A Phase 2 Study of Microsatellite Stable Colorectal Cancer (Stage 2 or 3) With Radiographic Occult Molecular Residual Disease Treated With Botensilimab (AGEN1181; Bot) Plus Balstilimab (AGEN2034, Bal) After Established Definitive Therapy (COMBAT Study)

This phase II trial tests the effect of the botensilimab in combination with balstilimab in treating patients with stage II/III colorectal adenocarcinoma with detectable circulating tumor (ct) deoxyribonucleic acid (DNA) in the blood. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab may be an effective combination to remove any remaining microscopic cancer cells in the bloodstream in patients with stage II/III colorectal adenocarcinoma. In addition, clearing the ctDNA from the blood may serve as an early indicator of treatment response.

Start Date25 May 2027

Sponsor / Collaborator

National Cancer Institute

NCT07516366

/ RecruitingPhase 2IIT

Pilot Phase II Trial Evaluating Safety and Feasibility of Neoadjuvant Botensilimab and Balstilimab in Clear Cell Renal Cell Carcinoma (NEO RoBOT)

This phase II trial tests the effect of botensilimab and balstilimab before surgery (neoadjuvant) in treating patients with high-risk clear cell renal cell cancer that has not spread from where it first started to other areas of the body (non-metastatic). The current standard treatment for patients with non-metastatic clear cell renal cell cancer may include surgery to completely remove the tumor. This typically involves removing the kidney or part of the kidney (nephrectomy). Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant botensilimab and balstilimab may be safe, tolerable, and/or effective in treating patients with high-risk non-metastatic clear cell renal cell cancer before undergoing a nephrectomy.

Start Date17 May 2027

Sponsor / Collaborator

National Cancer Institute

NCT07735624

/ RecruitingPhase 2IIT

A Phase 2 Study of the Safety and Efficacy of Neoadjuvant Botensilimab in Combination With Balstilimab in the Treatment of Microsatellite Stable / Mismatch Repair Proficient Early Rectal Cancer (RECTIFY-1)

This is a multi-site, prospective, non-randomized phase 2 study evaluating neoadjuvant botensilimab in combination with balstilimab for patients with microsatellite stable (MSS) / mismatch repair proficient (MMRp) early rectal cancer staged T1-T2 N0 by MRI and considered candidates for surgical resection without standard neoadjuvant therapies. Participants will receive a single IV dose of botensilimab on Day 1 followed by balstilimab IV every 2 weeks for up to 6 months, with tumor response assessments during treatment and follow-up afterward.

Start Date01 Sep 2026

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+2]

100 Clinical Results associated with Balstilimab

100 Translational Medicine associated with Balstilimab

100 Patents (Medical) associated with Balstilimab

245

Literatures (Medical) associated with Balstilimab

04 Aug 2026·ONCOGENE

Transcriptomic profiling identifies immunotherapy-responsive phenotypes in microsatellite-stable metastatic colorectal cancer

Article

Author: Tamazyan, Melina ; Mnatsakanyan, Sveta ; Stepanyan, Luiza ; Binder, Hans ; Chand, Dhan ; Loeffler-Wirth, Henry ; Mednick, Gabriel ; Konecny, Tomas ; Bourdelais, Sean ; Grigoryan, Arpine ; Zadirako, Nate ; Delepine, Chloe

Abstract:

Conventional immune checkpoint inhibitors (ICIs) remain largely ineffective in microsatellite-stable metastatic colorectal cancer (MSS mCRC), where low tumor immunogenicity and molecular heterogeneity across metastatic sites underpin therapeutic resistance. We present a comprehensive transcriptomics analysis of metastatic and primary tumor biopsies from MSS mCRC patients treated with botensilimab (BOT; Fc-enhanced anti– CTLA-4 ) ± balstilimab (BAL; anti– PD-1) . Self-organizing map (SOM) machine learning stratified tumors into four molecular types, including a liver-like (LIV) subtype characterized by metabolic reprogramming and immunosuppressive signatures, and proliferative (PRO), inflammatory (INF), and mesenchymal (MES) types concordant with pan-cancer classifications. PRO, INF, and MES types were enriched for epithelial tumor cells, immune cells, and fibroblasts, respectively, defining immune-depleted, immune-enriched, and fibrotic states along a plasticity gradient. We observed treatment-related transcriptomic shifts toward immune-enriched states via upregulation of antigen presentation, T cell recruitment, and cytotoxicity pathways. INF and MES tumor types exhibited improved clinical responses and survival vs PRO and LIV types. This study identified distinct tumor microenvironment states that align along an immunophenotype axis marked by CD74, interferon-γ, and APOBEC3 expression identified previously for primary CRC. Our findings provide novel insights into molecular correlates of immunotherapy response in MSS mCRC, potentially informing future therapeutic strategies to expand ICI efficacy to historically unresponsive tumors.

21 Jul 2026·Oncotarget

WIN-MTB-2024017 - WIN International Molecular Tumor Board: A 48-year-old female with multiple primary cancers

Article

Author: Liu, Jia ; Bresson, Catherine ; Oberoi, Arjun ; Hattum, Crystal ; Hernando-Calvo, Alberto ; Magidi, Shai ; Meissner, Tobias ; Cheng, Liang ; El-Deiry, Wafik S. ; Hu, Zhihuang ; Grisson, Ricky ; Liu, Liu ; Dizon, Don ; Kurzrock, Razelle ; Wunder, Fanny ; Frankel, Naftali Z.

Copyright: © 2026 El-Deiry et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Multiple primary cancers (MPC), the occurrence of two or more distinct malignancies in the same patient, pose significant clinical challenges due to their complexity and the need for individualized treatment strategies. This case, discussed at the WIN Consortium International Molecular Tumor Board, illustrates the clinical journey of a 48-year-old female with a BRCA1 germline mutation who developed multiple primary cancers: breast, skin, high-grade serous carcinoma of the ovary, colon and small bowel cancers. Her treatment history included doxorubicin and cyclophosphamide for breast cancer, Mohs surgery for basal cell carcinoma, and carboplatin and paclitaxel for ovarian cancer. After participating in the PRIMA trial with niraparib, she was diagnosed with PIK3CA-mutated colon cancer, leading to resection and CAPOX chemotherapy. A subsequent diagnosis of small bowel adenocarcinoma, molecularly resembling her colon cancer, along with a unique BRCA1-STARD3 fusion in inguinal lymph nodes prompted a comprehensive MTB review. The panel discussed several precision strategies, including combinations of cetuximab, niraparib, and temsirolimus; FOLFIRI with anti-EGFR inhibitors; anti-CTLA-4 and anti-PD-1 (botensilimab and balstilimab); regorafenib with anti-CTLA-4 and anti-PD-1 (ipilimumab and nivolumab); trifluridine/tipiracil with bevacizumab; regorafenib alone; aspirin for potential benefits in patients with PIK3CA mutations; therapies targeting PIK3CA and EGFR alterations; regular imaging and liquid biopsies assessments for monitoring disease progression and guide future treatment decisions; and vaccines targeting PIK3CA, STARD3 and TP53. This case underscores the complexity of managing MPC and highlights the essential role of international molecular tumor boards in generating innovative, tailored treatment recommendations for patients with rare and multifaceted disease courses.

01 Mar 2026·Immuno-oncology technology

Refractory microsatellite-stable metastatic colorectal cancer: a comparison between botensilimab + balstilimab and current standard of care

Article

Author: Picone, V ; Bengala, E ; Santini, D

Background:

The combination of botensilimab + balstilimab demonstrated promising clinical activity in heavily pre-treated patients with microsatellite-stable metastatic colorectal cancer (mCRC) in a recently published phase I study (NCT03860272).

Patients and methods:

Our objective was to derive overall survival (OS), progression-free survival (PFS) and safety data from the trials of reference of the current standard of care for refractory mCRC and from the above-mentioned study, and to compare them. After a systematic search of PubMed, we selected four studies (SUNLIGHT, FRESCO-2, RECOURSE, CORRECT). Individual patient OS and PFS data were extracted from Kaplan-Meier curves and more frequent toxic effect rates were collected.

Results:

Immunotherapy showed higher efficacy in terms of median OS both compared with trifluridine-tipiracil plus bevacizumab [hazard ratio (HR) 0.62, 95% confidence interval (CI) 0.44-0.89] and to later lines of treatment: fruquintinib, regorafenib, and trifluridine-tipiracil alone. These results were confirmed by median PFS comparison of all the therapies except for the trifluridine-tipiracil + bevacizumab combination (HR 0.46, 95% CI 0.35-0.61 in favor of trifluridine-tipiracil + bevacizumab). As for treatment-related adverse events the most frequent with immunotherapy were fatigue and diarrhea. The other regimens were associated with hematologic toxic effects, nausea, hypertension, and dermatological toxicity.

Conclusion:

These findings suggest that the immunotherapy combination appears to be a potential option for patients with refractory mCRC while being associated with a completely different toxicity profile. However, confirmation of its efficacy awaits the results of randomized studies. Better comprehension of disease characteristics related to treatment response, such as metastatic sites and molecular biology, is warranted for patient selection.

211

News (Medical) associated with Balstilimab

23 Oct 2026

·www.biospace.com

Agenus to Provide Third Quarter 2026 Financial Report and Development Update

LEXINGTON, Mass.--(BUSINESS WIRE)-- $AGEN #AGEN -- Agenus Inc. (“Agenus”) (Nasdaq: AGEN ), a leader in immuno-oncology innovation, today announced that the Company will release its third quarter 2026 financial results before the market opens on Thursday, November 5, 2026. The earnings release will review Agenus’ recent progress in advancing botensilimab and balstilimab (BOT+BAL) toward the Phase 3 neoadjuvant ROBBIN trial in earlier-stage colon cancer and strengthening the clinical and regulatory foundation for the combination, which now includes its first marketing authorizations in Armenia. It will also cover Agenus’ continued commitment to expanding access to BOT+BAL for more patients globally. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. BOT augments immune responses across a wide range of tumor types by priming and activating T cells, reducing intratumoral regulatory T cells, activating myeloid cells and inducing durable memory responses. BOT+ balstilimab (BAL) has been studied in over 1,500 patients across more than nine tumor types, spanning late-line refractory disease and early-stage neoadjuvant settings. The combination is being developed to expand immunotherapy benefit to more patients, including those with microsatellite stable (MSS) disease and tumors considered immunologically “cold” or resistant to existing immunotherapies. Agenus’ Phase 3 ROBBIN study is designed to evaluate BOT+BAL given before surgery in earlier-stage colon cancer. For more information about botensilimab trials, visit . About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability pro several tumor types. The Ministry of Health of the Republic of Armenia has granted marketing authorizations for Botvymo ® (botensilimab) and Evamplix ® (balstilimab), each approved for use in combination with the other for the treatment of adult patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases who have previously received available standard therapies. Botvymo and Evamplix were separately submitted and approved for use as a combination regimen. Their use in other indications and in other countries remains investigational. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Contacts Investors: 917-362-1370 | investor@agenusbio.com Media: 781-674-4422 | communications@agenusbio.com

ImmunotherapyDrug ApprovalPhase 3Financial Statement

12 Oct 2026

·www.biospace.com

Agenus to Participate in Chardan’s 10th Annual Healthcare Investor Conference

LEXINGTON, Mass.--(BUSINESS WIRE)-- $AGEN #Botensilimab -- Agenus Inc. (Nasdaq: AGEN) , a leader in immuno-oncology innovation, today announced that Zack Armen, Head of Corporate Development and Investor Relations, will participate in a fireside chat and one-on-one investor meetings at Chardan’s 10 th Annual Healthcare Conference: The Next 10 Years of Disruptive Innovation, on October 20, 2026. Chardan 10 th Annual Healthcare Conference: The Next 10 Years of Disruptive Innovation Date: Tuesday, October 20, 2026 Location : Lotte New York Palace, New York, NY Fireside Chat: Tuesday, October 20, 2026 | 11:00am ET Webcast Link: An archived recording of the fireside chat will be available for 30 days following the event and will be available as a replay on the Events & Presentations section of the Agenus investor relations website at Agenus Inc. - Events . About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Contacts Investors 917-362-1370 | investor@agenusbio.com Media 781-674-4422 | communications@agenusbio.com

Immunotherapy

08 Oct 2026

·www.biospace.com

Armenia Grants First Marketing Authorizations for Agenus’ BOT+BAL in Previously Treated MSS Metastatic Colorectal Cancer

Botvymo ® (botensilimab) and Evamplix ® (balstilimab) receive separate approvals for use in combination Armenia is the first country to approve marketing authorization of BOT+BAL, following a rigorous review of quality, nonclinical, clinical and pharmacovigilance data Approvals supported by clinical evidence published in peer-reviewed journals and presented at major oncology congresses, including two-year Phase 1b survival findings and randomized Phase 2 data in MSS metastatic colorectal cancer without active liver metastases Agenus will evaluate the potential for approvals in other Eurasian Economic Union countries that support this regulatory path LEXINGTON, Mass.--(BUSINESS WIRE)-- $AGEN #Armenia -- Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that the Ministry of Health of the Republic of Armenia has granted marketing authorizations for Botvymo ® (botensilimab, BOT) and Evamplix ® (balstilimab, BAL), each approved for use in combination with the other for the treatment of adult patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases who have previously received available standard therapies. These are the first marketing authorizations for either medicine anywhere in the world. The approvals are expected to benefit patients in Armenia as well as patients who travel to Armenia for treatment under the care of Armenian oncologists. Botensilimab is a multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to activate innate and adaptive antitumor immune responses, including in tumors that have historically responded poorly to conventional immunotherapy. Balstilimab is an anti-PD-1 antibody designed to sustain antitumor T-cell activity. The approvals are effective as of October 2, 2026. They follow a rigorous review by Armenia’s regulatory authorities of the complete registration dossier, submitted in the international Common Technical Document format used under Eurasian Economic Union rules. The review covered product quality and manufacturing (chemistry, manufacturing and controls), nonclinical data, clinical efficacy and safety data, and the pharmacovigilance system and risk management plan. BOT and BAL were separately submitted and approved for use as a combination regimen. Under the approved product information, Botvymo is administered at 75 mg intravenously every 6 weeks for up to 4 doses, in combination with Evamplix at 240 mg intravenously every 2 weeks for up to 2 years or until disease progression or unacceptable toxicity. Each marketing authorization is conditional and valid for one year and is renewable based on the clinical updates that Agenus will provide to the Armenian regulator each year. “Armenia is the first country in the world to grant marketing approval for BOT+BAL,” said Garo H. Armen, PhD, Chairman and Chief Executive Officer of Agenus. “The evidence behind this decision has been published in peer-reviewed journals and presented at major cancer conferences, and it has consistently pointed to clinical benefit for patients with metastatic colorectal cancer. We thank Armenia’s health authorities for the depth and care of their review. Patients who have exhausted standard treatments now have a new option, and we are proud to bring it to them.” Clinical Evidence Supporting the Approvals The Armenian approvals were based on the totality of clinical evidence for BOT+BAL in MSS mCRC, including mature results from the fully enrolled MSS mCRC patient cohort from the Phase 1b C-800-01 study and data from the randomized Phase 2 C-800-25 study. Results from this clinical program have been published in peer-reviewed journals, including Nature Medicine and Clinical Cancer Research , and presented at major oncology congresses, including the ASCO Gastrointestinal Cancers Symposium. The efficacy and safety data supporting the approvals are summarized in the approved product information for Botvymo and Evamplix. Regional Opportunities Following the Armenian approvals, Agenus will evaluate the potential to seek marketing authorizations for BOT+BAL in the MSS metastatic colorectal cancer setting in other Eurasian Economic Union member countries. Access to BOT+BAL Outside Armenia The Armenian marketing authorizations apply within the territory of Armenia. In France, the national Autorisation d’Accès Compassionnel (AAC) program provides fully reimbursed, hospital-based access to BOT+BAL for eligible patients with MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. In a growing number of other countries, BOT+BAL is available through physician-initiated named-patient programs under local regulations. BAP Pharma serves as Agenus’ global partner for the French AAC pathway and named-patient access programs. Physicians seeking information about authorized access pathways can visit the Patient Access section of our corporate website. Important Safety Information The approved product information for Botvymo and Evamplix includes warnings and precautions for immune-mediated adverse reactions, including colitis and diarrhea, hepatitis, pneumonitis, endocrinopathies, nephritis, myocarditis and pancreatitis, as well as infusion-related reactions. Healthcare professionals in Armenia should consult the approved product information before prescribing. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. BOT augments immune responses across a wide range of tumor types by priming and activating T cells, reducing intratumoral regulatory T cells, activating myeloid cells and inducing durable memory responses. BOT+ balstilimab (BAL) has been studied in over 1,500 patients across more than nine tumor types, spanning late-line refractory disease and early-stage neoadjuvant settings. The combination is being developed to expand immunotherapy benefit to more patients, including those with microsatellite stable (MSS) disease and tumors considered immunologically “cold” or resistant to existing immunotherapies. Agenus’ Phase 3 ROBBIN study is designed to evaluate BOT+BAL given before surgery in earlier-stage colon cancer. For more information about botensilimab trials, visit . About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability pro several tumor types. Botvymo and Evamplix are authorized in Armenia for use in combination for the treatment of previously treated MSS metastatic colorectal cancer without active liver metastases. Their use in other indications and in other countries remains investigational. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, the conditional Armenian marketing authorizations and their renewal, the availability of treatment to patients who travel to Armenia, potential regulatory submissions in other countries, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Contacts Investors 917-362-1370 | investor@agenusbio.com Media 781-674-4422 | communications@agenusbio.com

Clinical ResultImmunotherapyDrug ApprovalPhase 2Phase 3

100 Deals associated with Balstilimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11820	-	-	DB15676

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Unresectable Colorectal Carcinoma	Phase 3	Canada	Agenus, Inc.	31 Mar 2026
Liver metastases	Phase 3	France	Agenus, Inc.	08 Dec 2025
Metastatic gastric adenocarcinoma	Phase 3	France	Agenus, Inc.	08 Dec 2025
Anus Neoplasms	Phase 3	Netherlands	Agenus, Inc.	29 Jan 2024
Esophageal Squamous Cell Carcinoma	Phase 3	Netherlands	Agenus, Inc.	29 Jan 2024
MSI-H/dMMR Solid Tumors	Phase 3	Netherlands	Agenus, Inc.	29 Jan 2024
Advanced cancer	Phase 3	United States	Agenus, Inc.	02 Aug 2021
Advanced cancer	Phase 3	Armenia	Agenus, Inc.	02 Aug 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	United States	Agenus, Inc.	02 Aug 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Armenia	Agenus, Inc.	02 Aug 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05205330 (ESMO2026)	Phase 1/2	Metastatic Digestive System Carcinoma PD-L1 CPS ≥5 \| PD-L1 CPS <5	27	Vorbipiprant + balstilimab (gastric cancer (GC) with PD-L1 CPS ≥5)	ozirelfipl(xnteubmobq) = Only one anti-PD-1-related serious adverse event (immune-mediated pneumonitis) was observed feoqpsrymc (bajxoytsrw )	Positive	23 Oct 2026
				Vorbipiprant + balstilimab (gastric cancer (GC) with PD-L1 CPS <5)
ESMO2026	Not Applicable	pMMR/MSS/MSI-L Colon Cancer pMMR \| MSS	43	Botensilimab 75 mg Q6WBalstilimab 240 mg Q2W + Botensilimab 75 mg Q6WBalstilimab 240 mg Q2W	pwjxeqlgau(jeudpigbgw) = uxjrslgdqk dpmkfwklxd (mgdewqwllu ) View more	Positive	23 Oct 2026
NCT06279130 (NEOASIS, ESMO2026)	Phase 2	Microsatellite instability-high colorectal cancer Neoadjuvant dMMR	18	Botensilimab 50mg + Botensilimab 50mg	qdvuucaztq(zvlqjxzmkj) = jwnixpiuro wivhexkgfc (ccoaghufpn ) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	Advanced Sarcoma	25	BotensilimabBalstilimabb + BotensilimabBalstilimab	jijwnylgil(payjmrcpir) = pxcfkvwbmf dtfivbylkr (xpvlnjjukn ) View more	Positive	23 Oct 2026
NCT03495882 (CTgov)	Phase 1/2	Locally Advanced Malignant Solid Neoplasm \| Uterine Cervix Adenocarcinoma \| Uterine Cervical Cancer ... View more	175	Balstilimab+Zalifrelimab (Phase 2: Zalifrelimab + Balstilimab)	zaolbecxrb = imoeljqkig eeqnamqhwu (wudzjmwojb, tjqxmqcxxy - vpwgvyrzop) View more	-	11 Aug 2026
				Balstilimab+Zalifrelimab (Phase 1 - Dose 1: Zalifrelimab + Balstilimab)	msvwalswaw = nojonhqywu xwvkmvahki (sslyflitdb, aovqvivrgx - xoiaubyqyd) View more
NCT03860272 (C-800-01, ESMO_GI2026)	Phase 1	Metastatic Microsatellite Stable Colorectal Carcinoma microsatellite-stable	123	Botensilimab (BOT) + balstilimab (BAL)	oprndvdlja(fctgtyugyh) = zpaifsqtgr rupgnexyfi (ozrrmtzpgw, 14 - 29) View more	Positive	02 Jul 2026
				Botensilimab (BOT) + balstilimab (BAL) (exposed to late-line tx)	oprndvdlja(fctgtyugyh) = sifxxmyhvd rupgnexyfi (ozrrmtzpgw, 10 - 38) View more
NCT07227636 (ASCO2026)	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma Adjuvant microsatellite-stable	54	balstilimabb + balstilimab (Stage III MSS CRC)	ydmpurwwcw(nfuogzhahh) = zfoapcdtaf hscuidkkuy (qyoljyluxe )	Positive	29 May 2026
NCT07152821 (CO.33/BATTMAN, ASCO2026)	Phase 3	Unresectable Colorectal Carcinoma	834	botensilimabbalstilimabb + botensilimabbalstilimab	rezgkamofr(fuqjzykrsh) = psnjoitkzg iobzymswib (qadncrnrfk )	Positive	29 May 2026
NCT05571293 (NEST-1 \| NEST, CTgov)	Phase 2	Microsatellite instability-high colorectal cancer \| Rectal Cancer \| Colonic Cancer ... View more	26	Botensilimab+Balstilimab (Cohort A: Botensilimab and Balstilimab (Bot/Bal))	vrhzgcanli = smzluiszgd maxiafbqpw (yddphnmkoi, madkusfsxm - rmqemkzssx) View more	-	22 May 2026
				Botensilimab+Balstilimab (Cohort B:)	vrhzgcanli = bbsbgvnbsz maxiafbqpw (yddphnmkoi, majlrsgpjf - tkhjnixalg) View more
NCT03860272 (C-800-01, Company_Website) Manual	Phase 1	Advanced cancer	341	botensilimab+balstilimab	eblxdhdksl(ugukedphlb) = gbhihynrmw onarxgtvez (zdennmkqgz ) View more	Positive	19 Feb 2026
				botensilimab+balstilimab (imAEs within the first 12 weeks)	ldtqcjblvs(jidekceytx) = ovjtsjexts yhsncyzcxa (byonmukxbw )

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis