Creation of an Anti-CD40 Superagonistic Monoclonal Antibody

Award Information
Department of Health and Human Services
Award Year:
Phase I
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
IMMURX Inc., 16 Cavendish Court, LEBANON, NH, 03766
Hubzone Owned:
Minority Owned:
Woman Owned:
Principal Investigator:
(603) 650-8262
Business Contact:
() -
Research Institution:
Description: The overall goal of this revised SBIR application is to produce and test monoclonal antibodies (mab) to human CD40 that possess super-agonistic activity, as part of an adjuvant platform. The term superagonist is defined by specific immuno logical activities that these mabs possess, activities that are distinct from and superior to those of current CD40 agonists. At this time, anti-murine CD40 superagonists exist, however their anti-human (h) CD40 counterparts do not exist. ImmuRx is committ ed to the development of super-agonistic anti-hCD40 mabs as part of a novel, proprietary vaccine adjuvant platform. This adjuvant will be an integral component of therapeutic anti-tumor immunity. This proprietary adjuvant platform is based on the comb ined use of CD40 superagonists and TLR agonists to amplify cell-mediated immunity effectively and safely. The goal here is to produce and identify lead CD40 superagonists for continued development into a Phase II program. Super-agonistic mabs specifi c for hCD40 will be identified and produced through a modified Phage display approach. Under contract with Alligator BioSciences, a human H-L molecular library will be produced from 8 previously identified agonistic anti-human CD40 mabs. From these 8 mabs, the VH/VL library will be mutated using the FIND proprietary technology allowing millions of new variants to be produced and thousands to be tested. An additional round of affinity/functional maturation will be performed. Alligator will provide 40-100 mab s to hCD40 with high levels of agonistic activities. These will represent the starting library of mabs for the SBIR from which lead super-agonistic mab candidates will be tested and selected. In addition, ImmuRx will also take a conventional, independent a pproach and produce mouse anti-h CD40 mabs. While super- agonists will be identified by their in vitro activities, definitive verification of the activities of lead candidates and their ability to synergize with TLR agonistics will be determined by in vi vo testing in hCD40 knock-in mice. These humanized knock-in mice will allow the testing of lead CD40 superagonists for inducing heightened cell-mediated immunity and the assessment of possible toxicity due to antibody-based therapy, prior to advancing in to sub-human primates. There is a substantial need for potent and safe adjuvants to immunize against melanoma. Super-agonistic anti-CD40 mabs represent part of a powerful and new adjuvant platform that will allow the development of such vaccines. PUBLIC HEALTH RELEVANCE: Vaccines have been the most successful interventional therapy that mankind has known. They have all but wiped certain diseases from the face of the earth. This application is to produce a drug that will enhance the power of vaccines to improve their capacities to treat metastatic melanoma.

* information listed above is at the time of submission.

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