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Agenus to Highlight Emerging Survival Plateaus with Botensilimab/Balstilimab in Oral Presentation of Study in Refractory Patients Across Five Tumor Types at ESMO 2025

Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced that four abstracts highlighting clinical progress across its botensilimab and balstilimab immunotherapy programs have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2025, taking place in Berlin, Germany from October 17-21. The highlight is an oral presentation that will feature emerging survival plateaus from a study of botensilimab plus balstilimab in 343 evaluable patients with refractory metastatic solid tumors across five tumor types. Three additional poster presentations will feature data from investigator-sponsored studies in cervical cancer, MSS metastatic colorectal cancer (mCRC), and non-melanoma skin cancers, underscoring the broad potential of botensilimab and balstilimab based combinations in difficult-to-treat cancers.

Presentation Details:

1. Oral Presentation Title: Emerging survival plateaus with botensilimab and balstilimab: Pan tumor data from a large phase 1b trial of advanced solid tumors
 
Presenting Author:

Dr. Michael Gordon; HonorHealth Research Institute-AZ, USA

Mini Oral Session:

Investigational Immunotherapy

Session Date:

Friday, October 17, 2025

Session Time:

2:00-3:00 PM CEST / 8:00-9:30 AM EDT

Location:

Hall 5.2

Abstract Number:

3220

 

2.

Poster Presentation Title: Efficacy and safety of balstilimab with or without zalifrelimab in recurrent cervical cancer: Results from the global phase 2 RaPiDs trial
 
Presenting Author: Dr. David O’Malley; The Ohio State University Comprehensive Cancer Center- OH, USA

Session Date:

Saturday, October 18, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

2952

Poster Number:

1164P

 

3.

Presentation Title: A Phase I trial of botensilimab, balstilimab and regorafenib (BBR) in chemotherapy-resistant patients with microsatellite stable (MSS) metastatic colorectal cancer
 

Presenting Author:

Dr. Marwan Fakih; City of Hope- CA, USA

Session Date:

Sunday, October 19, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

6197

Poster Number:

851P

 

4.

Presentation Title: A phase 2, open label study to evaluate the safety and clinical activity of balstilimab in patients with advanced/metastatic non-melanoma skin cancers (AGENONMELA)
 

Presenting Author:

Dr. Iwona Lugowska; Maria Sklodowska-Curie National Research Institute and Oncology Center - Poland

Session Date:

Monday, October 20, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

7273

Poster Number:

1662P

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 (through SaponiQx). 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 www.agenusbio.com 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 is a multifunctional, human Fc enhanced CTLA-4 blocking 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. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. Approximately 1,200 patients have been treated across the botensilimab/balstilimab program in phase 1 and phase 2 clinical trials. For more information about botensilimab trials, visit www.clinicaltrials.gov.

 

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 >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.

 

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 2024, 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.

 

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