Syndax Pharmaceuticals, a biopharma startup, has entered an exclusive worldwide licensing agreement with Bayer Schering Pharma for rights to the German company's selective histone deacetylase inhibitor. Syndax plans to develop the HDACi in combination with other therapies, the firm announced April 13.

Waltham, Mass.-based Syndax will develop and commercialize the compound, SNDX-275, in exchange for paying Bayer upfront and milestone payments. Financial terms of the agreement were not disclosed.

Privately held Syndax announced April 3 that it had closed $40 million in Series A financing and planned to use the proceeds to develop a clinical pipeline in oncology. The company intends to specialize in "programs to treat cancers in optimized, mechanistically driven combinations with other known cancer therapies."

The industry needs "to move away from the way that we used to develop [drugs], which was much more empiric because we didn't have so many things to combine, and we need to really think about how we use these agents," Syndax Chief Executive Officer Joanna Horobin told "The Pink Sheet" DAILY in an interview.

Mechanism-driven drug combining "requires us to be very thoughtful about why we combine [agents] and not just saying, this one's approved in this patient population, so let's add the agent to that. We need to move beyond that," Horobin said.

SNDX-275, formerly Bayer's MS-275, has the potential to treat a variety of tumor types in combination with other cancer therapies, the company said.

The HDAC inhibitor has already been studied in combination with Boulder, Colo.-based Pharmion's Vidaza (azacitidine), a DNA methltransferase inhibitor that was approved in 2004 for treatment of myelodysplastic syndromes (¹ Also see "Pharmion Vidaza To Be Launched By July 1 For Bone Marrow Disorder" - Pink Sheet, 19 May, 2004.).

Syndax intends to initiate Phase II studies in hematological and solid tumor indications where there is a significant unmet medical need and where accelerated approval may be possible, the company said.

Clinical trials are expected to begin in late 2007. The company will also continue to collaborate with the National Cancer Institute under an agreement established by Schering AG, now Bayer Schering Pharma.

Merck's Zolinza (vorinostat) is the only HDAC inhibitor to win FDA approval so far. The oncologic was approved in October for treatment of cutaneous T-cell lymphoma (² Also see "Merck’s Zolinza Approved For Rare Skin Cancer" - Pink Sheet, 6 October, 2006.).

- Shirley Haley (s.haley@elsevier.com)

Bayer Schering Oncology Candidate Becomes First Syndax Pipeline Compound

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