Affinivax Announces Award from CARB-X for up to $22 Million to Advance its Staphylococcus aureus MAPS™ Vaccine Candidate into Clinical Trials - BioSpace

Novel MAPS™ vaccine is designed to induce both a B-cell and T-cell protective immune response to multiple, highly conserved staphylococcal protein antigens

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Affinivax, Inc. ("Affinivax"), a clinical stage biotechnology company with its novel MAPS™ technology platform for vaccines and immunotherapies, today announced it has received an award from CARB-X, a global non-profit organization, to develop a MAPS™ vaccine targeting Staphylococcus aureus (S. aureus) bacterial infections. The award from CARB-X will substantially fund all development activities for the MAPS S. aureus vaccine program through completion of the initial clinical study to assess safety and preliminary efficacy. The award commits funding of up to $22 million with the successful achievement of future manufacturing, preclinical and clinical development milestones.

Affinivax's novel vaccine is being developed for the prevention of S. aureus infections, the most common form of staph infections, in high risk adult populations using the company's Multiple Antigen Presenting System (MAPS™) vaccine technology platform. The MAPS™ vaccine will include multiple highly conserved staphylococcal protein antigens, designed to elicit a robust immune response to address the complexity of the infection process of S. aureus. Leveraging the distinctive capability of the MAPS™ platform, the vaccine is expected to induce protective B‑cell (antibody) responses, as well as Th17 and Th1 responses, against each of the protein antigens included in the vaccine. This offers the potential for effective and broad protection not only against invasive staphylococcal infections, but also from a reduction in mucosal colonization by the bacteria, which is often the first step in pathogenesis.

Preclinical data from a lead MAPS S. aureus vaccine candidate developed at Boston Children's Hospital¹ have demonstrated that impacting multiple immune pathways, with a single vaccine, offers the potential for both robust and broad protection from Staphylococcus aureus infection. In preclinical studies, the protein antigens induced B-cell (antibody) responses that led to a reduction in mortality following invasive disease challenge, Th1 or Th17 responses that led to prevention of skin abscesses and the clearance of bacteria from the gastrointestinal tract, and both B-cell and T‑cell responses that contributed to the prevention of dermonecrosis. Affinivax is currently optimizing this lead candidate to initiate manufacturing and the required IND-enabling preclinical studies, and advance toward submission of an investigational new drug (IND) application and evaluation in clinical studies.

"We very much appreciate the support of CARB-X and look forward to our partnership together as we advance this critically important vaccine towards clinical trials," said Steven B. Brugger, CEO of Affinivax. "As we face the significant global health challenges caused today by antimicrobial resistance, we believe our MAPS™ platform represents a significant step forward in vaccine technology and an opportunity to provide vaccines to protect the high-risk and older adult community from the impact from Staphylococcus aureus and other healthcare-associated infections."

"To date, attempts at developing Staphylococcus aureus vaccines have not been successful, with approaches based on the premise that antibody responses are sufficient to provide protection," said Richard Malley, MD, Senior Physician in Medicine, Infectious Diseases, at Boston Children's Hospital, Professor of Pediatrics at Harvard Medical School, and a scientific founder of Affinivax. "Data from our group and others support the view that, in addition to antibodies, Th1 and Th17 responses to Staphylococcus aureus proteins are critical to achieve broad protection against this pathogen. Our MAPS technology is ideally suited for this purpose."

About Staphylococcus aureus

Healthcare-associated infections (HAIs) have now emerged as a major global health concern due to the significant increase in antimicrobial resistance. HAIs can significantly delay patient recovery and increase healthcare costs, with the direct costs to medical facilities estimated at between $28 billion and $45 billion². Of the approximately two million patients who acquire a HAI annually in the U.S. alone, an estimated 90,000 will die². Accounting for almost 10% of all healthcare associated infections (HAIs) today,³Staphylococcus aureus infections are one of the most common HAIs and a leading cause of morbidity and mortality worldwide. Staphylococcus aureus is a gram-positive bacterium frequently found in the upper respiratory tract and on the skin. About 30% of people in the U.S. carry Staphylococcus aureus in their nasal passage⁴ which, while most of the time does not cause invasive infection, can sometimes lead to serious and life-threatening complications. Manifestations of Staphylococcus aureus infection span from minor skin infections such as folliculitis and abscess, to severe life-threatening infections such as bacteremia, meningitis, endocarditis, pneumonia, osteomyelitis, sepsis, and invasive soft tissue infections. In healthcare settings, such as long-term care facilities and hospitals, the transmission of Staphylococcus aureus can cause infections in high risk and older adult patients, as well as in previously healthy individuals. The spread of multidrug-resistant strains, often described as methicillin-resistant Staphylococcus aureus strains (MRSA), has limited antibiotic treatment options and challenged the development of new therapies and vaccines.

About Multiple Antigen Presenting System (MAPS™)

The MAPS™ technology platform uses proprietary chemistry that capitalizes on the specific and durable non-covalent, affinity binding between biotin and rhizavidin, a biotin-binding protein. The MAPS™ complex created by this affinity binding contributes to a simple, modular, and efficient approach to the development of novel vaccines and immunotherapies. Conventional vaccine conjugation technology seeks to optimize the generation of protective antibody responses mainly to polysaccharide antigens, using the protein antigen as a carrier. In contrast, a MAPS™ vaccine can present both the polysaccharide and the protein antigens to the host immune system to induce both a B- and T-cell immune response. This unique capability of the MAPS™ technology allows for the tailored development of each MAPS™ vaccine or immunotherapy based on the specific type of immune response desired for each pathogen and disease.

About CARB-X

CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early development antibacterial R&D to address the rising threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services; the Wellcome Trust, a global charity based in the UK working to improve health globally; Germany's Federal Ministry of Education and Research (BMBF); the UK Department of Health and Social Care's Global Antimicrobial Resistance Innovation Fund (GAMRIF); the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) within the US Department of Health and Human Services. CARB-X is investing up to US$480 million from 2016-2022 to support innovative antibiotics and other therapeutics, vaccines and rapid diagnostics. CARB-X focuses exclusively on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is headquartered at Boston University School of Law. For more information, visit https://carb-x.org/. Follow us on Twitter @CARB_X.

About Affinivax, Inc.

Affinivax is a clinical stage biopharmaceutical company pioneering the development of a novel class of vaccines designed to induce a broad and robust protective immune response to both disease-relevant polysaccharides and disease-relevant proteins in a single vaccine. Affinivax designs each of its vaccine candidates to optimize the protective immune response to one or both of these antigens utilizing the distinctive plug-and-play nature of its proprietary MAPS™ platform technology, presenting the potential opportunity to make a significant step forward in addressing major healthcare challenges posed by novel and resistant infectious diseases. Affinivax's lead vaccine candidate, ASP3772, is a Streptococcus pneumoniae vaccine that is being co-developed in collaboration with Astellas Pharma Inc. ASP3772 includes 24 pneumococcal polysaccharides, more than any other vaccine on the market or in clinical trials today, as well as two conserved pneumococcal proteins. ASP3772 was observed to be safe and highly immunogenic in a Phase 1 study in adults aged 18 to 64. A Phase 2 study in adults aged 65 to 85 is now completed with data analyses ongoing. The clinical program targeting the infant pneumococcal indication has been initiated with an ongoing Phase 1 study in healthy toddlers 12 to 15 months of age. Affinivax is also developing a next generation pneumococcal MAPS vaccine candidate to provide even broader protection than ASP3772, with an aim to establish and maintain a new standard-of-care vaccine for the protection against Streptococcus pneumoniae infections in both adults and infants. In addition, Affinivax is developing vaccine candidates against bacterial pathogens where previous vaccine approaches have not been successful, with active programs targeting healthcare-associated infections that primarily impact adults in medical and nursing home facilities, including Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus, and Clostridium difficile, as well as exploratory programs targeting the SARS-CoV-2 virus and melanoma. Affinivax was founded in 2014 with a seed investment from the Bill & Melinda Gates Foundation and an exclusive license to the MAPS technology from Boston Children's Hospital. For more information, visit www.affinivax.com.

1. Protection against Staphylococcus aureus colonization and infection by B- and T-cell-mediated mechanisms. Zhang F, Ledue O, Jun M, Goulart C, Malley R, Lu YJ. (2018) mBio 9:e01949-18. https://doi.org/10.1128/mBio.01949-18.
2. Patricia W Stone (2014) "Economic burden of healthcare-associated infections: an American perspective," Expert Review of Pharmacoeconomics & Outcomes Research, 9:5, 417-422, DOI: 10.1586/erp.09.53. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2827870/.
3. 5 Multistate Point-Prevalence Survey of Health Care–Associated Infections. Shelley S. Magill, M.D., Ph.D., Jonathan R. Edwards, M.Stat., Wendy Bamberg, M.D., Zintars G. Beldavs, M.S., Ghinwa Dumyati, M.D., Marion A. Kainer, M.B., B.S., M.P.H., Ruth Lynfield, M.D., Meghan Maloney, M.P.H., Laura McAllister-Hollod, M.P.H., Joelle Nadle, M.P.H., Susan M. Ray, M.D., Deborah L. Thompson, M.D., M.S.P.H., Lucy E. Wilson, M.D., and Scott K. Fridkin, M.D. for the Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. N Engl J Med 2014; 370:1198-1208, March 27, 2014.
4. Centers for Disease Control and Prevention: https://www.cdc.gov/hai/organisms/staph.html

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