Syndax Pharmaceuticals Inc (NASDAQ: SNDX)

Syndax Pharmaceuticals Inc., also known as SNDX, is a clinical-stage biopharmaceutical company that specializes in the development of innovative cancer therapies. The company's primary focus is on two lead product candidates: revumenib and axatilimab. Revumenib is a potent, selective, small molecule inhibitor of the menin-MLL binding interaction, which is used for the treatment of KMT2A rearranged, or KMT2Ar, acute leukemias, including acute lymphoblastic leukemia and acute myeloid leukemia, as well as necleophosmin 1 mutant AML and solid tumors such as metastatic colorectal cancer. Axatilimab is a monoclonal antibody that blocks the colony stimulating factor 1 receptor, used for the treatment of chronic graft-versus-host disease and idiopathic pulmonary fibrosis.

Syndax Pharmaceuticals has a robust product pipeline, including the two aforementioned candidates, as well as entinostat, an oral, small molecule product candidate. Entinostat has direct effects on both cancer cells and immune regulatory cells, potentially enhancing the body's immune response to tumors. However, the company has deprioritized the development of entinostat, but maintains a license, development, and commercialization agreement with Eddingpharm International Company Limited for the development and commercialization of entinostat in China and certain other Asian countries.

The company's position within the industry is strengthened by its collaborations and license agreements, including a collaboration and license agreement with Incyte for the development and commercialization of axatilimab. Under this agreement, Incyte received exclusive commercialization rights outside of the United States, and Syndax Pharmaceuticals and Incyte will have co-commercialization rights in the United States, with respect to axatilimab. Syndax Pharmaceuticals also has a license agreement with Vitae Pharmaceuticals, Inc., a subsidiary of AbbVie plc, under which Vitae granted Syndax Pharmaceuticals an exclusive, sublicensable, worldwide license to preclinical, orally-available, small molecule inhibitors of the interaction of menin with the MLL protein.

Syndax Pharmaceuticals has a commercial infrastructure in place to support sales of its product candidates in the United States. The company expects to manage sales, marketing, and distribution through internal resources and third-party relationships. In accordance with its agreement, Incyte will lead the commercialization of axatilimab globally and Syndax Pharmaceuticals has elected to co-promote axatilimab in the United States.

The company's intellectual property portfolio includes patents and patent applications directed to its product candidates, their methods of use and processes for their manufacture, as well as for other technologies, where appropriate. Syndax Pharmaceuticals' owned intellectual property portfolio includes pending U.S. and non-U.S. patent applications directed to combinations of entinostat and axatilimab, as well as patent applications directed to the treatment regimens and methods of using axatilimab.