Day One nabs its first ADC from MabCare for $55M
Drug ApprovalADCAcquisitionPhase 1License out/in
Hot off its first FDA approval, Day One Biopharmaceuticals added a new early-stage programme to its oncology pipeline on Tuesday, hopping into the much-hyped antibody-drug conjugate (ADC) space. For more analysis on deals involving the modality, see Vital Signs: Tracking the new converts to ADCs.
The California-based biotech licensed ex-China rights to MTX-13, a PTK7-targeting ADC, from MabCare Therapeutics. Day One will rename the candidate DAY301 and plans to start a Phase I trial in solid tumours by the first quarter of 2025.
The Chinese firm will receive $55 million upfront and is eligible for up to $1.15 billion in development, regulatory and commercial milestones, plus low-to-mid single-digit royalties.
Solving PTK7
Day One is betting on a less-well-known target for its first ADC. According to the company, PTK7 is a catalytically inactive transmembrane protein that is overexpressed in multiple solid tumours and underexpressed in healthy tissues.
However, an ADC against the kinase has yet to find clinical success. AbbVie and Pfizer had been working together to develop a PTK7-targeting ADC, cofetuzumab pelidotin, but both pharmas binned the candidate last year.
Genmab may have the only PTK7-directed ADC in the clinic. The company gained PRO1107, which is in a Phase I/II study for solid tumours, when it agreed in April to buy out ProfoundBio for $1.8 billion in cash. For more, see ViewPoints: How ProfoundBio fits into Genmab’s growth strategy.
Samuel Blackman, Day One’s head of R&D, said that the company believes “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.”
Wednesday’s deal gives Day One its fourth cancer programme. The FDA in April approved Day One’s pan-RAF kinase inhibitor Ojemda (tovorafenib) to treat relapsed or refractory low-grade glioma with an activating BRAF alteration. The company’s pipeline also includes MEK 1/2 inhibitorMEK 1/2 inhibitor pimasertib, which is in a Phase I/II trial for solid tumours with MAPK pathway aberrations, and a preclinical VRK1 inhibitor gained from Sprint Bio last year for a mere $3 million upfront.
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