Date: 2015-06-29
Type of information: Clinical research agreement
Compound: IMCgp100, in combination with galunisertib (LY2157299) and merestinib (LY2801653)
Company: Eli Lilly (USA - IN) Immunocore (UK)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: kinase inhibitor/immunotherapy product. Immunocore\'s ImmTACs (Immune mobilizing mTCR Against Cancer), a new class of drug with ultra-high affinity for intracellular cancer targets, are synthetic, soluble T cell receptors (TCRs) that recognize diseased cells containing disease specific targets. The ImmTACs enable circulating T cells to selectively identify and kill diseased cells. The most advanced ImmTAC, IMCgp100, is currently in Phase IIa clinical trials for the treatment of late stage melanoma. Following completion of a Phase I study at the end of 2013, Immunocore initiated a Phase IIa study to optimize the dosing regimen of IMCgp100. Immunocore has a growing internal pipeline of ImmTACs addressing many different cancer types and has developed a broad database of intracellular cancer targets. Galunisertib is a TGF beta R1 kinase inhibitor that in vitro selectively blocks TGF beta signaling. TGF beta promotes tumor growth, suppresses the immune system and increases the ability of tumors to spread in the body. Merestinib is Lilly\'s multi-kinase inhibitor that in vitro selectively blocks signaling of MET, MST1R (RON), AXL, and MKNK1/2.
Disease: metastatic cutaneous melanoma, uveal melanoma
Details: * On June 29, 2015, Eli Lilly and Immunocore announced that they have entered into an immunotherapy-based clinical trial collaboration to explore the utility of Immunocore\'s lead T cell receptor-based investigational therapeutic, IMCgp100, in combination with Lilly\'s galunisertib (LY2157299) and merestinib (LY2801653) for the treatment of melanoma. The goal of the collaboration is to identify combination regimens that provide synergies in efficacy and durability in patients with metastatic cutaneous and uveal melanomas. Under the terms of the agreement, Immunocore and Lilly will conduct a Phase Ib/II clinical study evaluating the safety and preliminary efficacy of IMCgp100 in combination with galunisertib in metastatic cutaneous melanoma. A second Phase Ib/II study will be conducted combining IMCgp100 with merestinib in metastatic uveal melanoma. Lilly will act as trial sponsor. These studies are anticipated to begin in 2016. No financial terms were disclosed. Immunocore and Lilly entered into a co-discovery and co-development collaboration, announced in July 2014, to research and potentially develop other novel T cell-based cancer therapies built on Immunocore\'s ImmTAC platform. Immunocore recently announced clinical efficacy data in a Phase I/IIa trial with IMCgp100 in patients with advanced melanoma, as well as in the expansion cohort with uveal melanoma.
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