Community-Acquired Infections

SAN DIEGO, March 18, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies, today announced two upcoming presentations at the 38th International Conference on Antiviral Research (ICAR). The conference takes place from March 17-21, 2025 in Las Vegas, Nevada. Cidara’s presentations will highlight the study design, demographic information, and preliminary safety data from the ongoing Phase 2b NAVIGATE trial of CD388, as well as dose optimization models for evaluation of CD388 in a Phase 3 study. Presentation details: Title: NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Study to Evaluate the Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for Prevention of Influenza in Subjects not at Risk for Influenza ComplicationsPresenter: James AlexanderAbstract number: 361 Date/Time: Poster Session 1: Tuesday, March 18, 2025, 5:15-6:15pm PT; Poster Session 2: Thursday, March 20, 2025, 9-10am PT Summary: The Phase 2b NAVIGATE trial to evaluate the safety and preventative efficacy of CD388 in a real-world environment completed enrollment of more than 5,000 participants in the United States and the UK. Prior Phase 1 and Phase 2a clinical data have shown that CD388, administered by subcutaneous injection, appeared to be well-tolerated and efficacious in healthy human volunteer studies. The results of the Phase 2b trial will inform dose selection and design for the planned Phase 3 development program. Title: Real World Data-Based Modeling of Seasonal Influenza Variations to Support Clinical Dose Selection of CD388, A Novel Antiviral in Development for Prevention of Seasonal and Pandemic Influenza Presenter: Shawn FlanaganAbstract number: 352 Date/Time: Poster Session 1: Tuesday, March 18, 2025, 6:15-7:15pm PT; Poster Session 2: Thursday, March 20, 2025, 8-9am PT Summary: In trials involving community acquired infections, like influenza, variations in disease incidence over time may complicate interpretation of drug effect in Phase 2 and Phase 3 trials across multiple seasons, especially for long-acting drugs like CD388. Advanced model-based analysis was conducted to improve decision power based on simulated Phase 2 results over different flu seasons. While a standard proportions test was shown to be sensitive to influenza seasonal variations, the model-based analysis was not and increased decision power for clinical dose selection of CD388 for Phase 3. About CD388CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/. About Cidara TherapeuticsCidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company announced completion of enrollment of its Phase 2b NAVIGATE trial in December 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com. Forward-Looking StatementsThis release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “intends,” “believes,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the potential of and future plans for CD388, and promising CD388 clinical data generated to date. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s clinical trials and other risks related to clinical development, delays in action by regulatory authorities, other obstacles on the enrollment of patients or other aspects of CD388 or other DFC development and other risks and uncertainties associated with Cidara’s business in general. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and other filings subsequently made with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT:Brian RitchieLifeSci Advisors(212) 915-2578britchie@lifesciadvisors.com MEDIA CONTACT:Michael FitzhughLifeSci Communications(628) 234-3889mfitzhugh@lifescicomms.com

ZURICH, Switzerland I February 17, 2025 I LimmaTech Biologics AG , a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participants have been vaccinated in a Phase 1 controlled study of its multivalent vaccine candidate, LBT-SA7. The candidate is designed to prevent skin and soft tissue infections (SSTIs) caused by the bacterial pathogen Staphylococcus aureus ( S. aureus ). In this context, the company also announced the award of US$6.5 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to advance the clinical development of LBT-SA7. S. aureus infections pose a significant global health challenge, causing an estimated 1 million deaths annually. Notably, 90% of all community-acquired S. aureus infections are SSTIs. The absence of a vaccine to prevent S. aureus , coupled with only limited treatment options – particularly against multidrug-resistant strains of the pathogen, often described as methicillin-resistant S. aureus (MRSA) – highlights the urgent need for effective preventive solutions. LimmaTech’s vaccine candidate, LBT-SA7, is the first multivalent vaccine entirely based on secreted antigens to address this critical need. LBT-SA7 contains weakened forms of the pathogen’s toxins, referred to as toxoids, designed to prevent infections by neutralizing the toxins secreted by S. aureus . This approach offers a promising solution to combat the widespread bacterial threat. LimmaTech started a Phase 1 clinical trial ( NCT06719219 ) in the U.S. after receiving a Fast Track designation from the U.S. Food and Drug Administration (FDA). This first-in-human study aims to evaluate the safety and immunogenicity of LBT-SA7 against S. aureus . It is a randomized, double-blinded, and controlled dose-escalation study expected to enroll 130 healthy adults aged 18-50 years. Initial results are anticipated in the second half of 2025. “Developing an S. aureus vaccine has long been a significant scientific challenge,” explained Dr. Patricia Martin-Killias, Chief Operating Officer of LimmaTech . “We believe LBT-SA7 has the potential to provide a much-needed solution for those suffering from S. aureus infections. We are excited to launch the first-in-human clinical trial for LBT-SA7, bringing us closer to addressing an urgent global health challenge.” “We are grateful for the significant support from CARB-X, which is not only instrumental in accelerating the clinical development of our S. aureus vaccine candidate LBT-SA7 but also underscores the importance of our mission to develop efficient solutions for preventing microbial infections and protecting from their threatening consequences for affected people,” added Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech . Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), and the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. About Staphylococcus aureus Staphylococcus aureus ( S. aureus ), a Gram-positive bacterial pathogen, affects approximately 30% of the human population while causing a spectrum of infections, from SSTI to severe conditions like pneumonia and bloodstream infections. S. aureus is the leading cause of antimicrobial resistance (AMR)-attributed fatalities with community-acquired and hospital-acquired infections being the most prevalent. SSTIs caused by S. aureus range from mild to severe and entail microbial invasion into the skin layers and underlying soft tissues. Traditional antibiotic treatments, both oral therapy and intravenous administration reserved for severe cases, have become increasingly less effective due to the rise of antibiotic resistance. S. aureus has been designated as a “high priority” pathogen by the World Health Organization (WHO), underscoring the urgency for innovative vaccine approaches and effective treatment strategies. About LimmaTech Biologics AG LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile. For more information, please visit www.lmtbio.com . SOURCE: LimmaTech Biologics

SCHLIEREN, Switzerland--( BUSINESS WIRE )-- LimmaTech Biologics AG , a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LimmaTech’s multivalent toxoid vaccine candidate, LBT-SA7, designed to prevent skin and soft tissue infections (SSTIs) caused by the bacterial pathogen, Staphylococcus aureus ( S. aureus ). The FDA grants Fast Track designation to products under development that have the potential to treat or prevent serious conditions and address an unmet medical need. The Fast Track designation is designed to expedite the review by enabling LimmaTech to engage more frequently with the FDA to discuss LBT-SA7’s clinical development plan. The designation aims to get important new products to patients and individuals earlier. Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech , commented, “ Staphylococcus aureus infections are a major cause of global mortality and morbidity, with traditional antibiotic treatments becoming increasingly ineffective due to rising antibiotic resistance. Despite this urgent medical need, no vaccine is currently available to prevent the consequences of an S. aureus infection. The FDA’s Fast Track designation for LBT-SA7 allows us to accelerate the development of a much-needed solution for SSTIs by effectively preventing recurrence.” It is estimated that more than 1 million deaths are attributed to S. aureus each year. Notably, 90% of all community-acquired S. aureus infections are SSTIs, which LBT-SA7 aims to address. The vaccine candidate contains weakened forms of the pathogen’s toxins, referred to as toxoids, to prevent infections by neutralizing the toxins the pathogen would otherwise secrete to cause an infection. “LBT-SA7 represents a fundamentally novel approach to Staphylococcal vaccine development, designed to neutralize toxins and prevent their harmful effects on affected people,” explained Dr. Michael Kowarik, Chief Scientific Officer of LimmaTech . “Our Phase 1 clinical trial aims to demonstrate the safety of our vaccine candidate in healthy volunteers and confirm the toxin-neutralizing activity induced by the vaccine.” LBT-SA7 will be tested in a randomized, double-blinded, and controlled dose-escalation Phase 1 study at a clinical trial center in the U.S., including 130 participants aged 18-50 years. The trial aims to evaluate the safety and immunogenicity of the vaccine candidate, with initial results anticipated in the second half of 2025. Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), and the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. About Staphylococcus aureus Staphylococcus aureus ( S. aureus ), a Gram-positive bacterial pathogen, affects approximately 30% of the human population while causing a spectrum of infections, from SSTI to severe conditions like pneumonia and bloodstream infections. S. aureus is the leading cause of antimicrobial resistance (AMR)-attributed fatalities with community-acquired and hospital-acquired infections being the most prevalent. SSTIs caused by S. aureus range from mild to severe and entail microbial invasion into the skin layers and underlying soft tissues. Traditional antibiotic treatments, both oral therapy and intravenous administration reserved for severe cases, have become increasingly less effective due to the rise of antibiotic resistance. S. aureus has been designated as a "high priority" pathogen by the World Health Organization (WHO), underscoring the urgency for innovative vaccine approaches and effective treatment strategies. About LimmaTech Biologics AG LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile. For more information, please visit www.lmtbio.com .