vaccine pipeline

A new era of MAPS vaccines combating the most challenging and resistant diseases.

Affinivax tailors the design of each of its MAPS vaccine candidates to optimize the protective immune response desired from the polysaccharide and/or protein antigens. We believe MAPS represents a significant step forward to help address major healthcare challenges posed by novel and resistant bacterial infections, and also actively exploring programs targeting viral infections and oncology.

1. Global commercial license agreement.
2. Research collaboration agreement.
3. Recognizing the ongoing need to increase protection against additional, emerging pneumococcal serotypes, Affinivax is developing a MAPS vaccine designed to prevent infection from an even greater number of pneumococcal strains.

 

Addressing diseases for global impact.

Lead MAPS vaccine program for Streptococcus pneumoniae

Disease Challenge:
Streptococcus pneumoniae is a bacterium frequently found in the upper respiratory tract of healthy children and adults, and can cause serious infections ranging from pneumonia, meningitis, and sepsis, representing a major global health problem. The World Health Organization estimates that half a million deaths in children under 5 years old occur each year worldwide due to infection by this bacterium. The U.S. Center for Disease Control estimates that about 900,000 cases of pneumococcal pneumonia occur in the U.S. alone, resulting in up to 400,000 hospitalizations with an associated 5-7% mortality rate in hospitalized patients. Streptococcus pneumoniae is the leading cause of lower respiratory infection morbidity and mortality globally, contributing to more pneumonia deaths than all other etiologies combined in 2016.1 Prevnar 13® is currently the top-selling vaccine worldwide and the top selling product in Pfizer’s entire product portfolio, generating 2019 sales of $5.8 billion and more than $30 billion since 2015. 2,3 By overcoming the technical challenges of conventional conjugate vaccine approaches and inducing a broader protective immune response, a more effective MAPS vaccine offers the potential to be a blockbuster product making a significant global impact on Streptococcus pneumoniae.

MAPS Solution:

In Affinivax’s MAPS vaccine against Streptococcus pneumoniae, pneumococcal polysaccharide and proprietary pneumococcal protein antigens enable the potential for an additional and more robust immune response beyond what is provided by today’s pneumococcal vaccines. In addition to B-cell protection provided by both the polysaccharide and protein antigens, the MAPS vaccine technology also enables protein antigens to elicit an additional T cell response to reduce nasopharyngeal colonization (nasal carriage of pneumococcal bacteria), the first and essential step in pneumococcal infection. Preclinical data with Affinivax’s MAPS pneumococcal vaccine have demonstrated that the MAPS technology enables the creation of a defined structure and highly reproducible macromolecular construct with the desired ratio of antigen components – pneumococcal polysaccharides and pneumococcal proteins – and induces a robust and multipronged immune response. This includes antibody responses comparable to current standard of care vaccines, as well as additional protective antibody and Th1 and Th17 responses.

Clinical Status:
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 testing today, as well as two conserved pneumococcal proteins. ASP3772 was observed to be safe and highly immunogenic in a Phase 1 study in adults. A Phase 2 study in adults is now completed with ongoing data analyses. 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.

Recognizing the ongoing need to increase protection against additional, emerging pneumococcal serotypes, 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.

 

MAPS vaccine program for healthcare-associated infections

Disease Challenge:
Healthcare-associated infections (HAIs) have now emerged as a significant global health concern due to the significant increase in antimicrobial resistance. The Centers for Disease Control and Prevention estimates that 4% of patients in the U.S. alone will contract an HAI each year in medical facilities including ambulatory surgical centers, hospice centers, nursing homes and rehabilitation centers. HAIs can significantly delay patient recovery and increase healthcare costs, with the direct costs to medical facilities estimated at between $28 and $45 billion4. Of the approximately two million patients who acquire a HAI annually in the U.S. alone, an estimated 90,000 will die4. The most common bacterial pathogens causing HAIs in U.S. medical facilities include Clostridium difficile, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa and Escherichia coli,5 many of which are highly resistant to available antibiotic therapies. Current therapeutic options against HAIs are limited and there are no vaccines available today to address this expanding global health crisis.

MAPS Solution:
Addressing antimicrobial resistance head-on, Affinivax is advancing several first-in-class MAPS vaccines targeting Klebsiella pneumoniae and Pseudomonas aeruginosa (through a research partnership with Astellas Pharma), Clostridium difficile, and Staphylococcus aureus.

 

Additional MAPS vaccine programs

Disease Challenge:
Infectious diseases cause deaths of over 17 million people a year worldwide and at least 30 new diseases have emerged in the last 20 years, which threatens the health of hundreds of millions of people6, most recently the COVID-19 pandemic. In addition to bacterial infections and viral infections, there are also opportunities for cancer vaccines as areas to apply innovative vaccine technologies.

MAPS Solution:
Applicability of the MAPS technology has been demonstrated for additional bacterial pathogens which have a significant impact on healthcare in the developing world. Affinivax will explore initiation of these important additional MAPS vaccine programs in collaboration with global health and government partners.

While the company’s initial focus has been on bacterial infections, it is now also advancing discovery efforts to develop preventive and therapeutic vaccines in other therapeutic areas, including viruses and cancer immunology. We believe that our novel MAPS platform technology offers a significant step forward to combat these infections, with the potential to make a meaningful impact on global public health.

 

1 GBD 2016 Lower Respiratory Infections Collaborators. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory infections in 195 countries, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet Infect Dis. 2018 Sep 19. pii: S1473-3099(18)30310-4. doi: 10.1016/S1473-3099(18)30310-4.

2 Top Vaccine Products Worldwide, Statista.

3 A vaccine is Pfizer’s best-selling drug. Axios. February 5, 2019.

4 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/.

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.

6 https://www.who.int/whr/1996/media_centre/press_release/en/

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