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Syndax Pharma Updates On Interim Phase 1 Data From SNDX-5613 Leukemia Trial

Syndax Pharma Updates On Interim Phase 1 Data From SNDX-5613 Leukemia Trial
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX), in its Q1 earnings, also announced new data from the ongoing Phase 1 dose-escalation portion of the Phase 1/2 AUGMENT-101 trial evaluating SNDX-5613 in patients with MLLr and NPM1c mutant relapsed/refractory (R/R) acute leukemias.
  • The new data showed that two prior responders have improved from a complete response with incomplete platelet recovery (CRp) to a complete response (CR) with no evidence of minimal residual disease (MRD)
  • With the addition of these two patients, a total of 7/31 patients (23%) have achieved CR/CRh.
  • Syndax announced positive data from the Phase 1 portion of the AUGMENT-101 trial last month.
  • As of the data cutoff date, the overall response rate (ORR) among evaluable patients was 48% (n=15), with 67% (n=10) of these responders achieving MRD- status and four moving to receive stem cell transplant.
  • The ORR in evaluable patients harboring an MLL-rearrangement (n=24), was 54% (n=13), and in evaluable patients harboring an NPM1c mutation (n=7), was 29% (n=2).
  • Syndax remains on track to initiate the pivotal Phase 2 portion of the trial this quarter.
  • Q1 Earnings: Syndax clocked a net loss of $27.7 million or ($0.54) per share, higher than $19.1 million or $0.56 per share a year ago.
  • Increased clinical trial activities and CMC activities resulted in higher R&D expenses of $21.9 million, up from $9.6 million in Q1 2020.
  • The company ended the quarter with cash, cash equivalents, and short-term investments of $271.3 million.
  • Guidance: For Q2 2021, R&D expenses are expected to be $30 million - $35 million, and total operating costs are seen at $35 million - $40 million.
  • For FY21, Syndax forecasts R&D expenses of $90 million - $100 million and total operating expenses of $110 million - $120 million.
  • Price Action: SNDX shares closed at $16.04 on Tuesday.

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