Delving into the Latest Updates on Fore Biotherapeutics, Inc. with Synapse

Overview

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Neoplasms

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

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Targets

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Disease Domain	Count

Nervous System Diseases	1
Hemic and Lymphatic Diseases	1
Neoplasms	1
Immune System Diseases	1
Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

CYP3A4 x CYP3A5 x CYP3A7	1
BRAF(Serine/threonine-protein kinase B-raf)	1

Evaluating the sensitivity and feasibility of using ctDNA assays optimized for detecting very low ctDNA counts from cerebrospinal fluid (CSF) and plasma. The investigators will evaluate the sensitivity of ctDNA from plasma and CSF at baseline (defined as Cycle1 Day1 (C1D1) pre-treatment) and over time in response to treatment with plixorafenib co-administered with cobicistat in BRAF-V600E mutant glioma refractory to prior therapies.

Start Date02 Jan 2025

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+2]

NCT06385119 / RecruitingPhase 1

A Phase 1, Open-Label, 2-Part, Single Dose, Crossover Study to Examine the Effect of Food and Cobicistat Administration on the Pharmacokinetics and Safety of Plixorafenib in Healthy Participants.

The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine the following in two parts:
Part A
* The effect of food on the single dose PK of plixorafenib administered with cobicistat.
* The effect of cobicistat administration on the single dose PK of plixorafenib.
* The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants.
Part B
* To examine the effect of a high-fat and a low-fat meal versus fasted state on the single dose PK of plixorafenib administered alone.
* To examine the effect of a low-fat meal versus fasted state on the single dose PK of plixorafenib administered with cobicistat.
* To determine the safety of plixorafenib administered alone or with cobicistat (low-fat meal only) in a single dose regimen.

Start Date24 Apr 2024

Sponsor / Collaborator

Fore Biotherapeutics, Inc.

CTIS2024-513578-23-00 / Recruiting

A Phase 2 Master Protocol to assess the efficacy and safety of FORE8394,an inhibitor of BRAF class 1 and class 2 alterations, in participants withcancer harboring BRAF alterations - F8394-201

Start Date11 Jul 2023

Sponsor / Collaborator

Fore Biotherapeutics, Inc.

100 Clinical Results associated with Fore Biotherapeutics, Inc.

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0 Patents (Medical) associated with Fore Biotherapeutics, Inc.

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40

News (Medical) associated with Fore Biotherapeutics, Inc.

19 Dec 2024

·www.businesswire.com

FORE Biotherapeutics to Present at the 43rd Annual J.P. Morgan Healthcare Conference

PHILADELPHIA--( BUSINESS WIRE )--FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today announced that William Hinshaw, Chief Executive Officer of Fore Biotherapeutics, will present at the 43 rd Annual J.P. Morgan Healthcare Conference. The presentation will take place on Tuesday, January 14, 2025, at 5:30 p.m. PT at the Westin St. Francis Hotel in San Francisco. Mr. Hinshaw will detail progress and anticipated milestones for Fore’s lead asset, plixorafenib, a novel, small-molecule, next generation, orally available selective inhibitor of mutated BRAF. Plixorafenib is currently being evaluated in a clinical trial with registrational intent in three distinct indications. Please contact Argot Partners to schedule one-on-one meetings with the management team. About FORE Biotherapeutics Fore is a registration stage targeted oncology company dedicated to developing innovative treatments that provide better outcomes for patients with the hardest-to-treat cancers. The Company’s lead asset plixorafenib (FORE8394; formerly PLX8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1 st and 2 nd generation BRAF inhibitors. Plixorafenib has demonstrated single-agent efficacy signals across a variety of tumor types with a manageable safety profile in a Phase 1/2a clinical trial of over 100 patients and is currently enrolling patients in a clinical trial with registrational intent in three distinct indications. For more information, please visit www.fore.bio or follow us on X and LinkedIn .

Phase 1

05 Dec 2024

·www.businesswire.com

FORE Biotherapeutics to Participate in the Wells Fargo Virtual Private Biotech Symposium

PHILADELPHIA--( BUSINESS WIRE )--FORE Biotherapeutics today announced that the Company will participate in the Wells Fargo Virtual Private Biotech Symposium on Thursday, December 12. William Hinshaw, Chief Executive Officer and Michael Byrnes, Chief Financial Officer, will host and participate in one-on-one meetings. Please contact Argot Partners to schedule one-on-one meetings with the management team. About FORE Biotherapeutics Fore is a registration stage targeted oncology company dedicated to developing innovative treatments that provide better outcomes for patients with the hardest-to-treat cancers. The Company’s lead asset plixorafenib (FORE8394; formerly PLX8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1 st and 2 nd generation BRAF inhibitors. Plixorafenib has demonstrated single-agent efficacy signals across a variety of tumor types with a manageable safety profile in a Phase 1/2a clinical trial of over 100 patients and is currently enrolling patients in a clinical trial with registrational intent in three distinct indications. For more information, please visit www.fore.bio or follow us on X and LinkedIn .

Phase 1

07 Nov 2024

·www.businesswire.com

FORE Biotherapeutics to Participate in Upcoming November Conferences

PHILADELPHIA--( BUSINESS WIRE )--FORE Biotherapeutics today announced that the Company will participate at the following investor conferences: Stifel 2024 Healthcare Conference. The Company will attend on Monday, November 18, and will provide a corporate presentation at 2:25 p.m. – 2:55 p.m. ET. Jefferies London Healthcare Conference. The Company will attend and participate in one-on-one meetings on Wednesday, November 20, and Thursday, November 21. Management will host and participate in one-on-one meetings. Please contact Argot Partners to schedule one-on-one meetings with the management team. About FORE Biotherapeutics Fore is a registration stage targeted oncology company dedicated to developing innovative treatments that provide better outcomes for patients with the hardest-to-treat cancers. The Company’s lead asset plixorafenib (FORE8394; formerly PLX8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1 st and 2 nd generation BRAF inhibitors. Plixorafenib has demonstrated single-agent efficacy signals across a variety of tumor types with a manageable safety profile in a Phase 1/2a clinical trial of over 100 patients and is currently enrolling patients in a clinical trial with registrational intent in three distinct indications. For more information, please visit www.fore.bio or follow us on X and LinkedIn .

100 Deals associated with Fore Biotherapeutics, Inc.

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100 Translational Medicine associated with Fore Biotherapeutics, Inc.

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Pipeline

Pipeline Snapshot as of 29 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 1

1

Phase 2

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