On April 3, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported a strategic reprioritization based on the rapidly changing commercial landscape for Bruton’s tyrosine kinase inhibitors (BTK inhibitors) (Press release, Oncternal Therapeutics, APR 3, 2023, View Source [SID1234629765]). The Phase 3 study and the Phase 1/2 study of zilovertamab in combination with ibrutinib will be closed, and other project and indirect expenses will be reduced, resulting in extending the expected cash runway into 2025. The projected cash runway will support the clinical advancement of our two pipeline assets ONCT-808 and ONCT-534.
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"It is an extremely difficult decision to halt the clinical development of zilovertamab in combination with ibrutinib for patients with hematologic malignancies," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "The dramatic adoption of recently approved Bruton’s tyrosine kinase inhibitors made the continued development of zilovertamab with ibrutinib an unviable commercial opportunity. The decision was not based on any concerns about the safety or efficacy of zilovertamab. Going forward we will focus on reaching clinical proof of concept and data catalysts from the clinical trials of ONCT-808 in patients with resistant aggressive lymphoma, and ONCT-534 in patients with prostate cancer resistant to standard of care androgen receptor inhibitors."
ONCT-808: Our ROR1 targeting autologous CAR T cell therapy is being tested in a recently initiated Phase 1/2 clinical trial for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including those who have failed previous CD19 CAR T therapy. Preclinical models show robust and specific activity against ROR1 expressing cells from multiple tumor types. We have developed a manufacturing process that is reproducible, scalable, and only 8 days in duration. We expect to present initial clinical data in late 2023, with additional clinical data readouts in 2024.
ONCT-534: Our novel dual-action androgen receptor inhibitor (DAARI) has concluded IND-enabling studies and we expect to submit an Investigational New Drug Application (IND) in mid-2023. Preclinical models suggest activity directed to both the N-terminal and ligand binding domain (LBD) of the androgen receptor (AR), and activity against the most common forms of resistance to current standard of care AR inhibitors. A Phase 1/2 clinical trial in patients with metastatic castrate-resistant prostate cancer (mCRPC) who are resistant to AR inhibitor treatment is expected to open shortly thereafter. We expect to present initial clinical data in mid-2024.
Zilovertamab: This reprioritization includes closing two studies of zilovertamab in combination with ibrutinib, ongoing Phase 1/2 Study CIRM-0001 and Phase 3 Study ZILO-301, a global registrational study in patients with relapsed/refractory MCL. We plan to continue exploring the potential value of zilovertamab in areas of high unmet medical need. The robust response rates and prolonged PFS seen for MCL and CLL patients expressing TP53 aberrations will be further investigated preclinically and extended into other tumor types, such as lung cancer and prostate cancer. We expect partnerships and collaborations to be essential for executing future late-stage clinical trials of zilovertamab.
In addition, management will continue to drive operational efficiencies and prudent cost reduction and cost containment measures. We estimate that our cash, cash equivalents and short-term investments were $54.3 million, and we had 58.7 million shares of common stock outstanding, as of March 31, 2023, and we expect our cash, cash equivalents and short-term investments to support our planned operations into 2025.