ASCO2016: Immunocore Presents Positive Imcgp100 Phase I Data At The 2016 ASCO Annual Meeting

• Full data presented from the First-In-Human study of IMCgp100 in metastatic melanoma, treating 84 patients
• Prolonged responses were observed in both uveal and cutaneous melanoma
• IMCgp100 showed a favourable safety profile with manageable immune mediated toxicity
• The data presented support development in uveal and cutaneous melanoma

OXFORD, England--(BUSINESS WIRE)--Immunocore, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, infectious diseases and autoimmune disease, today announced that positive data from the first in human, Phase I clinical trial of its lead ImmTAC (Immune mobilising monoclonal TCRs Against Cancer), IMCgp100, was presented in a poster discussion session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 5^th 2016.

“We are delighted that the data strongly supports the expansion of the IMCgp100 programme into both cutaneous and uveal melanoma Phase II trials and we look forward to progressing our lead programme through further clinical development.”

IMCgp100 is a first-in-class bi-specific biologic known as a T cell redirector. This ImmTAC binds, with picomolar affinity, to a melanoma associated target, gp100; once bound IMCgp100 redirects all T cells, including non-cancer specific T cells, to kill the cancer cells.

In a presentation entitled: “Safety, Pharmacokinetics and Efficacy of IMCgp100, a First-in-Class Soluble TCR Anti-CD3 Bispecific T Cell Redirector With Solid Tumour Activity: Results From the FIH Study in Melanoma” Mark Middleton MD, Professor of Experimental Cancer Medicine at the University of Oxford, and Principal Investigator for the Study, presented data from the First-In-Human study of IMCgp100 in metastatic melanoma, treating 84 patients in total.

In the study, IMCgp100 showed a favourable safety profile at the established recommended Phase II dose, with prolonged responses observed in both uveal and cutaneous melanoma. Tumour shrinkages in patients with a particularly poor prognosis and those with checkpoint resistant disease were also reported. Some immune mediated toxicities were observed predominantly in the first few doses and were manageable. Rapid T cell infiltration into tumours coinciding with immune activation occurred within days following the first dose in both cutaneous and uveal melanoma patients.

Mark Middleton, Principal Investigator, commented: “These are promising data, we know how to give the drug safely and we are seeing prolonged responses in both uveal and cutaneous melanoma. It is also really encouraging to see tumours shrink in patients with high LDH and/or liver tumour burden. These exciting data strongly support the further development of IMCgp100, in patients with uveal and cutaneous melanoma.”

Dr. Christina Coughlin, Chief Medical Officer of Immunocore, added: “We are delighted that the data strongly supports the expansion of the IMCgp100 programme into both cutaneous and uveal melanoma Phase II trials and we look forward to progressing our lead programme through further clinical development.”

In January 2016 the US Food and Drug Administration (FDA) also granted Orphan Drug Designation to IMCgp100 for the treatment of uveal melanoma. Furthermore, Immunocore has participated in the European Medicines Agency’s (EMA) Adaptive Pathway pilot programme with IMCgp100. Earlier this year, Immunocore initiated a Phase I clinical study of IMCgp100 in patients with uveal melanoma and a combination Phase Ib/II trial with MedImmune’s checkpoint inhibitors durvalumab and tremelimumab.

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Notes for editors

About Immunocore

Immunocore is one of the world’s leading biotechnology companies, with a highly innovative immuno-oncology platform technology called ImmTACs. ImmTACs are a novel class of biologic drugs based on the Company’s proprietary T cell receptor (TCR) technology which have the potential to treat diseases with high unmet medical need including cancer, infectious diseases and autoimmune diseases. Immunocore, based on decades of world-leading scientific innovation in the discovery of HLA targets and T cell receptor technology, has a pipeline of wholly-owned and partnered ImmTAC programmes with robust clinical data, validated by collaborations with world-leading pharmaceutical companies. Immunocore is developing programmes with its TCR-based platform as a potential therapy for HIV and other infectious diseases, ImmTAVs. Immunocore aims to leverage the utility of its platform across a wide range of indications to become a Premier Biotech company and world-leader in its field.

Immunocore’s world-leading science and strong IP position has attracted major pharmaceutical companies including Genentech, GlaxoSmithKline, MedImmune, the biologics division of AstraZeneca, via discovery collaborations, as well as a co-discovery and co-development partnership with Lilly. The Company has also entered into combination trials with its lead programme, IMCgp100 in melanoma, with MedImmune and Lilly. Founded in 2008 originally out of Oxford University and headquartered outside Oxford with US offices outside Philadelphia, Immunocore has more than 220 staff. Immunocore’s current investors are well-renowned, leading international institutions including Woodford Investment Management, Malin Corporation, Eli Lilly and Company, RTW Investments, Fidelity Management & Research Company as well as other private shareholders. For more information, please visit www.immunocore.com

About ImmTACs

Immunocore’s proprietary technology is focused on small protein molecules called ImmTACs (Immune mobilising monoclonal TCRs Against Cancer) that enable the immune system to recognise and kill cancerous. Immunocore’s ImmTACs, a new class of drug with ultra-high affinity for intracellular cancer targets, are synthetic, soluble T cell receptors (TCRs) that recognise diseased cells containing disease specific targets. The ImmTACs enable circulating T-cells to selectively identify and kill diseased cells. The ImmTAC platform is unique in its high specificity and potency and broad applicability to a wide range of intracellular targets and disease indications. ImmTACs can access up to nine-fold more targets than typical antibody-based therapies, including monoclonal antibodies.

TCRs naturally recognise diseased cells and Immunocore’s world-leading competitive advantage is its ability to engineer high affinity TCRs and link them to an antibody fragment that activates a highly potent and specific T cell response to recognise and destroy cancer cells. The most advanced ImmTAC, IMCgp100, is currently in Phase I/IIa clinical trials for the treatment of late stage melanoma. Immunocore has a growing internal pipeline of ImmTACs addressing many different cancer types and has developed a broad database of intracellular cancer targets.

The TCR-based platform can address a significantly larger range of disease indications than currently respond to existing immuno-oncology agents and combine the characteristics of very high potency, encouraging safety and low cost of goods.

About Uveal Melanoma

Melanoma arises from pigment containing cells (melanocytes) present in the skin, eye and mucus membranes. Melanoma most frequently occurs in the skin, however ocular melanoma arises from pigmented cells in the eye. The primary cause of melanoma is thought to be radiation induced DNA damage from ultraviolet (UV) light exposure. Melanoma is the most deadly of skin cancers. Globally, in 2012, melanoma occurred in 232,000 people and resulted in 55,000 deaths. Uveal melanoma (UM) is a rare type of melanoma where the incidence has ranged from 5.3 to 10.9 cases per million (Singh 2003). Despite its rare incidence rate (representing approximately 3% of melanoma cases, approximately 4000 cases globally per year), UM is the most frequent primary intraocular malignancy of the adult eye in 85% of cases (Patel 2011, Maio 2013). Advanced uveal melanoma currently has no effective treatment options.