On June 14, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova" or "the Company"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported preclinical data on narazaciclib at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place in Lugano, Switzerland, through June 17, 2023 (Press release, Onconova, JUN 14, 2023, View Source [SID1234632708]).
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Data from the Josep Carreras Leukaemia Research Institute expanded on a prior presentation at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, showing that narazaciclib’s antitumor activity against mantle cell lymphoma (MCL) cell lines was superior to that of the FDA-approved CDK 4/6 inhibitors palbociclib and ribociclib, and similar to that of the FDA-approved CDK 4/6 inhibitor abemaciclib. Combining narazaciclib with the FDA-approved Bruton’s tyrosine kinase inhibitor ibrutinib led to synergistic increases in antitumor activity against both ibrutinib-sensitive and ibrutinib-resistant MCL cell lines. In addition, treatment with narazaciclib combined with ibrutinib led to significant inhibition of tumor growth and significant reductions in malignant B cell infiltration into the bone marrow in multiple chicken embryo chorioallantoic membrane xenograft models of MCL.
Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, "The data being presented at ICML provide further evidence of narazaciclib’s potential to combine synergistically with a wide range of therapeutic classes, derived from its ability to inhibit CDK 4, 6, and additional kinases involved in cancer cell survival and metastasis. This differentiated kinase inhibitory profile also confers expansive therapeutic potential across a variety of indications and may enable narazaciclib to overcome the efficacy limitations and safety concerns of currently marketed CDK 4/6 inhibitors. Given ibrutinib is the standard-of-care in mantle cell lymphoma, the preclinical results showing narazaciclib improving antitumor responses in combination represents a promising development that speaks to its potential therapeutic utility in this high unmet need indication. We look forward to discussing our data throughout ICML as we continue to evaluate additional opportunities for clinical studies with narazaciclib and advance our ongoing Phase 1/2a combination trial of narazaciclib plus estrogen blockade in endometrial cancer."
The ICML poster, titled, "Prolonged cell cycle arrest by the CDK 4/6 antagonist narazaciclib restores ibrutinib response in preclinical models of BTKi-resistant mantle cell lymphoma," is currently available to registered attendees of ICML via the conference’s e-poster gallery. The poster will also be displayed during the in-person poster sessions being held throughout the conference. A copy of the poster will be available on the "Scientific Presentations" section of the Onconova website following the conclusion of the conference.