lines of therapy in colorectal cancer, including neoadjuvant, first-line, and refractory settings.
AI Summary
Agenus Inc presented promising new data on botensilimab (BOT) and balstilimab (BAL) at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco. The data, shown in five presentations, highlights the transformative potential of the BOT/BAL combination in treating colorectal cancer. The studies included patients across multiple treatment settings, such as neoadjuvant (before surgery), first-line, and refractory (hard-to-treat) cases. Early studies in the U.S. and Europe, involving over 80 patients, suggest that this treatment may enable chemo-free and non-operative management options. Additionally, a Phase 2 trial with more than 230 patients with refractory metastatic colorectal cancer demonstrated durable responses and a favorable safety profile. The combination also showed encouraging results when paired with chemotherapy and targeted therapies, offering hope for improving outcomes in microsatellite stable colorectal tumors, a group that typically does not respond to standard immuno-oncology treatments.
Read Announcement
Botensilimab FDA Regulatory Timeline and Events
Botensilimab is a drug developed by Agenus for the following indication: In MSS Colorectal Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Botensilimab
- Announced Date:
- March 17, 2026
- Indication:
- In MSS Colorectal Cancer
Announcement
Agenus Inc. announced that preliminary results from an investigator-sponsored study evaluating botensilimab (BOT) in combination with balstilimab (BAL) in first-line microsatellite stable colorectal cancer (MSS CRC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 18–23 in San Diego, CA.
AI Summary
Agenus announced that preliminary results from an investigator‑sponsored study of botensilimab (BOT) plus balstilimab (BAL) in first‑line microsatellite stable colorectal cancer (MSS CRC) will be presented at the American Association for Cancer Research (AACR) Annual Meeting, April 18–23, 2026, in San Diego. The poster, from the BBOpCo study, reports on optimization of BOT+BAL in MSS CRC patients without liver, bone, or brain metastases.
Botensilimab is an Fc‑enhanced anti‑CTLA‑4 designed to activate both innate and adaptive immune responses, while balstilimab is an anti‑PD‑1 intended to sustain immune activity. Together the drugs target complementary immune pathways to try to make “cold” tumors more responsive to immunotherapy.
The study promotes a chemo‑sparing approach that aims to extend survival and reduce use of cytotoxic chemotherapy. The BBOpCo data add to growing research testing BOT+BAL earlier in treatment, where immune activation may have greater benefit. Balstilimab has been studied in more than 900 patients with a generally favorable tolerability profile.
Read Announcement- Drug:
- Botensilimab
- Announced Date:
- February 9, 2026
- Indication:
- In MSS Colorectal Cancer
Announcement
Agenus Inc announced that new translational and clinical biomarker analyses from its botensilimab (BOT) immunotherapy program have been accepted for poster presentation at the American Association for Cancer Research- Immuno-Oncology (AACR-IO) Conference, taking place in Los Angeles, CA on February 18–21, 2026.
AI Summary
Agenus announced that new translational and clinical biomarker analyses from its botensilimab (BOT) immunotherapy program will be presented as a poster at the AACR‑IO Conference in Los Angeles, February 18–21, 2026. The poster, titled “Systemic and tumor‑microenvironment inflammation shape outcomes in patients with immunologically cold, treatment‑refractory tumors treated with Fc‑enhanced anti–CTLA‑4 botensilimab,” examines how systemic inflammatory markers, tumor microenvironment immune activity, and peripheral immune cell states relate to clinical outcomes in patients treated with BOT alone or with balstilimab (BAL).
Botensilimab is an Fc‑enhanced anti‑CTLA‑4 antibody designed to prime and activate the immune system. Balstilimab is an anti‑PD‑1 IgG4 intended to sustain anti‑tumor immune activity and has been studied in over 900 patients. Together, BOT+BAL target complementary pathways and are being evaluated across multiple solid tumors, including immunologically “cold” and treatment‑refractory cancers. The poster will share biomarker patterns that may help explain response differences and guide future use of BOT and BOT+BAL.
Read Announcement- Drug:
- Botensilimab
- Announced Date:
- May 30, 2025
- Indication:
- In MSS Colorectal Cancer
Announcement
Agenus Inc. today presented new translational data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Agenus Inc. presented new translational data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, focusing on botensilimab’s ability to activate the body’s T cells against treatment-resistant colorectal cancer. The study showed that botensilimab-based therapy quickly activates T cells—in some cases within two weeks—which then continue to expand and sustain their attack on the tumor. This is significant because metastatic colorectal cancer, particularly the microsatellite stable type, has traditionally not responded well to immunotherapy. The research, led by Dr. Gertjan Rasschaert in collaboration with international partners, highlights how botensilimab may help overcome the resistance seen in these “cold” tumors by making them visible to the immune system. These findings offer promising insights into improving outcomes for patients with this common, challenging-to-treat type of colorectal cancer.
Read Announcement
Botensilimab + balstilimab FDA Regulatory Timeline and Events
Botensilimab + balstilimab is a drug developed by Agenus for the following indication: Metastatic heavily pretreated microsatellite stable colorectal cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Botensilimab + balstilimab
- Announced Date:
- March 16, 2026
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc. highlighting progress for the botensilimab (BOT) plus balstilimab (BAL) immunotherapy program across patient access, clinical execution, and commercial readiness. BOT+BAL is a next-generation CTLA-4/PD-1 immunotherapy combination which activates both innate and adaptive immunity and has demonstrated immunotherapy benefit in tumors historically resistant to checkpoint inhibition.
AI Summary
Agenus’ BOT+BAL is a next‑generation CTLA‑4/PD‑1 immunotherapy combination that activates both innate and adaptive immunity and has shown benefit in tumors historically resistant to checkpoint inhibitors. Clinical data from late 2025 and early 2026 reinforce its differentiated immune‑modulating activity. The global Phase 3 BATTMAN trial in refractory microsatellite‑stable (MSS)/pMMR metastatic colorectal cancer has been initiated, aiming to enroll about 830 patients across more than 100 sites in Canada, France, Australia and New Zealand to support potential regulatory filings.
Agenus has expanded patient access through regulatory‑authorized early access pathways, including France’s AAC program and paid named‑patient programs where allowed, which also help physicians gain real‑world experience with the combination. Initial revenue has been recognized from these paid early access treatments. Access outside trials may involve out‑of‑pocket or insurance arrangements depending on local rules.
A 2026 collaboration with Zydus triggered a $20 million contingent payment, bolstering the company’s balance sheet and securing U.S. manufacturing infrastructure to support clinical, regulatory and commercial readiness as Agenus prepares for potential submissions in the U.S. and Europe.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- December 23, 2025
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc. announced the publication of clinical results from the ovarian cancer cohort of its Phase 1b C-800-01 trial evaluating botensilimab plus balstilimab (BOT+BAL) in The Journal for ImmunoTherapy of Cancer (JITC).
AI Summary
Agenus announced publication in The Journal for ImmunoTherapy of Cancer of results from the ovarian cancer cohort of its Phase 1b C-800-01 trial testing botensilimab plus balstilimab (BOT+BAL). The peer‑reviewed paper reports data from 44 heavily pretreated, treatment‑refractory patients—many platinum‑resistant or platinum‑refractory—showing a 23% overall response rate and a 31% clinical benefit rate. Responses were durable (median duration 9.7 months), median overall survival was 14.8 months, and an estimated 75% of patients were alive at 12 months.
Activity was seen across ovarian subtypes including high‑grade serous, clear cell, and endometrioid tumors, and in primary platinum‑refractory patients. The safety profile was consistent with CTLA‑4 and PD‑1 therapies and was generally manageable and reversible; common treatment‑related adverse events included diarrhea/colitis (43%, 16% grade 3), fatigue and nausea (36%), with no treatment‑related deaths reported. Authors say the findings support further randomized study of BOT+BAL in this hard‑to‑treat population.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- October 17, 2025
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc. announced new data from its botensilimab (BOT), a multifunctional, Fc-enhanced CTLA-4 antibody and balstilimab (BAL), a PD-1 inhibitor, combination demonstrating durable survival across multiple cancer types in late-stage patients who have limited treatment options.
AI Summary
Agenus Inc. announced new data from its multifunctional, Fc-enhanced CTLA-4 antibody botensilimab (BOT) and PD-1 inhibitor balstilimab (BAL) combination showing durable survival in late-stage cancer patients with limited treatment options. In 411 heavily pretreated patients across refractory colorectal, sarcoma, ovarian, non-small cell lung and liver cancers, the combo achieved a 17% objective response rate and a median overall survival of 17.2 months. About 39% of patients were alive at two years, including those who had failed prior immunotherapies and had active liver metastases. Immune activation correlated with improved survival, most side effects were reversible and gastrointestinal in nature, and no treatment-related deaths occurred.
The study enrolled 61% of patients who had received three or more prior therapies. Findings were presented at the European Society for Medical Oncology Congress and highlight the combination’s broad, tumor-agnostic impact, supporting advancement to a Phase 3 trial for patients with few remaining options.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- May 15, 2025
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc announced new data from its ongoing Phase 1 trial evaluating botensilimab and balstilimab (BOT/BAL) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) at the 2025 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress in Barcelona, Spain.
AI Summary
Agenus Inc. unveiled new data at the 2025 ESMO Gastrointestinal Cancers Congress in Barcelona from its ongoing Phase 1 trial of botensilimab and balstilimab (BOT/BAL) in patients with microsatellite stable metastatic colorectal cancer. The updated analysis, which now includes an expanded cohort of 123 patients, offers a more mature dataset with extended follow-up. Key findings include improvements in overall survival, with metrics showing a reported median survival and promising 2-year overall survival rates. The study highlights the potential of this dual immunotherapy approach to enhance clinical activity by boosting both innate and adaptive immune responses, providing hope for patients with tumors that are typically resistant to conventional treatments. The results, detailed in a poster presented by Dr. Benjamin Schlechter from the Dana Farber Cancer Institute, underscore the promising role this combination may play in treating challenging colorectal cancers.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- April 28, 2025
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc announced that data from the investigator sponsored NEOASIS study were presented in an oral session at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois.
AI Summary
Agenus Inc announced that data from the investigator-sponsored NEOASIS study were presented during an oral session at the AACR Annual Meeting in Chicago, Illinois. This study focused on the use of botensilimab and balstilimab (BOT/BAL) in the neoadjuvant setting to treat various solid tumors, including those that are both mismatch repair–proficient and deficient. The presentation covered initial findings that showed significant pathological responses in patients, with notable responses in cases such as triple-negative breast cancer, following just two doses of treatment. Importantly, no dose-limiting toxicities were observed, and all patients were able to proceed to surgery on schedule. The study marks the third clinical evaluation of the BOT/BAL combination in the neoadjuvant setting, expanding its potential use beyond colorectal cancer to other early-stage solid tumors.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- March 25, 2025
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc. announced two upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 25–30, 2025 in Chicago, Illinois.
AI Summary
Agenus Inc. announced two key presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, from April 25–30, 2025. At the event, the company will showcase important developments in its neoadjuvant immunotherapy program using botensilimab and balstilimab. The first presentation is an oral session delivering initial results from the NEOASIS trial, which studied the treatment of early-stage cancers in patients with MSI-H and MSS solid tumors. Additionally, a poster will present new data from the Phase 1 study focusing on treatment refractory hepatocellular carcinoma (HCC) patients. These sessions aim to provide insights into how the combination therapy supports anti-tumor immune responses and may offer fresh treatment avenues, underscoring Agenus’s commitment to advancing cancer care through innovative immunotherapy approaches.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- January 29, 2025
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc. announced publication in the Journal of Clinical Oncology showcasing data from its study of botensilimab (BOT) in combination with balstilimab (BAL) in patients with relapsed/refractory (R/R) metastatic sarcomas.
AI Summary
Agenus Inc. announced the publication of a study in the Journal of Clinical Oncology that showcased data on the use of botensilimab (BOT) combined with balstilimab (BAL) in patients with relapsed or refractory metastatic sarcomas. This Phase 1 trial focused on hard-to-treat sarcoma subtypes, which are typically resistant to standard treatments. The study highlighted that the BOT/BAL combination produced durable responses and extended survival for patients who had limited treatment options. Additionally, the therapy was well tolerated, showing a manageable safety profile. These results underscore the potential of this combination to treat “cold” tumors, which historically have not responded well to conventional checkpoint inhibitors. The publication supports continued research into this promising treatment approach for advanced sarcomas.Read Announcement
- Drug:
- Botensilimab + balstilimab
- Announced Date:
- December 18, 2024
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc. announced five presentations featuring botensilimab (BOT, an Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (BAL, an anti-PD-1 antibody) at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium.
AI Summary
Agenus Inc. announced that five new presentations featuring their combination therapy botensilimab and balstilimab will be showcased at the upcoming ASCO GI Symposium in San Francisco, January 23-25, 2025. The presentations will provide fresh data on the combination’s activity in treating colorectal cancer across different settings, including neoadjuvant, first-line, and late-line metastatic treatment. Researchers will highlight the potential of the BOT/BAL therapy, particularly in microsatellite stable colorectal cancer, which is the most common form of the disease, and in microsatellite instability-high tumors. One presentation will also explore using BOT/BAL with invariant natural killer T cells for patients with refractory gastric cancer. These studies aim to demonstrate the combination’s consistent activity and broaden the range of treatment options available to patients in need of new therapeutic approaches in cancer care.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- September 9, 2024
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc. announced that updated data from the clinical trial of botensilimab and balstilimab in refractory sarcomas will be featured in a mini oral presentation at the European Society for Medical Oncology (ESMO) Congress, taking place September 13-17, 2024, in Barcelona, Spain.
AI Summary
Agenus Inc. announced that updated data from its ongoing Phase 1 trial evaluating the combination of botensilimab and balstilimab in refractory sarcomas will be presented at the European Society for Medical Oncology (ESMO) Congress. This mini oral session, scheduled for September 13, 2024, in Barcelona, Spain, will focus on safety and efficacy findings from the trial.
The study looks at the potential of this novel immunotherapy approach, especially for patients with hard-to-treat sarcomas like visceral angiosarcoma and leiomyosarcoma. Botensilimab, an investigational CTLA-4 inhibitor, paired with balstilimab, a PD-1 antibody, has shown promising clinical responses, even in tumors that typically do not react well to standard treatments. This updated data could provide fresh insights into treatment options for patients with limited alternatives.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- July 18, 2024
- Target Action Date:
- Q3 2024
- Estimated Target Date Range:
- July 1, 2024 - September 30, 2024
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc announced that Strategic meeting with the European agency scheduled for Q3 2024 to explore additional regulatory opportunities
AI Summary
Agenus Inc has announced a strategic meeting with the European regulatory agency scheduled for Q3 2024. The purpose of this upcoming meeting is to explore additional regulatory opportunities for its novel immunotherapy combination aimed at treating microsatellite stable colorectal cancer. While progress continues globally, the European discussions mark an important step in expanding the company's registration pathways outside the United States.
This initiative demonstrates Agenus’ commitment to addressing significant unmet needs in cancer care by seeking new avenues for treatment approval. The planned dialogue with European regulators is expected to help define innovative routes for bringing the therapy to market, thereby offering hope to patients facing limited treatment options. Through these discussions, Agenus aims to strengthen its global development efforts and further its mission of improving outcomes for those affected by challenging cancers.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- July 18, 2024
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc announced the results of its end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), for the advancement of its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for the treatment of adult patients with relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM).
AI Summary
Agenus Inc. announced the results of its end-of-Phase 2 meeting with the FDA regarding its immunotherapy combination of botensilimab (BOT) and balstilimab (BAL). The meeting focused on advancing the combination treatment for adult patients with relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) without active liver metastases.
During the discussion, the FDA agreed to the proposed Phase 3 dosing regimen of 75 mg BOT every 6 weeks for up to 4 doses, combined with 240 mg BAL every 2 weeks for up to 2 years. However, the agency advised against seeking accelerated approval at this stage, noting that objective response rates may not necessarily translate into a survival benefit. Additionally, the FDA recommended the option to include a BOT monotherapy arm in the Phase 3 study.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- June 27, 2024
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc announced that the Cancer Therapy Evaluation Program (CTEP) is accepting Letters of Intent (LOIs) to conduct clinical studies using botensilimab (BOT), a human Fc enhanced next-generation anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, which is being developed by CTEP as an anticancer agent in collaboration with Agenus Inc.
AI Summary
Agenus Inc. announced that the Cancer Therapy Evaluation Program (CTEP) is now accepting Letters of Intent (LOIs) for clinical studies using botensilimab, a next-generation anti-CTLA-4 antibody developed in collaboration with CTEP. Botensilimab is designed to boost the body’s immune response against cancer and is intended to work by enhancing both innate and adaptive immunity. Researchers interested in conducting clinical studies, as well as those planning nonclinical investigations with the drug, are encouraged to apply. All approved proposals will be forwarded to Agenus for a commitment to supply botensilimab for the study. This initiative reflects a broader effort to explore new therapeutic approaches and potentially expand treatment options for various cancers through additional research into botensilimab’s benefits and applications.
Read Announcement- Drug:
- Botensilimab + balstilimab
- Announced Date:
- May 16, 2024
- Indication:
- Metastatic heavily pretreated microsatellite stable colorectal cancer
Announcement
Agenus Inc. announced it will conduct a Type B End-of-Phase 2 (EOP2) meeting in July with the U.S. Food and Drug Administration (FDA) to discuss the botensilimab plus balstilimab (BOT/BAL) combination therapy studies in patients with relapsed/refractory metastatic colorectal cancer that is not MSI-high or dMMR (r/r MSS mCRC), as well as the critical elements of the program to support a future biologics license application (BLA) submission.
AI Summary
Agenus Inc. announced it will hold a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) in July. The meeting will focus on reviewing the ongoing studies of the botensilimab plus balstilimab (BOT/BAL) combination therapy. This therapy targets patients with relapsed or refractory metastatic colorectal cancer that is not MSI-high or dMMR (r/r MSS mCRC). During the meeting, the company aims to discuss the study results and the overall critical elements of the program. These discussions are a key step in building the groundwork for a future biologics license application (BLA) submission. The purpose is to ensure that the upcoming data and development path align with the FDA’s requirements and guidelines, helping to potentially accelerate the program’s regulatory progress.
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