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Monday, April 27, 2020

-=Syndax Pharmaceuticals (SNDX) : initial data for SNDX-5613

  • Announced positive early-stage data on candidate SNDX-5613, a small molecule inhibitor designed to block the interaction between a tumor suppressor protein called menin and another protein called MLL that plays a key role in the development of acute leukemia. 
  • Kura also has a menin-MLL inhibitor in development, KO-539, currently in Phase 1/2 development.
  • Price target raised to $33 from $27 at Baird. 
  • Surged to all-time highs.

Syndax Pharmaceuticals presents preclinical and initial data for SNDX-5613 in adults with relapsed/refractory acute leukemias 

  • Syndax Pharmaceuticals today presents preclinical and initial clinical data for SNDX-5613, the company's potent, highly selective oral menin inhibitor. The oral presentation will be featured during the New Drugs on the Horizon session at the 2020 AACR Virtual Annual Meeting I.
    • As of the April 17 data cutoff date, a total of six patients have been treated in the Phase 1 portion of the ongoing open-label AUGMENT-101 trial at increasing dose levels of SNDX-5613. Responses were observed in two of three patients harboring an MLL rearrangement. This included one patient, whose drug exposure was consistent with that needed for activity in preclinical models, who had a complete response with incomplete blood count recovery (CRi) after 28 days of therapy and subsequently improved to a complete response (CR). The second patient achieved a partial response with incomplete blood count recovery (PRi) after 28 days of therapy. Both patients continue to receive SNDX-5613. A third patient harboring an MLL rearrangement did not achieve drug exposure levels consistent with that needed for activity in preclinical models and was removed from the trial due to progressive disease.
    • Treatment with SNDX-5613 has been tolerated well, with no dose limiting toxicities reported. One patient experienced a Grade 2 QTc prolongation but remains on treatment.
  • The company also announced today that SNDX-5613 was recently granted Orphan Drug Designation for the treatment of adult and pediatric acute myeloid leukemia by the FDA.
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