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Oncternal Therapeutics Announces Clinical Trial Collaboration to Advance Zilovertamab Phase 3 Study in combination with Ibrutinib for Patients with MCL

  • Clinical trial collaboration supports global registrational Phase 3 study ZILO-301, to treat patients with relapsed or refractory MCL with zilovertamab plus ibrutinib
  • Agreement is supportive of the planned initiation of ZILO-301 in Q3 2022 and will also supply ibrutinib for the open-label companion study ZILO-302

Excerpt from the Press Release:

SAN DIEGO, July 14, 2022 (GLOBE NEWSWIRE) — Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced it entered into a clinical trial collaboration with Pharmacyclics, an AbbVie company, that includes supply of ibrutinib for its Phase 3 clinical trial.

“This agreement represents a significant milestone for Oncternal as we advance towards the planned initiation of our registrational study ZILO-301 in the third quarter of 2022,” said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “Ibrutinib was the first Bruton’s tyrosine kinase (BTK) inhibitor in the market and its approval changed the treatment paradigm for patients suffering from certain hematological malignancies. We are pleased that this collaboration will support the development of an innovative combination of zilovertamab and ibrutinib that we believe may address important unmet needs of patients with MCL.”

Under the terms of the collaboration, the supply of ibrutinib will support the company’s global registrational Phase 3 clinical trial of zilovertamab for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL), ZILO-301. The agreement also includes the supply of ibrutinib for Study ZILO-302, an open-label companion study of zilovertamab plus ibrutinib for patients who have progressive disease during the initial four months of ibrutinib monotherapy from Study ZILO-301.

About Zilovertamab (formerly Cirmtuzumab)
Zilovertamab is an investigational, humanized, potentially first-in-class monoclonal antibody targeting Receptor tyrosine kinase-like Orphan Receptor 1 (ROR1). Zilovertamab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with MCL, chronic lymphocytic leukemia (CLL) or marginal zone lymphoma (MZL), in a collaboration with the University of California San Diego (UC San Diego) School of Medicine and the California Institute for Regenerative Medicine (CIRM).

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