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Articles from FORE Biotherapeutics

FORE Biotherapeutics Presents New Plixorafenib Results at AACR 2025 Demonstrating Pharmacodynamic Effect in Clinical Tumor Biopsies and Decreased V600E Mutant Allele Frequency in ctDNA of 85% of Patients
FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today presented new plixorafenib results from the Phase 1/2a clinical trial that demonstrate that circulating tumor DNA (ctDNA) accurately detects BRAF mutations in tumor biopsies and change in variant allele frequency (VAF) of BRAF mutation in ctDNA may be a surrogate marker for monitoring disease. The data is being presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30 in Chicago.
By FORE Biotherapeutics · Via Business Wire · April 25, 2025
FORE Biotherapeutics to Present Two Plixorafenib Abstracts at the American Association for Cancer Research Annual Meeting 2025
FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today announced two plixorafenib abstracts have been selected for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30 in Chicago.
By FORE Biotherapeutics · Via Business Wire · March 25, 2025
FORE Biotherapeutics to Participate in the Raymond James Private Biotech Symposium
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 Raymond James Private Biotech Symposium. The presentation will take place on Thursday, February 20, 2025 at 4:00 p.m. ET in a virtual format.
By FORE Biotherapeutics · Via Business Wire · February 13, 2025
FORE Biotherapeutics Highlights Recent Pipeline Achievements for its Targeted-Oncology Program and Provides Strategic Objectives for 2025
FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today highlighted its recent pipeline achievements and provided its key strategic objectives for 2025.
By FORE Biotherapeutics · Via Business Wire · January 9, 2025
FORE Biotherapeutics to Present at the 43rd Annual J.P. Morgan Healthcare Conference
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 43rd 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.
By FORE Biotherapeutics · Via Business Wire · December 19, 2024
FORE Biotherapeutics to Participate in the Wells Fargo Virtual Private Biotech Symposium
FORE Biotherapeutics today announced that the Company will participate in the Wells Fargo Virtual Private Biotech Symposium on Thursday, December 12.
By FORE Biotherapeutics · Via Business Wire · December 5, 2024
FORE Biotherapeutics to Participate in Upcoming November Conferences
FORE Biotherapeutics today announced that the Company will participate at the following investor conferences:
By FORE Biotherapeutics · Via Business Wire · November 7, 2024
FORE Biotherapeutics to Participate in Upcoming Investor Conferences
FORE Biotherapeutics today announced that the Company, will participate at the following investor conferences:
By FORE Biotherapeutics · Via Business Wire · September 4, 2024
FORE Biotherapeutics Names Michael Byrnes as Chief Financial Officer
FORE Biotherapeutics today announced the appointment of Michael Byrnes as chief financial officer of the company. Mr. Byrnes brings over 20 years’ experience in the biotechnology industry, both in private and public companies, spanning all phases of development from pre-clinical to pre-commercial stages and across multiple indications. As CFO, he has led multiple companies through equity and debt transactions and been involved in M&A totaling close to $4B.
By FORE Biotherapeutics · Via Business Wire · August 12, 2024
FORE Biotherapeutics to Present Nonclinical Data at the 2024 AACR Annual Meeting Supporting Superior Potency for Plixorafenib Compared with BRAF or Pan-Raf Inhibitors, When Combined with MEK Inhibition
FORE Biotherapeutics today announced new nonclinical data related to plixorafenib (FORE8394; formerly PLX8394), the company's novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations, will be presented at the AACR Annual Meeting 2024, taking place April 5-10, 2024, in San Diego and virtually. The data show nonclinical synergistic activity of plixorafenib when combined with MEK inhibition across all BRAF alterations tested. In cells with BRAF V600 or non-V600 mutations or BRAF fusions, the combination of plixorafenib and binimetinib is most potent of the BRAF and pan-RAF inhibitors tested. In plixorafenib resistant cells, these cells can be resensitized with the addition of binimetinib. To date, plixorafenib has demonstrated encouraging efficacy and safety data from the phase 1/2a study; these nonclinical data help build the foundation for potential future development of plixorafenib in combination with a MEK inhibitor.
By FORE Biotherapeutics · Via Business Wire · April 9, 2024
FORE Biotherapeutics Names William R. Hinshaw as Chief Executive Officer
FORE Biotherapeutics today announced the appointment of William R. Hinshaw as the Chief Executive Officer and Director of the Board.
By FORE Biotherapeutics · Via Business Wire · February 29, 2024
FORE Biotherapeutics to Participate in Upcoming Investor Conferences
FORE Biotherapeutics today announced that the Company, will participate at the following investor conferences:
By FORE Biotherapeutics · Via Business Wire · February 1, 2024
FORE Biotherapeutics to Present at the 2023 RBC Capital Markets Private Company Conference
FORE Biotherapeutics today announced that the Company will be presenting at the 2023 RBC Capital Markets Private Company Conference. The virtual presentation will take place on Thursday, December 14, 2023, from 8:00-8:30 a.m. ET.
By FORE Biotherapeutics · Via Business Wire · December 7, 2023
FORE Biotherapeutics Announces Oral Presentation at SNO 2023 Reporting Updated Phase 1/2a Results for Plixorafenib in BRAF V600 Advanced Solid Tumors, Including Novel Data for Patients with BRAF V600 Primary CNS Tumors
FORE Biotherapeutics today reported updated safety and efficacy data from the Phase 1/2a clinical trial evaluating plixorafenib (FORE8394; PLX8394), a novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations. The results continue to demonstrate promising single-agent activity against BRAF V600-mutated tumors, including primary central nervous system tumors (PCNSTs), as presented at the Society for Neuro-Oncology (SNO) 2023 Annual Meeting, being held November 15-19, 2023, in Vancouver, Canada.
By FORE Biotherapeutics · Via Business Wire · November 17, 2023
FORE Biotherapeutics Announces Oral Presentation of Phase 1/2a Plixorafenib Data at the Society for Neuro-Oncology 2023 Annual Meeting
FORE Biotherapeutics today announced an oral presentation highlighting updated Phase 1/2a clinical data for plixorafenib (FORE8394; PLX8394), the company’s novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations, will be given at the Society for Neuro-Oncology (SNO) 2023 Annual Meeting, taking place November 15-19, 2023, in Vancouver, Canada. The data being presented continue to demonstrate that plixorafenib has a favorable safety profile and results in durable responses in adults with primary central nervous system tumors with BRAF V600 alterations.
By FORE Biotherapeutics · Via Business Wire · November 10, 2023
FORE Biotherapeutics to Present Plixorafenib Nonclinical Data Highlighting Potential Differentiation at the 2023 AACR-NCI-EORTC International Conference
FORE Biotherapeutics today announced the acceptance of an abstract on new nonclinical data related to plixorafenib (FORE8394), the company's novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations at the 2023 AACR-NCI-EORTC International Conference, taking place October 11-14, 2023, in Boston and virtually. The data set presented in the poster shows improved drug activity for both V600 and non-V600 BRAF alternations from other pan-RAF and BRAF inhibitors.
By FORE Biotherapeutics · Via Business Wire · October 12, 2023
FORE Biotherapeutics Announces $75M in Series D Financing and CEO Transition
FORE Biotherapeutics today announced the closing of its $75 million Series D financing, led by the SR One and co-led by Medicxi and joined by existing investors. FORE Biotherapeutics’ syndicate now includes new investor Medicxi, as well as existing investors OrbiMed, HBM Healthcare Investments, Novartis Venture Fund, 3B Future Health Fund, Cormorant Asset Management, Wellington Management and Samsung Securities. In connection with the financing, Giovanni Mariggi, Partner at Medicxi, was appointed to FORE Biotherapeutics’ Board of Directors.
By FORE Biotherapeutics · Via Business Wire · August 23, 2023
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
FORE Biotherapeutics today announced new clinical data from the Phase 1/2a clinical trial for plixorafenib (FORE8394), a novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations. 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.
By FORE Biotherapeutics · Via Business Wire · May 26, 2023
FORE Biotherapeutics Announces Two Abstracts Accepted for Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
FORE Biotherapeutics today announced the acceptance of two abstracts on new clinical data related to FORE8394, the company's novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 3-7, 2023, in Chicago and virtually. The datasets from the phase 1/2a clinical trial, evaluating the safety, tolerability, and efficacy of FORE8394 as a monotherapy will be presented.
By FORE Biotherapeutics · Via Business Wire · April 26, 2023
FORE Biotherapeutics Receives FDA Orphan Drug Designation for FORE8394 for the Treatment of Primary Brain and CNS Malignancies
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.
By FORE Biotherapeutics · Via Business Wire · March 20, 2023
Fore Biotherapeutics Announces First Patient Dosed in Global Phase 2 Trial Evaluating FORE8394 in BRAF-Mutated Solid and Brain Tumors
Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, today announced that the first patient has been dosed in the global Phase 2 FORTE clinical trial evaluating FORE8394 with cobicistat in patients with solid or central nervous system (CNS) tumors with BRAF gene fusions and recurrent primary CNS tumors with BRAFV600E mutations refractory to standard therapies. The FORTE master protocol trial builds upon the design and interim data of the ongoing Phase 1/2a clinical trial evaluating FORE8394 in advanced solid and CNS tumors with BRAF alterations.
By Fore Biotherapeutics · Via Business Wire · February 23, 2023
Fore Biotherapeutics Announces Fast Track Designation Granted by FDA to FORE8394 for the Treatment of Cancers Harboring BRAF Class 1 and Class 2 Alterations
Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to FORE8934, its investigational, novel, small-molecule, orally available inhibitor for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 (including fusions) alterations who have exhausted prior therapies.
By Fore Biotherapeutics · Via Business Wire · September 28, 2022
Fore Biotherapeutics Presents Positive Interim Data From Phase 1/2a Trial Evaluating FORE8394 in Patients With Advanced Tumors With Activating BRAF Alterations at ESMO 2022
Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, announced the presentation of new data demonstrating that FORE8394, a next-generation BRAF inhibitor, provides evidence of durable anti-tumor activity and patient benefit in BRAF-mutated (V600+) cancers. Data from the ongoing Phase 1/2a study evaluating FORE8394 for the treatment of advanced solid and central nervous system (CNS) tumors with activating BRAF alterations were presented in a poster session at the European Society of Medical Oncology Congress (ESMO) taking place in Paris, France.
By Fore Biotherapeutics · Via Business Wire · September 12, 2022
Fore Biotherapeutics to Present Phase 1/2a Data on FORE8394, a Next-Generation BRAF Inhibitor, at ESMO 2022
Fore Biotherapeutics, a precision oncology company developing treatments for patients with genetically defined cancers whose current treatment options are limited, today announced that data from the ongoing Phase 1/2a study of lead asset, FORE8394, will be presented in the Developmental Therapeutics poster session at the European Society of Medical Oncology Congress (ESMO) taking place in Paris, France, September 9-13, 2022.
By Fore Biotherapeutics · Via Business Wire · August 9, 2022
Fore Biotherapeutics Appoints Matthew E. Ros as Chief Executive Officer
Fore Biotherapeutics (or the “Company”), a clinical-stage biotechnology company focused on precision oncology, today announced the appointment of Matthew E. Ros as the Chief Executive Officer and Director of the Board.
By Fore Biotherapeutics · Via Business Wire · April 18, 2022
Fore Biotherapeutics Issues Statement
Fore Biotherapeutics, a precision oncology company focused on providing people with unaddressed cancer mutations new hope by connecting them with hyper-targeted medicines using its proprietary functional genomics platform, today issued the following statement:
By Fore Biotherapeutics · Via Business Wire · December 2, 2021
Fore Biotherapeutics Continues to Build Leadership Team with Executive and Board Appointments
Fore Biotherapeutics, a precision oncology company focused on providing people with unaddressed cancer mutations new hope by connecting them with hyper-targeted medicines using its proprietary functional genomics platform, today announced the appointment of Kim Blackwell, M.D., as a member of the Board of Directors and R&D/Science Chair, and Sujit Basu, Ph.D., as Senior Vice President of Manufacturing and Technical Operations.
By Fore Biotherapeutics · Via Business Wire · September 20, 2021
Fore Biotherapeutics Strengthens Leadership Team with Executive and Board Appointments
Fore Biotherapeutics (formerly NovellusDx), a precision oncology company focused on providing people with rare cancer mutations rapid access to the right medicines, today announced the expansion of its leadership team with the appointments of Stacie Peacock Shepherd, M.D., Ph.D., as Chief Medical Officer and Nora Brennan as Chief Financial Officer. Additionally, experienced biopharma executive Meenu Chhabra will join the company’s Board of Directors and serve as Audit Chair. These key appointments, which follow the establishment of Fore’s new U.S. headquarters in Philadelphia, will support the company’s efforts to become a global leader in precision oncology therapeutics.
By Fore Biotherapeutics · Via Business Wire · May 19, 2021
Fore Biotherapeutics Opens U.S. Headquarters in Philadelphia’s Biotech Hub
Fore Biotherapeutics (formerly NovellusDx), a precision oncology company focused on providing people with rare cancer mutations rapid access to the right medicines, today announced that it is opening its global headquarters in Philadelphia. Fore’s discovery and functional genomics platform team will continue to be based out of Jerusalem, Israel, while future operational growth across clinical, manufacturing, G&A and commercial operations will be planned in and around the Philadelphia biotech hub.
By Fore Biotherapeutics · Via Business Wire · May 10, 2021