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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 (IMCR) has initiated patient treatment in a Phase 1/2 trial for IMC-R117C, their fifth ImmTAC candidate, targeting PIWIL1 in colorectal and other gastrointestinal cancers. The trial will evaluate both monotherapy and combination treatments with standard care in HLA-A*02:01-positive patients with advanced solid tumors.
IMC-R117C represents the first immunotherapy program targeting PIWIL1, a cancer-testis antigen overexpressed in multiple malignancies, including colorectal cancer (CRC). The company estimates up to 20,000 colorectal cancer patients globally are positive for both PIWIL1 and HLA-A*02:01. This development addresses a significant unmet medical need, particularly in advanced colorectal cancer cases resistant to standard treatments.
Immunocore (NASDAQ: IMCR) and EORTC have initiated the first Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM), enrolling their first patient. The trial aims to evaluate if tebentafusp can prevent or delay relapse in high-risk uveal melanoma patients after primary treatment, compared to observation.
The open-label, international, multicenter trial will enroll 290 HLA-A*02:01-positive patients who have undergone surgery or radiotherapy. Participants will be randomized 1:1 to receive either tebentafusp for six months or observation. The study will assess overall survival, safety, tolerability, and explore ctDNA as a marker of residual disease.
Tebentafusp (KIMMTRAK®) is currently approved in 38 countries for treating HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Immunocore (IMCR) announced that KIMMTRAK (tebentafusp) has been recommended for funding through England's National Health Service (NHS) by NICE. This recommendation overturns their initial negative decision from May 2023. KIMMTRAK is approved for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, marking the first treatment to improve survival for this rare form of melanoma. The therapy will be funded on the NHS in England starting December 2, 2024, representing Immunocore's 13th launch this year.
Immunocore Holdings (Nasdaq: IMCR), a commercial-stage biotechnology company focused on developing immunomodulating medicines, has announced its participation in two upcoming investor conferences. The company will present at the Guggenheim Securities Healthcare Innovation Conference on Tuesday, November 12, 2024, at 1:00 p.m. EST, and the Jefferies London Healthcare Conference on Wednesday, November 21, 2024, at 9:00 a.m. GMT.
Both presentations will be available via webcast on Immunocore's website in the 'Events & Presentations' section, with replays available for a time after the events.
Immunocore (IMCR) reported strong Q3 2024 financial results with KIMMTRAK net revenues of $80.2 million, representing 28% growth over Q3 2023. The company achieved earnings per share of $0.17, compared to $0.02 in Q3 2023. KIMMTRAK is now approved in 38 countries and launched in 21 countries globally. The company continues to advance its pipeline with ongoing Phase 3 trials in cutaneous melanoma and plans to start randomization for the Phase 3 ATOM trial in adjuvant uveal melanoma in Q4 2024. Cash position remains strong at $901.3 million as of September 30, 2024.
Immunocore Holdings plc (Nasdaq: IMCR) presented Phase 1 data for brenetafusp, an ImmTAC bispecific targeting PRAME, in platinum-resistant ovarian cancer patients at the 2024 ESMO Congress. Key findings include:
1. Monotherapy: 58% disease control rate, 6.5% RECIST response rate, and 3.3 months median PFS in heavily pre-treated patients.
2. Chemotherapy combination: 69% disease control rate and 23% RECIST response rate.
3. T cell fitness (TCF) gene expression signature in blood associated with improved clinical outcomes across different tumor types.
The data suggests potential for brenetafusp in ovarian cancer, particularly in earlier-line treatment where TCF is expected to be higher.
Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company, which focuses on developing immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases, will be part of a fireside chat on Thursday, September 19, 2024, at 12:45 p.m. EDT.
The presentation will be webcast live and can be accessed through the 'Events & Presentations' section under 'Events' on the 'Investors' page of Immunocore's website. A replay of the presentation will be available for a time after the event.
Immunocore Holdings plc (Nasdaq: IMCR) announced that its Chief Financial Officer (CFO) and Head of Strategy, Brian Di Donato, will be leaving the company at the end of 2024. Di Donato has accepted a position as CEO of a private, early-stage biotech in San Diego. He will remain in his current role through the end of the year to ensure a smooth transition, while Immunocore initiates a search for a new CFO.
CEO Bahija Jallal praised Di Donato's contributions over his four-year tenure, highlighting his role in the company's successful IPO and building a strong Finance department. Di Donato expressed pride in Immunocore's achievements, including becoming a commercial-stage biotech with the launch of the world's first TCR therapy.
Immunocore Holdings plc (Nasdaq: IMCR) reported Q2 2024 financial results and provided a business update. Key highlights include:
- KIMMTRAK net revenues of $75.3 million in Q2 2024, driven by US growth
- Ongoing Phase 3 TEBE-AM trial with KIMMTRAK in previously treated cutaneous melanoma
- Started randomization for Phase 3 PRISM-MEL-301 trial evaluating brenetafusp + nivolumab in first-line cutaneous melanoma
- Presented Phase 1 data of brenetafusp in late-line cutaneous melanoma at ASCO 2024
- R&D expenses increased to $51.1 million in Q2 2024
- Cash, cash equivalents, and marketable securities at $859.6 million as of June 30, 2024
The company is advancing multiple clinical programs and expects data readouts over the next 18 months.
Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company, has announced it will report its second quarter 2024 financial results on Thursday, August 8, 2024, before the US markets open. The company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) to discuss the financial results and provide a business and portfolio update.
Investors and interested parties can access the audio webcast through the 'Events' section under 'Events and Presentations' on Immunocore's website. For those who prefer to join via phone, domestic toll-free and international toll numbers have been provided. A replay of the event will be available for a time after the call.
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