Expanded Access Policy

Immunocore is focused on delivering first-in-class biological therapies that have the potential to transform the lives of people with serious diseases. These novel therapies are tested in clinical trials to study the safety and effectiveness of the investigational treatment. The data generated from theses clinical trials may be used to support an application to regulatory bodies such as the US Food and Drug Administration and the European Medicines Agency. For a list of our clinical trials currently recruiting patients, please visit www.clinicaltrials.gov.

In general, patients obtain access to investigational agents prior to regulatory approval by participating in clinical trials. There may, however, be circumstances in which a patient is facing a serious or life-threatening condition, has exhausted available treatment options, and is unable to participate in a clinical trial. In those cases, regulators may permit companies such as Immunocore to provide special access to investigational medicines outside of a clinical trial setting. These situations are often called expanded access programmes, but are also referred to as compassionate use, early access, pre-approval access, or emergency use. An investigational treatment has not yet been demonstrated to be safe and effective and has not been approved by the FDA.

Current Status of Medicines in Development

Immunocore currently has three medicines in clinical development:

• Tebentafusp (IMCgp100)
•  GSK01 (NY-ESO-1)
•  IMC-C103C (MAGE-A4)

Based on the policy outlined below, and specifically the guiding principle that there must be sufficient clinical data to support a positive benefit/risk before early access can be considered, we do not currently offer any of our developmental medicines through a compassionate use or expanded access programme.  We continue to study and actively enrol patients in these clinical development programmes and encourage those who are interested in learning more to visit www.clinicaltrials.gov.

How Expanded Access Works

Consistent with applicable laws and regulations, Immunocore may, at its discretion, provide patients with access to our investigational treatments through expanded access programmes when there is sufficient evidence of the investigational agent's safety and efficacy to support its use in a particular situation.

The decision to allow expanded access to an investigational treatment is complex and Immunocore's policy is aligned with guidelines from FDA and other regulatory authorities. Consideration of a request for expanded access to an investigational treatment may be granted only if each of the following criteria are met:

• The patient has a serious or life-threatening disease
• The patient is ineligible for an ongoing clinical trial of that investigational treatment
• The patient's disease is similar to the indication(s) for which the investigational treatment is currently being evaluated in pivotal study(ies)
• No comparable therapies (investigational or approved) are available
• Immunocore must be able to review data from certain completed studies to determine whether, for patients with disease or condition to be treated, the potential benefits of the investigational treatment outweigh the potential risks.
• There is an adequate supply of the investigational treatment
• It is logistically feasible to make the investigational treatment available and it can be safely administered in a controlled setting. The physician and site must be experienced with the safe use of the product via clinical study(s) participation.
• Physician is willing to complete and adhere to regulatory mechanism for access, and have adequate staff and facilities to safely administer and monitor patient.
• The treatment plan and required observation/follow-up (inclusion/exclusion criteria, treatment plan, follow-up and safety monitoring) must be adhered as provided.
• Required informed consent must be obtained
• The expanded access to the investigational treatment will not in any way compromise the planned development or interfere with the regulatory approval process

Immunocore will evaluate each request for expanded access in a timely and fair manner. A request for expanded access to an investigational treatment must be made by a qualified and licensed physician to medicalinformation@immunocore.com.

Immunocore will acknowledge receipt of a request within 5 business days. Each request will be evaluated by key members of our medical and regulatory team based on the criteria above for each experimental agent, and a decision will be provided to the requesting healthcare provider.

Immunocore may revise this policy at any time and will remain aligned with the 21st Century Cures Act. This website and policy will be updated with a hyperlink or other reference to the expanded access record on www.clinicaltrials.gov after such record becomes active.