Immunomic Therapeutics: A game-changer in allergy vaccines

05/23/2016| Amanda Winters

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Immunomic Therapeutics: A game-changer in allergy vaccines

05/23/2016 | Amanda Winters

For those in the health and life sciences industry, May is known as National Asthma and Allergy Awareness Month. According to the Asthma and Allergy Foundation of America, more than 50 million Americans suffer from allergies, and more than 24 million Americans are affected by asthma. And while there still isn't a known cure for these conditions, one Rockville biotechnology company is working to change that.

Immunomic Therapeutics, Inc.(ITI) has created a vaccine to change how the body responds to allergens. The vaccine is based on LAMP technology, or the lysosomal associated membrane protein, created by Dr. Tom August of the Johns Hopkins University School of Medicine.

According to the company, LAMP-vax utilizes the body's natural biochemistry to develop a complete immune response, ultimately eliminating an allergic reaction. This next-generation DNA vaccine is currently being used to investigate Japanese red cedar tree allergies and peanut allergies. As of last year, the vaccine studies in the red cedar category showed to be 100% effective in skin tests.

ITIhas licensed the LAMP-vax platform to Japan-based Astellas Pharma for $300 million, who will continue developing the allergy-prevention product and has promised a peanut allergy vaccine in the next 5-8 years. Meanwhile, ITIwill shift its focus to the LAMP-vax's effect on cancer immunotherapy. The company hopes to "activate the immune system against cancer" by including tumor markers, or substances produced by the body or the cancer itself, in the LAMP-vax vaccine.

The company was recently named Life Science Company of the Year by the Tech Council of Maryland. Founder and CEO, Bill Hearl, sat down with MDBizNews to answer a series of questions.

Tell us a little more about your deal with Astellas Pharma.
Thanks for asking. The license agreement with Astellas Pharma in October is our most significant milestone to date. The license exchanged the right to use the LAMP technology platform to treat human allergic disease for $300 million and included a future royalty rate of 10% on all sales.

This transaction, in combination with the Japanese red cedar (JRC) agreement earlier in the year, brought the total pre-royalty value of the allergy deals to a stunning $370 million, with $315 million received as upfront payments. Considering the magnitude of these deals, it is perhaps tempting to think that this represents the upper limit of ITI's potential; rather, I believe it's more likely that the company and the LAMP technology platform are just getting started.

Further, the two deals with Astellas represent the culmination of a well-planned and well-considered strategy. Our plan was to develop two high-value allergy targets – JRC & peanut – to Phase I clinical trials and then identify the right partner to advance these products, and indeed the entire product family, through the clinic and to commercialization. We succeeded.

Astellas is developing the Japanese red cedar product and other allergy products with clinical and pre-clinical studies. JRC is the main allergy problem in Japan and causes many health problems for the Japanese people.

How did the Immunomic Therapeuticslaboratory land in Rockville?
We were pleased to grow our company in Maryland, which is quickly becoming an elite biotech hub and is one of the richest sources of healthcare knowledge and research innovation in the world. In 2006, we began working with Dr. Tom August at Johns Hopkins on the technology that would become the foundation of ITI.

Because of Maryland's growing biotechnology industry, access to rich sources of research, innovation and support, we were able to get incubator space inside Capital Genomix in Gaithersburg. As a result, Rockville naturally evolved as our home laboratory.

How does Maryland's growing science and technology community impact the business?
We enjoy working in a community that boasts 500 life sciences companies, 70 federal labs and regulatory agencies such as the U.S. Food and Drug Administration (FDA). Maryland provides many of the resources a biotech company needs to grow and develop. Further, the collaboration and partnership opportunities found in Maryland are excellent.

The vaccine you are developing is based on research from Johns Hopkins University. Are you still working with JHU?
We have an excellent relationship with JHU's tech transfer office. They were quite understanding of the pressures of a startup and really worked with us to help ITI through the challenges of the early stages of our existence.

When I sat down with Dr. August over breakfast more than a decade ago, I could not have anticipated that the meeting would result in the development of a game-changing vaccine platform with the potential to fundamentally improve the use of vaccines across a wide variety of diseases.

While we will remain focused on the LAMP technology platform for now, we absolutely welcome further opportunities to collaborate with JHU.

How will your research and development affect individuals with food allergies, seasonal allergies, and health and cancer?
We believe the LAMP technology platform could revolutionize the way both allergies and cancer is treated. LAMP technology uniquely re-educates the immune system to make a vaccine more effective.

This is important given that food allergies today cause more than 30,000 cases of severe allergic reactions (anaphylaxis) and 100 to 200 deaths in the United States every year. Peanut allergies affect more than 1.5 million Americans who have to maintain constant dietary vigilance to reduce the risk of accidental peanut-induced anaphylaxis.

Currently, medical professionals can only treat the symptoms of allergies, with antihistamines, steroids, etc. Besides conventional allergy shots that don't work well for everyone, we've never had medicines or strategies that address the underlying biology of the disease.

To date, nucleic acid immunotherapies employing LAMP have been studied in early phase studies for glioblastoma multiforme, acute myeloid leukemia and metastatic melanoma. We are excited to see LAMP-based nucleic acid immunotherapy move forward in clinical studies as a way to potentially create new and amplify immune responses to cancers.

What advice would you give to startup companies in the biotech and life sciences industry?
Starting in 2006, we employed a unique strategy of funding through angel investments to obtain small, early licenses for our technology. This proved to be a capital-efficient method and we have been able to raise a minimal amount of money and successfully execute our strategy.

Our first partnership was strategically chosen to maximize the value of our initial pipeline – in allergy. Proving our technology in a niche DNA vaccine created a process that was low-cost and resulted in a short timeline for clinical trials.

I would advise others to adopt a similarly focused strategy and put significant effort into identifying the right partner to help you achieve results with minimal investment.

What is next for Immunomic Therapeutics?
We have begun our search to find an opportunity in cancer that is similar to the Japanese red cedar trials. That is, applications where clinical conditions favor the ability to demonstrate the value of LAMP-Vax expeditiously and in a cost-effective manner.

To that end, we are establishing relationships that will take us into the clinic in 2016. We are supporting the recurrent glioblastoma (GBM) clinical studies of Duane Mitchell, M.D., Ph.D., director of the University of Florida Tumor Immunotherapy Program in the Department of Neurosurgery, which will include some very interesting work helping us understand how LAMP works as a cancer vaccine.

Our long term vision for Immunomic Therapeutics is to continue to advance the LAMP technology platform and build products that will play a critical role in improving human health.

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