San Jose, CA, United States

Aridis Pharmaceuticals, Llc

www.aridispharma.com
San Jose, CA, United States
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"Dr. Cohen's expertise has been invaluable over the last ten years as we have advanced our multiple monoclonal antibody product candidates through Phase 1 and 2 clinical trials, and we are excited to bring him into this new full-time role," stated Paul-André de Lame, M.D., Chief Medical Officer for Aridis Pharmaceuticals. "Dr. Cohen's many years of experience leading clinical development programs will be critical as we continue to advance our lead candidates combating life-threatening infectious diseases through late-stage clinical development and potential FDA approval." Dr. Cohen stated, "I look forward to helping shepherd Aridis Pharmaceuticals' lead pipeline candidates through pivotal clinical trials on the Aerucin and AR-301 mAb programs. This is an exciting time for the Company, as we advance multiple potential life-saving therapies. I am confident I can move these programs forward as efficiently and expeditiously as possible, which are desperately needed in this time of rising antibacterial-resistant pathogens." Dr. Alan Cohen is a board-certified pediatric pulmonologist with more than 100 peer-reviewed articles, abstracts, platform presentations and book chapters in his areas of expertise, including pulmonary disorders such as idiopathic pulmonary fibrosis (IPF), cystic fibrosis (CF), premature lung disease, asthma, lung transplantation as well as respiratory infectious diseases – including bacterial, fungal and viral pathogens.  He also has extensive industry experience in clinical development and product planning. He was most recently Senior Vice President & Chief Medical Officer of Therabron Therapeutics, a biotech company focused on secretoglobin biology in respiratory disorders. Previously, he was Chief Medical Officer at Eddingpharm, a China-based global biopharmaceutical company supporting over 15 therapeutics in addition to being responsible for all global clinical development programs in Oncology and Cardiopulmonary conditions. He served as Executive Director of Clinical Development & Medical Affairs at Boehringer Ingelheim, focusing on respiratory drug development in IPF, COPD and asthma. Prior to that Alan was SVP of Medical Affairs at InterMune (before being acquired by Genentech / Roche), as well as VP of Clinical Development and Medical Affairs at MAP Pharmaceuticals where he oversaw respiratory clinical development and new product planning. MAP was eventually acquired by Allergan. Dr. Cohen was Chief Medical Officer, and VP of Global Medical Affairs, Safety and Pharmacovigilance at Jazz Pharmaceuticals, supporting orphan drugs for sleep medicine, inborn errors of metabolism, toxicology and CNS disorders. He started his drug development career in biotechnology as Senior Director of Medical Affairs at Medimmune (acquired by Astra Zeneca) – where he was involved in the development and support of monoclonal antibodies and flu vaccines for respiratory illnesses in both adults and children. Dr. Cohen served as adjunct faculty at Stanford University School of Medicine, Dept. of Pediatric Pulmonology from 2001 to 2017, where he cared for patients, taught residents, supervised medical students and fellows in both allergy and pulmonary medicine. He has held faculty appointments at a number of prestigious centers of learning and healthcare including most recently, Stanford University, Johns Hopkins School of Medicine, Morehouse School of Medicine, Washington University School of Medicine – where he was the co-director of the largest Pediatric Pulmonary Lung Transplant program in North America, as well as the University of Colorado / National Jewish Center for Immunology and Respiratory Diseases – where he successfully completed his residency and fellowship. About Aridis Pharmaceuticals, Inc. Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® to produce novel infectious disease focused therapies.  Aridis' product pipeline includes AR-101 (or 'Aerumab™') anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 (or 'Salvecin®') anti-Staphylococcus aureus human monoclonal antibody to treat acute pneumonia; Aerucin®, a broadly reactive monoclonal antibody against Pseudomonas aeruginosa initially being developed to treat acute pneumonia; Panaecin™, a small molecule anti-infective gallium compound with broad spectrum activities against bacteria, viruses, and fungi; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody. Forward-Looking Statements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  Such forward-looking statements include statements relating to the therapeutic applications of AR-101, AR-301 (Salvecin®), Aerucin®, Panaecin™, AR-401, AR-201, Aridis' proprietary formulation and delivery technologies, about Aridis' strategy, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Aridis' expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Aridis' research and clinical studies and its ability to obtain additional financing.  These forward-looking statements represent Aridis' judgment as of the date of this release. Aridis disclaims any intent or obligation to update these forward-looking statements.


"We are excited to advance the development of Aerucin into a pivotal clinical trial," stated Vu Truong, Ph.D., Founder and CEO of Aridis.  "This study evaluates the potential therapeutic benefits of our anti-P. aeruginosa antibody Aerucin® as an adjunctive therapy in combination with antibiotics in critically ill pneumonia patients.  Propelled by positive safety data in humans and preclinical evidence that Aerucin is effective against a broad range of P. aeruginosa clinical isolates – including antibiotic-resistant strains – we look forward to evaluating its ability to improve clinical outcomes compared to standard of care antibiotics alone in a diverse, global patient population.  We expect to complete the study in the second half of 2018." Aerucin is a fully human monoclonal IgG1 antibody that binds to alginate, a cell surface polysaccharide that is widely distributed on P. aeruginosa.  Once bound, Aerucin improves recognition and destruction by the immune system through enhanced complement deposition. Aerucin has proven effective in promoting phagocytic killing of a wide range of both mucoid and non-mucoid P. aeruginosa clinical isolates, including antibiotic-resistant strains from pneumonia and cystic fibrosis patients. In an animal model of acute pneumonia, Aerucin protected mice from lethal P. aeruginosa challenges at doses as low as 0.004 mg/kg.  It also protected animals against eye infections in a keratitis model and sepsis in a systemic infection model. These studies support both therapeutic and prophylactic uses of Aerucin against a broad range of P. aeruginosa infections. Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® to produce novel infectious disease focused therapies.  Aridis' product pipeline includes AR-101 (or 'AerumabTM') anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 (or 'Salvecin®') anti-Staphylococcus aureus human monoclonal antibody to treat acute pneumonia; Aerucin®, a broadly reactive monoclonal antibody against Pseudomonas aeruginosa initially being developed to treat acute pneumonia; Panaecin™, a small molecule anti-infective gallium compound with broad spectrum activities against bacteria, viruses, and fungi; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody. Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  Such forward-looking statements include statements relating to the therapeutic applications of AR-101, AR-301 (Salvecin®), Aerucin®, Panaecin™, AR-401, AR-201, Aridis' proprietary formulation and delivery technologies, about Aridis' strategy, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Aridis' expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Aridis' research and clinical studies and its ability to obtain additional financing.  These forward-looking statements represent Aridis' judgment as of the date of this release. Aridis disclaims any intent or obligation to update these forward-looking statements.


"Hospital-acquired bacterial pneumonia (HABP) due to S. aureus affects more than 500,000 patients a year in the U.S., Europe, and Japan," stated Vu Truong, Ph.D., Chief Executive Officer of Aridis. "In addition to finding Salvecin safe and tolerable, encouraging efficacy indicators were observed. We believe our approach will help significantly improve the clinical course of patients with HABP. Advancing this new, antibody-based immunotherapy towards late-stage clinical studies in the coming months is a priority for Aridis, especially in these times of emerging multi-drug resistant S. aureus. This innovative and potentially break-through treatment may represent a much-needed therapeutic advance for patients hospitalized in an ICU with S. aureus pneumonia." About Aridis Pharmaceuticals, Inc. Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® to produce novel infectious disease focused therapies.  Aridis' product pipeline includes AR-101 (or 'Aerumab™') anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 (or 'Salvecin™') anti-Staphylococcus aureus human monoclonal antibody to treat acute pneumonia; Aerucin®, a broadly reactive monoclonal antibody against Pseudomonas aeruginosa initially being developed to treat acute pneumonia; Panaecin™, a small molecule anti-infective gallium compound with broad spectrum activities against bacteria, viruses, and fungi; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody. Forward-Looking Statements Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  Such forward-looking statements include statements relating to the therapeutic applications of AR-101, AR-301, Aerucin®, Panaecin™, AR-401, AR-201, Aridis' proprietary formulation and delivery technologies, about Aridis' strategy, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Aridis' expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Aridis' research and clinical studies and its ability to obtain additional financing.  These forward-looking statements represent Aridis' judgment as of the date of this release. Aridis disclaims any intent or obligation to update these forward-looking statements. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/aridis-pharmaceuticals-inc-presents-positive-phase-2a-safety-and-efficacy-data-of-salvecin-ar-301-in-patients-with-severe-pneumonia-caused-by-staphylococcus-aureus-during-the-2017-asm-microbe-congress-300468282.html


News Article | August 15, 2017
Site: www.prnewswire.com

"Diagnostics play a vital role in providing the best possible patient care and combatting the global health threat of antimicrobial resistance," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara Therapeutics and Chairman of the AWG. "T2 Biosystems is a leading innovator in the field and their T2MR detection technology enables the delivery of life-saving medicines more rapidly to patients and reduces the use of unnecessary drug exposure. We're excited to have their expertise in the fight against superbugs and drug resistant infections. In addition, I believe that immunotherapeutics, such as those being developed by Aridis, represent the wave of the future and will become an increasingly important source of potent, highly selective treatments in our antimicrobial armamentarium." "T2 is proud to become the first diagnostic company member of the AWG," said John McDonough, President & CEO of T2 Biosystems. "We look forward to adding our voice along with the rest of the AWG membership to help improve the regulatory, investment and commercial environment for emerging companies." Vu Truong, Ph.D., Founder and CEO of Aridis said: "We welcome the opportunity to work with the AWG membership, regulators and policymakers to help revitalize the pipeline of new antimicrobial drugs. The AWG has been very influential in their work to date and we are excited to contribute to these critically important efforts." T2 Biosystems is dedicated to developing innovative diagnostic products to improve patient health. With the FDA-cleared T2Dx® Instrument and T2Candida® Panel targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance technology, or T2MR, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of patient sample types, including whole blood. For more information, please visit www.t2biosystems.com. Aridis is a privately held biopharmaceutical company applying proprietary monoclonal antibody discovery technology MabIgX® to produce novel infectious disease focused therapies. Aridis' product pipeline includes AR-101 (or 'Aerumab™') anti-Pseudomonas aeruginosa LPS human monoclonal antibody; AR-301 (or 'Salvecin®') anti-Staphylococcus aureus human monoclonal antibody to treat acute pneumonia; Aerucin®, a broadly reactive monoclonal antibody against Pseudomonas aeruginosa initially being developed to treat acute pneumonia; Panaecin™, a small molecule anti-infective gallium compound with broad spectrum activities against bacteria, viruses, and fungi; AR- 401 anti-Acinetobacter baumannii human monoclonal antibody; and AR-201 anti-RSV human monoclonal antibody. AWG was founded in 2012 with the vision of utilizing collective power to improve the regulatory, investment, and commercial environment for emerging antibiotics and antifungal companies. Today, AWG is comprised of fourteen antimicrobials and diagnostics companies: Amplyx Pharmaceuticals, Aridis Pharmaceuticals, Arsanis Inc., Cidara Therapeutics Inc., ContraFect Corporation, Iterum Therapeutics Ltd., Melinta Therapeutics Inc., Nabriva Therapeutics US Inc., Paratek Pharmaceuticals Inc., SCYNEXIS Inc., T2 Biosystems Inc., Theravance Biopharma U.S. Inc., Viamet Pharmaceuticals Inc., and Zavante Therapeutics Inc. For more information, please visit www.antimicrobialsworkinggroup.org. The Conafay Group is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for AWG, led by Stephen R. Conafay, Principal. For more information, please visit www.conafaygroup.com.


Ohtake S.,Aridis Pharmaceuticals, Llc | Kita Y.,Keio University | Arakawa T.,Alliance Protein Laboratories
Advanced Drug Delivery Reviews | Year: 2011

A variety of excipients are used to stabilize proteins, suppress protein aggregation, reduce surface adsorption, or to simply provide physiological osmolality. The stabilizers encompass a wide variety of molecules including sugars, salts, polymers, surfactants, and amino acids, in particular arginine. The effects of these excipients on protein stability in solution are mainly caused by their interaction with the protein and the container surface, and most importantly with water. Some excipients stabilize proteins in solution by direct binding, while others use a number of fundamentally different mechanisms that involve indirect interactions. In the dry state, any effects that the excipients confer to proteins through their interactions with water are irrelevant, as water is no longer present. Rather, the excipients stabilize proteins through direct binding and their effects on the physical properties of the dried powder. This review will describe a number of mechanisms by which the excipients interact with proteins in solution and with various interfaces, and their effects on the physical properties of the dried protein structure, and explain how the various interaction forces are related to their observed effects on protein stability. © 2011 Elsevier B.V.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase II | Award Amount: 2.92M | Year: 2011

DESCRIPTION (provided by applicant): Over the past two decades, the number of new antimicrobials being developed has experienced a greater than 60% decline, while the number of antibiotic resistant microorganisms has been steadily increasing. Only one newantibacterial drug with a novel mechanism of action (linezolid) has been introduced during this period making the long term outlook for sustained infection control increasingly precarious. One particularly concerning example is a Gram negative bacterium called Pseudomonas aeruginosa in which 30% of clinical isolates from ICU (intensive care unit) or nursing home patients were reported to be resistant to 3 or more drugs. The Infectious Diseases Society of America (IDSA) also identified P. aeruginosa as one of six superbugs on the top priority hit list of dangerous pathogens that are becoming increasingly drug resistant. P. aeruginosa poses a particularly deadly threat for lung infections in hospital acquired pneumonia (HAP), particularly ventilator associated pneumonia (VAP) cases and in cystic fibrosis (CF) patients. The major hypothesis to be tested in this application is whether a human monoclonal antibody (mAb) targeted against a prevalent cell surface carbohydrate (alginate) on P. aeruginosa can be used clinically to treat P. aeruginosa lung infections resulting in improvement in lung function and a reduction in morbidity and mortality. Preliminary data indicate that these human mAbs recognize an epitope on alginate that is expressed on a broad arrayof P. aeruginosa clinical isolates. The mAb kills these isolates through an immune mediated process called opsono-phagocytosis and can be used therapeutically to protect animals from lethal lung infections. In this application, we propose to scale-up themanufacturing process for the mAb and produce clinical material for future clinical trials. We propose to test the clinical material in toxicity studies in animals according to Good Laboratory Procedures (GLP) to demonstrate that the mAb is safe to administer to people in human clinical testing. Finally, we propose to schedule a pre-IND (investigational new drug) meeting with the FDA to present and discuss the Mab preclinical data and our proposed clinical plan. Incorporating feedback from the FDA, we willthen file an IND application. PUBLIC HEALTH RELEVANCE: The proposed studies will result in further development of a human monoclonal antibody for the treatment of severe bacterial lung infections due to Pseudomonas aeruginosa in patients with hospital acquired pneumonia and cystic fibrosis. Clinical material will be produced, safety data in animals will be generated and an IND will be filed with the FDA.


Patent
Aridis Pharmaceuticals, Llc | Date: 2012-11-29

The present invention provides antigenic polypeptides expressed during an infection by a pathogenic organism, such as Acinetobacter and compositions comprising these polypeptides. The invention further provides compositions for use in treating, preventing or detecting a bacterial infection, in particular vaccine compositions using the antigenic polypeptides. The invention further provides antibodies directed to said antigenic polypeptides.


This invention is directed to an antibody construct or fragment thereof derived from an RSV-infected human, such that the antibody construct binds with specificity to RSV fusion protein antigenic region II/A with an affinity of greater than 110^(9 )M. Preferably, the antibody construct is capable of neutralizing RSV strains, including at least one RSV strain that is resistant to palivizumab. The invention further relates to nucleic acids encoding the antibody construct or portions thereof, and cell lines expressing the antibody. This invention further relates to methods for producing said antibody construct, and to the use of said antibody construct for treating or preventing infection of a patient by RSV having a normal or mutated version of F protein.


The present invention relates to a human monoclonal antibody specific for the alpha-toxin of S. aureus and a hybridoma producing said monoclonal antibody. In addition, the present invention relates to pharmaceutical compositions comprising at least one antibody or at least one nucleic acid encoding said antibody. Further, the present inventions relates to the use of said monoclonal antibody for treating or preventing abscess formation.


Patent
Aridis Pharmaceuticals, Llc | Date: 2012-08-14

This invention provides methods of spray drying pharmaceutical powders from a vibrating nozzle at low pressures. The method can effectively spray dry thick or viscous solutions or suspensions to provide small uniform particles. The invention includes dry particle compositions prepared by methods of low pressure spraying from vibrating nozzles.

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