IMC-P115C (PRAME-HLE-A02) targets the same peptide and has the same CD3 effector and TCR specificity as brenetafusp, and is designed with extended half-life  

The Phase 1 trial will assess the safety and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with advanced solid tumors that express PRAME

OXFORDSHIRE, UK & CONSHOHOCKEN, PA & GAITHERSBURG, MA, USA I December 23, 2024 I Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announces that the first patient has been dosed in the Phase 1 trial of IMC-P115C (PRAME-HLE-A02), which is a half-life extended ImmTAC candidate.

IMC-P115C was developed to improve patient convenience by reducing the frequency of treatment administration. It is Immunocore’s first half-life extended candidate, and sixth ImmTAC candidate to enter the clinic. IMC-P115C is a PRAME x CD3 ImmTAC bispecific protein, with the same CD3 and targeting the same HLA-A*02:01 PRAME (PReferentially expressed Antigen in MElanoma) peptide as brenetafusp.

“I am very proud of the Immunocore team who have worked diligently with the clinical sites to start the Phase 1 trial with IMC-P115C – our half-life extended PRAME-targeted candidate,” said Mohammed Dar, Senior Vice President, Clinical Development and Chief Medical Officer of Immunocore. “With brenetafusp, we have the largest Phase 1/2 PRAME data set, which served as the basis for starting the first Phase 3 trial with a PRAME therapy. We look forward to the data from this Phase 1 trial, which will add to the understanding of the potential of our PRAME candidates.”

The Phase 1 dose escalation trial will evaluate the safety, pharmacokinetics and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with a range of advanced cancers expressing PRAME.

About ImmTAC® molecules for cancer

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors.

About the IMC-P115C Phase 1 trial

IMC-P115C-1005 is a first-in-human, Phase 1 trial in patients with advanced solid tumors expressing PRAME. The dose escalation portion of the trial is designed to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-P115C, a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first half-life extended molecule.

About Immunocore

Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune diseases and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including nine active clinical and pre-clinical programs​ in oncology, infectious diseases, and autoimmune diseases. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK, has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

SOURCE: Immunocore