Are two breakthrough cancer drugs better than one? Pharma giant Merck ($MRK) and Waltham, MA-based Syndax plan to find out in a Phase Ib/II study matching the tiny biotech's entinostat with Keytruda, Merck's big anti-PD-1 therapy, for either non-small cell lung cancer or melanoma. Investigators plan to start recruiting for the study in the second half of this year.
Syndax was one of the chosen few among the little biotechs to gain a breakthrough drug designation for a cancer drug, joining the first wave of BTDs back in 2013 for an experimental histone deacetylase (HDAC) inhibitor now in Phase III testing in treatment-resistant postmenopausal women with metastatic ER-positive breast cancer. The FDA issued the designation--which offers a potentially shorter path to an approval--after reviewing promising progression-free survival and overall survival data racked up in Phase II.
This latest immuno-oncology collaboration follows a lengthy string of pacts inked by Merck, which sees its PD-1 drug as a natural combo for a wide range of targeted drugs. Keytruda works by dismantling a natural cloaking device cancer cells use to stay hidden from the immune system. And Merck has been close behind Bristol-Myers, the leader in the field with Opdivo, an IO drug recently approved to treat lung cancer.
Syndax tried to capitalize on its BTD win at the FDA with an IPO last year, but later threw in the towel on the offering and inked a $100 million licensing deal with Kyowa Hakko Kirin in January, which included a $25 million upfront payment for rights to the Japanese and Korean markets. Syndax CEO Arlene Morris told Xconomy's Ben Fiedler a few weeks ago that the biotech decided to steer clear of the IPO market for now after determining the drug's potential in an immuno-oncology combo, hinting about the Merck deal then in the works.
But no one is offering up telltale financial details, including who's paying for the new study, which could pave the way to a pivotal late-stage trial.
Syndax is a 2007 Fierce 15 company. The biotech has been financed by Domain Associates, which brought in their Russian partners at RusnanoMedInvest on a syndicate that also includes MPM Capital and Forward Ventures. Domain founded the company with technology developed at the Salk Institute
"The broad base of clinical data involving our anti-PD-1 therapy, Keytruda, continues to provide a strong foundation for advancing the study of different novel combination regimens," said Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories.
- here's the release
Special Report: FierceBiotech's 2007 Fierce 15 - Syndax Pharmaceuticals