KURA - Kura Oncology falls Syndax gains after Phase 1/2 data for leukemia candidates

Kura Oncology ( NASDAQ: KURA ) fell ~14% on Monday after the clinical-stage biotech announced updated data from a Phase 1/2 trial for lead asset ziftomenib in patients with relapsed/refractory acute myeloid leukemia (AML)

Meanwhile, Kura’s rival for menin-targeting cancer therapies Syndax Pharmaceuticals ( NASDAQ: SNDX ), added ~14% in reaction to updated data from an ongoing Phase 1/2 trial for its lead candidate revumenib (SNDX-5613) in relapsed/refractory AML or acute lymphoid leukemias (ALL).

Both data were included in two separate presentations at the ongoing American Society of Hematology (ASH) Annual Meeting.

Kura’s ( KURA ) Phase 1a dose-escalation trial for ziftomenib indicated that the menin inhibitor led to one event of complete remission (CR) with no evidence of minimal residual disease (MRD) among 30 patients with R/R AML.

The company said that the patient with CR, who had received seven prior lines of therapy, remains on ziftomenib after two years.

Meanwhile, a Phase 1b trial for 53 patients indicated a 30% CR rate at 600 mg among 20 patients with relapsed/refractory mNPM1-mutant (nucleophosmin mutant) AML (6/20) compared to 17% (1/6) at 200 mg (1/6).

However, Kura ( KURA ) said that patients with KMT2A-rearranged AML failed to receive adequate treatments due to symptoms of differentiation syndrome, and only one patient achieved a CR/CRh (CR with partial hematologic recovery).

The company expects to start dosing in a potentially pivotal Phase 2 trial for ziftomenib in NPM1-mutant AML in Q1 2023. Kura ( KURA ) also said further studies on the treatment would be targeted at KTM2A-rearranged AML as a combination regimen with standards of care.

Meanwhile, Syndax ( SNDX ) said that its oral menin inhibitor revumenib indicated 53% ORR and 30% CR/CRh rate in efficacy evaluable AML patients in the Phase 1 portion of the ongoing Phase 1/2 AUGMENT-101 trial as of March 2022 data cutoff date.

CR/CRh rate stood at 27% in both mNPM1 (3/11) and KMT2Ar (MLLr) (10/37) R/R acute leukemia patients treated at recommended Phase 2 dose (RP2D).

As for safety, 10% treated at the RP2D and 13% treated at all doses experienced asymptomatic Grade 3 QT prolongation, which, the company said, was the only dose-limiting toxicity. No patients discontinued the treatment due to related adverse events.

The Phase 2 pivotal portion of AUGMENT-101 is currently underway, with topline data expected in Q3 2023 ahead of a potential New Drug Application (NDA) filing by the 2023 end.

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