Nilotinib Hydrochloride

TERN-701 is an oral allosteric BCR-ABL tyrosine kinase inhibitor (TKI). Image Credit: crystal light / Shutterstock. The US Food and Drug Administration (FDA) has granted an orphan drug designation to Terns Pharmaceuticals’s TERN-701 for the treatment of chronic myeloid leukaemia (CML). The orphan drug status gives sponsors tax credits from clinical trials, exemption from user fees, and a potential seven years of market exclusivity for the therapy after approval. TERN-701 is an oral allosteric BCR-ABL tyrosine kinase inhibitor (TKI) and is one of the two therapies that Terns plans to focus its resources on this year. The treatment is being evaluated in a Phase I CARDINAL trial (NCT06163430) in participants with chronic phase CML who experienced treatment failure on at least one prior second-generation TKI. Interim data from the trial is expected in H2 2024. The other drug, TERN-601, which is being developed as a treatment for obesity, is in a Phase I first-in-human trial, with topline data expected in H2. CML therapies are expected to generate $3.5bn in sales across eight major pharmaceutical markets (the US, France, Germany, Italy, Spain, UK, Japan, and Canada), as per a GlobalData report . The current market leaders in the field include Bristol Myers Squibb ’s Sprycel (dasatinib) and Novartis ’ Tasigna (nilotinib). Sprycel and Tasigna generated $1.4bn and $1.8bn in global sales in 2023, according to the companies’ financials. See Also: Pearl Bio and Merck partner for discovery of cancer therapies Selecta Biosciences files patent for enhanced gene therapy using viral vectors and immunosuppressants GlobalData is the parent company of Pharmaceutical Technology . Earlier this year, Terns paused the development of its most advanced candidate, the oral thyroid hormone receptor-beta (THR-β) agonist, TERN-501, as a treatment for nonalcoholic steatohepatitis (NASH), despite reporting positive data from the Phase IIa DUET trial (NCT05415722). The company cited the current regulatory and developmental MASH landscape for limiting funding for the NASH therapy. Meanwhile, Terns said it plans to evaluate TERN-501, as a combination therapy for obesity. The company also has additional early-stage candidates in the pipeline for obesity. TERN-800, an oral small molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulator, is currently in the discovery stage as an obesity treatment.

PHILADELPHIA--(BUSINESS WIRE)-- FORE Biotherapeutics today announced the appointment of William R. Hinshaw as the Chief Executive Officer and Director of the Board. Mr. Hinshaw is a 30+-year veteran of the biotechnology and pharmaceutical industries. Prior to joining Fore, he was the President, CEO and Board member of Axcella Therapeutics, a clinical-stage and publicly traded biopharmaceutical company developing novel therapies for complex diseases. Prior to Axcella, Mr. Hinshaw led all aspects of Novartis’ >$6B revenue U.S. Oncology business, including products such as Tasigna®, Gleevec®, and Kymriah®, as well as the integration of the GSK oncology portfolio, including Tafinlar® and Mekinist®. He also played a key role on the Global Oncology Executive Committee, including leading crucial strategic programs to maximize the portfolio and develop the pipeline. Prior to this role, Mr. Hinshaw held a number of leadership positions of increasing responsibility and expanding global scope at Novartis, including Head of the NCE (Northern and Central Europe) Region for Novartis Oncology, GEM (Group Emerging Markets), Head of the Hematology Business Franchise, and Global Head of Infectious Disease and Transplantation (IDTI). Before joining Novartis, Bill worked at the former Schering Plough Corporation where he held a series of commercial roles, including the Head of US Oncology. Mr. Hinshaw holds a B.S. in Molecular Biology from the University of Wisconsin. Dieter Weinand, the Chairman of the Board of Directors commented: “After an extensive search, we are delighted and very excited to welcome Bill as our next CEO. Bill brings highly relevant experience to grow and scale Fore given his track record in both large and emerging life sciences companies. He is the right leader for this stage of our company’s journey and the Board and I are delighted to partner with Bill to navigate Fore’s path to continued success.” “I am privileged and excited to lead Fore and work alongside the talented and committed team and build upon what has been accomplished to date. Fore is poised to develop targeted treatments that can have a transformational impact on the lives of patients suffering from cancer,” said Mr. Hinshaw. “On behalf of the Board of Directors, I would like to sincerely thank Dr. Shawn M. Leland, PharmD, RPh for his leadership, dedication and many contributions during this transitionary period toward the advancement of plixorafenib to its next seminal phase of clinical development as Advisor and Interim CEO to the Company,” said Dieter Weinand, Chairman of the Board of FORE Biotherapeutics. “We welcome Bill as CEO and Board member as we enter this next phase of growth for the company.” About Plixorafenib Plixorafenib 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. Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors but also disrupts constitutively active dimeric BRAF class 2 mutants, fusions, splice variants and others. Unlike first-generation RAF inhibitors, plixorafenib does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a “paradox breaker”, plixorafenib could therefore treat acquired resistance to current RAF inhibitors and, more generally, yield improved safety and more durable efficacy than first-generation RAF inhibitors. Plixorafenib is currently being evaluated in Phase 1/2a clinical trial in patients with advanced solid tumors (including brain and spinal cord tumors) with activating BRAF alterations. Interim clinical data presented at ESMO 2022, ASCO 2023 and SNO 2023 provided evidence of durable anti-tumor activity in patients with BRAF-mutated cancers. 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 an inhibitor of BRAF dimerization allowing for the targeting of V600 and non-V600 driven tumors. In Phase 1/2a, plixorafenib demonstrated deep and durable responses in V600-mutated MAPK inhibitor-naïve patients, including a 42% overall response in patients with solid tumors with a median duration of response of 17.8 months and a 67% overall response rate in patients with primary central nervous system tumors with a median duration of response of 13.9 months. Plixorafenib is currently being investigated in the ongoing, potentially registrational Phase 2 FORTE study. For more information, please visit or follow us on X (formerly Twitter) and LinkedIn.