Astellas Pharma has licensed exclusive worldwide rights to research, develop, manufacture, and commercialize next-generation DNA vaccines for human allergic diseases based on Immunomic Therapeutics’ LAMP-vax technology platform, the companies said today.

The deal will generate at least $300 million upfront for Immunomic, which will also be entitled to receive 10% royalties on net sales of potential products.

Those products include the vaccine candidate ARA-LAMP-vax for the treatment or prevention of peanut allergy, as well as other research-stage programs for food or environmental allergies, Astellas and Immunomic said.

ARA-LAMP-vax has been developed based on the LAMP-vax platform licensed by Immunomic from Johns Hopkins University. ARA-LAMP-vax is made up of one DNA plasmid encoding the major peanut allergens, encoded as fusion proteins with LAMP for the conversion of the immune system response from a type 2 helper T cell/ immunoglobulin E allergen response to a type 1 helper T cell / immunoglobulin G antigen response, with simultaneous elimination of allergy symptoms.

The LAMP-vax platform is designed to enhance the effectiveness of DNA vaccines by stimulating an immune response against a particular protein, injecting the DNA encoding the protein rather than the protein itself. The companies reason that the platform could potentially enable effective vaccinations for a wide spectrum of diseases.

The companies are studying indications for the LAMP-vax vaccines beyond allergies.

“With this new partnership, Astellas can explore the LAMP-vax platform for allergic disease, while we continue applications in other areas, like cancer immunotherapy,” Immunomic Founder and CEO William Hearl, Ph.D., said in a statement.

Immunomic also wants to develop products for infectious disease and animal health.

LAMP-vax differs from conventional DNA vaccines by including a short DNA sequence encoding the Lysosomal Associated Membrane Protein or LAMP.  This allows DNA vaccines developed based on the LAMP-vax platform to utilize the body's natural biochemistry to develop a more complete immune response compared to the conventional DNA vaccines, according to the companies.

While conventional DNA vaccines primarily elicit a cytotoxic T cell immune response, vaccines developed using LAMP-vax initiate a more complete immune response, including antibody production, cytokine release and critical immunological memory, Astellas and Immunomic said.

The collaboration builds on a January agreement giving Astellas exclusive licensing rights for Japan to ASP4070™ (formerly JRC2-LAMP-vax), a vaccine candidate designed to treat rhino-conjunctivitis induced by Japanese red cedar pollen. Astellas launched a Phase I trial of ASP4070 earlier this year in Japan.

According to Immunomic, ASP4070 is the first immunotherapy to treat the allergy that does not expose the patient to the free allergen. ASP4070 is expected to require only four shots, rather than the 100 or more often required for traditional, extract-based immunotherapy.

Astellas agreed to pay Immunomic $15 million upon execution of the agreement, plus up to $55 million in development and regulatory milestone and technology transfer payments, as well as tiered double-digit royalties on net sales of the product.

Astellas also agreed to fund clinical trial development costs and supporting development expenses for Japan—while receiving from Immunomic 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.

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