Access to Investigational Medicines Policy

When participation in an ongoing clinical trial is not possible a patient with a serious or life-threatening disease and no available alternative satisfactory treatment option, a company may provide a treating healthcare professional with access to investigational medicines outside of a clinical trial setting. This is done via Expanded Access, which may also be referred to, amongst other terms, as “managed access”, “early access”, “compassionate use” or “named patient supply”. It is important to remember that investigational medicines have not yet received regulatory approval; therefore, potential risks and benefits are not formally established. Healthcare professionals and patients should consider all possible benefits and risks when seeking Expanded Access to an investigational medicine.

Agenus will review requests for Expanded Access to its investigational medicines according to the following criteria:

• The patient’s disease is serious or life-threatening.
• The patient has undergone appropriate standard treatments; there are no comparable or satisfactory alternative treatments for the disease or condition; the treatment is adjunct to an existing treatment option, and the treatment is not medically contra-indicated.
• Sufficient efficacy and safety evidence exists to make a benefit-risk analysis consistent with this policy and the potential patient benefit justifies any potential risks of treatment. (Such conditions are usually met at the end of Phase 1b studies, and depending on the clinical program, potentially even later.)
• Sufficient clinical data are available to identify an appropriate dose and treatment duration.
• The patient’s treating physician and qualified medical personnel at Agenus agree there is sufficient evidence to assume the potential benefit to the patient justifies potential risks. The policy “Access to Investigational Medicines” was updated in November 2024.
• The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine, including lack of access due to geographic limitations.
• Expanded Access will not adversely impact any clinical development program, in particular, the conduct of a pivotal clinical trial that is required for regulatory approval.
• The request must be made by the patient’s treating physician, who must be a qualified and licensed MD, unsolicited by Agenus or any other individual or organization working on behalf of Agenus.

If all these conditions are met, Agenus will consider Expanded Access requests from treating physicians.

All requests will be evaluated in a fair, unbiased manner. Patients with comorbidities that are contraindicated for the requested investigational medicine, which may impose safety risks, or which have not been sufficiently studied, will be excluded. Any access to an investigational medicine must comply with applicable country regulations and investigational medicine importation requirements, may require approval from applicable regulatory bodies, and may require Institutional Review Board or Ethics Committee approval from the treating institution. If approved, the patient (or guardian) must provide informed consent for treatment with the investigational medicine and consent to comply with the safety and monitoring requirements defined by standard medical practice and Agenus. The treating physician must equally agree to comply with the safety and monitoring requirements.

Expanded Access will cease being made available if ongoing clinical trials do not continue to demonstrate a positive risk/benefit profile for patients or at the discretion of Agenus.

Treating physicians can initiate a request for Expanded Access by sending an email to med.info@agenusbio.com. Please do not include any identifying patient information in the initial email. Receipt of a request will be acknowledged within one business day