Hadassah School of Dental Medicine

Phase 2a clinical study of SGX945 in Behçet's Disease initiating in 2024 PRINCETON, N.J., Feb. 8, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the formation of a Medical Advisory Board (MAB) to provide medical/clinical strategic guidance to the Company as it advances the clinical development of SGX945 (dusquetide) for the treatment of Behçet's Disease. The Company previously announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for dusquetide in the treatment of oral lesions of Behçet's Disease. "I am honored to have such a prestigious and dedicated group of physicians committed to working with us as we develop dusquetide therapy for Behçet's Disease," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We have assembled some of the world's leading experts in this field who collectively have hundreds of publications and have the experience of treating thousands of patients with this chronic condition. The initiation of a Phase 2a clinical study in Behçet's Disease later this year will be another important milestone for our company and we look forward to working with the MAB to advance this program." Comprised of internationally renowned rheumatologists with extensive experience in Behçet's Disease, the MAB will play an important advisory role in the conduct of the upcoming Phase 2a clinical study, as well as in the design of subsequent clinical studies and associated regulatory interactions with health authorities. The MAB will provide feedback, input and guidance on clinical strategies and their implementation, as well as on other critical items, such as health economics and reimbursement, to assist Soligenix in meeting the needs of patients suffering from Behçet's Disease. The MAB Members Gülen Hatemi, MD Dr. Hatemi is one of the world's leading physicians in the treatment of Behçet's Disease and leads the largest Behçet's research center in the world at Istanbul University – Cerrahpaşa, Behçet's Disease Research Center. Dr. Hatemi has over 250 publications in her field and has conducted numerous clinical research trials to understand the life impact of Behçet's syndrome, to develop management strategies, and to improve outcome measures for clinical trials of Behçet's Disease. Dr. Hatemi is the convener of the Disease Assessment Study Group of the International Society for Behçet's Disease and co-chair of the OMERACT (Outcome Measures in Rheumatology) Behçet's syndrome working group where she focuses on developing outcome measures for clinical trials and improving outcomes for patients with Behçet's Disease. She is also a member of the European Union of Medical Specialists Section of Rheumatology. Dr. Hatemi completed rheumatology training in Istanbul University, Cerrahpaşa Medical School, Department of Internal Medicine, after completing residencies in both Internal Medicine and Pulmonary Medicine at Instanbul University. She received her medical degree from Cerrahpaşa Medical School. Johannes Nowatzky, MD Dr. Johannes Nowatzky is the Saul J. Farber Associate Professor of Medicine and Pathology at New York University (NYU) Grossman School of Medicine, where he directs the NYU Behçet's Disease Center. Dr. Nowatzky has extensive experience in Behçet's Disease, seeing thousands of patients, and sits on the Medical Advisory Board for the American Behçet's Disease Foundation. Clinically trained in the Middle East, Europe, and the U.S., he has unique expertise with Behçet's Disease from large referral centers in these regions. Dr. Nowatzky is a physician-scientist who, in addition to running the most extensive clinical Behçet's Disease program in the U.S., directs an immunology research laboratory focused on the biology of Behçet's Disease and ocular inflammation. His numerous publications in the field include primary research in impactful immunology/rheumatology journals, such as Annals of the Rheumatic Diseases. Dr. Nowatzky completed his fellowship at NYU Langone Medical Center and his residency in Internal Medicine at Hadassah Medical School, Israel. He received his medical degree from the Faculty of Medicine, Freie University Berlin, Germany. Andrew Sulich, MD Dr. Sulich is a rheumatologist in private practice at Shores Rheumatology, St. Clair Shores, MI, and Chief of Rheumatology at Ascension Saint John Medical Center in Detroit. He is also Assistant Clinical Professor at the William Beaumont Oakland University School of Medicine, and a clinical instructor of rheumatology for the residency programs at Saint John Hospital and Medical Center in the Beaumont Hospital System. Dr. Sulich has been honored with multiple awards, including Hour magazine "Top Docs" for 2010 to 2020. Dr. Sulich is a fellow of the American College of Rheumatology and is a member of organizations such as the American College of Physicians, the Michigan State Medical Society, the Arthritis Foundation and a member of the Medical Advisory Board for the American Behçet's Foundation. Dr. Sulich completed his internship at Mount Carmel Mercy Hospital in Detroit. He completed his residency at St. John Hospital and Medical Center, where he served as chief resident. His rheumatology fellowship was completed at Henry Ford Hospital and he received his medical degree from the American University of the Caribbean School of Medicine in Saint Maarten. Yusuf Yazici, MD Dr. Yazici is an internationally renowned rheumatologist, researcher and expert in clinical trial design and management. He is a Clinical Associate Professor at NYU. His areas of interest are Behçet's Disease, osteoarthritis, rheumatoid arthritis, early arthritis, patient reported outcomes, database and registry management and monitoring of arthritis patients in regard to clinical response and adverse events related to treatment. He has published more than 250 medical papers and book chapters and has given numerous national and international presentations. Dr. Yazici has been Chief Medical Officer of Biosplice Therapeutics, Inc. since 2013, leading the development of new therapies for osteoarthritis, various oncologic conditions and Alzheimer's disease, and sits on the Medical Advisory Board for the American Bechet's Disease Foundation. Dr. Yazici completed his fellowship in rheumatology at the Hospital for Special Surgery and Weill Medical College of Cornell University, New York City, NY and his residency in internal medicine at Creighton University, Omaha, NE. Dr. Yazici received his medical degree from Istanbul University, Istanbul, Turkey. About Dusquetide Dusquetide (the active ingredient in SGX945 (Behçet's disease) and SGX942 (oral mucositis) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective, and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. Dusquetide also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma, and chemo- and/or radiation therapy. Preclinical efficacy and safety have been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome as well as bacterial infections. In addition, potential anti-tumor activity has been demonstrated in multiple in vitro and in vivo xenograft studies. Dusquetide has demonstrated safety and tolerability in a Phase 1 clinical study in 84 healthy human volunteers. In Phase 2 and 3 clinical studies with dusquetide in over 350 subjects with oral mucositis due to chemoradiation therapy for head and neck cancer, positive efficacy results were demonstrated, including potential long-term ancillary benefits. Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. About Behçet's Disease Behçet's Disease is commonly known as an inflammatory disorder of the blood vessels (vasculitis). Often first diagnosed in young adults, its effects and severity will wax and wane over time. Major signs and symptoms usually include mouth sores (approximately 95% of patients), skin rashes and lesions (approximately 50% of patients), genital sores (approximately 50% of patients), leg ulcers (approximately 40% of patients) and eye inflammation (approximately 15% of patients). It is a painful disease, directly impacting the patient's quality of life and ability to productively engage in life activities, including work. Behçet's Disease is thought to be an auto-immune disease with both genetic and environmental factors. It is most common along the "Silk Road" in the Middle East and East Asia, including Turkey, Iran, Japan and China. There are approximately 18,000 known cases of Behçet's Disease in the U.S. and 80,000 in Europe. There are as many as 1,000,000 people worldwide living with Behçet's Disease. There is no cure for Behçet's Disease, rather treatments are prescribed to manage symptoms. Treatments may include both maintenance therapies and those specifically addressing flares (e.g., mouth ulcers, genital ulcers and leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that become more concerning with more chronic use. Genital ulcers are often associated with significant genital scarring while leg ulcers can result in a post-thrombotic syndrome. Other treatments for Behçet's Disease flares involve suppressing the immune system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and kidney problems, low blood counts and high blood pressure. Finally, anti-inflammatory drugs are also used, including anti-TNF medications. The only approved drug in Behçet's Disease is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers. Unfortunately, apremilast must be used continuously to be effective and is associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and headache. About Soligenix, Inc. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer (SGX942) and in Behçet's Disease (SGX945). The Company also is developing proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation such as pediatric Crohn's disease (SGX203). Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg, Sudan and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA). For further information regarding Soligenix, Inc., please visit the Company's website at and follow us on LinkedIn and Twitter at @Soligenix_Inc. This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, and include the expected amount and use of proceeds from the offering and the expected closing date of the offering. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Despite the statistically significant result achieved in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful. Notwithstanding the result in the HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma and the Phase 2a clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Despite the positive efficacy results demonstrated in the Phase 2 and 3 clinical studies of SGX942 for the treatment of oral mucositis due to chemoradiation therapy for head and neck cancer, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events. Company Codes: NASDAQ-SMALL:SNGX

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 BX004BiomX 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 BiomXBiomX 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 HarborThis 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, LLCJohn Mullaly(617)-698-9253jmullaly@lifesciadvisors.com BiomX, Inc.Anat PrimovichCorporate Project Manager+972 (50) 697-7228anatp@biomx.com Source: BiomX Inc.

Data from 53 countries shows that men in those regions share the significant decline in total sperm counts (TSC) and sperm concentration (SC) seen previously in North America, Europe and Australia. Furthermore, this study shows an accelerated post-2000 decline in TSC and SC globally. An international team led by Professor Hagai Levine of Hebrew University of Jerusalem's Hadassah Braun School of Public Health, with Prof. Shanna Swan at the Icahn School of Medicine, Mount Sinai, New York, along with researchers in Denmark, Brazil, Spain, Israel and the USA, published the first meta-analysis to demonstrate declining sperm counts among men from South and Central America, Asia and Africa. Alarmingly, this study also shows that the decline in sperm counts in North America, Europe, and Australia -- reported by this team in 2017 -- has continued and even accelerated in the 21st century. Sperm count is not only an indicator of human fertility; it also is an indicator of men's health, with low levels being associated with increased risk of chronic disease, testicular cancer and a decreased lifespan. The authors say the decline reflects a global crisis related to our modern environment and lifestyle, with broad implications for the survival of the human species. This latest analysis, with data from 53 countries, was published today in the journal Human Reproduction Update. It includes an additional seven years of data collection (2011-2018) and focuses on sperm count trends among men in regions not reviewed previously, specifically South America, Asia and Africa. The data shows, for the first time, that men in those regions share the significant decline in total sperm counts (TSC) and sperm concentration (SC) seen previously in North America, Europe and Australia. Furthermore, this study shows an accelerated post-2000 decline in TSC and SC globally. As Levine summarized these results, "Overall, we're seeing a significant worldwide decline in sperm counts of over 50% in the past 46 years, a decline that has accelerated in recent years." While the current study did not examine the causes of sperm count declines, Levine pointed to recent research indicating that disturbances in the development of the reproductive tract during fetal life are linked to lifetime impairment of fertility and other markers of reproductive dysfunction. Additionally, Levine explained that "lifestyle choices and chemicals in the environment are adversely affecting this fetal development." Time is running out, cautioned Levine. "Our findings serve as a canary in a coal mine. We have a serious problem on our hands that, if not mitigated, could threaten humankind's survival. We urgently call for global action to promoted healthier environments for all species and reduce exposures and behaviors that threaten our reproductive health." Swan stressed that low sperm counts do not only affect men's fertility, but have serious ramifications for men's health more generally, and are linked with other adverse trends, termed together as testicular dysgenesis syndrome. "The troubling declines in men's sperm concentration and total sperm counts at over 1% each year as reported in our paper are consistent with adverse trends in other men's health outcomes, such as testicular cancer, hormonal disruption, and genital birth defects, as well as declines in female reproductive health. This clearly cannot continue unchecked."