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Immunocore Holdings plc reports commercial and clinical developments for a biotechnology issuer whose Nasdaq-listed ADSs represent ordinary shares. The company uses its ImmTAX TCR bispecific immunotherapy platform across oncology, infectious disease and autoimmune programs, with KIMMTRAK (tebentafusp-tebn) approved for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia and the United Kingdom.
Recurring updates cover KIMMTRAK sales and long-term survival data, lifecycle-management studies in uveal and cutaneous melanoma, the PRAME-A02 candidate brenetafusp, earlier ImmTAX candidates, HIV functional-cure research, autoimmune disease pipeline activity, financial results, investor presentations and R&D governance changes.
Immunocore presented new clinical data for KIMMTRAK at the 2024 ASCO Annual Meeting. The data showed that patients with unresectable or metastatic uveal melanoma who had stable disease and confirmed tumor reduction experienced similar clinical outcomes to those with a partial response. The Phase 2 trial indicated that 25% of 127 patients had any tumor reduction, including 6 partial responses. In the Phase 3 trial, the durability of tumor reduction was similar for patients with stable disease and partial response, both lasting 11 months. This reinforces KIMMTRAK as a standard treatment for HLA-A*02:01-positive patients.
Immunocore has released updated Phase 1 data for brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients. The study showed promising disease control rates, progression-free survival (PFS), and molecular responses, particularly in PRAME positive patients. Brenetafusp was well tolerated as a monotherapy and in combination with anti-PD1. The Phase 3 clinical trial (PRISM-MEL-301) is now enrolling patients for first-line advanced cutaneous melanoma treatment. Detailed results will be presented at the ASCO 2024 meeting.
Immunocore, a Nasdaq-listed commercial-stage biotech firm specializing in immunomodulating medicines for cancer, infectious and autoimmune diseases, announced its participation in the Jefferies Global Healthcare Conference.
The event is scheduled for June 6, 2024, at 2:30 p.m. EDT.
A live webcast of the presentation will be available on the Immunocore website, with a replay accessible post-event.
Immunocore has announced the conversion of its Phase 2/3 TEBE-AM trial into a registrational Phase 3 trial to evaluate KIMMTRAK (tebentafusp-tebn) for previously treated advanced cutaneous melanoma. Following FDA consultation, all patients from the Phase 2/3 trial will be included in the Phase 3 intent-to-treat population. The Phase 3 trial will continue with three arms: KIMMTRAK monotherapy, KIMMTRAK with pembrolizumab, and a control.
This decision is expected to accelerate the time to the final overall survival analysis. The conversion was motivated by KIMMTRAK’s promising results in uveal melanoma and Phase 1 cutaneous melanoma trials. The Phase 1b study showed that KIMMTRAK, combined with checkpoint inhibitors, had a one-year overall survival rate of approximately 75% in patients with metastatic cutaneous melanoma.
Immunocore reported first quarter financial results with KIMMTRAK® net revenues of $70.3 million in Q1 2024. The company continues to expand global access with 7 additional launches since January 2024. Phase 1/2 brenetafusp clinical data in post-checkpoint late-line cutaneous melanoma selected for oral presentation at ASCO 2024. Financially, the company saw a 36% increase in net product revenue, with total revenue reaching $70.3 million in Q1 2024. However, research & development expenses also grew, resulting in a net loss for the quarter. Cash and cash equivalents stood at $832.8 million as of March 31, 2024.
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