Latest news with #KIF18A
Business Upturn
4 days ago
- Business
- Business Upturn
KIF18A Targeting Therapies FDA EMA Approval Clinical Trials By Indication Company Country Drug Class Report
Delhi, July 12, 2025 (GLOBE NEWSWIRE) — Global KIF18A Targeting Therapies Market Trends, Clinical Trials, Technology Platforms & Future Outlook 2025 Report Highlights & Findings: First KIF18A Targeting Therapy Commercial Availability Expected By 2030 Highest Phase Of Development: Phase-I/II KIF18A Targeting Therapies In Clinical Trials: > 10 Therapies KIF18A Targeting Therapies Clinical Trials Insight By Company, Country, Indication & Phase KIF18A Targeting Therapies Market Development Trends Insight KIF18A Therapies Technology Platforms Insight Download Report: The global KIF18A targeting therapies market is rapidly gathering momentum as KIF18A has emerged as a key vulnerability in cancers characterized by chromosomal instability. As a mitotic kinesin motor protein essential for chromosome alignment during cell division, KIF18A is overexpressed in malignancies such as ovarian and triple-negative breast cancers, making it a promising target for precision oncology with potentially lower toxicity than traditional chemotherapies. Although no KIF18A-targeted therapy is commercially available yet, the field is progressing quickly. Clinical pipelines include more than 10 therapies, with several in early clinical development. Among the frontrunners is ATX‑295 from Accent Therapeutics, an oral, best-in-class small-molecule inhibitor that recently entered a Phase I/II dose-escalation study in patients with advanced solid tumors, including ovarian and triple-negative breast cancer. It's employed with biomarker-enriched enrollment based on genomic instability markers like whole-genome doubling, and has received FDA Fast Track status—accelerating its path forward. The clinical landscape includes global contributions from leading biotechs such as Volastra Therapeutics, advancing multiple small-molecule inhibitors including Sovilnesib (AMG‑650) in Phase I for platinum-resistant ovarian cancer, and VLS‑1488 in Phase I/II across chromosomal instability-high tumors. Accent's ATX‑295 stands currently at the most advanced Phase I/II stage, with trials in the US and potentially Asia-Pacific, suggesting geographic development convergence. Technological innovation underpins expansion in this field. Development is dominated by small-molecule inhibitors designed to halt KIF18A's motor activity at kinetochores, causing mitotic catastrophe in cancer cells. Alternative approaches include disrupting upstream regulatory pathways like phosphorylation, and leveraging AI-driven drug discovery platforms. For example, Insilico Medicine's Chemistry42 and PandaOmics platforms generated a macrocyclic KIF18A inhibitor (ISM9682), showcasing the power of AI to enhance specificity and efficiency in drug design. Market trends demonstrate strong growth potential. The first commercial KIF18A-targeting therapy is expected by 2030, propelled by fast track designations and positive preclinical data. The rich pipeline, combined with precision biomarker strategies, supports a robust developmental roadmap, aligning with unmet clinical needs in CIN-high solid tumors and potentially extending to hematologic malignancies where KIF18A overexpression correlates with poor prognosis. Regional development trends show clinical leadership based in the US and Europe, where companies like Accent and Volastra are active, while China and other Asia-Pacific markets are engaging through global trial participation and local biotech collaborations. Multi-region trial footprints and biomarker-defined patient enrollment strategies are shaping global development dynamics. Our Global KIF18A Targeting Therapies Market Report offers detailed insights into this evolving therapeutic area. It profiles more than ten clinical-stage candidates by company, indication, country, and development phase, with a deep focus on ATX‑295 as the leading Phase I/II program. The report evaluates technology platforms, including small-molecule motor inhibitors and AI-enabled discovery, and analyzes biomarker-led patient selection models. Regional development trends and regulatory environments are mapped, and strategic partnerships and investments are examined. For pharmaceutical executives, biotech investors, and drug development leaders, this report provides a strategic foundation. It outlines market drivers, technological innovations, and clinical milestones that are poised to transform KIF18A from a promising target into an approved therapeutic by 2030, potentially offering new treatment options for patients with chromosomally unstable tumors. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Yahoo
24-06-2025
- Business
- Yahoo
KIF18A Inhibitor Clinical Trials FDA Approved KIF18A Targeting Therapies Market Report
KIF18A Therapy Commercial Launch Expected By 2030 Says Kuick Research in New Research Study Delhi, June 24, 2025 (GLOBE NEWSWIRE) -- Global KIF18A Targeting Therapies Market Trends, Clinical Trials, Technology Platforms & Future Outlook 2025 Report Highlights & Findings: First KIF18A Targeting Therapy Commercial Availability Expected By 2030 Highest Phase Of Development: Phase-I/II KIF18A Targeting Therapies In Clinical Trials: > 10 Therapies KIF18A Targeting Therapies Clinical Trials Insight By Company, Country, Indication & Phase KIF18A Targeting Therapies Market Development Trends Insight KIF18A Therapies Technology Platforms Insight Download Report: The global oncology landscape is witnessing rapid progress in precision medicine, and one of the most lead nominees in emerging targets is Kinesin Family Member 18A (KIF18A). It is a mitotic motor protein that is essential for chromosome alignment during mitosis, which facilitates proper segregation of chromosomes. Its perturbation leads to genomic instability, which is a distinguishing feature of cancer. Extrapolations of KIF18A have also been seen in various cancers such as ovarian and breast cancer, with an association with prognosis, drug resistance, and the potential to metastasize. As a crucial protein involved in mitosis and overexpression in cancer, KIF18A is now a promising therapeutic target. Targeting KIF18A interferes with mitotic mechanisms in chromosomally unstable (CIN-positive) cancer cells, causing selective death of cancer cells. In contrast to conventional chemotherapies, which indiscriminately impact all proliferating cells, KIF18A inhibitors provide a more selective and less toxic option by taking advantage of cancer cells' vulnerability to proper mitosis. The major approach is small molecule inhibitors that disrupt KIF18A's motor activity, hindering it from modulating microtubule dynamics at the kinetochore. It leads to mitotic arrest and failure of chromosome alignment, ultimately triggering apoptosis in cancer cells. Clinical development is progressing well. Volastra Therapeutics, a forerunner in this arena, is developing two KIF18A-targeting molecules: Sovilnesib (AMG650), acquired from Amgen and underway in Phase I trials for platinum-resistant high-grade serous ovarian cancer, and VLS-1488, an in-house oral inhibitor in Phase I/II. Both molecules displayed favorable safety profiles and early anti-tumor effects, with particular efficacy in high-chromosomal-instability tumors. Volastra's pipeline demonstrates the therapeutic potential of inhibiting KIF18A to treat difficult-to-treat cancers. Accent Therapeutics is also advancing with ATX-295, an oral KIF18A inhibitor in initial clinical testing for solid tumors such as triple-negative breast and high-grade serous ovarian cancers. Their biomarker strategy makes use of genomic instability markers such as whole-genome doubling to better optimize patient selection and optimize therapy outcomes. AI based drug discovery is providing additional impetus to this area. Insilico Medicine has utilized proprietary platforms such as Chemistry42 and PandaOmics to discover ISM9682, a new macrocyclic KIF18A inhibitor with high preclinical efficacy. The AI platforms facilitate rapid optimization of candidates with increased specificity and pharmacological profiles, highlighting the growing use of sophisticated computational approaches in drug discovery. Aside from clinical advancement, the market opportunity for KIF18A inhibitors is also robust. As precision oncology gains more attention, the therapies are well poised to capture the opportunity of targeted therapies, particularly in diseases that are refractory to current treatments. Various companies, including Nvidia-funded Iambic Therapeutics, Aurigene Oncology, Simcere Zaiming Pharmaceutical, and Amgen, are developing promising product candidates in preclinical phases. Overall, the KIF18A-targeted therapy market is changing very quickly, powered by strong scientific justification, initial clinical success, and novel development approaches. As additional preclinical and clinical information becomes available, the market has significant potential for strong growth, powered by partnerships, application of artificial intelligence and machine learning tactics, and the overall dedication to creating targeted and individualized cancer therapeutics. CONTACT: Neeraj Chawla Research Head Kuick Research neeraj@ in to access your portfolio
Yahoo
27-05-2025
- Business
- Yahoo
Volastra Therapeutics Announces Appointment of David P. Southwell as Chief Executive Officer
NEW YORK, May 27, 2025--(BUSINESS WIRE)--Volastra Therapeutics, a clinical-stage cancer biotechnology company, today announced the appointment of David P. Southwell as Chief Executive Officer. Mr. Southwell brings over 30 years of C-level executive biotechnology experience to Volastra as the company continues to advance its pipeline, which is led by two novel clinical stage KIF18A inhibitors. "We are delighted to welcome David to Volastra," said Sandi Peterson, Chair of Volastra's Board of Directors. "David's deep biotech leadership experience and proven track record make him the ideal CEO to lead Volastra through this exciting period of growth." "Volastra has pioneered novel therapeutic approaches in the emerging field of chromosomal instability, which is central to the progression of many cancers," said David Southwell. "With exciting early clinical data and a world-class team of management and investors, Volastra is well-positioned to be a leader in oncologic therapies." Mr. Southwell has built a strong foundation of financial, operational and strategic expertise throughout his career leading innovative biotechnology and pharmaceutical companies. He most recently served as President and Chief Executive Officer of TScan Therapeutics, an immune-oncology company advancing T-cell receptor-based therapies. Prior to that, he was President, Chief Executive Officer, and Board member of Inotek Pharmaceuticals, guiding the company through its merger with Rocket Pharmaceuticals in early 2018. Mr. Southwell also held senior executive roles as CFO at Human Genome Sciences through its acquisition by GlaxoSmithKline, and at Sepracor Inc., where he served as Executive Vice President and CFO for over a decade. He has served on the Boards of several public and private life sciences companies and currently serves on the Boards of PTC Therapeutics and Rocket Pharmaceuticals. Mr. Southwell succeeds Charles Hugh-Jones, who has led Volastra Therapeutics from its inception as CEO. The Board greatly appreciates Charles' leadership, vision and substantial contributions to the Company's success over the past 5 years. He will continue as an advisor to the Company. Separately, Volastra will be presenting dose escalation data from its first-in-human VLS-1488 trial in an oral presentation on June 2nd at the 2025 ASCO Annual Meeting. About Volastra TherapeuticsVolastra Therapeutics is a clinical-stage biotechnology company pioneering novel approaches to the treatment of cancer by targeting chromosomal instability. The company leads the field with two differentiated, oral KIF18A inhibitors, VLS-1488 and sovilnesib (formerly AMG-650). Both assets are currently being evaluated in Phase 1 clinical trials for platinum resistant ovarian cancer and other advanced solid tumors. Volastra is also developing new techniques to understand the biology of chromosomal instability and leveraging these insights to drive forward a preclinical pipeline of therapies against innovative targets. Volastra was founded in 2019 by Lewis Cantley, Ph.D., Samuel Bakhoum, M.D., Ph.D., and Olivier Elemento, Ph.D., and is funded by key investors including Polaris Partners, ARCH Ventures, B-Capital, Droia Ventures, Vida Ventures, Catalio Capital Management and Eli Lilly & Company. Notable partners include Tailor Bio and Microsoft. For more information, please visit View source version on Contacts Media Contact: Maeve Morse-SeavernsVolastra Therapeuticsmedia@
Yahoo
27-05-2025
- Business
- Yahoo
Volastra Therapeutics Announces Appointment of David P. Southwell as Chief Executive Officer
NEW YORK, May 27, 2025--(BUSINESS WIRE)--Volastra Therapeutics, a clinical-stage cancer biotechnology company, today announced the appointment of David P. Southwell as Chief Executive Officer. Mr. Southwell brings over 30 years of C-level executive biotechnology experience to Volastra as the company continues to advance its pipeline, which is led by two novel clinical stage KIF18A inhibitors. "We are delighted to welcome David to Volastra," said Sandi Peterson, Chair of Volastra's Board of Directors. "David's deep biotech leadership experience and proven track record make him the ideal CEO to lead Volastra through this exciting period of growth." "Volastra has pioneered novel therapeutic approaches in the emerging field of chromosomal instability, which is central to the progression of many cancers," said David Southwell. "With exciting early clinical data and a world-class team of management and investors, Volastra is well-positioned to be a leader in oncologic therapies." Mr. Southwell has built a strong foundation of financial, operational and strategic expertise throughout his career leading innovative biotechnology and pharmaceutical companies. He most recently served as President and Chief Executive Officer of TScan Therapeutics, an immune-oncology company advancing T-cell receptor-based therapies. Prior to that, he was President, Chief Executive Officer, and Board member of Inotek Pharmaceuticals, guiding the company through its merger with Rocket Pharmaceuticals in early 2018. Mr. Southwell also held senior executive roles as CFO at Human Genome Sciences through its acquisition by GlaxoSmithKline, and at Sepracor Inc., where he served as Executive Vice President and CFO for over a decade. He has served on the Boards of several public and private life sciences companies and currently serves on the Boards of PTC Therapeutics and Rocket Pharmaceuticals. Mr. Southwell succeeds Charles Hugh-Jones, who has led Volastra Therapeutics from its inception as CEO. The Board greatly appreciates Charles' leadership, vision and substantial contributions to the Company's success over the past 5 years. He will continue as an advisor to the Company. Separately, Volastra will be presenting dose escalation data from its first-in-human VLS-1488 trial in an oral presentation on June 2nd at the 2025 ASCO Annual Meeting. About Volastra TherapeuticsVolastra Therapeutics is a clinical-stage biotechnology company pioneering novel approaches to the treatment of cancer by targeting chromosomal instability. The company leads the field with two differentiated, oral KIF18A inhibitors, VLS-1488 and sovilnesib (formerly AMG-650). Both assets are currently being evaluated in Phase 1 clinical trials for platinum resistant ovarian cancer and other advanced solid tumors. Volastra is also developing new techniques to understand the biology of chromosomal instability and leveraging these insights to drive forward a preclinical pipeline of therapies against innovative targets. Volastra was founded in 2019 by Lewis Cantley, Ph.D., Samuel Bakhoum, M.D., Ph.D., and Olivier Elemento, Ph.D., and is funded by key investors including Polaris Partners, ARCH Ventures, B-Capital, Droia Ventures, Vida Ventures, Catalio Capital Management and Eli Lilly & Company. Notable partners include Tailor Bio and Microsoft. For more information, please visit View source version on Contacts Media Contact: Maeve Morse-SeavernsVolastra Therapeuticsmedia@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
22-05-2025
- Business
- Business Wire
Volastra Announces Initial Data from First-in-Human Phase I/II Trial of Novel KIF18A Inhibitor VLS-1488 to be Presented at 2025 ASCO Annual Meeting
NEW YORK--(BUSINESS WIRE)-- Volastra Therapeutics, a clinical-stage cancer biotechnology company focused on chromosomal instability, today announced preliminary safety and efficacy data from its ongoing, first-in-human Phase I/II trial of its novel, oral KIF18A inhibitor, VLS-1488. These results will be featured in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 2. 'We are excited by these results from our VLS-1488 KIF18A inhibitor program, demonstrating a favorable safety profile at clinically active doses, with tumor shrinkage in patients with heavily pre-treated ovarian cancer,' said Scott Drutman, M.D., Ph.D., Chief Medical Officer and Head of R&D of Volastra Therapeutics. 'These initial data represent a major milestone for the field of chromosomal instability and provide a clear path for dose and patient population selection for the next phase of development.' As of the January 10, 2025 data cutoff, 52 patients with advanced solid tumors were enrolled to the dose escalation portion of the trial across dose levels ranging from 50 mg to 800 mg. Drug exposures exceeded preclinically-defined efficacious thresholds for anti-tumor activity. No dose limiting toxicities were observed and a maximum tolerated dose was not reached. Less than 45% of patients experienced treatment-related adverse events (TRAEs) of any grade and less than 16% of all patients experienced G3 TRAEs. No patients experienced >G3 TRAEs. Of the 20 patients with advanced high grade serous ovarian cancer, the majority were platinum resistant and heavily pretreated with a median of 5 prior lines of therapy. At the time of data cutoff, 7 of the 17 response-evaluable patients demonstrated a reduction in tumor size, including 3 Partial Responses per RECIST, with 5 patients remaining on therapy. 'These early data show VLS-1488 to be very well tolerated, with promising initial efficacy in ovarian cancer,' said Ecaterina Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and investigator on the trial. 'The data that will be presented demonstrate the potential of KIF18A as a novel, relevant therapeutic target for hard-to-treat cancers and I look forward to continued development.' Volastra continues to enroll patients in this study and explore the broad potential of its two KIF18A inhibitors, VLS-1488 and sovilnesib in ovarian and other cancers. Details of the ASCO Rapid Oral Abstract Session are as follows: Title: Preliminary results from a first-in-human, phase I/II study of VLS-1488, an oral KIF18A inhibitor, in patients with advanced solid tumors Presenter: Ecaterina Dumbrava, M.D., Assistant Professor of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology – Small Molecules Session Date and Time: Location: McCormick Place Convention Center, S406 About VLS-1488 VLS-1488 is a novel, oral small molecule inhibitor of KIF18A, a kinesin protein essential for cancer cell division and a synthetic lethal target in chromosomally unstable cancers. VLS-1488 was granted Fast Track Designation from the FDA in October 2024 for the treatment of patients with platinum-resistant high-grade serous ovarian cancer. About VLS-1488-2201 Trial (NCT05902988) The Phase 1/2 trial is evaluating the safety, tolerability, PK, and antitumor activity of VLS-1488 in patients with advanced solid tumors, including high grade serious ovarian cancer. The study consists of two parts, Dose Escalation and Dose Expansion. Enrollment to the dose expansion portion of this study is ongoing. About Ovarian Cancer and Chromosomal Instability In the U.S. alone, there are more than 20,000 new cases of ovarian cancer each year, over 75% of which are advanced. Most of these patients will experience disease progression on platinum-based therapy. High grade serous ovarian cancer accounts for approximately 75% of all ovarian cancers, about 80% of all deaths and is almost universally chromosomally unstable. About Volastra Therapeutics Volastra Therapeutics is a clinical-stage biotechnology company pioneering novel approaches to the treatment of cancer by targeting chromosomal instability. The company leads the field with two differentiated, oral KIF18A inhibitors, VLS-1488 and sovilnesib (formerly AMG-650). Both assets are currently being evaluated in Phase 1 clinical trials for platinum resistant ovarian cancer and other advanced solid tumors. Volastra is also developing new techniques to understand the biology of chromosomal instability and leveraging these insights to drive forward a preclinical pipeline of therapies against innovative targets. Volastra was founded in 2019 by Lewis Cantley, Ph.D., Samuel Bakhoum, M.D., Ph.D., and Olivier Elemento, Ph.D., and is funded by key investors including Polaris Partners, ARCH Ventures, B-Capital, Droia Ventures, Vida Ventures, Catalio Capital Management and Eli Lilly & Company. Notable partners include Tailor Bio and Microsoft.
