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

Overview

Tags

Neoplasms

Nervous System Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

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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39

News (Medical) associated with Fore Biotherapeutics, Inc.

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 .

04 Sep 2024

·www.businesswire.com

FORE Biotherapeutics to Participate in Upcoming Investor Conferences

PHILADELPHIA--( BUSINESS WIRE )--FORE Biotherapeutics today announced that the Company, will participate at the following investor conferences: Cantor 2024 Global Healthcare Conference. The Company will attend and participate in one-on-one meetings on Wednesday, September 18. UBS 2024 Virtual Biotechnology Private Company Symposium. The Company will attend on Thursday, September 19, and will provide a corporate presentation from 10:00 a.m. – 10:25 a.m. ET. Bank of America Healthcare Trailblazers Private Company Conference. The Company will attend and participate in one-on-one meetings on Wednesday, September 25. RBC Capital Markets 2024 Virtual Biotechnology Private Company Conference. The Company will attend on Tuesday, October 1, and will sit for a fireside chat from 10:40 a.m. – 11:10 a.m. ET. 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 Bio is a precision 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 with manageable clinical safety and early efficacy signals in an ongoing Phase 1/2a clinical trial. The Fore Bio research and development team is optimizing drug development by identifying existing compounds with known clinical profiles and a clear path through clinical development to advance new medicines for patients without treatment options. For more information, please visit www.fore.bio or follow us on X (formerly Twitter) 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 23 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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