On October 19, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova", the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that one of the Company’s scientific collaborators, Gaël Roué, Ph.D., from the Josep Carreras Leukaemia Research Institute, Spain, made a podium presentation during the European MCL Network Annual Meeting in Dublin, Ireland on October 7, 2023 regarding promising ongoing preclinical studies of narazaciclib, in combination with ibrutinib and other targeted therapies used in the treatment for mantle cell lymphoma (Press release, Onconova, OCT 19, 2023, View Source [SID1234636148]).
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"Mantle cell lymphoma (MCL) is an aggressive and devastating disease, marked by frequent relapses and poor prognosis. The biology of MCL is very interesting to Onconova because of the link to cyclin D1 (CD1) overexpression. Onconova’s proprietary multi-kinase inhibitor, narazaciclib, has nanomolar potency across a range of targets including CD1. We believe this molecular feature could make MCL amenable to treatment combinations that include narazaciclib," said Steven Fruchtman, M.D., President and CEO of Onconova. "Dr. Roué’s recent work expands the dataset regarding the potential use of narazaciclib in combination with ibrutinib and other targeted therapies in sensitive and resistant MCL cell lines. Together, these data provide a foundation of support for using narazaciclib in MCL and other cyclin-dependent indications. We look forward to incorporating these important findings into the development plan for narazaciclib as we advance the clinical program, led by the Phase 1/2a study in patients with LGEEC."
Onconova plans to provide an update on the Phase 1/2a clinical program with narazaciclib in patients with low grade endometriod endometrial cancer (LGEEC), including topline safety, pharmacology data, and selection of a recommended Phase 2 dose, in Q4 2023.
Data featured in the presentation in Dublin and in a prior presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April of 2023 outlined promising results from preclinical studies that compared combinations of narazaciclib and other approved CDK4/6 inhibitors with ibrutinib and other next-generation BTK inhibitors to assess potential treatment synergies. Data from the combination of narazaciclib and ibrutinib showed significant synergistic anti-tumor activity in both sensitive and ibrutinib-resistant MCL models.