Immunocore Holdings plc American Depositary Shares - IMCR STOCK NEWS

Immunocore has received FDA approval for KIMMTRAK® (tebentafusp-tebn), the first therapy for unresectable or metastatic uveal melanoma (mUM). This groundbreaking treatment shows a median overall survival of nearly 22 months, with a hazard ratio of 0.51. The approval marks several milestones, including the first T cell receptor therapeutic to gain regulatory approval. The company aims to commercialize KIMMTRAK in the U.S. shortly, having established an early access program for patients. Immunocore's CEO highlighted this achievement as a significant step toward addressing the unmet needs in treating mUM.

Immunocore Holdings Plc (Nasdaq: IMCR) will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 7:30 a.m. ET. The conference will be held virtually, and the presentation along with a Q&A session will be streamed live on Immunocore’s website. Immunocore is known for its innovative T cell receptor (TCR) bispecific immunotherapies that target diseases like cancer and autoimmune disorders. The company's leading therapeutic candidate, tebentafusp, has shown promise in extending overall survival in metastatic uveal melanoma.

Immunocore Holdings Plc (Nasdaq: IMCR) has announced initial Phase 1 data for its bispecific T cell engager, IMC-C103C, targeting MAGE-A4, showing clinical activity in ovarian cancer and head and neck squamous cell carcinoma (HNSCC). Among 44 patients in the trial, there were confirmed durable responses, even in heavily pre-treated patients with low MAGE-A4 expression. The safety profile was manageable, with reversible adverse events primarily related to cytokine release syndrome. An expansion arm in high-grade serous ovarian cancer has been initiated at a dose of 140 micrograms.

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.