On June 6, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that the first patient has been dosed in the Phase 1/2 dose escalation/dose expansion study of ONCT-808, the company’s ROR1 targeting autologous CAR T cell therapy (Press release, Oncternal Therapeutics, JUN 6, 2023, View Source [SID1234632519]).
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"We are excited to announce the first patient, who had failed previous CD19 CAR T therapy, has been treated with ONCT-808," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We believe ONCT-808 has the potential to produce robust and durable responses for patients suffering from aggressive lymphoma. It builds on our extensive clinical experience with zilovertamab, as well as that with zilovertamab vedotin, an antibody drug conjugate, which has shown that ROR1 can be targeted without unwanted off-tumor, on-target activity. We particularly appreciate that this first patient is under the care of Dr. Michael Wang, Endowed Professor in the Department of Lymphoma & Myeloma at the MD Anderson Cancer Center in Houston, Texas."
ONCT-808 is a ROR1 targeting autologous CAR T cell therapy that is being tested in a 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. Oncternal has developed a manufacturing process that is reproducible, scalable, and only 8 days in duration. The company expects to present initial clinical data in late 2023, with additional clinical data readouts in 2024.
About Study ONCT-808-101
Study ONCT-808-101 is a Phase 1/2, single-arm, open-label, multi-center study to evaluate the safety and tolerability, pharmacokinetics, and anti-tumor activity of ONCT-808 in subjects with aggressive B cell lymphoma, including large B-cell lymphoma (LBCL) and mantle cell lymphoma (MCL). After the safety and tolerability of ONCT-808 have been assessed to select the recommended Phase 2 dose (RP2D) in Phase 1, Phase 2 will commence to further validate the dose and evaluate the safety and efficacy of ONCT-808. In Phase 2, subjects with LBCL or MCL will be enrolled into 2 separate dose expansion cohorts. Current leading clinical sites for ONCT-808-101 are the MD Anderson Cancer Center in Houston, TX, the Dana-Farber Cancer Institute in Boston, MA, the City of Hope Comprehensive Cancer Center in Duarte, CA and the Mass General Cancer Center in Boston, MA.