Agenus Names BAP Pharma as Exclusive Global Partner for BOT+BAL Access Programs

Key Terms

autorisation d’accès compassionnel (aac) regulatory

A autorisation d’accès compassionnel (AAC) is a regulated permission that allows patients to receive an unapproved or not-yet-commercial medicine outside of clinical trials when no satisfactory approved treatment exists. Investors should watch AACs because they can signal early real-world use, create limited revenue channels, affect regulatory timelines and public perception, and provide real-world safety and effectiveness data that may influence a drug’s commercial prospects—think of it as a controlled early-release to a few users before full market launch.

named-patient programs (npp) regulatory

Named-patient programs (NPP) are special-access arrangements that allow individual patients to receive a medicine that is not yet approved locally, typically when a doctor requests it for a serious condition. For investors, NPPs act like early market access or pre-orders: they can generate initial sales, produce real-world safety and usage data, and help build clinical and regulatory relationships that may speed broader approval and commercial rollout.

metastatic colorectal cancer medical

Metastatic colorectal cancer is cancer that started in the colon or rectum and has spread to other parts of the body, most often the liver or lungs, making it harder to treat. For investors, it matters because advanced disease drives demand for more intensive treatments, ongoing clinical trials, and long-term care costs; think of it like a fire that has jumped from one room to multiple rooms, requiring bigger, more expensive responses and creating larger market opportunities and regulatory scrutiny.

platinum-resistant medical

Platinum-resistant describes a cancer that no longer responds to chemotherapy drugs containing platinum, such as cisplatin or carboplatin. Like a key that no longer fits a lock, these tumors stop shrinking after treatment, which matters to investors because it narrows standard therapy options, drives demand for novel drugs or combination regimens, affects clinical trial design and endpoints, and can change a treatment’s potential market size and regulatory path.

soft-tissue sarcomas medical

Soft-tissue sarcomas are a group of cancers that arise in the body's connective tissues—such as muscle, fat, nerves, blood vessels and fibrous tissue—rather than in organs. They matter to investors because they represent a set of distinct, often rare medical needs that drive clinical trials, regulatory decisions and specialized drug development; successful therapies can translate into niche but valuable markets, much like unique models within a single car brand serving different customer needs.

microsatellite stable medical

Microsatellite stable describes a tumor whose short, repeating DNA sequences (microsatellites) show few or no errors, meaning the cancer’s internal “spell-check” system is largely intact. For investors, this matters because microsatellite stability is a biomarker that helps predict how likely a tumor is to respond to certain therapies and clinical trials, affecting drug development prospects, regulatory decisions, and the size of the potential patient market.

phase 3 medical

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

marketing authorization regulatory

An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.

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• Partnership enables timely access to botensilimab plus balstilimab through France’s government-reimbursed Autorisation d’Accès Compassionnel (AAC) pathway and paid named-patient programs (NPP) in select countries

LEXINGTON, Mass. & MARLOW, England--(BUSINESS WIRE)-- Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, and BAP Pharma, a global medicines access and clinical trial supply company, today announced the exclusive appointment of BAP Pharma as Agenus’ global partner for botensilimab (BOT) plus balstilimab (BAL) authorized global access programs.

The partnership supports compliant, patient-focused access to BOT+BAL through authorized pathways where permitted by local regulations. Effective immediately, BAP Pharma will serve as Agenus’ exclusive partner for the coordination of BOT+BAL global access program operations, including program requests, case coordination, distribution logistics, and related payment processing.

These programs include France’s Autorisation d’Accès Compassionnel (AAC) pathway as well as paid named-patient programs (NPPs) in select countries outside the United States. As previously disclosed, Agenus has received more than 270 physician inquiries from more than 30 countries across these pathways.

“Physicians around the world continue to express strong interest in BOT+BAL through authorized early access pathways, informed by the growing body of clinical data generated to date and the urgent need for better options for patients with serious cancers,” said Garo H. Armen, PhD, Chairman and CEO of Agenus. “Our exclusive partnership with BAP Pharma strengthens the infrastructure behind these programs and reinforces our commitment to act responsibly and efficiently. Where access is permitted, we believe we have a moral responsibility to help enable appropriate, compliant access for patients whose physicians are seeking new alternatives.”

France’s AAC program provides hospital-based, fully government-reimbursed 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 under a nationally defined protocol. These patients typically have advanced cancers for which standard treatment options have been exhausted. Outside France, BOT+BAL may be available in select countries through paid NPPs initiated by treating physicians and governed by local regulations, including where a treating physician determines that BOT+BAL is an appropriate option for an individual patient based on the clinical data generated to date, medical need, and applicable local requirements.

Physician interest in BOT+BAL access has broadened across regions. Patients have already been treated through regulatory-authorized paid named-patient programs in multiple countries across South and Central America and Europe, including the United Kingdom, Switzerland, Greece, Brazil, and Argentina, with expansion into Spain where permitted by local regulations.

Under the collaboration, BAP Pharma will coordinate Agenus’ global access operations across these programs. BAP Pharma brings extensive global medicines access experience, a professional and responsive approach to physician and site engagement, and the operational rigor required to streamline logistics, strengthen regional coordination, and support treating physicians navigating country-specific regulatory frameworks.

“BAP Pharma’s team has demonstrated the professionalism, responsiveness, and operational rigor that are essential in supporting global access programs,” said Kamel Djazouli, M.D., Head of Medical Affairs of Agenus. “Their approach aligns well with our commitment to physicians and patients seeking access through authorized pathways, and we believe this partnership will help strengthen the experience for health care teams around the world.”

Bashir Parkar, M.D., Founder of BAP Pharma, commented, “Being selected as Agenus’ exclusive global partner is a significant milestone for BAP Pharma. It reflects the trust placed in our ability to deliver compliant, patient-focused access solutions at scale. Our role is to remove complexity and ensure physicians can access critical therapies for their patients with confidence, speed, and full regulatory alignment.”

Rebecca Bibby, Group Director, Medicines Access at BAP Pharma, added, “This partnership demonstrates the growing importance of well-structured global access programs in today’s clinical and regulatory environment. By combining Agenus’ innovative therapies with BAP Pharma’s global operational expertise, we are enabling a more seamless, reliable pathway for physicians and patients navigating early access options.”

Agenus’ early access efforts complement its ongoing clinical development strategy for BOT+BAL, including the global Phase 3 BATTMAN trial in refractory MSS/pMMR metastatic colorectal cancer. Until marketing authorization is granted, BOT+BAL is available only through clinical trials and authorized access pathways where permitted and available under local regulatory frameworks. Visit Agenus’ website for more information on patient access at Access to Investigational Medicines Policy.

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.

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.

About BAP Pharma

BAP Pharma is a global partner to the pharmaceutical and biotech industry, delivering clinical trial supply and medicines access solutions. Its core focus is Medicines Access, enabling timely, compliant access to critical therapies through early and managed access programmes worldwide. Across its services, BAP Pharma aims to deliver certainty—removing complexity and ensuring confidence for sponsors, physicians, and patients.

Website: https://bappharma.com/

LinkedIn: https://linkedin.com/company/bap-pharma

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.

Source: Agenus Inc. & BAP Pharma

View source version on businesswire.com: https://www.businesswire.com/news/home/20260421146539/en/

Agenus Investors: 917-362-1370 | investor@agenusbio.com

Agenus Media: 781-674-4422 | communications@agenusbio.com

BAP Pharma Media: Jason De Kauwe | Jason.DeKauwe@bappharma.com

Source: Agenus Inc. & BAP Pharma