Day One Biopharmaceuticals (NASDAQ: DAWN), a California-based biotech company that recently celebrated its first drug approval, has announced an expansion of its pipeline through a licensing agreement with Shanghai-based MabCare Therapeutics. Day One will acquire exclusive development, manufacturing, and commercialization rights to MTX-13, an antibody-drug conjugate (ADC) targeting protein-tyrosine kinase 7 (PTK7), for global markets outside Greater China.
Per the agreement, Day One will pay MabCare an upfront fee of USD 55 million and is committed to paying up to USD 1.152 billion in additional milestone payments based on development, regulatory, and commercial success. The deal also includes low-to-mid single-digit royalties on future net sales outside of Greater China.
MTX-13, now renamed DAY301, received its first Investigational New Drug (IND) approval from the US FDA in April 2024, with Day One planning to initiate a Phase I study in the fourth quarter of 2024 or the first quarter of 2025. PTK7, a Wnt signaling pathway protein, is implicated in cancer development and metastasis and is overexpressed in various adult and pediatric cancers, making it a promising target for drug development.
This deal marks Day One’s entry into the biologics development space, having previously focused on small-molecule cancer therapies. The company received its first approval in April for Ojemda (tovorafenib), a Type II RAF inhibitor for the treatment of BRAF-altered pediatric low-grade glioma (pLGG), the most common pediatric brain tumor.
MabCare Therapeutics, which has maintained a low profile, revealed in an academic paper that MTX-13/DAY301 conjugates its PTK7-targeted antibody to eight molecules of topoisomerase I inhibitor exatecan, a payload also used in Enhertu (trastuzumab deruxtecan). Preclinical studies have shown promising anti-tumor activity in a range of solid tumors, and the molecule exhibits a higher therapeutic index compared to other PTK7 ADCs in development. Other multinational corporations with PTK7 ADCs in development include GenMab-acquired ProfoundBio and AbbVie, which has PF-06647020/cofetuzumab pelidotin in Phase I development.- Flcube.com
