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Immunomic Therapeutics, Inc.
www.immunomix.com
Next-generation DNA vaccine technology for
allergy, infectious disease and oncology
histocompatibility complex class II (MHC II) for
display on the surface of antigen-presenting
dendritic cells. Other DNA vaccines tend to elicit
primarily MHC class I-mediated, cytotoxic T-cell
responses, according to Hearl, because they lack
the ability to directly stimulate MHC II antigen
presentation or because they are administered
to cells that lack MHC II altogether, such as
muscle cells. LAMP vaccines have the potential to evoke an immune response comprising
cellular immunity (cytotoxic T cells) as well as
adaptive immunity (the helper T-cell pathway that
spurs cytokine release and antibody production).
Though additional study in humans is needed to
evaluate the safety and effectiveness of the technology, preliminary evidence suggests that it may
be useful for diverse patient populations, from
those with cedar allergy to those with high-risk
acute myeloid leukemia.
“Our vaccine technology is uniquely suited to
allergy,” explained Hearl. “By administering DNA,
we don’t expose the patient to the allergen itself,
and because the allergen proteins are digested
to present antigens to T cells, there’s no secreted
allergen exposure outside the cell, either.”
ITI has chosen to focus its internal R&D on
allergy vaccines. The global allergy market is
enormous—the World Allergy Organization estimates imply that up to 25% of the global population is allergic, and ITI suggests the addressable
market for its allergy therapies could comprise
nearly 400 million people. Although this suggests a potential market size in the hundreds
of billions ($), the current market for allergy
products is dominated by symptom-easing therapies and is worth just over $6 billion annually,
according to ITI. A growing but still small market
for immunotherapy products to treat allergy is at
about $2 billion, according to the company. This
means that there’s a lot of opportunity and market for ITI’s allergy vaccines to capture.
Meanwhile, the Company also is out-licensing
the rights to pursue LAMP-enabled vaccines
in other therapeutic areas. In 2006, Geron
Corporation licensed exclusive rights to use
LAMP in cancer vaccines. In 2013, Geron sold
those rights to Asterias, a subsidiary of BioTime.
LAMP has been applied in HIV, and the University
of Florida is pursing two other oncology applications for LAMP-vax. The company has also
partnered with the animal health division of a
large pharmaceutical company to co-develop
LAMP-vax products for allergies to companion
animals as well as in oncology and infectiousdisease indications for companion and herd
animals.
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Immunomic Therapeutics.indd 25
ITI, founded in 2005 to develop products from
the LAMP-vax DNA vaccine platform, licensed its
technology from the Johns Hopkins University
School of Medicine where it had been developed
by J. Thomas August under funding from the
US National Institutes of Health. The company
is based in Hershey, Pennsylvania, with labs in
Rockville, Maryland. A 2014 series A financing
brought in about $6.5 million from angel investors and family offices; the company has raised
about $15 million in total since its inception in
addition to the up-front licensing revenue from
the Astellas deal that took place early this year.
Revenues from the licensing deals with Geron
and the animal health division of the large pharmaceutical company also contributed the company’s current financial position.
ITI’s LAMP technology has significant potential
applications outside of the biotech’s own pipeline. It could be evaluated for use with other
companies’ DNA vaccines or peptide- or proteinbased vaccines, which could be reformulated as
LAMP-enabled DNA vaccines, Hearl elaborated.
Eventually, the company hopes to develop multivalent ‘universal’ vaccines against the allergens
that are dominant in particular geographies—for
example, a combination vaccine against grass
pollen, dust mites and animal danders (the
company’s JRC2-LAMP-vax product, partnered
with Astellas, comprises two DNA plasmids
encoding two major cedar allergens, providing a
measure of proof of concept for the combination
concept).
In the meantime, ARA-LAMP-vax, the company’s
preclinical candidate against peanut allergy
and anaphylaxis, will target three major peanut
allergens. ITI is working with a leading expert in
food allergy, Hugh Sampson at the Icahn School
of Medicine at Mount Sinai, readying the program
for an IND later this year. “For the first time in 20
years, there are new and important allergy products being developed,” said Hearl. “There is unaddressed medical need in this space, and though
additional research is needed, I am encouraged
that this technology may help us confront the
enormity of several lifelong chronic illnesses.”
Reference
1. Okubo, K. et al. Allergol. Int. 63, 357–375 (2014).
CONTACT DETAILS
William Hearl, CEO
Immunomic Therapeutics, Inc.
Hershey, PA 17036
Tel: + 1 240 401 7496
Email: [email protected]
biopharmadealmakers
F
resh off a transformative licensing deal
with Astellas Pharma for its lead nextgeneration DNA vaccine candidate,
Immunomic Therapeutics, Inc. (ITI) aims to
expand its proprietary allergy immunotherapy
pipeline in 2015 and file an investigational
new drug (IND) application for a vaccine to treat
peanut allergy in the second half of the year.
In late January, ITI partnered with Astellas to
continue the development of JRC2-LAMP-vax,
a vaccine currently in phase 1 trials against
allergy to Japanese red cedar pollen. More
than a quarter of Japan’s population suffers
from this seasonal allergy1, and a related allergen, mountain cedar, affects the population of
the southwest United States. Astellas paid ITI
$15 million up front for rights to the product in
the Japanese market. The biotech is also eligible to receive $55 million in development and
regulatory milestone and technology-transfer payments, and tiered double-digit royalties should
JRC2-LAMP-vax hit the market. Astellas is responsible for all costs associated with developing the
product in Japan.
JRC2-LAMP-vax is ITI’s lead asset and the first
allergy program to emerge from an early-stage
but burgeoning pipeline. DNA vaccines are packaged as nonviral plasmid DNA, small loops of
genetic material that are transcribed and translated once inside a cell. In late 2014, ITI inked
a deal with the drug-delivery company Bioject
Medical Technologies to use the company’s
needle-free injection technologies to deliver its
DNA vaccines. To encourage uptake of the plasmids by target cells, ITI uses a bacterial plasmid
much smaller than other plasmids in use, combined with Bioject’s technology. “We know we
can transfect dendritic cells,” explained ITI CEO
Bill Hearl. “We may have significant advantages
in overall plasmid design” that avoid the need
for techniques such as electroporation, in which
pulses of electric current are used to temporarily
open up gaps in cell membranes so plasmids
can enter.
But where ITI really differentiates itself is in
its ability to provoke the right reaction from the
immune system. The biotech incorporates into
its DNA vaccines a specific nucleotide sequence
designed to help boost the immune system’s
response to the desired vaccine antigens.
LAMP (lysosome-associated membrane protein)
is a glycoprotein that coats the membranes
of lysosomes; by adding the LAMP-encoding
sequence to its DNA vaccines, ITI can steer the
synthesized protein products to the lysosome,
where they form complexes of antigen and major
www.nature.com/biopharmadealmakers
Immunomic Therapeutics, Inc. (ITI) is leveraging its proprietary LAMP-vax technology to build a broad
portfolio of DNA vaccines to treat debilitating and sometimes deadly allergic conditions.
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12/02/2015 09:54