Vaccinex believes that the ACTIVMAb® technology is one of the most
advanced for generating monoclonal antibodies against difficult immune
targets, which include highly conserved proteins and multi-pass membrane
receptors. Vaccinex’s strategy is to leverage the capabilities of
our ACTIVMAb® antibody technology to develop a pipeline of therapeutic
antibody products, while utilizing the near-term revenues from antibody
collaborations to help support our operating costs.
Key components of our business strategy include the following:
Identification of Attractive Antibody Targets. Using
our ACTIVMAb® technology, Vaccinex has the ability to discover
promising immune targets, such as our proprietary breast cancer target,
C35. In addition, we are accelerating our development efforts by in-licensing
validated or partially validated targets from partners and reviewing
promising targets in the public domain.
Generation and Evaluation of Fully Human Antibodies.
Vaccinex’s antibody technology provides the potential to generate
fully human antibodies that may form the basis for therapeutic products.
As described above, Vaccinex’s ACTIVMAb® technology offers
one of the only means of generating complete, fully functional antibodies
against a broad range of target antigens. These capabilities are important
as they may allow Vaccinex to select antibodies against targets that
cannot be addressed by others and to directly incorporate functional
assays in the antibody selection process. Importantly, our in-house
discovery capabilities eliminate the need to pay fees or royalties
to other firms for antibody discovery.
Initiation of Clinical Development: Building on the expertise of its current management team and advisors, Vaccinex intends to perform proof of concept studies to validate the scientific potential of each antibody product prior to development. Vaccinex is currently performing such studies on C35-based antibodies relevant to breast cancer. We have built a core development team and engaged experienced consultants to enhance our clinical development capabilities.
Antibody Manufacturing: Antibody manufacturing is a key component of the clinical and commercial development of antibody products. To secure manufacturing capacity, Vaccinex has established a strategic alliance with Lonza Biologics, one of the world’s leading contract manufacturers of antibodies. This alliance provides Vaccinex and its corporate partners with dedicated access to cGMP antibody manufacturing capacity for five years and customized access to Lonza’s GS expression system. In addition, Vaccinex has entered into a development partnership with Biocon Limited, India’s leading biotechnology company with world-class manufacturing and development capabilities.
Corporate Collaborations and Client Services: Because
few companies have the ability to generate fully human antibodies,
Vaccinex can leverage its ACTIVMAb® technology by assisting others
in discovering novel therapeutic antibodies. Corporate partners provide
Vaccinex with their target antigen and Vaccinex uses its ACTIVMAb®
technology to select one or more fully human monoclonal antibodies
that are specific to the target. Vaccinex can license the antibodies
discovered to our partners in exchange for upfront and milestone fees
and royalties on product sales. In addition, on a selected basis,
Vaccinex is establishing collaborations structured as co-development
partnerships where we will share in product development responsibilities
and revenues.
Quality: The industry to which Vaccinex provides research services and with which it establishes co-development partnerships places considerable emphasis on quality and regulatory compliance. The company’s management is committed to providing services and fulfilling co-development obligations which meet all client and partner requirements. The company’s management is also committed to developing and commercializing its pipeline of biopharmaceutical and diagnostic products in compliance with internal quality policies and standards, as well as with applicable government regulatory requirements. Accordingly, Vaccinex has established and maintains a documented Quality Management System (QMS) to ensure the highest level of quality of services and products.