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Affinivax Launches Novel Conjugate Vaccine for Global Impact on Infectious Diseases

Investment from the Bill & Melinda Gates Foundation to Support Company Launch and Advance Lead Program targeting Pneumococcal Disease

Exclusive License to Intellectual Property from Boston Children’s Hospital for Innovative MAPS Technology Platform

Cambridge, Mass., October 30, 2014 – Affinivax Inc., a biotechnology company dedicated to developing novel vaccines, today announced its launch with a $4 million investment from the Bill & Melinda Gates Foundation. This commitment from the Gates Foundation also includes additional investments in Affinivax based on the achievement of future success-based milestones. Proceeds from the funding will be used to develop Affinivax’s Multiple Antigen Presenting System (MAPS) technology platform and enable the development of novel vaccines to protect children and adults in both the developed and developing worlds, with an initial focus on the company’s lead drug program for Streptococcus pneumoniae (pneumococcus).

The company also announced it has secured an exclusive license from Boston Children’s Hospital to the intellectual property related to the MAPS technology platform, initially developed at Boston Children’s by Richard Malley, M.D., Affinivax’s scientific founder and the Kenneth McIntosh Chair in Pediatric Infectious Diseases at Boston Children’s.

“It is unacceptable that pneumonia remains the leading cause of death among children under five,” said Trevor Mundel, president of Global Health at the Bill & Melinda Gates Foundation. ”We are enthusiastic about Affinivax’s vaccine program targeting pneumococcal pneumonia because it is urgent that we reach all children with the vaccines they need.”

“The seed financing from Bill & Melinda Gates Foundation, alongside strong intellectual property and a high quality team of experts in the development of conjugate vaccines, have strongly positioned Affinivax to build a pipeline of important vaccines for diseases that afflict children and adults around the world,” said Steven B. Brugger, President and Chief Executive Officer of Affinivax.

Innovative Proprietary MAPS Conjugate Vaccine Technology
MAPS is uniquely suited to target many complex diseases, such as those caused by mucosal pathogens, for which both antibodies and T cells play important roles in immune protection. A MAPS vaccine combines protective polysaccharides and proteins in a single vaccine and induces a broad protective immune response. The MAPS technology capitalizes on the highly specific and durable non-covalent binding between biotin and rhizavidin. This highly stable complex offers a simple, modular, and efficient approach to develop conjugate vaccines against a wide range of diseases. A MAPS vaccine is distinct from conventional conjugate vaccines that are designed to only optimize antibody responses to the polysaccharide antigen and do not induce a sufficient and consistent immune response to the protein antigen. By also using the distinct functionality of conserved and protective B and T cell protein antigens from target pathogens, a MAPS vaccine induces a much broader and protective immune response against disease.

In Affinivax’s MAPS vaccine against Streptococcus pneumoniae, proprietary protein antigens enable the potential for an additional antibody response to protect against disease due to a broader range of pneumococcal serotypes, as well as a T-cell response to reduce nasopharyngeal colonization, the first and essential step in pneumococcal infection. The company has achieved preliminary preclinical proof-of-concept for several MAPS vaccines and is currently advancing its lead vaccine against Streptococcus pneumoniae to clinical proof-of-concept.

Driven by Renowned Scientific Leaders
Affinivax was established based on the expertise and insights of world-leading experts in the fields of infectious diseases and vaccines. Supported by an investment from the Bill & Melinda Gates Foundation, Affinivax has brought together a global coalition of individuals and partners with demonstrated expertise in successfully developing and commercializing novel vaccines.

Richard Malley, MD, is Affinivax’s scientific founder and the Kenneth McIntosh Chair in Pediatric Infectious Diseases at Boston Children’s Hospital. For more than a decade, and in collaboration with colleagues and global nonprofit health organizations, including PATH and the Bill & Melinda Gates Foundation, Dr. Malley has led an international effort in the development of novel vaccines.

George Siber, MD, is Affinivax’s lead scientific advisor and served as Executive Vice President and Chief Scientific Officer of Wyeth Vaccines, where he oversaw the development and approval of multiple widely used childhood vaccines, including Prevnar, a pneumococcal vaccine which has achieved multibillion dollar revenues. Prior to his tenure at Wyeth, Dr. Siber was at Harvard Medical School and Dana Farber Cancer Institute.

“I am very excited about the launch of Affinivax and the opportunity to realize the full global potential of this new approach to vaccines,” said Dr. Malley. “The company’s lead candidate targeting pneumococcal disease offers the potential to be the first vaccine of its kind, where both the protein and polysaccharide components contribute to provide broader immune protection than is currently available today.”

“Affinivax’s novel, next generation approach to vaccine conjugation offers the potential to harness the protective activities of both polysaccharide and protein antigens in a single formulation. By increasing the effectiveness and streamlining the development and manufacture of conjugate vaccines, we can make them more available to people in need throughout the world.” said Dr. Siber.

About Affinivax
Affinivax is advancing a next generation conjugate vaccine technology platform to enable the development of vaccines that provide the highest level of protection against challenging infectious diseases. Backed by an investment from the Bill & Melinda Gates Foundation and working with world experts in vaccine discovery and development, Affinivax is focused on creating a pipeline of vaccines for children and adults in both the developed and developing worlds. The company’s proprietary vaccine platform, called Multiple Antigen Presentation System (MAPS), enables the conjugation of protective polysaccharides and proteins in a single vaccine and uniquely induces a broad and protective immune response. The MAPS technology provides a highly stable, modular, and efficient approach to develop vaccines against a wide range of diseases. The company has achieved preliminary preclinical proof-of-concept for several MAPS vaccines and is currently advancing its lead vaccine candidate against Streptococcus pneumoniae.

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