Oncternal Therapeutics Announces Strategic Reprioritization, Stops Two Zilovertamab Studies

  • Oncternal Therapeutics Inc ONCT will suspend Phase 3 and the Phase 1/2 studies of zilovertamab in combination with ibrutinib, citing the rapidly changing commercial landscape for Bruton's tyrosine kinase inhibitors (BTK inhibitors). 
  • Cash, cash equivalents, and short-term investments of $54.3 million as of March 31, 2023, will support planned operations into 2025, supporting two pipeline assets, ONCT-808 and ONCT-534.
  • ONCT-808: ROR1 targeting autologous CAR T cell therapy is being tested in a recently initiated Phase 1/2 clinical trial for relapsed or refractory aggressive B-cell lymphoma. 
    • Preclinical models show robust and specific activity against ROR1-expressing cells from multiple tumor types. 
    • The manufacturing process is reproducible, scalable, and only eight days in duration. 
    • The company expects to present initial clinical data in late 2023, with additional clinical data readouts in 2024.
  • ONCT-534: Dual-action androgen receptor inhibitor (DAARI) has concluded IND-enabling studies and an Investigational New Drug Application (IND) is expected to be submitted in mid-2023. 
    • Initial clinical data is expected to be presented in mid-2024.
  • Price Action: ONCT shares are down 58.20% at $0.33 on the last check Tuesday.
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