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Immunocore Holdings plc (NASDAQ: IMCR) is a leading biotechnology company at the forefront of developing groundbreaking T cell receptor (TCR) bispecific immunotherapies. Leveraging its world-class TCR technology, Immunocore aims to harness the body's immune system to target and destroy diseased cells. The company's proprietary platform, known as ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer), is designed to treat a variety of serious conditions, including cancer, infectious diseases, and autoimmune disorders.
Based in the United Kingdom, Immunocore has a significant presence in the United States, where the majority of its revenue is generated. The company's most notable product, KIMMTRAK® (tebentafusp-tebn), is the first approved TCR therapy for metastatic uveal melanoma, available in the United States, European Union, Canada, Australia, and the United Kingdom.
In recent news, Immunocore has entered into a clinical trial collaboration with Bristol Myers Squibb to investigate IMC-F106C, an ImmTAC bispecific TCR candidate, in combination with nivolumab for treating advanced cutaneous melanoma. This Phase 3 trial aims to assess the efficacy and safety of this combination therapy.
Immunocore's robust pipeline includes several clinical-stage programs in oncology and infectious diseases. Notable developments include ongoing trials for IMC-I109V for Hepatitis B Virus (HBV) and advanced pre-clinical programs in autoimmune diseases. Additionally, the company is expanding its PRAME ImmTAC franchise with two new candidates, IMC-P115C and IMC-T119C, targeting solid tumors.
Financially, Immunocore has successfully transitioned from a research-focused organization to a revenue-generating entity. The company's collaborative efforts with partners like DELFI Diagnostics aim to enhance cancer therapy monitoring through innovative liquid biopsy assays.
Immunocore continues to pioneer in the field of immunotherapy, with a mission to deliver transformative treatments that radically improve patient outcomes.
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.
Immunocore Holdings Plc has announced that the FDA and EMA have accepted applications for the approval of tebentafusp for metastatic uveal melanoma. The FDA granted Priority Review with a target action date of February 23, 2022. Tebentafusp showed significant survival benefits in a Phase 3 trial, achieving a hazard ratio of 0.51. The EMA also recognized the treatment's major public health interest, allowing for an accelerated review process that may reduce the evaluation timeframe to 150 days. This progress marks a crucial step in bringing this promising therapy to patients.
Immunocore (IMCR) reported its Q2 2021 financial results, highlighting significant advancements in its product pipeline, particularly for tebentafusp, aimed at treating metastatic uveal melanoma. The company is on track to submit its Biologics License Application (BLA) in the U.S. by Q3 2021, with accelerated submissions for the European Market Authorization Application (MAA). Financially, while the company reported an operating loss of £34.5 million, it ended the quarter with approximately £385 million in cash. Revenue from collaborations decreased compared to the previous year, reflecting challenges in monetizing its innovations.
Immunocore presented clinical data regarding tebentafusp at the 2021 ASCO Annual Meeting, highlighting its overall survival benefit in metastatic uveal melanoma. In a subset analysis from the Phase 3 study, tebentafusp showed a superior overall survival (OS) with a hazard ratio of 0.43 compared to the investigator's choice. Notably, over half of the patients with progressive disease responded positively to treatment, and no new safety signals were reported. Tebentafusp has received several designations from the FDA and plans for a BLA submission are expected in Q3 2021.
Immunocore (Nasdaq: IMCR) announces its management will present at key investor conferences in June 2021. The Jefferies Virtual Healthcare Conference will feature a fireside chat on June 3 at 8:00 a.m. ET, followed by the Goldman Sachs 42nd Annual Global Healthcare Conference on June 9 at 10:30 a.m. ET. Both events will be accessible via live webcasts on Immunocore's website. As a late-stage biotechnology company, Immunocore is focused on developing TCR bispecific immunotherapies for various diseases, including cancer and autoimmune disorders.
Immunocore announced the dosing of the first patient in a clinical trial for IMC-I109V, a bispecific immunotherapy for chronic hepatitis B (CHB). This marks the first use of Immunocore's ImmTAV® platform in clinical trials. The trial will assess the safety, antiviral activity, and pharmacokinetics of IMC-I109V in non-cirrhotic, HBeAg-negative patients. The aim is to achieve a 'functional cure' by eliminating HBV-infected hepatocytes. Approximately 240 million individuals are chronic carriers of HBV, highlighting the urgent need for new treatment options.
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