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Business Wire
25-04-2025
- Business
- Business Wire
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
PHILADELPHIA--(BUSINESS WIRE)--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. 'Plixorafenib was designed to inhibit mutated oncogenic BRAF V600, without causing paradoxical MAPK pathway activation, and also confers dimer - breaking properties and activity against non-V600 BRAF alterations,' said Rona Yaeger, M.D., Gastrointestinal Medical Oncologist and Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center. 'The data from this clinical study, demonstrating molecular response and durable clinical responses (including when given without a MEK inhibitor) and the absence of emergent MAPK pathway alterations on treatment, further support the unique mechanism of action and the potential to benefit patients with BRAF-altered malignancies.' 'These results are important because they show additional evidence of the strong clinical activity of plixorafenib, in both BRAF V600 mutations and BRAF fusions,' said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. 'In addition, this analysis also demonstrated high concordance of ctDNA BRAF mutations with biopsy tissue and changes in ctDNA corresponded closely to tumor size across tumor types; thus, liquid biopsies with widely used next-generation sequencing methodologies may provide a straightforward approach to identify appropriate patients for plixorafenib treatment, monitor disease status, and response. We are excited to share this data, along with the study design for our ongoing registrational FORTE study in BRAF altered advanced solid tumors, as we develop plixorafenib to help patients with BRAF driven tumors and generate further data to inform treatment.' The ctDNA results are from over 70 plixorafenib-treated patients and were an exploratory endpoint from a previously completed Phase 1/2a study. Utilizing next-generation sequencing (NGS), the plasma ctDNA results demonstrated high concordance with tissue biopsy at baseline across tumor types and mutations. Declines of V600 VAF% were observed in 85% of study participants after one cycle of plixorafenib treatment. Declines of class 2 and class 3 BRAF alterations in ctDNA were also observed. In participants with available paired tumor biopsies, decreases in pERK validated ctDNA results and demonstrated the suppression of the MAPK pathway at clinically relevant exposures. In addition, participants with V600E-mutated advanced solid tumors, early changes in V600E VAF% may predict response to plixorafenib, as responders had larger decreases in VAF% from baseline to cycle 2. In longitudinal samples, changes in ctDNA corresponded to tumor size across tumor types, suggesting that ctDNA may be a surrogate marker for monitoring disease. Compared to acquired mutations driving resistance to early generation BRAF inhibitors, no new mutations in MAPK pathway genes were found following plixorafenib treatment, supporting the dimer - breaker property and novel mechanism of action of plixorafenib from the early generation BRAF inhibitors. In participants without response, co-occurrent drivers at baseline included RAS, MAPK-associated or NF1 mutation, including melanoma patients who all received prior MAPKi therapies. Also being presented at AACR 2025 is a trial in progress poster showcasing the global FORTE master protocol with a basket design, including three monotherapy sub-protocols in patients with BRAF fusions, rare BRAF V600-mutated tumors, and BRAF V600 primary recurrent central nervous system tumors. An interim analysis is planned for each of the monotherapy baskets during 2025. A fourth, exploratory sub-protocol will assess preliminary activity of plixorafenib in BRAF V600-mutated select solid tumors. Alongside primary and key secondary endpoints of overall response rate, duration of response, safety, progression-free survival, overall survival, and pharmacokinetics, key exploratory endpoint of each of the four sub-protocols is a longitudinal ctDNA assessment. Poster Presentation Details: Title: Circulating tumor DNA analysis of patients with BRAF-mutated advanced unresectable solid tumors treated with plixorafenib (FORE8394/PLX8394) in Phase 1/2a study Poster Session: Liquid Biopsy Circulating Nucleic Acids 1 Date and Time: Monday, April 28, 2025, 2:00 – 5:00 p.m. CT Abstract Number: 3248 Presenter: Jessica C. Jang, Fore Biotherapeutics Title: FORTE: A phase 2 master protocol assessing plixorafenib for BRAF-altered cancers Poster Session: Late Breaking and Clinical Trials – Phase II and Phase III Clinical Trials in Progress Date and Time: Tuesday, April 29, 2025, 2:00 – 5:00 p.m. CT Abstract Number: CT247 Presenter: Macarena I. de la Fuente, M.D., Sylvester Comprehensive Cancer Center 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 FORTE, a global registrational basket trial to support three distinct indications. For more information, please visit or follow us on X and LinkedIn.
Yahoo
03-04-2025
- Business
- Yahoo
Vividion Therapeutics Doses First Patient in Phase I Study of RAS-PI3Kα Inhibitor for Treatment of Advanced Solid Tumors
VVD-159642, Vividion's fourth clinical-stage program stemming from its chemoproteomics discovery platform, is designed to improve patient outcomes by inhibiting RAS-PI3Kα, a key signaling pathway implicated in solid tumor development and progression Preclinical data support clinical trials with a broad patient population, and may deliver increased efficacy in combination with other RAS/MAPK pathway inhibitors Approximately 20 percent of all cancers are driven by mutations of the RAS family of genes1 Vividion continues to advance the chemoproteomics technology platform with goal to unlock disease-causing, yet traditionally undruggable targets with precision small-molecule therapeutics SAN DIEGO & BERLIN, April 03, 2025--(BUSINESS WIRE)--Vividion Therapeutics, Inc. (Vividion) today announced that the first patient has been dosed in a Phase I clinical trial evaluating VVD-159642, an investigational oral inhibitor designed to target RAS-driven cancers. Vividion is a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, utilizing innovative discovery technologies to unlock targets with strong disease-link, yet traditionally undruggable and develop small molecule precision therapeutics for devastating cancers and immune disorders. The new Phase I study (NCT06804824) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of VVD-159642 as a single agent and in combination with either sotorasib or trametinib in patients with advanced solid tumors. "Despite being a major driver in approximately 20% of cancers, the RAS gene has proven exceptionally difficult to target with drugs, largely due to its essential role in the RAS-PI3Kα signaling pathway, which is vital for healthy cell function," said Jenna Goldberg, M.D., Chief Medical Officer of Vividion. "VVD-159642 is designed and being studied to selectively prevent RAS activation of the PI3Kα pathway, thus blocking oncogenic signaling without disrupting normal cellular function. Preclinical studies of VVD-159642 give us confidence in its potential to inhibit tumor growth while avoiding the on-target toxicities that have limited prior attempts to drug this important target. In addition to providing a more tolerable alternative to current therapies, we believe that VVD-159642 has potential to treat a broad patient population, including in both RAS-mutant and HER2-overexpressed tumors, and may deliver increased efficacy in combination with other RAS/MAPK pathway inhibitors." "We're excited to bring our fourth innovative oncology asset into the clinic, which not only represents continued validation of Vividion's covalent-first chemoproteomics platform but also provides a potential new treatment option for patients with RAS-driven cancers," said Aleksandra Rizo M.D., Ph.D., Chief Executive Officer of Vividion. "The team at Vividion is rapidly advancing scientific innovations into clinical development that have the potential to address multiple devastating diseases not reachable by current therapies," said Christian Rommel, Ph.D., Head of Research and Development at Bayer's Pharmaceuticals Division. "The initiation of this clinical trial marks a significant step forward in leveraging Vividion's innovative drug discovery approach to target a highly relevant signaling pathway and bring a potential new treatment option to people suffering from difficult-to-treat cancers." Vividion also has ongoing Phase I trials evaluating an oral KEAP1 activator in solid tumors and oral STAT3 inhibitor in solid and hematologic malignancies. The company is advancing multiple innovative drug discovery programs toward the clinic and has a rich pipeline of opportunities emerging in early discovery in the fields of oncology and immunology. About VividionVividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a clinical stage biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders. The company's platform has enabled it to identify hundreds of previously unknown functional pockets on well-validated protein targets implicated in a wide range of diseases, while simultaneously identifying compounds from its proprietary covalent chemistry library that interact in a highly selective manner with those pockets. The company is leveraging its proprietary chemoproteomic platform to advance a diversified pipeline of highly selective small molecule therapeutics targeting high value, traditionally undruggable targets in oncology and immunology. For more information, please visit About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to Find more information at Follow us on Facebook: aka (2025-0057) Forward-Looking StatementsThis release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Reference: 1. Ian A. Prior et al "The Frequency of RAS Mutations in Cancer". Cancer Res (2020) 80 (14): 2969–2974. Available at: Accessed: March 2025. View source version on Contacts Bayer Global Media Contact:Derin Denham, phone +1 973 610 7324 Email: Contact for media inquiries Bayer U.S.: Elaine Colon, phone +1 732 236 1587 Email: Vividion Media Contact: Laurie Sherman, phone +1 858 630 8246 Email: media@
Yahoo
29-01-2025
- Business
- Yahoo
Verastem Oncology to Present at the Guggenheim SMID Cap Biotech Conference
BOSTON, January 29, 2025--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that its management team will participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference on Wednesday, Feb. 5, 2025, at 1:00 pm EST. A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investors & Media section of the company's website at A replay of the webcast will be archived on the website for approximately 90 days following the presentation. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a late-stage development biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition and KRAS G12D inhibition. For more information, please visit and follow us on LinkedIn. View source version on Contacts For Investor and Media Inquiries: Julissa VianaVice President, Corporate Communications and Investor Relationsinvestors@ ormedia@ Sign in to access your portfolio
