Addition of CMO, Medical Director Chris Polage, MD, and enhancements in clinical operations position Company for success in the clinical development of ALX1 in bronchiectasis Morrisville, N.C., March 7, 2024 - Vast Therapeutics today announced the addition of Paul Bruinenberg, MD, MBA as Chief Medical Officer. Dr. Bruinenberg brings over 30 years of experience as a clinical development executive in respiratory medicine and orphan diseases. This appointment and the recent addition of microbiologist and clinical diagnostics expert Chris Polage, MD, as Medical Director, significantly bolster the company’s clinical development expertise in pulmonary infectious diseases and medical microbiology. “Paul’s development experience will guide Vast Therapeutics as we successfully transition to a clinical-stage organization,” said Nate Stasko, Chief Executive Officer at Vast Therapeutics. “He’s been here before. His early-stage clinical experience in cystic fibrosis and non-cystic fibrosis bronchiectasis patient populations is a perfect match for our drug candidates that we believe will reshape the respiratory infectious disease landscape.” “It is an amazing opportunity to join a company with an accepted IND for a novel treatment modality that shows promising efficacy against chronic infections caused by Pseudomonas aeruginosa and non-tuberculosis mycobacteria,” commented Paul Bruinenberg, Chief Medical Officer at Vast Therapeutics. “The high unmet medical need in this therapeutic area is significant. I am excited to advance our nebulized therapy to maximize clinical outcomes for these patients without concerns of renal toxicity and emergence of antibiotic resistance.” Vast plans to initiate its Phase 1 clinical development program in Q2 2024 and one or more proof-of-concept studies in subjects with bronchiectasis in 2025. Paul Bruinenberg, MD, MBA – Chief Medical Officer Dr. Bruinenberg has over 30 years’ experience in the pharmaceutical and biotechnology industry. He brings a wealth of respiratory infectious disease experience researching rare diseases like cystic fibrosis (CF), non-CF bronchiectasis (NCFB), tuberculosis (TB) and non-tuberculosis mycobacteria (NTM). His career includes development of several inhaled therapies including the approval of Pulmozyme® as the first mucolytic for CF as well as the early development of inhaled liposomal ciprofloxacin for the treatment of chronic Pseudomonas aeruginosa infections. Most recently, Dr. Bruinenberg served as the Senior Medical Officer of the TB Alliance leading clinical development against mycobacterial infections. Previously, he held medical leadership roles at Eagle Pharmaceuticals, Aradigm Corporation, Astellas and Roche, having a key role in the development and approval of 12 new drugs (Pulmozyme®, Pretonamid®, Globocef®, Rocephin®, Quinodis®, Bosentan®, Xolair®, CellCept®, Zenapax®, Belrapzo®, Bendeka®, and Ryanodex®). Dr. Bruinenberg is a graduate of the medical school of the University of the Stellenbosch, South Africa and obtained two MBAs from the University of Nijenrode in the Netherlands and Rochester University in the USA. Chris Polage, MD – Medical Director Dr. Polage is a physician-scientist and board-certified medical microbiologist with NIH clinical research training and over 15 years of experience leading top academic clinical laboratories. His award-winning research and publications have been cited more than 2500 times in the medical and scientific literature and changed medical practice regarding the diagnosis and treatment of C. difficile, an urgent antimicrobial resistance threat. Before coming to Vast, he was Medical Director of the Duke University Clinical Microbiology Laboratory where he oversaw specialized testing for a broad array of patient populations including CF and NCFB patients. Dr. Polage is a diagnostics expert for the NIAID/NIH Antimicrobial Resistance Leadership Group and an adjunct Associate Professor of Pathology at Duke University. He received his Doctor of Medicine from the University of New Mexico with residency and fellowship training at the University of Colorado and University of Utah/ARUP Laboratories, including two years of medical microbiology with a special focus on mycobacterial testing. About Vast Therapeutics
Vast is a life science company focused on breaking the debilitating cycle of infection and chronic inflammation in respiratory diseases. This cycle affects patients across the entire spectrum of human life, ranging from children with rare orphan diseases like Cystic Fibrosis to adults with highly prevalent diseases like chronic obstructive pulmonary disease (COPD). We believe our product candidates may provide an effective treatment for patients infected with Pseudomonas aeruginosa, NTM, and other drug-resistant microbes. Company targets novel inhaled therapies for drug-resistant chronic airway infections Morrisville, N.C., January 17, 2024 - Vast Therapeutics announces publication of a manuscript in the journal of Antimicrobial Agents & Chemotherapy describing the utility of its novel nitric oxide-releasing drug candidate targeting infections caused by non-tuberculosis mycobacteria (NTM). The preclinical results demonstrate in vivo bactericidal activity in both acute and chronic animal models of NTM infection with no evidence of drug resistance. At the optimal dose, the NO-releasing prodrug showed >99% reduction in Mycobacterium abscessus levels within the lungs of infected rodents when dosed once daily for a period of 7 days.
“This work is incomparable to any treatment strategy currently prescribed by clinicians to treat NTM,” stated Dr. Mark Schoenfisch, Founder and Chief Scientific Officer at Vast Therapeutics, and senior author of the study. “The broad-spectrum activity of our drug candidate plus the ability to kill mycobacteria that have invaded immune cells without engendering antimicrobial resistance is unprecedented.” There are approximately 90,000 patients in the U.S. with NTM pulmonary disease (NTM-PD) where initial diagnoses are followed by a decline in quality of life, hospitalizations, and increased mortality. The 5-year mortality rate for these patients is approximately 1 out of every 3 individuals. With the prevalence rising at 11% per year among Medicare participants, NTM-PD represents a growing public health concern. Current treatment approaches to NTM-PD require a cocktail of three or more daily antibiotics for over 12 months. None of these commonly used treatment regimens have been shown to be categorically safe, well-tolerated, or effective at resolving clinical endpoints. Mycobacteria readily develop resistance to these prolonged antibiotic regimens. Mycobacterium abscessus, the focus of Dr. Schoenfisch’s work, is a difficult multi-drug resistant bacteria for which there are currently no FDA-approved treatments. For M. abscessus infections, the median healthcare costs approach $50,000, largely driven by inpatient-treatment costs. “We believe a new product that can greatly reduce the use of ineffective, maintenance antibiotics that continue to propagate global antibiotic resistance will have significant patient and pharmacoeconomic benefits worldwide,” concluded Schoenfisch. About Vast Therapeutics Vast is a life science company focused on breaking the debilitating cycle of infection and chronic inflammation in respiratory diseases. This cycle affects patients across the entire spectrum of human life, ranging from children with rare orphan diseases like Cystic Fibrosis to adults with highly prevalent diseases like COPD. We believe our product candidates may provide an effective treatment for patients infected with Pseudomonas aeruginosa, NTM, and other drug-resistant microbes. |
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