Vitae Pharmaceuticals LLC

HANGZHOU, China, Sept. 5, 2024 /PRNewswire/ -- Venus Medtech (Hangzhou) Inc. (Venus Medtech, 02500.HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced that its in-house developed next-generation balloon-expandable dry-tissue transcatheter aortic valve replacement (TAVR) system, Venus-Vitae, successfully completed two inaugural implantations as part of its global multicenter pivotal trial, Venus-Vitae SMART-ALIGN, at Prince of Wales Hospital in Hong Kong, China. Continue Reading These successful implantations mark another leap forward for the company into the frontier of next-generation dry-tissue valves, representing a significant addition to our transcatheter heart valve solutions. Following the first two successful implantations, Venus-Vitae SMART-ALIGN pivotal clinical trial will be progressively launched at around 20 centers in Europe, North America and China, enrolling a total of 150 patients. The trial data will be used to support registration applications in the EU, Canada, China and other territories. The procedures were performed by Prof. So Chak Yu Kent and the team at Prince of Wales Hospital in collaboration with Prof. Scott Lim of University of Virginia Medical Center, supported by a multidisciplinary team from Ultrasound, Anesthesiology, and Imaging Departments. Both patients received 23mm Venus-Vitae implants. The procedures presented good immediate post-operative results with significant hemodynamic improvement. Venus-Vitae Smart-ALIGN, abbreviated from Multicenter Pivotal Study to Evaluate the TreatMent of Severe AoRTic VALve StenosIs UsinG the VeNus-Vitae Transcatheter Heart Valve System, is a prospective, multicenter, non-randomized interventional study to evaluate the safety and efficacy of the Venus-Vitae TAVR system in patients with severe aortic stenosis. "Recently, my colleague Dr. Michael Hainstock and I, at the University of Virginia Medical Center, completed the first patient implantation in the VenusP-Valve PROTEUS pivotal clinical trial in the United States, " said Prof. Scott Lim." Two months later, I am very pleased to have participated with Dr. Kent So in the implantation of the first two patients in the Venus-Vitae SMART-ALIGN international multicenter pivotal clinical trial at Prince of Wales Hospital in Hong Kong. These both represent important milestones in those studies. Additionally, both the VenusP Valve and the Vitae valve have been previously used in clinical applications, with excellent published results. Of note, the Venus-Vitae valve's stent frame is the shortest among current transcatheter aortic valves, and I am encouraged by its potential to treat aortic stenosis while maintaining coronary access. Furthermore, its dry valve leaflet technology facilitated rapid preoperative preparation time. We look forward to further international enrollment in the SMART-ALIGN clinical trial in the near future." "It was an honor to collaborate with Dr. Scott Lim to complete the first two confirmatory clinical implantations of this innovative dry valve," said Prof. So Chak Yu Kent after the procedures. "Venus-Vitae's active anti-PVL technology and short frame design effectively prevent leakage and minimize the risk of coronary artery obstruction. I'm eager to see expedited enrollment of patients for Venus-Vitae, so that more patients can benefit soon." "Venus-Vitae is our next generation balloon-expandable TAVR system, with global patent coverage," said Hou-Sen Lim, General Manager and CEO of Venus Medtech. "We have strong confidence in its international multi-center clinical trials and global strategy. The successful initial implantations provide a solid foundation for forthcoming trials in Europe, North America, and China. We are committed to advancing Vitae's global clinical application and regulatory registration, bringing our cutting-edge technology to physicians and patients worldwide." About Venus-Vitae Venus-Vitae utilizes the innovative Venus-Endura technology, which integrates multiple anti-calcification techniques, immunogenicity removal technology and 3D force-controlled dehydration technology, providing exceptional durability, biocompatibility, and excellent anti-calcification performance. In addition, this design allows for room temperature storage of the valve in a dry-tissue condition. Additionally, the product features a unique patented technology, Lockwire Technology, ensuring the stability and accuracy of the valve during delivery and deployment. The short stent frame of Venus-Vitae's valve along with its steerable NAVIMASTER delivery system, significantly optimizes the performance across the aortic arch and positioning within the native valve. Venus-Vitae also features a unique Coronary Alignment technology, addressing the fundamental challenge that current TAVR products have been unable to address—aiding in protection of the coronary arteries. By utilizing three gold markers at the base of the valve leaflets in conjunction with the delivery system's steering, telescoping, and balloon rotation capabilities, Venus-Vitae can effortlessly and precisely achieve coronary alignment during the deployment process. This aids in accomplishing coronary protection throughout the implantation procedure. Furthermore, Venus-Vitae features a self-adaptive anti-PVL technology, utilizing an adaptive polymer skirt. The proprietary polymer skirt material possesses a high compression ratio, excellent resilience, self-expanding properties, and adaptive sealing. It demonstrates adaptive deformation during valve crimping, without enlarging the profile of the delivery system. Upon deployment, it actively fills the gaps around the valve perimeter, achieving remarkable anti-PVL performance. About Venus Medtech Venus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment. For more information, please visit *Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content. *Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned. *VENUSMEDTECH, the stylized QI logo, Venus-Vitae, Venus-Endura etc. are trademarks of Venus Medtech (Hangzhou) Inc. *Venus-Vitae is currently restricted to research only in the EU, North America, and China. SOURCE Venus Medtech (Hangzhou) Inc.

BRISBANE, Calif.--( BUSINESS WIRE )--Gate Bioscience, a biotechnology company developing a new class of small molecule medicines to eliminate disease-causing proteins at their source, today announced the appointment of Jeff Hatfield to its Board of Directors. Mr. Hatfield brings more than three decades of successful industry leadership across biotech and pharmaceuticals. “We are thrilled that Jeff is joining Gate’s Board of Directors,” said Jordi Mata-Fink, Ph.D., Co-founder and Chief Executive Officer of Gate. “Jeff has built and led multiple chemistry platform companies based on novel cutting-edge approaches, leading to many first-in-class programs in critical disease areas and successful outcomes for patients and shareholders alike. We look forward to benefiting from his expertise as we develop our Molecular Gate medicines.” Mr. Hatfield’s significant platform company leadership experience includes serving as Chief Executive Officer of Vividion Therapeutics, a pioneer in the development of chemoproteomics. At Vividion, he led the development of a portfolio of first-in-class oncology and immunology programs before the company’s 2021 acquisition by Bayer Pharmaceuticals, which delivered $1.5 billion upfront and $0.5 billion in CVR earn-outs to shareholders. He also served as CEO of Vitae Pharmaceuticals, where he built an early innovator position in AI/ML computational drug discovery before that company’s 2016 acquisition by Allergan for $640 million. Mr. Hatfield currently serves as Chair of ROME Therapeutics and Vividion, as well as serving on the board of directors for VIR Biotechnology and the advisory boards of Lime Therapeutics and the Harvard Business School’s Blavatnik Fellowship in Life Science Entrepreneurship. Earlier in his career, Mr. Hatfield held senior leadership roles at Bristol Myers Squibb, including Senior Vice President, Immunology; President, BMS-Canada; and Head of U.S. Market Access. He earned an MBA from The Wharton School of the University of Pennsylvania, and a B.S. from the Purdue University College of Pharmacy. “Gate’s new therapeutic mechanism – selectively blocking the secretory translocon with small molecules to potently eliminate extracellular disease-causing proteins – is unique and powerful,” said Mr. Hatfield. “This science has the potential to quickly identify high-value, first-in-class therapeutics in the inflammatory, cancer and neurodegenerative fields. This is an exciting time to join the company, with the platform fully operational and multiple discovery programs rapidly taking shape. I look forward to working with Gate to bring new therapies to patients in need.” Mr. Hatfield joins Gate’s Board of Directors that includes Dr. Mata-Fink, Thomas Daniel, M.D., former President of Global Research and Early Development at Celgene, Clare Ozawa, Ph.D., Managing Director at Versant Ventures, and Vineeta Agarwala, M.D. Ph.D., General Partner at a16z Bio + Health. About Gate Bioscience Gate Bioscience is creating a new class of medicines called Molecular Gates, small molecules that selectively eliminate harmful extracellular proteins at their origin: inside the cell. Every extracellular protein—of which there are more than 4,000—must pass through a single channel in the cell before it can be secreted into the body. Molecular Gates recognize and block specific disease-causing proteins from exiting the channel, causing them to be degraded by the cell instead of being secreted. By eliminating the harmful protein at the source, Gate aims to eliminate the disease for patients. Founded in 2021, Gate is backed by Versant Ventures, a16z Bio + Health, ARCH Venture Partners, and GV. Learn more at www.gatebio.com .

Mr. Santini’s Extensive Global Commercial and Business Development Experience Strengthens Alzheon’s Board Leadership ALZ-801/Valiltramiprosate Has Potential to Become the First Oral Agent to Slow Alzheimer’s Pathology in Patients Fully Enrolled Pivotal APOLLOE4 Phase 3 Trial in Early Alzheimer’s Disease Patients on Track for Topline Data Readout and Initiation of NDA Submission in 2024 FRAMINGHAM, Mass.--(BUSINESS WIRE)-- Alzheon, Inc., a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today announced that it has appointed Gino Santini to its Board of Directors. "2024 is a transformational year at Alzheon and with the anticipated readout of our APOLLOE4 Phase 3 trial, we are preparing for potential approval and commercialization of our pathbreaking product. Gino’s addition to our Board of Directors will help guide this broadening of our focus from running clinical trials to executing regulatory submissions and planning for commercial launch in number of territories,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon. “Alzheon’s well differentiated and simplified approach to disease modification has the potential to address crucial roadblocks in a market struggling to activate, and I look forward to strategic and business guidance from someone as experienced and accomplished as Gino.” Mr. Santini retired from a long and distinguished career at Eli Lilly in 2010. During his tenure at Eli Lilly, Mr. Santini held various leadership positions of increasing responsibility, including manager of various international regions, President of the Women’s Health Franchise and President of U.S. Operations. Mr. Santini capped his career at Eli Lilly as a member of the company’s executive committee and as Senior Vice President of Corporate Strategy and Business Development. Mr. Santini currently serves on the Boards of Directors of Intercept Pharmaceuticals and Collegium Pharmaceuticals. He previously served on the boards of SORIN SpA, Vitae Pharmaceuticals, Horizon Therapeutics, and AMAG Pharmaceuticals, until their acquisitions, and of Intarcia Therapeutics and Allena Pharmaceuticals. Mr. Santini is fluent in four languages and holds an undergraduate degree in mechanical engineering from the University of Bologna and an MBA from the University of Rochester. “Alzheon’s pioneering precision medicine and therapeutic approach has an opportunity to transform the standard of care and improve access to treatment for all Alzheimer’s patients, and it is an honor to be joining the Alzheon Board during this impactful period,” said Mr. Santini. “Bringing safe and effective therapies to the Alzheimer’s community is a noble mission and I could not be more excited about the prospects for Alzheon and the potential for ALZ-801 to fill a tremendous unmet medical need. APOLLOE4 Phase 3 trial evaluating oral ALZ-801 is expected to read out in the third quarter of 2024, and we are now preparing for a potential NDA submission this year followed by a commercial launch of the product in the U.S. in 2025.” About ALZ-801 ALZ-801/valiltramiprosate is a potential first-in-class, investigational oral agent in Phase 3 development as a potentially disease modifying treatment for AD.1,2,4,5 ALZ‑801 is designed to block the formation of neurotoxic soluble beta amyloid oligomers implicated in cognitive decline in Alzheimer’s patients.1,2,4 In mechanism of action studies, ALZ-801 has fully inhibited the formation of neurotoxic soluble beta amyloid oligomers at the Phase 3 clinical dose.6,7 ALZ‑801 acts through a novel enveloping molecular mechanism of action to block formation of neurotoxic soluble amyloid oligomers in the human brain8 associated with the onset and progression of cognitive decline in AD patients.1,2,4 ALZ-801 received Fast Track designation from the U.S. Food and Drug Administration in 2017 for Alzheimer’s disease. In clinical trials, ALZ-801 has shown potential for robust clinical efficacy and favorable safety results with no increased risk of brain vasogenic edema.6–8,10 The initial Phase 3 program for ALZ-801 is focusing on Early AD patients with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), with potential future program expansion to AD treatment and prevention in patients carrying one copy of the APOE4 gene and noncarriers.1–5 ALZ-801 Phase 2 Biomarker Trial Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease (NCT04693520): This ongoing trial was designed to evaluate the effects of 265 mg twice daily oral dose of ALZ-801 on biomarkers of AD pathology in subjects with Early AD, who have either the APOE4/4 or APOE3/4 genotype and constitute 65-70% of Alzheimer's patients. The trial also included evaluation of clinical efficacy, safety, tolerability, and pharmacokinetic pro ALZ-801 over 104 weeks of treatment. An ongoing long-term extension of the trial evaluates ALZ-801 for an additional 104 weeks of treatment for a total of 208 weeks. ALZ-801 APOLLOE4 Phase 3 Trial An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early Alzheimer's Disease Subjects (NCT04770220): This ongoing trial is designed to evaluate the efficacy, safety, biomarker and imaging effects of 265 mg twice daily oral dose of ALZ-801 in Early AD subjects with two copies of the apolipoprotein ε4 allele (APOE4/4 homozygotes), who constitute approximately 15% of Alzheimer's patients. This is a double-blind, randomized trial comparing oral ALZ-801 to placebo treatment over 78 weeks. The APOLLOE4 trial is supported by a $51 million grant from the National Institute on Aging. An ongoing long-term extension of the trial evaluates ALZ-801 for an additional 52 weeks of treatment for a total of 130 weeks. About Alzheon Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of neurodegeneration. Our lead Alzheimer’s clinical candidate, ALZ-801/valiltramiprosate, is a first-in-class oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that has been observed to fully block the formation of neurotoxic soluble amyloid oligomers in preclinical tests. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients. Alzheon Scientific Publications 1 Tolar M, et al: The Single Toxin Origin of Alzheimer’s Disease and Other Neurodegenerative Disorders Enables Targeted Approach to Treatment and Prevention, International Journal of Molecular Sciences, 2024; 25, 2727. 2 Tolar M, et al: Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer’s Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression, International Journal of Molecular Sciences, 2021; 22, 6355. 3 Abushakra S, et al: APOE ε4/ε4 Homozygotes with Early Alzheimer’s Disease Show Accelerated Hippocampal Atrophy and Cortical Thinning that Correlates with Cognitive Decline, Alzheimer’s & Dementia, 2020; 6: e12117. 4 Tolar M, et al: Aducanumab, Gantenerumab, BAN2401, and ALZ-801—the First Wave of Amyloid-Targeting Drugs for Alzheimer’s Disease with Potential for Near Term Approval, Alzheimer’s Research & Therapy, 2020; 12: 95. 5 Tolar M, et al: The Path Forward in Alzheimer’s Disease Therapeutics: Reevaluating the Amyloid Cascade Hypothesis, Alzheimer’s & Dementia, 2019; 1-8. 6 Hey JA, et al: Discovery and Identification of an Endogenous Metabolite of Tramiprosate and Its Prodrug ALZ-801 that Inhibits Beta Amyloid Oligomer Formation in the Human Brain, CNS Drugs, 2018; 32(9): 849-861. 7 Hey JA, et al: Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease, Clinical Pharmacokinetics, 2018; 57(3): 315–333. 8 Abushakra S, et al: Clinical Effects of Tramiprosate in APOE4/4 Homozygous Patients with Mild Alzheimer’s Disease Suggest Disease Modification Potential, Journal of Prevention of Alzheimer’s Disease, 2017; 4(3): 149-156. 9 Kocis P, et al: Elucidating the Aβ42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer’s Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data, CNS Drugs, 2017; 31(6): 495-509. 10 Abushakra S, et al: Clinical Benefits of Tramiprosate in Alzheimer’s Disease Are Associated with Higher Number of APOE4 Alleles: The “APOE4 Gene-Dose Effect,” Journal of Prevention of Alzheimer’s Disease, 2016; 3(4): 219-228. View source version on businesswire.com: Contacts Source: Alzheon, Inc. View this news release online at: