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
BOT/BAL, AgenT-797, 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.
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:
- 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- Drug:
- BOT/BAL
- Announced Date:
- April 12, 2024
- Indication:
- In Metastatic MSS Colorectal Cancer
Announcement
Agenus Inc. announced updated results from its Phase 1 clinical trial of BOT/BAL combination therapy in patients with metastatic CRC that is not microsatellite instability-high (MSS) or deficient mismatch repair (dMMR).
AI Summary
Agenus Inc. has released updated Phase 1 results for its BOT/BAL combination therapy targeting metastatic colorectal cancer (CRC) in patients whose tumors are not microsatellite instability-high (MSS) or deficient in mismatch repair (dMMR). In the trial, which involved 77 patients with refractory MSS-CRC and no active liver metastases, a 23% overall response rate was observed with responses still ongoing. Notably, the data showed an overall survival rate of 71% at 12 months and 62% at 18 months, and a median overall survival time of 21.2 months. These promising survival figures emphasize the potential of the BOT/BAL regimen to offer new treatment options for patients with aggressive forms of CRC that have been difficult to treat.
Read Announcement
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:
- 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
Botensilimab FDA Regulatory 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:
- 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:
- 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
- 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:
- July 18, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 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:
- 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.
Read Announcement
