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 that 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 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 or med.info@agenusbio.com.

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

Program managed by MyTomorrows.

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, once certain patient eligibility criteria are met.

Patients with cancers where BOT+BAL could help, meeting local regulations.

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

Physicians should reach out to learn more.

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.

Easy steps for doctors:

Who may qualify?

Email Agenus Medical Affairs at med.info@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 (Expanded or Early Access)

For those rare situations where trials are not an option and no other treatments remain, compassionate use offers a potential lifeline for treatment with BOT+BAL.

Easy steps for doctors:

Email Agenus Medical Affairs at: med.info@agenusbio.com to begin.

Patient details are not needed in initial email—we'll review based on our policy rules and regulations.