Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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The proceeds will advance the development of PLX-8394 (plixorafenib), the company’s novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations in patients with BRAF-altered advanced solid and central nervous system tumors.


Lead Product(s): Plixorafenib

Therapeutic Area: Oncology Product Name: PLX-8394

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

Partner/Sponsor/Collaborator: SR One

Deal Size: $75.0 million Upfront Cash: Undisclosed

Deal Type: Series D Financing August 23, 2023

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FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF, it is being investogated for the treatment of primary brain and central nervous system (CNS) malignancies.


Lead Product(s): Plixorafenib,Cobicistat

Therapeutic Area: Oncology Product Name: FORE8394

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 March 20, 2023

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FORE8394 is a selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF. It is being developed for BRAF-mutated solid and brain tumors.


Lead Product(s): Plixorafenib,Cobicistat

Therapeutic Area: Oncology Product Name: FORE8394

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 23, 2023

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FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF.


Lead Product(s): Plixorafenib

Therapeutic Area: Oncology Product Name: FORE8394

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 28, 2022

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Details:

FORE8394 demonstrated confirmed single agent overall response rate of 43% and median duration of response of 17.8 months in MAPK-inhibitor naïve, V600+ population; 71% experienced clinical benefit of at least 24 weeks.


Lead Product(s): Plixorafenib

Therapeutic Area: Oncology Product Name: FORE8394

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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Details:

FORE8394 is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild type forms of RAF.


Lead Product(s): Plixorafenib

Therapeutic Area: Oncology Product Name: FORE8394

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 August 09, 2022

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PHARMACOMPASS
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