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Federally Funded Human Studies In COVID-19 Disease","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Onconova Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Onconova Begins Patient Dosing in Phase 2 Study of Rigosertib to Treat RDEB-Associated Locally Advanced\/Metastatic SCC","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Onconova Therapeutics","sponsor":"Not 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RDEB-Associated Squamous Cell Carcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Onconova Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Onconova Therapeutics Announces Dosing of First Participant in Investigator-Sponsored Phase 2 Trial of Rigosertib Plus Pembrolizumab in Metastatic Melanoma Patients Refractory to Immune Checkpoint Blockade","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Rigosertib
ON 01910 (rigosertib) is a small molecule that inhibits multiple cell signaling pathways that drive cancer growth while having little effect on normal cells. In contrast to many kinase inhibitors.
The collaboration will leverage Pangea Biomed’s proprietary algorithmic platform, ENLIGHT, for identifying biomarkers of response to Onconova’s proprietary investigational ON-01910 (rigosertib) with the ability to potently inhibit PLK1 to treat a range of solid cancers.
ON-01910 (rigosertib) is an investigational product candidate with a multi-faceted mechanism of action targeting proteins containing the RAS binding domain, allowing it to modulate the PI3K and PLK-1 pathways, as well as the tumor immune microenvironment.
ON-01910 (rigosertib) is a small molecule that inhibits multiple cellular signaling pathways driving cancer cell growth. The studied doublet study has been generally well tolerated. Treatment-related adverse events (TRAE) have been mostly mild and manageable.
In open-label investigator-initiated study, 12 patients will receive either oral or intravenous rigosertib at the clinician’s discretion given the various clinical manifestations of the disease, which may dictate the need for either oral/intravenous rigosertib administration.
Onconova Therapeutics has submitted an application with the National Institute of Allergy and Infectious Disease (NIAID), with the goal of obtaining funding from the National Institutes of Health (NIH) to conduct human studies with rigosertib in COVID-19 disease patients.
The authors found that non-clinical grade rigosertib used in in vitro studies by others contained impurities and degradation products in sufficient quantities to impact cellular function.
Results coupled with preliminary data from the phase II studies, support further clinical development of oral rigosertib in combination with standard dose azacitidine with a manageable safety profile and efficacy in patients with MDS both those HMA naïve and after HMA failure.
The investigator-initiated trial is an open-label, dose-escalating Phase 1 study followed by a Phase 2a dose-expansion phase to study the combination of oral rigosertib and nivolumab in metastatic KRAS+ lung adenocarcinoma patients who are on standard frontline treatment.