BRAF V600

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

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Safety, BRAF, Meki, Binimetinib, BRAF V600, Cell, MEK, Pharmaceutical industry

The data show nonclinical synergistic activity of plixorafenib when combined with MEK inhibition across all BRAF alterations tested.

Key Points: 
  • 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.
  • 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.
  • Poster Title: The paradox-breaker BRAF inhibitor plixorafenib (PLX8394; FORE8394) synergizes with MEK inhibitors (MEKi) in BRAF V600 and non-V600 alterations, with higher potency compared to early generation BRAFi and pan-RAFi

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

Retrieved on: 
Tuesday, February 20, 2024
BRAF, Cancer, Wuxi, TIL, Information, Melanoma, FDA, Food, U.S. FDA, BLA, PD-1, Interim, BRAF V600, Patient, Navy, Research, MEK, Pharmaceutical industry

PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.

Key Points: 
  • AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • AMTAGVI is also the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • "We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma.
  • "Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

Retrieved on: 
Tuesday, February 20, 2024
BRAF, Cancer, Wuxi, TIL, Information, Melanoma, FDA, Food, U.S. FDA, BLA, PD-1, Interim, BRAF V600, Patient, Navy, Research, MEK, Pharmaceutical industry

PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.

Key Points: 
  • AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • AMTAGVI is also the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • "We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma.
  • "Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Retrieved on: 
Friday, February 16, 2024
BRAF, SAN, Neoplasm, Cohort, Immune system, Kaplan–Meier estimator, Immunotherapy, TIL, Information, FDA, Melanoma, Food, News, Cytopenia, Infection, PD-1, AIM, National Cancer Institute, Respiratory failure, Travel, Epidemiology, Interim, Safety, Physician, BRAF V600, Patient, Journal, RECIST, ATC, Disease, Clinical trial, Kidney failure, MEK, Pharmaceutical industry

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Key Points: 
  • This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response.
  • AMTAGVI is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer.
  • “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.
  • Iovance will host a conference call and live audio webcast today to discuss the FDA approval of AMTAGVI.

FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

Retrieved on: 
Friday, February 16, 2024
Human services, BRAF, Skin cancer, Neoplasm, Fever, Immune system, Melanoma, Cosmetics, Multimedia, Febrile neutropenia, Immunotherapy, Diarrhea, Hair loss, Dietary supplement, FDA, Food, Infection, Growth, Swelling, Tachycardia, PD-1, Edema, Cell, Hypoxia, Vaccine, Risk, Antibody, Animal, Metastasis, Safety, Heated tobacco product, Fatigue, Accelerated approval (FDA), Death, Rash, Public, BRAF V600, Patient, Protein, Chills, Sunlight, Hypotension, MEK, Cancer, Pharmaceutical industry

"Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).

Key Points: 
  • "Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).
  • Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.
  • Treatment for unresectable or metastatic melanoma may include immunotherapy using PD-1 inhibitors, which are antibodies targeting certain proteins in the body to help the immune system fight off cancer cells.
  • Those patients whose melanoma has progressed with these therapies have a high unmet medical need.

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

Retrieved on: 
Friday, November 17, 2023
Oncology, FDA, Health, Genetics, Clinical Trials, Biotechnology, Associate, Safety, Annual general meeting, Cobicistat, Neuro, Patient, Pakistan Society of Neuro-Oncology, DOR, Neoplasm, MAPK, ORR, BRAF, University, MD, Doctor of Philosophy, BRAF V600, Diffuse leptomeningeal glioneuronal tumor, Society, SNO, HIV disease progression rates, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • “The updated data from our Phase 1/2a study continues to reinforce plixorafenib’s differentiated clinical profile in patients harboring BRAF V600 mutations,” said Stacie Shepherd, MD, PhD, and Chief Medical Officer of FORE.
  • “The data presented today at SNO 2023 demonstrate deep and durable confirmed responses in MAPK inhibitor-naïve patients, including a 67% overall response rate in patients with primary central nervous system tumors.

FORE Biotherapeutics Announces Oral Presentation of Phase 1/2a Plixorafenib Data at the Society for Neuro-Oncology 2023 Annual Meeting

Retrieved on: 
Friday, November 10, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, BRAF V600, BRAF, Annual general meeting, Society, SNO, Pakistan Society of Neuro-Oncology, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • Details for the SNO 2023 Oral Presentation:
    Title: Efficacy of BRAF inhibitor plixorafenib (FORE8394) in recurrent, primary central nervous system tumors (PCNST)

C4 Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Wednesday, November 1, 2023
Neoplasm, Controlled Impact Demonstration, Research, NSCLC, Public expenditure, National Medical Products Administration, Dexamethasone, Disease, CRC, Annual general meeting, Security (finance), Melanoma, BRAF, Wind, Caregiver, Roche, NHL, Safety, Therapy, Patient, Administration, BRAF V600, Research and development, Plasma, CCCC, Xerostomia, G&A, Conference, CTA, Synovial sarcoma, TPD, Clinical trial, ODI, Anemia, BRD9, Finance, Fatigue, Half-life, NMPA, Aes, Strategic planning, Colorectal cancer, R, High-level radioactive waste management, RECIST, Lung cancer, Combination therapy, Neutropenia, Pharmaceutical industry, Cryptocurrency, Fine chemical, Vaccine, Video game, Dysgeusia, Biogen

WATERTOWN, Mass., Nov. 01, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today reported financial results for the third quarter ended September 30, 2023, as well as recent business highlights.

Key Points: 
  • Revenue: Total revenue for the third quarter of 2023 was $11.1 million, compared to $6.8 million for the third quarter of 2022.
  • Research and Development (R&D) Expense: R&D expense for the third quarter of 2023 was $28.3 million, compared to $29.7 million for the third quarter of 2022.
  • Net Loss and Net Loss per Share: Net loss for the third quarter of 2023 was $27.0 million, compared to $32.0 million for the third quarter of 2022.
  • Net loss per share for the third quarter of 2023 was $0.55 compared to $0.65 for the third quarter of 2022.

C4 Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Tuesday, August 8, 2023
CCCC, Pharming, G&A, BRAF V600, Patient, Research and development, R, Disease, Multiple myeloma, Drug discovery, Lung cancer, Combination therapy, International Conference on Afghanistan, London (2006), Security (finance), BRD9, FDA, Conference, Safety, Appointment, Roche, BRAF, Medicine, NSCLC, Finance, Controlled Impact Demonstration, Administration, Colorectal cancer, Research, Therapy, Synovial sarcoma, Drug development, CRC, ICML, Clinical trial, Lymphoma, NHL, CNS, Dexamethasone, ASCO, Public expenditure, American Society of Clinical Oncology, Melanoma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Food, Pharmaceutical industry, Cryptocurrency, Fine chemical, Vaccine, Video game, Biogen, Calico, IND, Mutant

WATERTOWN, Mass., Aug. 08, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today reported financial results for the second quarter ended June 30, 2023, as well as recent business highlights.

Key Points: 
  • Revenue: Total revenue for the second quarter of 2023 was $2.7 million, compared to $13.8 million for the second quarter of 2022.
  • Research and Development (R&D) Expense: R&D expense for the second quarter of 2023 was $29.9 million, compared to $31.3 million for the second quarter of 2022.
  • General and Administrative (G&A) Expense: G&A expense for the second quarter of 2023 was $10.3 million, compared to $9.9 million for the second quarter of 2022.
  • Net loss per share for the second quarter of 2023 was $0.73 compared to $0.56 for the second quarter of 2022.

U.S. FDA Grants Orphan Drug Designation to ABM-1310 for the Treatment of Patients with Glioblastoma Harboring BRAF V600 Mutation

Retrieved on: 
Wednesday, August 2, 2023
GBM, Glioma, ODD, American Society of Clinical Oncology, Hope, BRAF, Traffic barrier, Medicine, BRAF V600, Glioblastoma, ABM, ASCO, HIV disease progression rates, Permeability, Patient, SAN, Cancer, Annual general meeting, Rare, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Food, Pharmaceutical industry, Medical imaging

SAN DIEGO and SHANGHAI, Aug. 2, 2023 /PRNewswire/ -- ABM Therapeutics (ABM) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310, a novel small molecule BRAF inhibitor developed by the company, for the treatment of patients with glioblastoma (GBM) bearing BRAF V600 mutation.

Key Points: 
  • SAN DIEGO and SHANGHAI, Aug. 2, 2023 /PRNewswire/ -- ABM Therapeutics (ABM) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310, a novel small molecule BRAF inhibitor developed by the company, for the treatment of patients with glioblastoma (GBM) bearing BRAF V600 mutation.
  • Orphan Drug Designation is a significant recognition bestowed by the FDA to the drugs used in the treatment of rare diseases.
  • This designation intends to encourage and support the development of drugs that are vital to patients with rare medical conditions.
  • Obtaining Orphan Drug Designation is a prestigious recognition from the FDA, which encourages ABM to accelerate the development of ABM-1310 for treating patients with GBM.