BiomX to Host Virtual Key Opinion Leader (KOL) Event to Review the Positive Results from Part 2 of Phase 1b/2a Trial of BX004 in Cystic Fibrosis Patients with Chronic Pseudomonas aeruginosa Infections on December 4, 2023
CAMBRIDGE, Mass. and NESS ZIONA, Israel, Nov. 30, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced it will host a virtual KOL Event on December 4, 2023 at 12:00 PM ET to discuss the positive topline results recently announced from Part 2 of Phase 1b/2a trial of BX004 in cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (P. aeruginosa) infections. To register for the event, please click here.
The event will feature Dr. Eitan Kerem, M.D. (Hadassah University Medical Center) and Dr. Robert T. “Chip” Schooley, M.D. (University of California, San Diego), who will discuss phage therapy, the current treatment landscape, and the unmet medical need in cystic fibrosis (CF) patients with chronic Pseudomonas aeruginosa (P. aeruginosa) respiratory infections.
Jonathan Solomon, Chief Executive Officer of BiomX, will review topline results from Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, as a potential treatment for chronic pulmonary infections caused by P. aeruginosa in CF patients.
BiomX is developing BX004, utilizing its proprietary BOLT platform, to address a significant unmet need facing thousands of CF patients who require new treatments to combat persistent and deadly lung infections. P. aeruginosa is a main contributor to morbidity and mortality in patients with CF.
A live question and answer session will follow the formal presentations.
About Dr. Eitan Kerem, M.D.
Dr. Eitan Kerem, M.D., Professor of Pediatrics, is the former Chairman of the Department of Pediatrics at the Pediatric Pulmonology Unit of the Hadassah University Medical Center in Jerusalem and former board member of the European Cystic Fibrosis Society. Professor Kerem built the Pulmonary and Cystic Fibrosis Clinic of the Shaare Zedek Medical Center in Jerusalem, and subsequently he was elected Head of the Department of Pediatrics at the Hadassah Medical Center, and Professor in Pediatrics at the Hebrew University–Hadassah Medical School in 2002. In 2011, he was appointed as Chairman of Pediatrics at the Hadassah University Medical Center.
Professor Kerem’s interest in cystic fibrosis (CF) spans all aspects of the condition. He was involved in formulating the guidelines that paved the road to the standardization of CF care in Europe and other parts of the world. He has been a principal investigator in many national and international multicenter clinical trials in CF and is an author of key publications in this field.
Professor Kerem was Chairman of the Medical Advisory Board for the Israeli CF Foundation and served as a board member of the European Cystic Fibrosis Society (ECFS), initiating the development of the ECFS Patient Registry. He has been a member of numerous organizing committees for national and international conferences, and was a president of the International Congress on Pediatric Pulmonology.
About Dr. Robert T. “Chip” Schooley, M.D.
Dr. Robert T. “Chip” Schooley, M.D., Distinguished Professor of Medicine, Division of Infectious Diseases and Global Public Health and Co-Director, Center for Innovative Phage Applications and Therapeutics at the University of California, San Diego, is an infectious disease specialist and an expert in HIV and hepatitis C (HCV) infection and treatment. Infectious disease specialists care for patients with infections or diseases caused by viruses, bacteria, fungi and parasites. These include hepatitis viruses, tuberculosis, influenza, and HIV/AIDS, in addition to infections of the sinuses, heart, brain, lungs, gastrointestinal system, urinary tract, pelvic organs and bones.
His research interests include influenza, global health and international medicine, and the diagnosis and management of infections that cause death and morbidity in resource-limited settings. Dr. Schooley is particularly interested in the origin and development (pathogenesis) of HIV and HIV therapy, and was one of the first researchers to describe the humoral and cellular immune responses to HIV infection.
Dr. Schooley has developed a multidisciplinary research program for hepatitis C. He leads the Universidade Eduardo Mondlane-UC San Diego Medical Education Partnership Initiative and supervises postdoctoral fellows.
Prior to joining UC San Diego Health, Dr. Schooley was head of the Division of Infectious Diseases at University of Colorado and director of the Colorado Center for AIDS Research Virology Core Laboratory. During his tenure at Colorado, Dr. Schooley was chair of the National Institute of Allergy and Infectious Diseases' AIDS Clinical Trials Group. Before that, he served as associate professor of medicine at Harvard Medical School. Dr. Schooley is extensively published, having edited numerous books and authored hundreds of articles and book chapters. He serves on the editorial board of several medical journals, including Journal of Acquired Immune Deficiency Syndromes and Clinical Infectious Diseases.
Dr. Schooley completed fellowships in infectious diseases at the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, and at Massachusetts General Hospital in Boston. He earned his medical degree from Johns Hopkins University. Dr. Schooley is board certified in internal medicine. He is a fellow of the Infectious Disease Society of America and Royal Society of Medicine (UK), and member of numerous professional societies, including the American Society for Clinical Investigation, the Association of American Physicians, and the American Society of Tropical Medicine and Hygiene. In 2013, Dr. Schooley was honored with the Best Doctors in America and America's Top Doctors award.
About BX004
BiomX is developing BX004, utilizing its proprietary BOLT platform, for the treatment of CF patients with chronic pulmonary infections caused by P. aeruginosa, a main contributor to morbidity and mortality in patients with CF. In September 2021, BX004 was cleared by the U.S. Food and Drug Administration to initiate a Phase 1b/2a study in CF patients with chronic pulmonary infections caused by P. aeruginosa. The Phase 1b/2a trial was composed of two parts. Part 1 of the study evaluated the safety, pharmacokinetics, and microbiologic/clinical activity of BX004 in nine CF patients in a single ascending dose and multiple dose design. Part 2 of the study evaluated the safety and efficacy of BX004 in 34 CF patients randomized to treatment or placebo in a 2:1 ratio. In August 2023, the U.S. Food and Drug Administration granted BX004 Fast Track designation for the treatment of chronic pulmonary infections caused by P. aeruginosa bacterial strains in patients with CF.
About BiomX
BiomX is a clinical-stage company developing both natural and engineered phage cocktails designed to target and destroy bacteria in the treatment of chronic diseases. BiomX discovers and validates proprietary bacterial targets and customizes phage compositions against these targets. For more information, please visit www.biomx.com, the content of which does not form a part of this press release.
Safe Harbor
This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. For example, when BiomX discusses the safety, tolerability and efficacy of BX004 and its potential ability to treat CF patients, as well as the potential to advance the BX004 program to a larger, pivotal Phase 2b/3 trial, including, among other things, timing, design, enrollment, regulatory approvals and funding of such trial, BiomX is making forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. In addition, past and current pre-clinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of BiomX clinical trials. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX’s control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 29, 2023, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.
BiomX Contacts:
Investor Relations:
LifeSci Advisors, LLC
John Mullaly
(617)-698-9253
jmullaly@lifesciadvisors.com
BiomX, Inc.
Anat Primovich
Corporate Project Manager
+972 (50) 697-7228
anatp@biomx.com
Source: BiomX Inc.
