- Daiichi Sankyo is bringing a seventh antibody-drug conjugate, or ADC, into its pipeline through a licensing agreement with German biotech Glycotope.
- Specific financials weren't disclosed, but the deal does offer Glycotope an upfront payment plus milestones and royalties on net worldwide sales should the drug in question, gatipotuzumab, come to market. In exchange, Daiichi gets exclusive development and commercialization rights.
- Gatipotuzumab is a potentially first-in-class monoclonal antibody that targets cancer cells expressing an epitope called tumor-specific epitope of mucin-1 (TA-MUC1). An epitope is the piece of an antigen to which antibodies bind, and the TA-MUC1 variety can be found on the surface of various tumor cells, including breast, lung and ovarian.
It's been nearly two decades since the Food and Drug Administration approved Wyeth's ADC Mylotarg (gemtuzumab ozogamicin). And yet, few others have broken into the market despite the global ADC pipeline continuing to broaden; business intelligence firm Informa counts 270 of the drugs currently in development.
Manufacturing challenges are largely to blame for the lack of new ADCs, as the drugs require linking a cytotoxic payload to a monoclonal antibody — and not many companies have the expertise to do that.
Daiichi has been trying to prove it's one of the companies that can handle ADC production. Last April, it announced plans to pump 15 billion Japanese Yen ($135 million) into three manufacturing facilities to improve or create new lines and thereby triple capacity by 2021. In a statement, the Japanese pharma said the upgrades were primarily to support its ADC pipeline.
"This strategic investment will bolster our leadership and expertise in ADC manufacturing, as we apply our proprietary ADC technology to more than two dozen biologics in preclinical or early stage development," Katsumi Fujimoto, head of Daiichi's supply chain division, said at the time.
According to a July 30 statement, the deal with Glycotope hands Daiichi its seventh novel ADC candidate.
Other investigational ADCs in the pharma's pipeline include trastuzumab deruxtecan, which is just entering Phase 3 testing in patients with HER2-positive, unresectable and/or metastatic breast cancer, and DS-1062, an anti-TROP2 drug in Phase 1 testing against advanced solid tumors.