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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.
Acacia Research reported significant financial developments for Q3 2021, highlighted by a nearly $120 million gain from the IPO of Oxford Nanopore. Pro forma book value increased to $6.31 per share, while cash and investments soared to $605.1 million. Gross revenue was $1.6 million, a decline from $19.5 million year-over-year, and the operating loss grew to $12.7 million. Notably, net income surged to $80.2 million or $0.86 per diluted share, compared to $29.2 million or $0.32 per share last year. A conference call is scheduled for November 15, 2021.
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.
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