Oncternal Therapeutics

Oncternal Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel oncology therapies for the treatment of patients with cancers that have critical unmet medical needs. The company's pipeline includes investigational product candidates targeting hematological malignancies and prostate cancer across multiple modalities.

ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets Receptor Tyrosine Kinase-Like Orphan Receptor one (ROR1) using the binding domain from zilovertamab. ONCT-808 has demonstrated activity in preclinical models against multiple hematological malignancies and solid tumors and has been shown to be specific for cancer cells expressing ROR1. Oncternal has initiated Study ONCT-808-101 (NCT05588440) in October 2023 for the treatment of patients with relapsed or refractory aggressive B-cell lymphoma, including patients who have failed previous CD19 CAR T treatment.

ONCT-534 is an investigational dual-action androgen receptor inhibitor (DAARI) with preclinical activity in prostate cancer models against both unmutated androgen receptor (AR) and multiple forms of AR aberrations. It is a potential treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with unmet medical needs. Oncternal received FDA clearance in August 2023 to initiate Study ONCT-534-101 (NCT05917470), a Phase 1/2 study in patients with mCRPC, and dosed the first patient in October 2023.

Zilovertamab is an investigational monoclonal antibody designed to inhibit the function of ROR1. It showed evidence of antitumor activity and was well-tolerated in Study CIRM-0001 (NCT03088878) in combination with ibrutinib for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and marginal zone lymphoma (MZL). Oncternal initiated a global Phase 3 Study ZILO-301 (NCT05431179) to evaluate zilovertamab in combination with ibrutinib for the treatment of patients with relapsed/refractory MCL.