Day One secures $1.2B deal for MabCare's solid tumor ADC

Day One Biopharmaceuticals has entered into a significant agreement with MabCare Therapeutics, offering up to $1.2 billion for the exclusive licensing rights to a promising antibody drug conjugate (ADC) aimed at treating solid tumors in both adults and children. This notable deal involves an upfront payment of $55 million to MabCare for the development and commercialization rights to the drug identified as DAY301—formerly known as MTX-13—excluding the Greater China region where MabCare operates.

As part of this agreement, MabCare is positioned to earn an additional $1.15 billion through various development and commercial milestones, along with single-digit royalties. DAY301 is an innovative ADC that targets protein-tyrosine kinase 7 (PTK7), a protein that is overexpressed in several types of cancer. Among adults, these cancers include esophageal, ovarian, lung, and endometrial cancers. In children, the ADC shows promise against neuroblastoma, rhabdomyosarcoma, and osteosarcoma.

The U.S. Food and Drug Administration (FDA) granted investigational new drug clearance for DAY301 in April, paving the way for in-human testing. Day One Biopharmaceuticals, based in California, plans to begin phase 1 dosing for the first patient either in the last quarter of this year or the first quarter of 2025.

Samuel Blackman, M.D., Ph.D., co-founder and head of R&D at Day One, expressed confidence in DAY301’s potential. In a statement released on June 18, Blackman emphasized that the ADC's linker-payload technology is designed to overcome the limitations of earlier PTK7-targeted ADCs, positioning DAY301 as a potential first-in-class drug against a clinically validated target.

Expanding its pipeline with in-licensed clinical-stage cancer candidates for patients across all age groups is a main objective for Day One Biopharmaceuticals this year, according to CEO Jeremy Bender, Ph.D. In the same release, Bender highlighted the company’s commitment to advancing its oncology portfolio to address the unmet needs in cancer treatment.

This collaboration marks a significant step for both companies. For Day One, it represents an opportunity to bolster its oncology pipeline with a potentially groundbreaking treatment. For MabCare, the deal offers substantial financial incentives, including development and commercial milestone payments that could total $1.15 billion, along with royalties. The agreement underscores the growing trend in the biopharmaceutical industry where companies are increasingly looking to collaborations and licensing deals to accelerate the development and commercialization of innovative treatments.

In summary, this partnership between Day One Biopharmaceuticals and MabCare Therapeutics is poised to advance the development of DAY301, a next-generation ADC targeting PTK7. With FDA clearance for clinical testing already secured, the prospects for DAY301 appear promising as it moves closer to becoming a new therapeutic option for adults and children suffering from various forms of solid tumors. The collaboration exemplifies strategic efforts within the biopharmaceutical industry to leverage innovative technologies and accelerate the delivery of new cancer treatments to patients worldwide.