Welcome to our dedicated page for Immunocore Holdings Plc news (Ticker: IMCR), a resource for investors and traders seeking the latest updates and insights on Immunocore Holdings Plc stock.
Immunocore Holdings plc (Nasdaq: IMCR) is a commercial-stage biotechnology company focused on T cell receptor (TCR) bispecific immunotherapies for cancer, infectious diseases and autoimmune diseases. News about Immunocore frequently centers on the commercial performance and clinical development of its lead product, KIMMTRAK, which is approved for HLA‑A*02:01‑positive adult patients with unresectable or metastatic uveal melanoma in multiple regions, and on its broader melanoma franchise.
Investors following IMCR news can expect regular updates on Phase 3 oncology trials, including the TEBE‑AM registrational trial of tebentafusp in second‑line or later advanced cutaneous melanoma, the ATOM adjuvant uveal melanoma trial, and the PRISM‑MEL‑301 trial evaluating brenetafusp plus nivolumab in first‑line advanced cutaneous melanoma. Company press releases also describe progress in Phase 1/2 studies of PRAME‑targeting ImmTAC candidates across ovarian cancer, non‑small cell lung cancer and other solid tumors.
Beyond oncology, Immunocore issues news on its ImmTAV infectious disease programs, such as IMC‑M113V for people living with HIV and IMC‑I109V for chronic hepatitis B infection, including early clinical data on safety, pharmacodynamic effects and viral antigen reductions. Updates on ImmTAAI candidates for autoimmune conditions, including type 1 diabetes and inflammatory dermatological diseases, are also part of the company’s communications.
This IMCR news page aggregates company press releases, conference participation announcements and SEC‑related disclosures, giving readers a single view of developments in KIMMTRAK commercialization, pipeline milestones, trial readouts and strategic priorities across oncology, infectious disease and autoimmune pipelines.
Immunocore will participate in a fireside chat at the Jefferies London Healthcare Conference from November 16-19, 2021. The on-demand presentation will be accessible starting November 18, 2021. As a late-stage biotechnology firm, Immunocore develops T cell receptor bispecific immunotherapies to treat diseases like cancer and autoimmune disorders. Their lead candidate, tebentafusp, demonstrated significant survival benefits in metastatic uveal melanoma during clinical trials.
Immunocore (IMCR) reported its Q3 2021 financial results, highlighting the acceptance of its Biologics License Application for tebentafusp in metastatic uveal melanoma, with the FDA setting a PDUFA date of February 23, 2022. The company has treated over 150 patients through an early access program. Financially, revenue fell to £5.9 million from £6.7 million year-over-year, while operating loss increased to £31 million, largely due to rising employee costs. As of September 30, 2021, cash reserves were approximately $346 million.
Immunocore presented new data on tebentafusp at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting, focusing on its use in metastatic cutaneous melanoma (mCM) and uveal melanoma (mUM). The Phase 1b trial showed a 76% one-year overall survival rate in mCM patients previously treated with anti-PD(L)1 therapy. Additionally, survival benefits were observed for tebentafusp monotherapy in mUM regardless of gp100 tumor expression levels. The findings highlight tebentafusp's potential in addressing unmet medical needs in melanoma treatment.
Immunocore has partnered with Medison Pharma to commercialize tebentafusp in Canada, Central Eastern Europe, and Israel for metastatic uveal melanoma treatment. This agreement follows regulatory acceptances for tebentafusp in the U.S. and Europe. Medison will aid in seeking regulatory authorization, enhancing access to this therapy in 22 markets. Tebentafusp has received multiple designations from the FDA, including Priority Review and Breakthrough Therapy designation, indicating its potential impact on patient care in this aggressive cancer.
Immunocore announced the publication of phase 3 data regarding tebentafusp in The New England Journal of Medicine, demonstrating significant overall survival benefits for previously untreated patients with metastatic uveal melanoma (mUM). This marks tebentafusp as the first T cell receptor therapeutic to show a survival advantage in this patient population. The study reported a hazard ratio of 0.51 (p 0.0001) favoring tebentafusp over investigator’s choice therapies. The FDA has accepted Immunocore’s biologics license application for tebentafusp, which has received multiple designations indicating its potential as a treatment option for mUM.
Immunocore presented significant findings at the European Society for Medical Oncology (ESMO) Congress 2021, highlighting that a reduction in circulating tumor DNA (ctDNA) while on tebentafusp correlates with improved overall survival in patients with metastatic uveal melanoma. In a Phase 2 trial, 70% of evaluable patients experienced some ctDNA reduction, with 14% achieving complete ctDNA clearance. The company submitted applications for tebentafusp approval to the FDA, EMA, and MHRA, building upon its Phase 3 study's positive outcomes.
iECURE announced the appointment of Brian Di Donato to its Board of Directors. Di Donato, who has over 20 years of financial leadership experience, currently serves as CFO and Head of Strategy at Immunocore (NASDAQ-NMS:IMCR). His expertise is expected to enhance iECURE's mission to develop gene insertion therapies for severe metabolic disorders. Di Donato holds an MBA from NYU and degrees in biology and mechanical engineering. CEO Joseph Truitt expressed optimism about Di Donato's contributions to advancing their pipeline.
Immunocore Holdings Plc (Nasdaq: IMCR) will present new data from its lead program, tebentafusp, at the European Society for Medical Oncology (ESMO) Congress 2021 from September 16-21. Key presentations include an oral presentation on ctDNA reduction associated with overall survival in metastatic uveal melanoma and several poster presentations focused on the efficacy and side effects of tebentafusp. This highlights Immunocore's innovative T cell receptor (TCR) bispecific immunotherapy platform aimed at cancer treatment and its potential impact on patient outcomes.
Immunocore Holdings plc (Nasdaq: IMCR) announced its participation in upcoming investor conferences in September 2021. The company, a pioneer in T cell receptor (TCR) bispecific immunotherapies, will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13 and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22. Both conferences will be held virtually, with presentations accessible on Immunocore's website. The company is focused on treating various diseases, including cancer, and has a promising pipeline including its lead candidate, tebentafusp.
Immunocore announces that the UK's MHRA has accepted the Marketing Authorization Application for tebentafusp to treat metastatic uveal melanoma. This follows similar acceptances from the FDA and EMA. Tebentafusp's efficacy is supported by data from the Phase 3 IMCgp100-202 trial, which showed a 52% improvement in overall survival compared to standard options. The regulatory submissions highlight the urgent need for effective treatments for this aggressive cancer. Immunocore aims to address this gap with tebentafusp as part of its expanding oncology pipeline.