Patients

Our 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.

Our technology

The ImmTAX™ platform generates a new class of bi-specific biologics that is designed to overcome the limitations of other immuno-oncology agents by combining a T cell receptor (TCR)-targeting system with an anti-CD3 effector function to activate a highly potent and specific T cell response to cancer cells.

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Disease indications

Oncology overview

Within oncology, we are applying our ImmTAC® platform to overcome the limitations of current anti-cancer therapies to deliver:

  • Potent and specific re-direction of a patient's own T cells to kill the target cancer cells.
  • Access to a pool of antigenic targets that is up to nine-fold greater than traditional antibody-based therapies.

This unique and potent mechanism of action provided by ImmTAC® molecules gives the potential to tackle diverse tumour types, including solid tumours that are characteristically immune excluded, or "cold" and thus resistant to the majority of existing immunotherapies that target activation of pre-existing immune cells. ImmTAC® molecules have been shown to convert "cold" tumours to "hot" through their T cell redirecting activity.

Uveal Melanoma

Uveal melanoma is an aggressive form of eye cancer that arises from melanocytes in the uveal tract of the eye. Survival in uveal melanoma has remained largely unchanged since the early 1970s with the greatest burden in metastatic disease. Currently, there is no proven standard of care for metastatic uveal melanoma, meanwhile various therapies, including checkpoint inhibitors, are used without definitive evidence of benefit in this patient population.

Tebentafusp is designed to specifically target the melanoma-associated antigen gp100 and engages T cells to direct a potent and specific response against the cancer cells.

Clinical trial locations

Europe

Europe

We have a number of clinical trials currently recruiting patients across Europe.

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North America

North America

We have a number of clinical trials currently recruiting patients across the US and Canada.

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Australasia

Australasia

We have a number of clinical trials currently recruiting patients across Australasia.

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Clinical trials information

We have a number of clinical trials currently recruiting patients.

Trial A Pivotal Study Investigating The Safety And Efficacy Of IMCgp100 Versus Investigator Choice In Advanced Uveal Melanoma (NCT03070392)

Conditions

Uveal Melanoma

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Trial A Phase 1 Study Of The Intra-Patient Escalation Dosing Regimen With IMCgp100 In Patients With Advanced Uveal Melanoma (NCT02570308)

Conditions

Uveal Melanoma

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Trial A Phase 1b/2 Study Of The Combination Of IMCgp100 With Durvalumab And/Or Tremelimumab In Cutaneous Melanoma (NCT02535078)

Conditions

Malignant Melanoma

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Trial IMCgp100-401 Rollover Study Designed To Provide Continued Access To IMCgp100 For Eligible Patients With Advanced Melanoma Who Have Previously Participated In An IMCgp100Study (NCT02889861)

Conditions

Malignant Melanoma

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Trial Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers (NCT03515551)

Conditions

Melanoma

Advanced NSCLC

Urothelial Carcinoma and Synovial Sarcoma

View details

Further Information

For more information on clinical trials see clinicaltrials.gov.

If you are a medical professional and require further information about Immunocore, our clinical research or clinical trials, please send an email to medicalinformation@immunocore.com.

Patients should contact their doctor for information regarding any aspect of their treatment or involvement in clinical trials.

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.

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.

Pipeline products

Immunocore has a robust pipeline of wholly-owned and partnered programmes

Alongside high value proprietary programmes, Immunocore has co-discovery and co-development programmes with Lilly and discovery programmes, including milestones and royalties, with Genentech, GlaxoSmithKline and MedImmune (AstraZeneca).