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Details:

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.


Lead Product(s): Rigosertib,Pembrolizumab

Therapeutic Area: Oncology Product Name: ON 01910

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 25, 2023

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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.


Lead Product(s): Rigosertib,Nivolumab

Therapeutic Area: Oncology Product Name: ON-01910

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Onconova Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration March 23, 2023

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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.


Lead Product(s): Rigosertib

Therapeutic Area: Oncology Product Name: ON-01910

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 07, 2023

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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.


Lead Product(s): Rigosertib,Nivolumab

Therapeutic Area: Oncology Product Name: ON-01910

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 12, 2022

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The trial continues to recruit patients as part of the expansion phase at the highest dose of oral rigosertib defined in the current protocol.


Lead Product(s): Rigosertib,Nivolumab

Therapeutic Area: Oncology Product Name: ON-01910

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 28, 2021

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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.


Lead Product(s): Rigosertib

Therapeutic Area: Genetic Disease Product Name: ON-01910

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 22, 2021

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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.


Lead Product(s): Rigosertib

Therapeutic Area: Infections and Infectious Diseases Product Name: ON-01910

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2020

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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.


Lead Product(s): Rigosertib

Therapeutic Area: Oncology Product Name: ON 01910

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 23, 2020

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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.


Lead Product(s): Rigosertib,Azacitidine

Therapeutic Area: Oncology Product Name: ON-01910

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 07, 2020

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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.


Lead Product(s): Rigosertib,Nivolumab

Therapeutic Area: Oncology Product Name: ON-01910

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 22, 2020

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The company announced updated aggregated baseline genomic data from HMA-failure patients screened for the INSPIRE trial were presented in an e-poster at the virtual 25th Annual EHA Congress.


Lead Product(s): Rigosertib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 12, 2020

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Company has completed the planned enrollment of 360 patients in the INSPIRE trial in higher-risk (HR) MDS patients. INSPIRE is one of the largest studies ever conducted in this patient population.


Lead Product(s): Rigosertib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 24, 2020

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