Aradigm Corp.

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 /PRNewswire/ -- 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. Contact: Nathan Stasko Chief Executive Officer Vast Therapeutics, Inc. nstasko@vasttherapeutics.com

WOBURN, Mass.--(BUSINESS WIRE)-- ImmunoMolecular Therapeutics, Inc. (“IM Therapeutics”), a clinical stage company developing personalized therapies for autoimmune disease, announced today that Jonathan Rigby has joined its Board of Directors. Mr. Rigby brings extensive company building and pipeline development experience in autoimmune and other diseases. IM Therapeutics is developing small molecule oral genetic medicines targeting specific human leukocyte antigen (HLA) variants known to play a strong role in autoimmune diseases. The Company’s lead drug candidate, IMT-002, is in Phase 1b clinical trials in type 1 diabetes (T1D). Patients in the study were preselected for HLA-DQ8, the gene variant present in about 60% of T1D patients. “Jonathan brings a strong corporate development and drug development perspective to our team as we position our technology platform towards multiple autoimmune conditions,” said Nandan Padukone, Ph.D., CEO of IM Therapeutics. “He is a great asset to the company as we complete Phase 1 studies in T1D, prepare for Phase 2 through early next year, and build our pipeline in celiac disease and other autoimmune diseases.” Mr. Rigby has three decades of experience building biopharmaceutical companies from early stages to IPO and acquisitions. He is currently President and Group CEO and a member of the Board of Immune Regulation Ltd, a company involved in developing novel treatments for autoimmune and allergic diseases. Previously, he established SteadyMed Therapeutics Inc, (NASDAQ IPO 2015, STDY), acquired by United Therapeutics (Nasdaq: UTHR) in 2018, and Zogenix, Inc. (NASDAQ IPO 2010, ZGNX). Prior to Zogenix, he worked at Aradigm Corp, a leader in the development of inhaled insulin, and held commercial and business development positions at Merck, Bristol Myers Squibb and Phillips Medical. Mr. Rigby currently serves on the Board of Directors of Thermalin Inc., and previously Xeris Pharmaceuticals (Nasdaq: XERS); and Chairman of CollPlant Biotechnologies, (Nasdaq: CLGN). He holds a Bachelor of Science Degree, with Honors, in Biological Sciences from Sheffield University, UK, and an MBA from Portsmouth University, UK. “I have a deep connection with autoimmune disease management, particularly type 1 diabetes, and am fascinated with the oral targeted drug approach of IM Therapeutics directed at genetic targets,” said Mr. Rigby. “I am also impressed by the clinical progress the team has achieved with IMT-002 as a lead drug in a short period of time and in the midst of a pandemic.” About IMT-002 IMT-002, the lead drug candidate of IM Therapeutics, is the first oral genetically targeted drug candidate to be tested in T1D patients, an incurable autoimmune disorder that affects nearly 1.6 million people in the United States. IMT-002 completed a Phase 1a study in August 2020 and is currently recruiting patients in a Phase 1b study in T1D preselected for the HLA-DQ8 gene variant. IMT-002 has been developed as a selective HLA-DQ8 blocker based on extensive computational work, in vitro and in vivo characterization. Previous studies of a tool drug, L-methyldopa, which is FDA-approved for treating hypertension, in a Phase 1b study, showed effective inhibition of DQ8 activity in new onset type 1 diabetes patients who had the DQ8 gene variant. Several in vivo IND studies indicate that IMT-002, which unlike the tool drug, is not metabolized physiologically, has more potency to block DQ8 activity and a favorable safety profile. About IM Therapeutics IM Therapeutics ( ) is a clinical stage company developing personalized medicines for autoimmune diseases by creating oral medicines against human leukocyte antigen (HLA) variants known to confer high risk of disease. The Company’s technology platform develops small molecule drugs using in silico docking of millions of compounds into pockets of an HLA variant where self-antigens may bind to trigger autoimmunity. Selected drug hits are then optimized using proprietary structure-based design and activity screening with cell-based assays for specificity of HLA inhibition. Lead drugs developed against an HLA variant have the ability to block a series of self-antigens and therefore the potential to treat several autoimmune indications related to a selected HLA. The Company is building a broad HLA-targeted pipeline in autoimmune disorders including type 1 diabetes, celiac disease, and lupus.

HAYWARD, CA -- (MARKET WIRE) -- November 06, 2006 -- The Board of Directors of Aradigm Corporation (NASDAQ: ARDM) today announced the appointment of John M. Siebert, Ph.D. to the Board of Directors. Dr. Siebert is currently the Chairman and CEO of CyDex, a privately-held company that has been successfully out-licensing its substituted cyclodextrin technology for use in drug development and formulation to a number of major pharmaceutical companies. CyDex also uses that technology to develop proprietary products which are out-licensed or may be brought to market by CyDex in the future.