Incyte will make additional $80M investment in new partner and pay up to $350M milestones per program
Incyte and Merus have signed a global strategic collaboration focused on the discovery and development of bispecific antibodies using The Netherlands-based firm’s Biclonics® technology platform. Incyte is paying Merus $120 million upfront and will make an additional $80 million equity investment in the firm for exclusive rights to up to 11 bispecific antibody programs, including two of Merus’s existing preclinical immune-oncology programs.
For eight of the eleven programs, Incyte will fund all global development and commercialization activities, and Merus could receive up to $350 million in development, regulatory, and sales milestones per program, plus royalties from global sales. Merus retains rights to develop and commercialize products for one of its existing preclinical programs in the U.S., with Incyte being granted rights to commercialize products from this program outside the U.S. Merus also has the option to co-fund the development of product candidates arising from two other programs, in which case it would be responsible for 35% of global development costs, in exchange for a 50% share of U.S. profits and losses and tiered royalties ranging from 6% to 10% on ex-U.S. sales by Incyte. Merus retains rights to both of its clinical candidates and preclinical candidate MCLA-158, as well as its technology platform and any programs that are outside the scope of the agreement.
“By virtue of a unique ability to simultaneously engage multiple protein targets, we believe bispecific antibodies have the potential to play an important role in the future of biotherapeutics,” said Reid Huber, Ph.D., Incyte CSO. “This collaboration with Merus expands our large-molecule discovery capabilities into an innovation-rich area of research, creating additional opportunities for us to deliver on our commitment to improving and extending the lives of patients with cancer and other serious diseases.”
Biclonics are bispecific, full-length human immunoglobulin G (IgG) antibodies, which Merus claims demonstrate better tumor-killing functionality than conventional monoclonal antibody combinations. In November 2016, Merus announced the award of a €1.5 million ($1.56 million) EUREKA Eurostars grant in partnership with Aquila BioMedical to fund a joint project, designated iMOD-ReACT, for the development of immunological assays that will support the selection of potent bispecific antibodies.
Merus’s Biclonics clinical pipeline is headed by MCLA-128, an antibody-dependent, cell-mediated cytotoxic (ADCC)-enhanced, human epidermal growth factor receptor 2 (HER2)/HER3-targeting bispecific antibody, which is currently in Phase I/II trials, initially against breast, colorectal, and ovarian cancer. In January 2016 Merus and the Gustave Roussy Institute signed a strategic collaboration for the design and conduct of studies with MCLA-128.
Merus’s second clinical candidate, MCLA-117, is a CD3/C-type lectin domain family 12 member A (CLEC12A)-targeting candidate, which is in Phase I/II development against acute myeloid leukemia and in preclinical development against myeloid dysplastic syndrome. Merus’s preclinical pipeline includes the colorectal cancer candidate MCLA-158, which targets Lgr5/epidermal growth factor receptor (EGFR), and MCLA-134, which targets programmed cell death protein 1 (PD-1)/T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) and is in development against various solid tumors. MCLA-145 is in preclinical development against various solid tumors and is directed against programmed cell death ligand-1 (PD-L1) and another, undisclosed, target.