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              OnKure Therapeutics

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              Reneo Pharmaceuticals and OnKure Announce Proposed Merger

              Details:

              The combined company will focus on advancing OnKure’s pipeline candidates targeting oncogenic mutations in phosphoinositide 3-kinase alpha (PI3Kα), including its lead program OKI-219, which is currently in a Phase 1 clinical trial for the treatment of solid tumors.

              Lead Product(s): OKI-219,Fulvestrant

              Therapeutic Area: Oncology Product Name: OKI-219

              Highest Development Status: Phase I Product Type: Small molecule

              Recipient: Reneo Pharmaceuticals

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Merger May 13, 2024

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              OnKure Therapeutics

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              Reneo Pharmaceuticals and OnKure Announce Proposed Merger

              Details:

              The combined company will advance OnKure’s pipeline targeting oncogenic mutations in PI3K alpha, including its lead program OKI-219, which is in Phase 1 trial for the treatment of solid tumors.

              Lead Product(s): OKI-219,Fulvestrant

              Therapeutic Area: Oncology Product Name: OKI-219

              Highest Development Status: Phase I Product Type: Small molecule

              Recipient: Reneo Pharmaceuticals

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Merger May 13, 2024

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              OnKure Therapeutics

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              OnKure Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for its Mutant Selective PI3Kα inhibitor, OKI-219

              Details:

              OKI-219 is a potential best-in-class, orally bioavailable, highly selective inhibitor of PI3Kα H1047R, which is being evaluated for the treatment of HER2+/ PI3Kα H1047R breast cancer.

              Lead Product(s): OKI-219

              Therapeutic Area: Oncology Product Name: OKI-219

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 04, 2024

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              OnKure Therapeutics

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              OnKure Therapeutics Announces $54 Million Series C Financing

              Details:

              The proceeds will be used to support the continued development of OnKure’s differentiated pipeline of next generation precision medicines, including the advancement of its lead discovery program OKI-219, a selective PI3K alpha H1047R inhibitor, into the clinic.

              Lead Product(s): OKI-219

              Therapeutic Area: Oncology Product Name: OKI-219

              Highest Development Status: IND Enabling Product Type: Small molecule

              Partner/Sponsor/Collaborator: Surveyor Capital

              Deal Size: $54.0 million Upfront Cash: Undisclosed

              Deal Type: Series C Financing May 23, 2023

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              OnKure Therapeutics Announces First Patient Dosed in the Phase 1b/2 Nautilus Trial of OKI-179 in Combination with Binimetinib in Patients with Advanced NRAS-Mutated Melanom...

              Details:

              OKI-179 is a novel, oral Class I histone deacetylase (HDAC) inhibitor for the potential treatment of a wide range of solid and hematological malignancies.

              Lead Product(s): OKI-179,Binimetinib

              Therapeutic Area: Oncology Product Name: OKI-179

              Highest Development Status: Phase I/ Phase II Product Type: Peptide

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 02, 2022

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              OnKure Therapeutics

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              OnKure Therapeutics Announces Promising Preclinical Data on OKI-179 in RAS-Mutated Tumor Models Presented in a Late-Breaking Session at AACR

              Details:

              OKI-179 combined with binimetinib in NRAS-mutated melanoma or combined with binimetinib + encorafenib in BRAF-mutated colorectal xenografts showed significantly increased regressions compared to either single agent following two weeks of dosing.

              Lead Product(s): OKI-179,Binimetinib

              Therapeutic Area: Oncology Product Name: OKI-179

              Highest Development Status: Phase I Product Type: Peptide

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 08, 2022

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              OnKure Therapeutics

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              OnKure Therapeutics to Present Late-Breaking Preclinical Data on OKI-179 at the AACR Annual Meeting 2022

              Details:

              OKI-179, a novel oral Class I histone deacetylase inhibitor for treatment of wide range of solid and hematological malignancies, increases tumor regressions when combined with the MEK inhibitor binimetinib in models of NRAS melanoma.

              Lead Product(s): OKI-179,Binimetinib

              Therapeutic Area: Oncology Product Name: OKI-179

              Highest Development Status: Phase I Product Type: Peptide

              Partner/Sponsor/Collaborator: University of Colorado

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 08, 2022

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              Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
              One Pharma aims to be one of the leading generic companies in Europe.
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