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Details:
ON123300 (narazaciclib) is a multi-kinase inhibitor targeting CDK 4, CDK 6, and other kinases important for cell proliferation and motility. It is being investigated in combination with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC).
Lead Product(s): Narazaciclib,Letrozole
Therapeutic Area: Oncology Product Name: ON 123300
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 May 11, 2023
Details:
In vitro and cell-based assays suggest ON 123300 (narazaciclib)'s inhibitory profile may provide safety and efficacy advantages over currently approved CDK4/6 inhibitors.
Lead Product(s): Narazaciclib
Therapeutic Area: Oncology Product Name: ON 123300
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
Narazaciclib (ON 123300) is a multi-kinase inhibitor targeting CDK 4/6 and additional kinases involved in tumor genesis, which presents an innovative approach to treating advanced cancers resistant to commercial CDK 4/6 inhibitors.
Lead Product(s): Narazaciclib
Therapeutic Area: Oncology Product Name: ON123300
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2022
Details:
ON 123300 (narazaciclib), a multi-kinase inhibitor targeting CDK 4/6, is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies for the treatment of HR+ HER2- metastatic breast cancer.
Lead Product(s): Narazaciclib
Therapeutic Area: Oncology Product Name: ON123300
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2022
Details:
First Patient enrolled in the U.S. Phase 1 Clinical Trial of ON 123300 based on preclinical and developing data to evaluate ON 123300 in advanced cancer patients including HR+ HER 2- metastatic breast cancer patients resistant to approved CDK 4/6 inhibitors.
Lead Product(s): Narazaciclib
Therapeutic Area: Oncology Product Name: ON 123300
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2021
Details:
The IND seeks permission to begin a Phase 1 trial with ON 123300 in relapsed/refractory advanced cancer including patients with HR+ HER 2- metastatic breast cancer with resistance to approved second-generation CDK4/6 inhibitors.
Lead Product(s): Narazaciclib
Therapeutic Area: Oncology Product Name: ON 123300
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
ON 123300 is a novel small molecule, and a dual inhibitor of CDK4/6 and ARK5, a key enzyme controlling cellular energy homeostasis. Inhibition of ARK5 by ON 123300 results in the collapse of oncogene-altered energy metabolism, leading to programmed cell death.
Lead Product(s): Narazaciclib
Therapeutic Area: Oncology Product Name: ON 123300
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: HanX Biopharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
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