Immunomic Therapeutics, Inc., a privately-held clinical stage biotechnology company, and Astellas Pharma Inc. (Astellas) have entered into 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. The companies expect to initiate a phase 1 trial of JRC2-LAMP-vax in Japan as soon as it is ready.

Under the agreement, Astellas is responsible to develop and commercialize JRC2-LAMP-vax in Japan, where Japanese red cedar pollinosis is endemic.  Immunomic Therapeutics will receive $15 million upon the execution of the agreement. Immunomic Therapeutics potentially will also receive 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.

“Our Japanese red cedar allergy vaccine therapy, JRC2-LAMP-vax, will provide millions of allergic subjects with a truly novel solution with a long-lasting disease treatment,” said Dr. William Hearl, president and CEO of Immunomic Therapeutics. “We are very pleased to be partnering with Astellas, a global pharmaceutical leader, to deliver this treatment to market. Throughout our global partnering effort, Astellas has consistently proven to be proactive, thoughtful and innovative partner that is committed to developing new medicines and technologies.”

“Immunomic Therapeutics uses a novel vaccine technology, LAMP-vax platform that will offer the next generation vaccines for allergy,” commented Kenji Yasukawa, Ph.D., senior vice president and chief strategy officer, at Astellas, “we are very excited to partner Immunomic Therapeutics and we hope that we will deliver to patients a safe and game-changing therapeutic approach with short administration period for Japanese red cedar pollinosis from which almost one-quarter of the population in Japan are suffering.”

This agreement reflects Astellas’ commitment to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.

The impact of this transaction has been accounted in revised Astellas’ forecasts for fiscal year ending March 2015, which was announced on October 31, 2014.

The Japanese red cedar tree is an economically and culturally important tree in Japan, however, it’s pollen has resulted in the sensitization of an estimated 26.5% of the Japanese population, significantly increased from 16.2% as of 1998 (Practical Guideline for the Management of Allergic Rhinitis in Japan, 2013)  During pollen season, each tree can produce up to 2 kg of pollen that readily disperse over vast areas. The pollen is believed to deliver a two-part allergenic punch: the pollen surface is coated with highly allergenic Cry j 1 protein and upon contact with a mucosal surface, the pollen grain lyses to release abundant Cry j 2 protein contained within the pollen grain.

Lysosomal Associated Membrane Protein (LAMP) is a glycoprotein found on the lysosomal membrane. LAMP-vax DNA vaccines utilize 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 a greatly 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 has been developed based on LAMP-vax platform of which 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 and require long-term, costly treatment options. The market opportunity for JRC2-LAMP-vax is to provide long-lasting symptom relief in a short, convenient dosing regimen.

Immunomic Therapeutics, Inc. (Immunomic Therapeutics) is a privately-held clinical stage biotechnology company dedicated to pioneering vaccines that transform lives.

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals.