GHENT, Belgium, Aug. 19, 2019 /PRNewswire/ -- ActoBio
Therapeutics, Inc., a wholly owned subsidiary of
Intrexon Corporation (NASDAQ: XON) and innovative
clinical-stage biotechnology company focused on a new class of
microbe-based therapeutic agents, announced that the U.S. Food and
Drug Administration (FDA) has given its permission to an
Investigational New Drug (IND) application for AG017, an innovative
orally-delivered therapeutic candidate for the treatment of celiac
disease. ActoBio Therapeutics™ plans to enroll celiac
disease patients in the Phase Ib/IIa study in the U.S. and
Europe later this
year.
ActoBio Therapeutics™ is dedicated to developing and
commercializing the next generation of oral antigen-specific
immunotherapy utilizing its proprietary delivery vehicle.
ActoBiotics® programs are very well suited to address
unmet needs in a wide range of autoimmune and allergic diseases
through induction of antigen-specific immune tolerance that can
prevent, retard or reverse the disease. ActoBiotics®
AG017 for the treatment of celiac disease will be the second
antigen-specific investigational immunotherapy candidate in
clinical development following ActoBiotics® AG019, which
is currently in a Phase Ib/IIa clinical study for the treatment of
type 1 diabetes. Both programs will help further advance the
Company's strategy to develop antigen-specific immunotherapies
toward other autoimmune indications.
ActoBio Therapeutics™ is developing oral
ActoBiotics® AG017 capsules based on the safe food-grade
bacterium Lactococcus lactis which is specifically
engineered to express a gliadin peptide in combination with an
immunomodulating cytokine. ActoBiotics® AG017 is an
antigen-specific investigational immunotherapy candidate with the
potential to reverse gluten sensitivity. Over 90% of patients with
celiac disease have an HLA-DQ2.5 genotype, and the target
population for the clinical trial is patients within this group
whose celiac disease is well controlled on a gluten‑free diet.
Celiac disease is a chronic intestinal inflammatory disorder
estimated to affect 1 in 100 people worldwide and is caused by an
autoimmune reaction triggered by ingestion of dietary gluten
proteins. The subsequent intestinal damage leads to malabsorption
of some nutrients, along with diarrhea, bloating, weight loss,
fatigue and anemia, as well as serious complications in some
individuals1. There is currently no FDA-approved drug
for celiac disease, with the only available treatment being
life-long adherence to a strict gluten free diet, which is
increasingly believed to be insufficient for many sufferers.
"Celiac disease has a significant physical, emotional and
practical impact on patients and their families. AG017 is a unique
candidate for treating the disease, which may allow patients to
relax their dietary restrictions. Therefore, we are excited to be
involved in the first clinical trial with this potential treatment
and look forward to exploring the promise of AG017 in addressing
unmet patient needs," commented Professor Knut Lundin, one of the leading investigators
for clinical studies in celiac disease and former consultant for
ActoBio Therapeutics™, professor of medicine and head of
clinical education at the University of
Oslo and senior consultant in gastroenterology at
Oslo University Hospital.
Pieter Rottiers, PhD, chief
executive officer of ActoBio Therapeutics™ stated, "We
are delighted to be moving forward and entering clinical trials
with our ActoBiotics® AG017 for celiac disease. We have
demonstrated that this product is safe and efficacious in animal
studies. Our approach with AG017 is to target the underlying cause
of celiac disease, and this next stage of the program will allow us
to evaluate how our preclinical results will translate in
patients."
1 Mayo Clinic. Celiac Disease: Symptoms and
Causes. Accessed August 2019 via the
Mayo Clinic website.
About Celiac Disease
Celiac disease is an autoimmune
disorder, which induces an immune response to dietary gluten in
genetically susceptible individuals, causing inflammation and
damage to the small intestine. Around 1 in 100 people worldwide are
estimated to suffer from this disorder, with many being undiagnosed
and therefore at a higher risk of developing serious complications
such as anemia, osteoporosis, neurological and autoimmune
disorders1.
About ActoBio Therapeutics, Inc.
ActoBio
Therapeutics™ is pioneering a new class of microbe-based
ActoBiotics® Lactococcus lactis
biopharmaceuticals that enable expression and local delivery of
disease-modifying therapeutics. The ActoBiotics®
platform produces biologics that through oral or topical
administration are being investigated as possible treatments for
many diseases including oral,
gastrointestinal and autoimmune/allergic disorders. This
approach is being developed to provide treatments that are an
alternative to injectable biologics. ActoBio
Therapeutics™ has a strong R&D pipeline with the
latest stage candidate in Phase IIb and an extensive portfolio of
candidates ready for clinical development across a number of
potential indications. For further information and updates please
visit us at www.actobio.com or follow us on Twitter at @ActobioT and LinkedIn.
About Intrexon Corporation
Intrexon Corporation
(NASDAQ: XON) is Powering the Bioindustrial Revolution with Better
DNA™ to create biologically-based products that improve
the quality of life and the health of the planet through two
operating units – Intrexon Health and Intrexon Bioengineering.
Intrexon Health is focused on addressing unmet medical needs
through a diverse spectrum of therapeutic modalities, including
gene and cell therapies, microbial bioproduction, and regenerative
medicine. Intrexon Bioengineering seeks to address global
challenges across food, agriculture, environmental, energy, and
industrial fields by advancing biologically engineered solutions to
improve sustainability and efficiency. Our integrated technology
suite provides industrial-scale design and development of complex
biological systems delivering unprecedented control, quality,
function, and performance of living cells. We call our synthetic
biology approach Better DNA®, and we invite you to
discover more at www.dna.com or follow us on Twitter at @Intrexon,
on Facebook, and LinkedIn.
Trademarks
Intrexon, ActoBio Therapeutics,
ActoBiotics, Powering the Bioindustrial Revolution with Better DNA,
and Better DNA are trademarks of Intrexon and/or its affiliates.
Other names may be trademarks of their respective owners.
Safe Harbor Statement
Some of the statements made in
this press release are forward-looking statements. These
forward-looking statements are based upon our current expectations
and projections about future events and generally relate to our
plans, objectives and expectations for the development of our
business. Although management believes that the plans and
objectives reflected in or suggested by these forward-looking
statements are reasonable, all forward-looking statements involve
risks and uncertainties and actual future results may be materially
different from the plans, objectives and expectations expressed in
this press release.
For more information, contact:
Investor
Contact:
|
Corporate
Contact:
|
Steven
Harasym
|
Marie Rossi,
PhD
|
Vice President,
Investor Relations
|
Vice President,
Communications
|
Tel: +1 (301)
556-9850
|
Tel: +1 (301)
556-9850
|
investors@dna.com
|
publicrelations@dna.com
|
|
Local contact
ActoBio Therapeutics
|
Kristoff
Baeten
|
PR &
Communications
|
T +32 474 88
1212
|
communications@actobio.com
|
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SOURCE ActoBio Therapeutics, Inc.