Latest news with #KIF18A
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.
Malaysian Reserve
28-04-2025
- Business
- Malaysian Reserve
Accent Therapeutics Presents Data Supporting Therapeutic Potential of First-in-Class DHX9 Inhibitor, ATX-559, and Novel KIF18A Inhibitor, ATX-295, at the AACR Annual Meeting 2025
ATX-559, a first-in-class oral DHX9 inhibitor, shown to induce potent and selective tumor growth inhibition in preclinical models of cancers with high genomic instability and replication stress Oral presentation showcases robust, selective activity of potentially best-in-class KIF18A inhibitor, ATX-295, in KIF18A-dependent ovarian cancer models exhibiting whole genome doubling LEXINGTON, Mass., April 28, 2025 /PRNewswire/ — Accent Therapeutics, a clinical-stage biopharmaceutical company pioneering novel, targeted, small molecule cancer therapeutics, today announced new preclinical data on its first-in-class oral DHX9 inhibitor, ATX-559, and its potentially best-in-class KIF18A inhibitor, ATX-295, in poster and oral presentations, respectively, at the AACR Annual Meeting 2025 taking place April 25-30 in Chicago, Illinois. ATX-559 and ATX-295 are currently under investigation in Phase 1/2 clinical trials. 'Our presentations at the AACR annual meeting showcase the outputs of Accent's precision oncology approach to drug development, with strong foundational data that inform our current and future clinical development plans for our lead programs, ATX-559 and ATX-295,' said Serena Silver, Ph.D., Chief Scientific Officer of Accent Therapeutics. 'These preclinical data reinforce our assets' therapeutic potential across several cancer indications with high unmet need.' The company's poster presentation includes preclinical data supporting continued clinical evaluation of ATX-559, a first-in-class potent, selective, and orally bioavailable small-molecule inhibitor of DHX9. Results within characterize the compound's activity in cancer cell lines with genomic instability and elevated replication stress spanning several indications, including dMMR/MSI-H colorectal cancer and BRCA-altered triple negative breast cancer, and in subtypes of lung, gastric, ovarian, and prostate cancers. ATX-559 was shown to be well tolerated in vivo, leading to robust and dose dependent tumor growth inhibition and regression in BRCA deficient breast cancer and dMMR/MSI-H cell- and patient-derived xenograft models. ATX-559 is currently under investigation in a first-in-human, Phase 1/2, open-label, dose-escalation and expansion study, with a focus on advanced or metastatic patients with BRCA-1 and/or BRCA-2-deficient breast cancer or MSI-H and/or dMMR solid tumors (NCT06625515). Additional undisclosed solid tumor indications undergoing replicative stress and representing significant patient populations may be explored either in parallel or in subsequent studies. For Accent's second lead program, preclinical data included in the company's oral presentation demonstrates sensitivity to KIF18A inhibition across several solid tumor indications with high chromosomal instability, signaling significant opportunity for patient impact by leveraging KIF18A as a selective oncology target. Results further characterize ATX-295 as a potent and selective KIF18A inhibitor capable of inducing mitotic arrest, cell death, and anti-tumor activity in cancer models with high chromosomal instability. Studies in relevant cellular and xenograft models exhibiting whole genome doubling confirm selective anti-cancer activity, providing rationale for whole genome doubling as a predictive biomarker of ATX-295 sensitivity in ovarian and triple negative breast cancer. Accent recently initiated clinical evaluation of ATX-295 in a first-in-human Phase 1/2 open-label, dose-escalation and expansion study designed to evaluate the molecule's safety, tolerability, and preliminary efficacy in patients with locally advanced or metastatic solid tumors, including high-grade serious ovarian cancer (NCT06799065). Details for the presentations are as follows: Presentation Title: Activity of the Novel KIF18A Inhibitor, ATX-295, is Enriched in Whole Genome Doubled Ovarian Cancer Pre-Clinical Models Abstract Number: 3784 Session Type: Minisymposium Session Title: Novel Antitumor Agents Session Date and Time: Monday, April 28, 2:30 pm – 4:30 pm CT Location: Room S103 – McCormick Place South (Level 1) Presenter: Maureen Lynes, Ph.D. Poster Title: ATX-559, a First in Class DHX9 Inhibitor, and Targeted Therapeutic for Molecularly Defined Tumors with Genomic Instability and Replicative Stress Abstract Number: 1758 Session Title: Novel Antitumor Agents 1 Session Date and Time: Monday, April 28, 9:00 am – 12:00 pm CT Location: Poster Section 22 Poster Board Number: 10 Presenter: Jennifer Castro About ATX-559ATX-559 is a first-in-class potent and selective inhibitor of DHX9, a novel and previously undrugged RNA and DNA/RNA helicase, shown to play a critical role in tumors with high levels of replication stress (including breast, ovarian, colorectal, endometrial, gastric, and others), representing large patient populations with significant unmet medical need. DHX9 has been reported to play important roles in replication, transcription, translation, RNA splicing, RNA processing, and maintenance of genomic stability, making it a compelling novel oncology target. In addition to exploiting key tumor vulnerabilities in DNA repair deficient backgrounds (e.g., BRCA) and hyper-mutated states (e.g., MSI-H/dMMR), Accent is exploring the sensitivity of other tumor types to DHX9 inhibition, and the potential to combine DHX9 inhibitors with other cancer treatments to maximize its full potential for helping patients. Accent retains full worldwide rights to ATX-559, currently being evaluated in a Phase 1/2 clinical trial (NCT06625515), and the DHX9 program. About ATX-295Accent's second lead program is a potential best-in-class inhibitor for KIF18A which may address a large patient population across several cancer indications, including ovarian and triple negative breast cancer (TNBC). KIF18A is a mitotic kinesin motor protein critical for cell division in select tumors with chromosomal instability, but not in healthy cells. KIF18A inhibitor treatment results in rapid cell death for cancers with an abnormal number of chromosomes (aneuploid) in vitro and in vivo, while cells with normal numbers of chromosomes (euploid) are unaffected. Accent retains full worldwide rights to ATX-295, which is currently being evaluated in a Phase 1/2 clinical trial (NCT06799065), and the KIF18A program. About Accent TherapeuticsAccent Therapeutics is pioneering a new class of small molecule precision cancer therapies targeting critical intracellular dependencies that span multiple types of cancer. Building upon industry-leading expertise in RNA-modifying proteins (RMPs) and the systematic mapping of both the RMP space and adjacent high-value areas for drug discovery, the company employs a flexible model that allows for a diversity of approaches to developing potentially transformative biomarker-driven cancer medicines. Accent's therapies are designed for both novel and known, but suboptimally addressed, high-impact oncology targets with the potential to benefit large patient populations with significant unmet need. For more information on Accent's mission to translate extraordinary science into life-changing therapeutics for patients living with cancer, visit or follow us on LinkedIn. Media ContactAmanda Sellers, Deerfield
