Access to Medicines in Development

Updated September 2025

At Agenus, we're dedicated to bringing hope to patients facing cancer by providing access to our promising investigational therapies. We're excited to offer options like botensilimab (BOT, a next-generation anti-CTLA-4) combined with balstilimab (BAL, a PD-1 inhibitor)—together known as BOT+BAL—in ways that are safe, structured, and supportive.

While these medicines are still under development and not yet approved, they've shown encouraging potential in clinical studies. We encourage patients and doctors to explore these paths together, weighing benefits and risks carefully.

For more information, see our Access to Investigational Medicines Policy.

1. France's Reimbursed Compassionate Access Pathway (Accès Compassionnel – AAC)

On behalf of eligible patients, we're pleased that France's health authority (ANSM) has authorized BOT+BAL for French patients through the AAC program—a positive step that validates its potential and provides fully reimbursed treatment in a hospital setting.

Treatment under AAC is governed by a national protocol that standardizes patient eligibility, treatment administration, data collection and follow-up under France’s ANSM. This means structured access with expert oversight and patient monitoring to ensure the best care is provided.

Who may qualify? Adult French patients with:

• MSS metastatic colorectal cancer without active liver metastases, following progression on standard therapies and not eligible for clinical trials,
• Platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, after being treated with approved treatment options, and
• Advanced or metastatic soft-tissue sarcomas, including multiple high-grade histologies, following failure of standard therapies

European Union and European Economic Area (EU/EEA) residents may be able to access treatment via cross-border care, often with home insurance coverage (check insurance for prior approval).

‍Easy steps for doctors:

Start by emailing Agenus Medical Affairs to learn more at: AAC@AgenusBio.com.

Patient details are not needed in your first message—we'll guide you from there.

2. Global Paid Named Patient Program (Select Countries Outside the US)

Many countries across the globe have hospitals able to provide treatment with BOT+BAL and other Agenus medicines in development through certain pathways through a Named Patient Program, once certain patient eligibility criteria are met.

For patients living in a specific country that does not have the facilities to offer treatment in their home country, Cross Border Medical Care may be an option in certain countries that do offer Named Patient Programs. Some countries operate treatment‑abroad programs on a case‑by‑case basis.

There is a treatment charge associated with this program. Costs are determined based on local regulations and program policies. Patients should consult their national health authority and/or insurer to learn if coverage for a medicine in development either in or outside their home country is covered or decide if private pay is an option for you.

Physicians should reach out to learn more.

Who may qualify? Patients with serious conditions where BOT+BAL could help and where local country regulations enable this option.

Easy steps for doctors:

Email Agenus Medical Affairs at: NPP@AgenusBio.com . We'll make it simple.

3. Clinical Trials

Joining a clinical trial is an important way to access innovative treatments in development like BOT+BAL while helping advance science that could benefit everyone. Many patients find it rewarding and empowering!

‍Who may qualify? Every study has different enrollment criteria to join the study and requires informed consent.

Get started: explore ongoing trials. Your doctor can help check if a trial is appropriate for you.

4. Compassionate Use Program in the US (Expanded or Early Access)

Agenus recognizes the urgency faced by patients and families affected by serious cancers and remains committed to advancing immunotherapies that can ultimately reach as many patients as possible.

At this time, clinical trials are the primary pathway for patient access to botensilimab and balstilimab in the United States. Decisions regarding expanded or early access are made in alignment with regulatory requirements, clinical considerations, and the need to preserve the integrity of ongoing development programs.

Access pathways vary globally, and in certain countries outside the United States, investigational therapies may be available through Named Patient Programs or other early access mechanisms in accordance with local regulations. Agenus continues to prioritize clinical development and regulatory progress to support broader future access for patients.