Astellas Pharma Inc. and Immunomic Therapeutics, Inc., a clinical-stage biopharmaceutical company developing vaccines, have formed an exclusive license agreement for Japan to develop and commercialize JRC2-LAMP-vax, Immunomic Therapeutics' vaccine designed to treat allergies induced by Japanese red cedar pollen.

Under the agreement, Astellas is responsible for developing and commercializing JRC2-LAMP-vax in Japan. Immunomic Therapeutics will receive $15 million upon the execution of the agreement. and potentially up to $55 million in total development and regulatory milestone and technology transfer payments as well as tiered double-digit royalties on net sales of the product. Astellas will fund clinical trial development costs and supporting development expenses for Japan. Immunomic Therapeutics also granted Astellas an exclusive option to negotiate a license for additional LAMP-vax DNA vaccines to treat allergy indications other than Japanese red cedar pollinosis in Japan. The companies expect to initiate a Phase I trial of JRC2-LAMP-vax in Japan as soon as it is ready.

Lysosomal-Associated Membrane Protein (LAMP) is a glycoprotein found on the lysosomal membrane. LAMP-vax DNA vaccines use the natural biochemistry of LAMP to intersect with the process that Antigen Presenting Cells (APCs) use to internalize, digest, and present exogenously derived antigens to the immune system as part of the lysosomal/MHC-II complex. The result is enhanced antigen presentation and enhanced immune system response to a vaccine.

Upon immunization with a LAMP-vax DNA vaccine, APCs take up the DNA and produce the encoded protein sequence inside the cell as part of a fusion protein with LAMP. In this way, LAMP-vax DNA vaccines activate APCs to the immunized antigen(s) through the CD4+ helper T-cell pathway. LAMP-vax DNA immunization contrasts with the immune response to conventional DNA vaccines, which are processed and primarily presented through MHC-I and elicit a cytotoxic T response. LAMP-vax DNA plasmids show no decrease in CD8+ cytotoxic T-cell response, yet also feature a CD4+ response. This initiates a more complete immune response, including antibody production, cytokine release, and critical immunological memory.

JRC2-LAMP-vax was developed based on the LAMP-vax platform of which an exclusive and worldwide license is granted to Immunomic Therapeutics by Johns Hopkins University. It is made up of two DNA plasmids, encoding the two major cedar allergens, Cry j 1 and Cry j 2, each encoded as fusion proteins with LAMP for the conversion of the immune system response from a TH2/ IgE allergen response to a TH1/ IgG antigen response with the concomitant elimination of allergy symptoms.

Current treatments for Japanese red cedar pollinosis are palliative. The market opportunity for JRC2-LAMP-vax is to provide long-lasting symptom relief in a short, convenient dosing regimen.

Source: Immunomic Therapeutics