Spinal Cord Neoplasms

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.

ALTSTAETTEN, Switzerland and EAST HARTFORD, Conn., Jan. 24, 2024 /PRNewswire/ -- icotec ag, the leading company in the field of innovative spinal tumor implants is pleased to announce a significant milestone in its growth journey by establishing a strategic partnership with MVM Partners ("MVM"), a global healthcare venture capital firm. icotec is commercializing groundbreaking BlackArmor® Carbon/PEEK products that may offer significant clinical advantages over traditional metal implants in the context of spine oncology, making the full potential of the treatment possibilities available for patients along their journey. Since receiving FDA clearance in 2019, many designated US cancer centers have adopted icotec's BlackArmor® products. This investment will enable icotec to continue its impressive growth and strengthen its research and development capabilities to expand the portfolio into the underserved indications of spinal infection and osteoporosis. "We are thrilled to partner with MVM, whose deep understanding of the healthcare landscape aligns seamlessly with our vision for the future," said Roger Stadler, Group CEO of icotec ag. "This partnership marks a pivotal moment for icotec, supporting us to advance our mission of improving patient outcomes by offering a convincing alternative to the 100-year-old material technology of metal implants." MVM has a strong track record of supporting and partnering with innovative healthcare companies and recognizes the potential of icotec's technology to transform patient care. The partnership represents a vote of confidence in icotec's leadership, products, and the overall trajectory of the company. "We are excited to support icotec in its mission to revolutionize the spinal implant industry," commented Thomas Casdagli, Partner at MVM. "icotec's BlackArmor® Carbon/PEEK implants represent a huge step forward in the treatment of complex spine disease. For the first time clinicians have the choice to be able to accurately visualize and treat patients after surgery without the artifacts and limitations of traditional metal implants. We see this as a big step forward for patient care. We look forward to working closely with the icotec team to drive continued success and growth." WISTAMA Finanz- und Beteiligungs AG, the family office of the Stadler family that founded icotec, remains fully invested as majority shareholder and committed to the long-term development of icotec. For media inquiries or further information, please contact: Remo Keller, Group CFO, [email protected], +41 71 757 00 96 About icotec ag icotec is the leading company for the treatment of spinal tumors with a new generation of high-tech implants. With its BlackArmor® Carbon/PEEK implants, icotec combines cutting-edge technologies and industry expertise to deliver innovative and reliable solutions for spine surgeons and their patients and is dedicated to advancing the field of spinal implantation. With a track record of clinical success and a commitment to continuous innovation, icotec is poised to shape the future of spinal surgery. The comprehensive product portfolio has received FDA approval and is supported by numerous Key Opinion Leaders and Cancer Therapy Centers worldwide. More information can be found at . About MVM Partners MVM has invested in high-growth healthcare businesses since 1997. With teams in Boston and London, MVM has a broad, global investment outlook spanning medical technology, pharmaceuticals, diagnostics, contract research and manufacturing, digital health, and other sectors of healthcare. More information can be found at . SOURCE icotec ag

ORR of 67% (6 of 9) in MAPK inhibitor (MAPKi)-naïve adults with V600-mutated primary recurrent central nervous system tumors, with a median duration of response (mDOR) of 13.9 months ORR of 42% (10 of 24) in MAPKi-naïve adults with V600-mutated advanced solid tumors, with a mDOR of 17.8 months Plixorafenib continues to demonstrate a favorable tolerability pro tumor types, including in patients with primary central nervous system (CNS) tumors PHILADELPHIA--(BUSINESS WIRE)-- 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 pro 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. I look forward to further elucidating plixorafenib’s potential in our ongoing, global Phase 2 FORTE study.” “These results continue to demonstrate that plixorafenib has a favorable safety and efficacy pro to the currently approved BRAF/MEK inhibitors and investigational pan-RAF inhibitors,” shared Macarena de la Fuente, MD, Associate Professor and Chief of Neuro-oncology at the University of Miami Sylvester Comprehensive Cancer Center. “I am excited to share these data today with the medical community and I look forward to the further study of plixorafenib to address the high unmet need of patients living with these difficult to treat cancers.” Key Findings from the Phase 1/2a Study Safety and Tolerability As of the data cutoff date of September 6, 2023, 113 patients have received plixorafenib under continuous dosing until disease progression and are included in the safety population. Plixorafenib continues to demonstrate a favorable tolerability pro a low frequency of symptomatic treatment emergent adverse events (TEAEs) relative to approved BRAF/MEK inhibitors The safety pro patients with PCNSTs (N=22) was consistent with that observed in the overall population Headache was the only symptomatic Grade ≥3 treatment emergent AE occurring in >5% of patients At the recommended Phase 2 dose (plixorafenib 900mg QD with PK booster: cobicistat 150mg QD), dose optimization maximizes dose intensity early in treatment with: No DLTs Most common laboratory abnormality TEAEs are predominantly Grade 1-2 Symptomatic TEAEs were almost all Grade 1 Efficacy Among the 9 MAPKi-naïve patients with V600-mutated PCNSTs, 6 achieved a response for an ORR of 66.7% (95% CI: 29.9, 92.5), all of which were confirmed responses mDOR was 13.9 months (range: 3.7, 32.3) with 4/6 (67%) of responders having DOR of 6 months or longer mPFS was not yet reached in patients with low grade glioma and glioneuronal tumors (range: 1.6, 27.8+ months; n=4) and 6.7 months (range: 2.8, 34.1 months; n=5) in high grade gliomas Among the 24 MAPKi-naïve patients with V600-mutated advanced solid tumors, 10 had a response for an ORR of 41.7%, all of which were confirmed responses mDOR was 17.8 months (range: 3.7, 59.2) Median time to response was 3.5 months in patients with V600-mutated solid tumors, including those treated with prior MAPK inhibitor About Plixorafenib (FORE8394; PLX8394) 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 BRAF V600 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 was granted Orphan Drug Designation by the U.S. Food and Drug Administration in March 2023 for the treatment of primary CNS malignancies. In September 2022, the Agency granted plixorafenib Fast Track Designation for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 alterations (including fusions) who have exhausted prior therapies. 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-altered cancers. About Fore Biotherapeutics Fore Bio is a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients. Its lead asset plixorafenib (FORE8394; PLX8394) is a Class 1/V600 and 2 BRAF inhibitor with demonstrated clinical safety and early efficacy signals in an ongoing Phase 1/2a clinical trial. Leveraging a proprietary functional genomics platform that can screen a wide range of known mutations for cancer-driving genes, the Fore Bio research and development team is optimizing drug development by identifying existing compounds with known clinical profiles and a clear path through clinical development to advance new medicines for patients without treatment options. For more information, please visit or follow us on Twitter and LinkedIn. View source version on businesswire.com: Contacts Investors and Media: Argot Partners 212.600.1902 | ForeBio@argotpartners.com Source: FORE Biotherapeutics View this news release online at: