V600

FORE Biotherapeutics to Present Promising New Data from Phase 1/2a Trial Evaluating Plixorafenib (FORE8394) in Patients With BRAF-Altered Advanced Solid and Central Nervous System Tumors at ASCO 2023

Retrieved on: 
Friday, May 26, 2023
Oncology, Health, FDA, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, University, PRS, PD, Shepherd, CRC, AE, Diarrhea, Neoplasm, Safety, Primary central nervous system lymphoma, DOR, Aes, MAPK, CYP3A, BRAF, Doctor of Philosophy, CNS, Associate, Glioblastoma, ASCO, V600, Malignancy, Neuro, American Society of Clinical Oncology, HIV disease progression rates, MD, Patient, Agency, Colorectal cancer, FORTE, Cancer, Annual general meeting, Memorial Sloan Kettering Cancer Center, Nausea, Orphan, Cobicistat, Ovarian cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Fasting, ORR, Food, Fatigue, Disease, Pharmaceutical industry, Medical imaging, Vaccine, Phosphorus

The results demonstrate promising single-agent activity against BRAF-altered tumors, including primary central nervous system (CNS) tumors, and will be featured in presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2-6, 2023, in Chicago, IL.

Key Points: 
  • The results demonstrate promising single-agent activity against BRAF-altered tumors, including primary central nervous system (CNS) tumors, and will be featured in presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2-6, 2023, in Chicago, IL.
  • “The updated data from our Phase 1/2a study further reinforces plixorafenib’s differentiated clinical profile,” said Stacie Shepherd, MD, PhD, and Chief Medical Officer of FORE.
  • “Plixorafenib has demonstrated both promising antitumor activity with durable responses and favorable tolerability as a single agent in patients with advanced BRAF-altered tumors.
  • Details for the ASCO 2023 presentations are as follows:
    Title: Safety and efficacy of the novel BRAF inhibitor FORE8394 in patients with advanced solid and CNS tumors: Results from a phase 1/2a study

FORE Biotherapeutics Receives FDA Orphan Drug Designation for FORE8394 for the Treatment of Primary Brain and CNS Malignancies

Retrieved on: 
Monday, March 20, 2023
Neurology, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Other Health, China Biologic Products, Central nervous system, Drug development, ODD, Neoplasm, ESMO, Cancer, BRAF, Genomics, CNS, Trial of the century, V600, Malignancy, Patient, FORTE, Fore, Rare, European Society for Medical Oncology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Food, RAF, Pharmaceutical industry

FORE Biotherapeutics (FORE Bio) a precision stage oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead program, FORE8394, for the treatment of primary brain and central nervous system (CNS) malignancies.

Key Points: 
  • FORE Biotherapeutics (FORE Bio) a precision stage oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead program, FORE8394, for the treatment of primary brain and central nervous system (CNS) malignancies.
  • This is the first orphan drug designation received by FORE Bio and the FORE8394 program.
  • "The receipt of Orphan Drug Designation is another important regulatory achievement that reinforces the FDA's recognition of the potential of FORE8394 to improve clinical outcomes in patients with BRAF-altered brain tumors,” said Stacie Shepherd, M.D., Ph.D., Chief Medical Officer of Fore Biotherapeutics.
  • Orphan Drug Designation is granted to drugs or biological products for the treatment of rare diseases or conditions that impact fewer than 200,000 people in the United States.

Fore Biotherapeutics Announces Fast Track Designation Granted by FDA to FORE8394 for the Treatment of Cancers Harboring BRAF Class 1 and Class 2 Alterations

Retrieved on: 
Wednesday, September 28, 2022
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The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.

Key Points: 
  • The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.
  • A drug that receives Fast Track designation may become eligible for Accelerated Approval, Priority Review, or Rolling Review if relevant criteria are met.
  • The FDA's Fast Track Designation for FORE8394 underscores the urgent need faced by patients with advanced BRAF-muted cancers who have no other options, said Stacie Shepherd, M.D., Ph.D., Chief Medical Officer of Fore Biotherapeutics.
  • We look forward to continuing to work closely with the FDA as we explore the potential for FORE8394 to improve outcomes for patients with these life-threatening cancers.

Fore Biotherapeutics to Present Phase 1/2a Data on FORE8394, a Next-Generation BRAF Inhibitor, at ESMO 2022

Retrieved on: 
Tuesday, August 9, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Genomics, ESMO, RAF, CNS, European Society for Medical Oncology, Fore, Cancer, Neoplasm, Patient, Twitter, Development of the human body, Safety, Drug development, BRAF, V600, LinkedIn, Pharmaceutical industry

The Phase 1/2a open-label study is assessing FORE8394, a next-generation BRAF inhibitor, in patients with advanced solid and CNS tumors with activating BRAF alterations.

Key Points: 
  • The Phase 1/2a open-label study is assessing FORE8394, a next-generation BRAF inhibitor, in patients with advanced solid and CNS tumors with activating BRAF alterations.
  • Details for the presentation are as follows:
    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 asset FORE8394 is a Class I/II BRAF inhibitor with demonstrated clinical safety and early efficacy signals in an ongoing Phase 1/2a clinical trial.