Day One Biopharmaceuticals Expands Pipeline with Promising New Cancer Drug DAY301
Day One Biopharmaceuticals, a company now in its commercial-stage journey after securing FDA approval for its first drug two months ago, is strengthening its product line. They've struck a deal that grants them rights to a novel cancer drug, ready for its first human trial.
Key Acquisition on Day One
The agreement, announced Tuesday, provides Day One Biopharmaceuticals with an antibody drug conjugate (ADC) from MabCare Therapeutics, a biotechnology company from Shanghai, China. Day One is investing $55 million upfront for the global rights to this drug candidate, now renamed DAY301.
What is DAY301?
DAY301 targets protein-tyrosine kinase 7 (PTK7), a protein that is highly expressed on the surface of certain cancer cells but found in limited quantities in healthy tissues. This makes PTK7 an excellent drug target. The cancers featuring PTK7 include:
- Adult cancers such as esophageal, ovarian, lung, and endometrial cancers.
- Pediatric cancers like neuroblastoma, rhabdomyosarcoma, and osteosarcoma.
Competitive Landscape
Other companies have shown interest in PTK7 before. For example, AbbVie acquired a similar drug candidate through their acquisition of StemCentrx in 2016, although that program was reportedly discontinued last year. Recently, Genmab acquired a PTK7-targeting ADC with their $1.8 billion purchase of ProfoundBio.
Advanced Technology and Expectations
The ADCs (antibody drug conjugates) from MabCare come from a platform technology that features:
- A higher drug to antibody ratio
- Improved stability
Preclinical research has shown that MabCare’s ADC can effectively bind to PTK7, releasing its drug payload and killing tumors across various solid cancers. Samuel Blackman, head of research and development, believes the linker-payload technology in DAY301 will overcome previous limitations, potentially offering a first-in-class drug against a clinically validated target.
Day One plans to begin the Phase 1 study for DAY301 in the fourth quarter of this year or early next year.
Business Model and Pipeline
Day One's strategy centers on securing rights to drug candidates initially developed by other companies. The company's recent success includes Ojemda, approved in April for treating pediatric low-grade glioma (pLGG), which was licensed from Takeda Pharmaceutical. Other drugs in the pipeline include pimasertib for MAPK-altered solid tumors and a VRK1 inhibitor in preclinical development.
The company is financially robust following the FDA approval of Ojemda, which came with a priority review voucher sold for $108 million.
CEO’s Vision for 2024
In a prepared statement, CEO Jeremy Bender outlined the company’s priorities for 2024:
- Successfully launching Ojemda
- Advancing existing programs
- Expanding the pipeline by in-licensing clinical-stage assets with transformation potential for cancer patients.
Financial and Partnership Details
Under Day One’s agreement with MabCare, the California-based company gets global rights to DAY301, excluding Greater China, where Mabcare retains rights. In addition to the upfront payment, Day One could pay up to $1.152 billion in development, regulatory, and commercial milestone payments. MabCare is also eligible for royalties on net sales of an approved product.
Day One Biopharmaceuticals is thus poised to continue its fight against cancer with the addition of DAY301 to its burgeoning pipeline, with hopes this new drug candidate will bring transformative outcomes to patients worldwide.
