Wednesday, October 09, 2024
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation. Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a combination trial with estrogen blockade in advanced endometrial cancer. Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib in additional indications. Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies. These studies include a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer, a Phase 2 program evaluating rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Positive Results Announced From Tivoxavir Marboxil Study. Positive data was announced from the Phase 1 clinical trial testing safety and pharmacokinetics of Tivoxavir Marboxil, Traw’s drug in development for seasonal and pandemic influenza. The study showed tolerability and bloodstream levels within the expected range, supporting use as a one-time treatment for flu. The dose for Phase 2 has been selected with the trial planned to begin in 1H2025.
Tivoxavir Inhibitor A Protease Needed For Viral Replication. Tivoxavir acts through inhibition of CAP-dependent endonucleases (CEN), a highly conserved influenza protein needed for the synthesis of its viral mRNA. Tivoxavir was designed for use across a broad range of flu viruses including the H5N1 bird flu virus. Preclinical studies have shown potent inhibition of drug-resistant influenza viruses.
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