Agenus Appoints Dr. José Iglesias as Chief Medical Affairs Officer to Lead Global Strategy for BOT/BAL and Early-Access Programs
Agenus Inc. (Nasdaq: AGEN), a biotechnology company recognized for its long-standing leadership in immuno-oncology, announced the appointment of José Iglesias, M.D., as its new Chief Medical Affairs Officer, effective November 10, 2025. His appointment comes at a critical and transformative time for the company, as Agenus prepares for the global expansion of its lead immunotherapy combination—botensilimab (BOT) and balstilimab (BAL)—as it progresses through late-stage development and enters early-access channels in select regions.
In his new role, Dr. Iglesias will be responsible for shaping and executing Agenus’ medical affairs strategy worldwide. This includes leading scientific and medical engagement efforts, guiding evidence-generation initiatives, supporting real-world data collection, and strengthening collaborative relationships with clinicians, investigators, policymakers, and regulators. His leadership will be particularly important as BOT/BAL becomes available through formal early-access pathways such as France’s Autorisation d’Accès Compassionnel (AAC) program, with additional countries expected to follow.
Advancing the BOT/BAL Immunotherapy Combination
Agenus’ therapeutic focus on next-generation immunotherapies has placed its BOT/BAL combination at the forefront of oncology innovation. BOT is an Fc-enhanced, multifunctional CTLA-4 antibody engineered to activate anti-tumor immune responses more effectively than traditional CTLA-4 agents. BAL is a PD-1 antibody designed to reinvigorate exhausted immune cells and enhance tumor response. Together, the combination aims to unlock meaningful clinical benefit for patient populations historically underserved by existing immunotherapies.
One such group is patients with microsatellite-stable colorectal cancer (MSS CRC). MSS CRC represents the majority of colorectal cancer cases, yet these patients typically show poor responses to conventional checkpoint inhibitors. With limited effective treatment options available, the unmet medical need in MSS CRC remains considerable. Early clinical data with BOT/BAL have generated significant interest, prompting global Phase 3 development through Agenus’ BATTMAN program and enabling early-access opportunities in select countries.
The growing clinical momentum—and the need for closely coordinated medical affairs leadership—makes Dr. Iglesias’ arrival timely and strategically important.
A Leader with Decades of Oncology and Immuno-Oncology Expertise
Dr. José Iglesias joins Agenus with more than three decades of experience spanning oncology research, drug development, and medical affairs leadership. His career has included major contributions across the oncology landscape, from early research to the commercialization of globally adopted cancer therapies.
During his tenure at Abraxis BioScience and Celgene, Dr. Iglesias was instrumental in the late-stage development and lifecycle management of Abraxane, a nanoparticle albumin-bound formulation of paclitaxel. Under his guidance, Abraxane advanced across multiple indications—including pancreatic cancer, non-small cell lung cancer (NSCLC), and metastatic breast cancer—and became an integral component of routine oncologic practice worldwide. The therapeutic’s adoption across diverse tumor types underscored Dr. Iglesias’ capacity to guide evidence-generation, shape treatment guidelines, and collaborate effectively with clinicians and regulators.
He later held influential senior roles at Bionomics, Biothera, and Apobiologix, where he oversaw broad oncology pipelines ranging from biologics to small molecules to immunotherapies. Across these roles, Dr. Iglesias led global medical, clinical, and scientific strategy, ensuring that new therapies were supported by rigorous data and aligned with real-world clinical needs.
His extensive publication record—more than 70 peer-reviewed papers—demonstrates his commitment to scientific advancement and evidence-based medicine. He remains an active member of leading oncology organizations, including the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), and the European Society for Medical Oncology (ESMO). His academic background includes a medical degree from Uruguay and post-doctoral fellowships at the University of Toronto, the Weizmann Institute of Science, and Duke University.
Strengthening Medical Affairs as BOT/BAL Moves Toward Global Access
As Chief Medical Affairs Officer, Dr. Iglesias will lead a comprehensive strategy designed to support the global clinical use of BOT/BAL. His responsibilities will include:
- Medical evidence generation: Developing medical strategies that integrate ongoing clinical trials, investigator-sponsored studies, and real-world data collection.
- Scientific communication: Ensuring clear, accurate, and timely dissemination of data to healthcare professionals, scientific communities, regulators, and payers.
- Engagement with clinicians and investigators: Strengthening relationships with oncologists, research sites, academic institutions, and global cancer networks.
- Regulatory and early-access support: Guiding appropriate use of BOT/BAL through AAC, named-patient programs, and other early-access frameworks internationally.
- Real-world evidence (RWE) strategy: Implementing programs to collect robust RWE to complement Phase 3 data and support potential future regulatory submissions, reimbursement decisions, and post-approval safety monitoring.
Crucially, Dr. Iglesias will help ensure that the transition of BOT/BAL from clinical trials to broader availability is done responsibly, safely, and in accordance with regulatory expectations.
France Grants Early-Access Authorization for BOT/BAL
France’s early-access decision marks a major step in recognizing the potential of the BOT/BAL combination for MSS CRC. The Autorisation d’Accès Compassionnel (AAC) framework allows patients with serious or life-threatening diseases to access promising therapies ahead of formal regulatory approval when no alternatives exist.
The French National Authority for Health has authorized BOT/BAL for eligible MSS CRC patients under the AAC program, providing:
- Full government reimbursement for treatment
- National early-access eligibility
- Institution-led submissions by treating hospitals and clinicians
Requests for BOT/BAL treatment have already begun, and dosing has been initiated for eligible patients. This AAC authorization is expected to serve as a benchmark for additional early-access decisions in Europe, Latin America, and other regions where Agenus is pursuing similar pathways.
The AAC launch also underscores the importance of medical affairs leadership in ensuring appropriate use, supporting clinicians with scientific resources, and establishing data-collection mechanisms that align with French and international expectations.
A Global Framework for Responsible Early Access
Beyond France, Agenus is working to broaden access to BOT/BAL through:
- Named-patient programs (NPPs)
- Early-access programs (EAPs)
- Compassionate-use mechanisms
- Localized regulatory pathways
These programs allow individual physicians or hospitals to request treatment for patients with few or no viable alternatives. Under Dr. Iglesias’ guidance, Agenus’ medical affairs teams will coordinate closely with global regulatory bodies and healthcare providers to ensure transparency, appropriate patient selection, and high-quality data collection.
This real-world evidence will complement ongoing clinical development efforts, supporting both safety monitoring and future decision-making by regulators and payers.
Executive Perspectives on Dr. Iglesias’ Appointment
Garo Armen, Ph.D., Chairman and Chief Executive Officer of Agenus, emphasized the significance of bringing Dr. Iglesias on board during this critical phase of BOT/BAL’s development.
“José has played a central role in the development and global adoption of important oncology medicines such as Abraxane,” said Dr. Armen. “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. His leadership will strengthen the way we collaborate with clinicians, regulators, and payers to advance care for patients with MSS colorectal cancer.”
For his part, Dr. Iglesias expressed enthusiasm for the opportunity to help shape the future of BOT/BAL and expand therapeutic options for patients who currently face limited treatment choices.
“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. Iglesias. “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.”
A Strategic Appointment for Agenus’ Next Phase of Growth
The addition of Dr. José Iglesias reflects Agenus’ commitment to advancing its late-stage immunotherapy pipeline with world-class scientific and medical leadership. As the BOT/BAL combination continues its Phase 3 evaluation and moves into broader global availability, the role of medical affairs becomes essential to ensuring responsible patient access, real-world insights, and continued scientific credibility.
With a proven track record in guiding oncology programs from development through global adoption, Dr. Iglesias brings the experience, vision, and operational expertise needed to support this next phase of Agenus’ evolution.
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