Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced the appointment of José Iglesias, M.D. as Chief Medical Affairs Officer, effective November 10, 2025. Dr. Iglesias will lead global medical affairs for botensilimab (BOT) and balstilimab (BAL) as the combination advances through Phase 3 evaluation and becomes available in selected countries through early-access mechanisms, including France’s Autorisation d’Accès Compassionnel (AAC) program.

BOT is an Fc-enhanced multifunctional CTLA-4 antibody and BAL is a PD-1 antibody. In combination, BOT/BAL is being investigated in patients with microsatellite-stable colorectal cancer (MSS CRC), a population that has historically derived limited benefit from immunotherapy despite substantial unmet medical need.

Dr. Iglesias brings over 30 years of global oncology and immuno-oncology drug development experience. Previously, at Abraxis BioScience and Celgene, he led late-stage development and life-cycle management of Abraxane in pancreatic, lung, and metastatic breast cancers, supporting its integration into routine practice across these tumor types. Most recently, Dr. Iglesias served in senior medical leadership roles at Bionomics, Biothera, and Apobiologix, where he directed global oncology programs across biologics, small molecules, and immunotherapies.

In his new role, Dr. Iglesias will oversee global medical affairs strategy for BOT/BAL, including medical evidence generation, communications, and scientific exchange with clinicians, investigators, and health authorities. He will also guide appropriate use of BOT/BAL within regulatory and early-access frameworks worldwide, including France’s AAC program, with a focus on robust data collection and real-world evidence.

France has granted BOT/BAL AAC authorization for MSS colorectal cancer, enabling eligible patients to access the combination with full government reimbursement under the national early-access framework. Hospitals and treating physicians in France have already begun submitting AAC requests, and treatment has been initiated. This AAC authorization complements existing and planned named-patient and early-access programs in additional geographies, where Agenus is pursuing access under local regulations. Under Dr. Iglesias’ leadership, medical affairs will support appropriate use, physician education, and real-world evidence across these pathways.

“José has played a central role in the development and global adoption of important oncology medicines such as Abraxane,” said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. “As BOT/BAL moves through our global Phase 3 BATTMAN program and becomes available through mechanisms like the French AAC and other early-access and named-patient pathways, his experience in evidence generation, access strategy, and post-approval data collection will be critical to how we work with clinicians, regulators, and payers to inform care for patients with MSS colorectal cancer.”

“Throughout my career, I have focused on building the clinical and real-world evidence needed to bring new oncology treatments, including Abraxane, into standard practice,” said Dr. José Iglesias, Chief Medical Affairs Officer, Agenus. “BOT/BAL is being studied in patients with MSS colorectal cancer, a group for whom current options remain limited. My priority is to build a medical affairs organization that collaborates closely with investigators and treating physicians, supports high-quality evidence generation, and ensures that early-access frameworks such as AAC in France and named-patient programs in other countries are used appropriately and responsibly for eligible patients.”

Iglesias has authored more than 70 peer-reviewed publications and is an active member of the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), and the European Society for Medical Oncology (ESMO). He earned his medical degree in Uruguay, completed a post-doctoral fellowship from the University of Toronto as well as fellowships at the Weizmann Institute of Science and Duke University. Dr. Iglesias began his career in oncology and hematology practice before transitioning to the biopharmaceutical industry.

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 www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.

Agenus’ Commitment to Patient Access

Agenus is dedicated to making investigational medicines available to patients with cancer at the appropriate time and in the correct manner. For more information, visit https://agenusbio.com/access-to-investigational-medicines-policy

About Botensilimab (BOT)

Botensilimab (BOT) is a human Fc-enhanced multifunctional 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. 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.

Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. 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 more than 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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