Day One Biopharmaceuticals, a recently FDA-approved commercial-stage company, is expanding its pipeline by acquiring rights to a novel drug from MabCare Therapeutics. The drug, now renamed DAY301, targets protein-tyrosine kinase 7 (PTK7), which is found in certain cancer cells and pediatric cancers. This drug candidate could potentially compete with a similar drug from Genmab, acquired as part of a $1.8 billion deal. Both companies are developing ADCs that target PTK7, with Day One’s technology poised to overcome limitations of previous PTK7-targeting ADCs.
Day One’s business model involves securing rights to drug candidates developed by other companies, with its first FDA-approved drug, Ojemda, licensed from Takeda Pharmaceutical. The company also has other drugs in its pipeline, including pimasertib for MAPK-altered solid tumors and a VRK1 inhibitor in preclinical development. Day One is well-funded, having sold a priority review voucher for $108 million and has plans to expand its pipeline by in-licensing additional clinical-stage assets to benefit cancer patients of all ages.
The agreement with MabCare gives Day One global rights to DAY301, excluding Greater China, where MabCare retains rights. Day One paid $55 million upfront and could potentially pay up to $1.152 billion in milestone payments. MabCare is also eligible for royalties on net sales of the approved product.
The Phase 1 study of DAY301 is expected to begin in the fourth quarter of this year or early next year. Day One’s CEO, Jeremy Bender, is optimistic about the potential of DAY301 and believes that the company has the right team in place to develop the program to its full potential. With a focus on successfully launching Ojemda, advancing existing programs, and expanding the pipeline, Day One is poised to make a significant impact on the field of oncology and improve outcomes for patients with various types of cancer.
June 19, 2024
Artificial Intelligence
FDAcop
