Day One Broadens Pipeline with Novel Clinical-Stage ADC Targeting PTK7 for Adult and Pediatric Solid Tumors

Day One Biopharmaceuticals, a company committed to developing and commercializing targeted therapies for various cancers, has announced an exclusive licensing agreement with MabCare Therapeutics for MTX-13. This novel antibody-drug conjugate (ADC), targeting protein-tyrosine kinase 7 (PTK7), will be developed and commercialized globally, with the exception of Greater China. In April 2024, the U.S. Food and Drug Administration (FDA) cleared MTX-13's investigational new drug (IND) application, renaming it as DAY301.

MTX-13, now DAY301, has demonstrated antitumor activity in pre-clinical studies across a spectrum of solid tumors. Jeremy Bender, Ph.D., CEO of Day One, emphasized the company's priorities for 2024, including the successful launch of OJEMDA™ (tovorafenib), advancement of current programs, and pipeline expansion through in-licensing promising clinical-stage assets like DAY301. Bender expressed confidence in the team's ability to develop DAY301 to its full potential.

PTK7, the target of DAY301, is a transmembrane protein overexpressed in various adult cancers—such as esophageal, ovarian, lung, and endometrial cancers—as well as pediatric cancers like neuroblastoma, rhabdomyosarcoma, and osteosarcoma. PTK7's limited expression in normal tissues makes it an attractive target for cancer therapies. Dr. Samuel Blackman, co-founder and head of research and development at Day One, stated that adding DAY301 aligns with the company's mission to address both pediatric and adult cancers with equal urgency. Blackman believes that DAY301's linker-payload technology will overcome limitations of earlier PTK7-targeted ADCs, potentially offering a first-in-class drug against a clinically validated target. The company plans to initiate clinical trials in the coming months.

Under the licensing agreement, MabCare will receive $55 million upfront and is eligible for up to $1.152 billion in additional milestone payments based on development, regulatory, and commercial successes, along with low-to-mid single-digit royalties on net sales outside Greater China. Day One anticipates dosing the first patient in the Phase I study by late 2024 or early 2025.

Day One Biopharmaceuticals, based in Brisbane, California, was founded to address the significant unmet need for pediatric cancer therapies. The company's name is inspired by "The Day One Talk" that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. Day One aims to transform cancer drug development and outcomes for patients of all ages. The company's pipeline includes tovorafenib (OJEMDA™) and pimasertib.

The commitment to developing innovative cancer therapies underscores Day One's mission. Their collaboration with leading clinical oncologists, families, and scientists aims to identify, acquire, and develop targeted cancer treatments. The company believes that by doing so, they can redefine possibilities for people living with cancer from the very first day of their diagnosis.

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