• LimmaTech receives an exclusive clinical development license from AbVacc for a multivalent, toxoid vaccine candidate to prevent infections caused by Staphylococcus aureus, the leading cause of antimicrobial resistance-related deaths in the U.S. and Europe
  • LimmaTech will initiate Phase 1 clinical development of the vaccine candidate in 2024 with an option to acquire full worldwide rights after the trial readout

SCHLIEREN, Switzerland & ROCKVILLE, MD, USA I December 19, 2023 ILimmaTech Biologics and AbVacc announced today a license agreement that grants LimmaTech the exclusive rights to further develop AbVacc’s multivalent toxoid vaccine candidate, LBT-SA7 (formerly IBT-V02), designed to prevent infections caused by the bacterial pathogen, Staphylococcus aureus (S. aureus). LimmaTech also receives an exclusive option, executable post Phase 1 read-out, to acquire full rights to the program. No further details of the transaction have been disclosed.

LBT-SA7 is a six valent toxoid vaccine candidate, designed and developed to date by AbVacc for the prevention of recurrent skin and soft tissue infections (SSTI) caused by S. aureus. The vaccine candidate contains weakened forms of toxins, referred to as toxoids, that would normally be secreted by the pathogen to cause an infection. The unique formulation of LBT-SA7 enables the body to fight against the infection by eliciting an immune response against the original S. aureus toxins. Preclinical studies in mice and rabbits demonstrated strong neutralizing activity against several clinically relevant forms of S. aureus infection. The vaccine candidate also showed efficacy in non-naïve mice pre-exposed to the pathogen.

S. aureus-related infections remain an urgent global medical priority, for which there is no vaccine currently available. Based on the original scientific work and the promising preclinical data generated by AbVacc, we aim to rapidly start clinical development and deliver an effective intervention for patients with a broad range of S. aureus infections,” said Dr. Franz-Werner Haas, Chief Executive Officer of LimmaTech. “Building on our extensive vaccine development expertise, including against S. aureus, adding this program to our pipeline is a key milestone in our strategy to pursue innovative approaches to prevent increasingly untreatable microbial infections and positively impact the dangerous rise of antimicrobial resistance.”

Javad Aman, PhD, President & Chief Scientific Officer of AbVacc stated, “This product candidate has the potential to solve the pressing medical need for SSTIs, by effectively preventing its recurrence. We highly value the LimmaTech team’s depth of experience and extensive know-how that will contribute to achieving successful clinical development moving forward.”

Michael Kowarik, PhD, Chief Scientific Officer of LimmaTech added, “We are convinced that this S. aureus toxoid vaccine candidate has the potential to solve the challenges posed by targeting S. aureus surface antigens by addressing a new mechanism of action that has not been explored before.”

AbVacc has been part of the Novo Holdings REPAIR Impact Fund’s portfolio since 2019. Financial support from REPAIR, combined with grants from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the National Institutes of Health, has bolstered the preclinical development of the IBT-V02 vaccine program. This has led to Phase 1 trial readiness, advancing a potential new tool in the fight against antimicrobial infections towards clinical trials.

Development of the LBT-SA7 (formerly IBT-V02) vaccine candidate has been funded in part by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health under award numbers R43AI085665 and R01AI111205 and 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; 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 Global Antimicrobial Resistance Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC). 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 skin and soft tissue infections (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. SSTI 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 AbVacc

AbVacc, Inc., a recent spin-off of Integrated Biotherapeutics, uses structure-guided rational design for the discovery and development of next generation “smart” vaccines and monoclonal antibodies. AbVacc’s portfolio includes vaccines and antibodies for serious emerging infectious diseases such as methicillin-resistant S. aureus (MRSA), C. difficile, B. anthracis, filoviruses Ebola, Sudan, and Marburg, Nipah virus, and Influenza at mid-to-late preclinical stages, and several more candidates in early discovery stage. AbVacc’s S. aureus vaccine (IBT-V02) has been supported by investments from the U.S. National Institute of Allergy and Infectious Diseases, CARB-X, and Novo Holdings. For more information please visit www.abvacc.com.

About LimmaTech Biologics

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. For more information, please visit www.lmtbio.com.

SOURCE: LimmaTech Biologics