June 1, 2015 (Vol. 35, No. 11)

Immunomic Therapeutics Reeducates the Immune System for a More Complete Response

Immunomic Therapeutics, or Immunomix, is reeducating the immune system in an attempt to alleviate or even cure allergies. The company’s DNA vaccine technology generates a solution that elicits a robust immune response.

For allergy sufferers, the body sees allergens using the same pathway that it uses to address parasites and other inflammatory targets and launches the wrong response cascade. To prevent such misfires, Immunomix takes an unusual approach.

“Rather than turn off the adaptive immune system, like a traditional immunotherapy, we interact with it positively and teach it the right way to respond to immune challenges with allergens,” says William Hearl, Ph.D., Immunomix’ CEO. “The process, essentially, uses LAMP protein as an immunologic chauffeur.”

Lysosomal-associated membrane protein (LAMP) is the key to the therapy. As Immunomix’ literature explains, “LAMP intersects 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.”

Immunomix’ therapeutics, therefore, generate a dual, positive response that involves both the innate and adaptive immune systems. The first response occurs at the immunization site, where “innate cells detect bacterial DNA, treat it like bacteria and viruses and automatically release cytokines,” Dr. Hearl explains. The second response occurs once that DNA is inside the dendritic cells. “Those cells see it as an antigen,” Dr. Hearl continues, and they produce the encoded protein sequence inside the cell.

An immune response is activated through emphasizing activation of the CD4+ helper T-cell pathway more than the CD8+ cytotoxic T-cell response typical of other DNA vaccines (although LAMP vaccination can also elicit CD8+ responses). The process produces antibodies, releases cytokines, and enhances immunological memory.

Immunomix is investigating a vaccine for treating patients suffering with allergies to Japanese red cedar (Cryptomeria japonica), pollen grains of which are depicted in this scanning electron micrograph. The grains are approximately 27 µm in diameter and dotted with yellow structures, “Ubisch bodies,” composed of CRY J1, a key allergen. [©2011 Martin Oeggerli]


Because LAMP technology uses a standardized, next-generation plasmid backbone, new vaccines can be developed within about three months. This enables a rapid response to emerging threats. Development also is speeded by a proprietary fermentation process that incorporates the HyperGRO™ process to produce high yields and support scale-up.

From a patient’s perspective, tolerability is the main benefit. No free protein is exposed to the immune system while it’s being reeducated, so there’s no allergic reaction to therapy. That means patients who drop out of allergen immunotherapy because of discomfort (that’s 70–80% for peanut immunotherapy) may now complete their treatments.

Japanese Red Cedar Allergy

Immunomix is working with peanuts, red cedar, and other allergen sources, and it is beginning to work in oncology. Of the allergen sources, Japanese red cedar presents a particularly appealing target.

Each Japanese red cedar tree makes 2–4 kg of pollen, a particularly allergenic pollen, it happens. In Japan, the cedar trees release their pollen early in spring, before most other plant-based allergens are present. This is a boon for researchers because it eliminates much of the background noise.

The world’s largest cedar forests, totaling some 10 million acres, are in Japan. Not surprisingly, Japan also has the second largest allergy market in the world, behind the United States.

“Approximately 35 million people—more than one quarter of its population—suffer from extreme allergies in February and March,” Dr. Hearl points out. He estimates the Japanese market for red cedar immunotherapeutics could be $35–50 billion.

Expanding Trials

“The best way to validate what we’re doing is to take a therapy targeting a specific, well-defined allergen through the clinic in a way that demonstrates efficacy and speaks to the regulatory agencies about what can be accomplished,” Dr. Hearl asserts.

In a Phase I clinical trial in Hawaii, patients were injected with four doses of a version of Immunomix’ LAMP vaccine for Japanese red cedar over the course of eight weeks and monitored by skin tests. By the end of the Phase I trial, 100% of those who initially tested positive for red cedar allergy tested negative.

Plans for a Phase II study were considered favorably by the FDA and Japan’s PMDA in January, when Immunomix signed a $70 million agreement with Astellas. Now expanded trials will begin in June under Astellas’ direction.

Immunomix also is testing ARA-LAMP-Vax, its peanut allergy vaccine, which uses the same technological principle as the red cedar vaccine. Clinical trials are slated to begin in the fourth quarter of this year.

Other Opportunities

Studies indicate LAMP technology can immunize patients against multiple antigens simultaneously. “For the next 12 to 18 months, we’ll focus on getting individual allergens through Phase I safety trials and then into multiallergen tests,” Dr. Hearl says.

“We want to make a series of combination vaccines for physicians that incorporate regional vaccines and food allergens, along with a companion diagnostic,” he elaborates. That will enable allergy treatment to begin upon patient presentation in a physician’s office, and to address the root cause of the allergy rather than just its symptoms.

The LAMP-vax approach also can be applied to oncology. Various university labs are testing LAMP in combination with their therapeutic technologies, including two leading institutions working in glioblastoma.

In addition to testing its allergy treatments, Immunomix is evaluating the possibility of needle-free injections, working with BioJet.

Great strides have been made in immunology in this decade, but much is still unknown, Dr. Hearl concludes. “Immunology is one of the great black boxes left in science.”

Immunomic Therapeutics

Location: 1214 Research Blvd, Suite 2016, Hershey, PA 17036

Phone: (717) 327-1919

Website: www.immunomix.com

Principal: William Hearl, Ph.D., CEO

Number of Employees: 20

Focus: Immunomic Therapeutics is a clinical-stage company developing novel DNA vaccines for allergies and, eventually, for cancer and infectious disease.

Previous articleA Sweet Tooth Is HIV’s Achilles Heel
Next articleSimplifying Protein Analysis