RARE Daily

Day One Expands Pipeline with Antibody Drug Conjugate Targeting PTK7

June 18, 2024

Rare Daily Staff

Day One Biopharmaceuticals entered into an exclusive licensing agreement with MabCare Therapeutics for MTX-13, a novel ADC targeting protein-tyrosine kinase 7.

Under the terms of the agreement, Day One has exclusive rights to develop, manufacture, and commercialize MTX-13 worldwide, excluding Greater China. MabCare will receive $55 million upfront, and is eligible to receive an additional $1.152 billion in development, regulatory and commercial success-based milestones, plus low-to-mid single-digit royalties on net sales outside of Greater China.

The U.S. Food and Drug Administration in April cleared MTX-13 to begin clinical studies. In pre-clinical studies, MTX-13, which is now known as DAY301, showed antitumor activity in a wide range of solid tumors. Day One expects the first patient to be dosed in the phase I study in the fourth quarter of 2024 or first quarter of 2025.

DAY301 targets PTK7, a highly conserved, catalytically inactive transmembrane protein that is overexpressed in multiple adult cancers, including esophageal, ovarian, lung, and endometrial cancer, as well as pediatric cancers such as neuroblastoma, rhabdomyosarcoma and osteosarcoma. PTK7 has limited expression in normal tissues or organs, making it an attractive target for therapeutic development.

“The addition of DAY301 to our pipeline strategically fits our mission of advancing both pediatric and adult medicines in areas of unmet need with equal urgency,” said Samuel Blackman, co-founder and head of research and development at Day One. “We believe the linker-payload technology embodied in DAY301 will overcome the limitations of earlier PTK7-targeted ADCs, giving us a potential first-in-class drug against a clinically-validated target.”

Photo: Samuel Blackman, co-founder and head of research and development at Day One

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