GHENT, Belgium, July 1, 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, has announced that it
will progress to the next stage of the Phase Ib/IIa clinical trial
for investigational drug AG019 for the treatment of early-onset
type 1 diabetes (T1D). This follows a scheduled review by the
independent Data and Safety Monitoring Board, which supported
moving forward with the study. Therefore, the Company may now
initiate enrollment of the next two patient cohorts of the study:
AG019 dosing in patients 12-17 years of age and combination dosing
of AG019 plus teplizumab (PRV-031) in adults.
![ActoBio Therapeutics Logo (PRNewsfoto/Intrexon Corporation) ActoBio Therapeutics Logo (PRNewsfoto/Intrexon Corporation)](https://mma.prnewswire.com/media/941329/ActoBio_Therapeutics_Logo.jpg)
ActoBiotics® AG019 is an investigational drug
designed to induce oral immune tolerance to reverse T1D, a disease
with no approved disease-modifying treatment that is currently
managed through lifestyle modification and diet combined with
exogenous insulin. AG019 is formulated as an oral capsule
consisting of engineered Lactococcus lactis specifically
modified to deliver human proinsulin and the tolerance-enhancing
cytokine human interleukin-10 to the mucosal lining of the
gastro-intestinal tissues. In the next stage of the study, AG019
will be utilized in combination with PRV-031, a Phase III anti-CD3
monoclonal antibody in development for the interception and
prevention of clinical T1D, pursuant to a collaboration with
Provention Bio. Inc., (NASDAQ: PRVB), a clinical-stage
biopharmaceutical company.
The Phase IIa study will evaluate AG019 administered for 8 weeks
in combination with PRV-031 for the first 12 days as compared to
placebo. Pre-clinical studies of AG019, in association with a
short-term treatment with a systemic anti-CD3 monoclonal antibody,
induced reversion to normal blood sugar levels in 60% of diabetic
mice and reversed the disease in 89% of mice treated at early stage
of the disease. The results of the current trial are expected in
2020 and will provide initial data regarding the safety and
efficacy of AG019 in humans.
"PRV-031 immunotherapy has shown remarkable promise as a
single agent for the interception and prevention of type 1
diabetes," commented Ashleigh
Palmer, Provention Bio's Co-Founder and Chief Executive
Officer. "Combination strategies offer potential opportunities to
improve outcomes for early onset type 1 diabetes. We share
ActoBio's commitment to investigating new disease-modifying
therapeutic options for type 1 diabetes patients and their
families, and we look forward to learning more about the
combination of PRV-031 plus AG019 as this study advances."
Pieter Rottiers, PhD, Chief
Executive Officer of ActoBio Therapeutics™ stated, "We are excited
to start the AG019 trial in the 12- to 17-year-old patient cohort,
since T1D onset occurs most frequently in adolescents. We are also
looking forward to collaborating with Provention Bio in this next
stage of testing in patients. We have high hopes that the
combination of AG019 and PRV-031 will prove safe and
well-tolerated, to allow us to then move on to study efficacy as we
aim to make a difference to T1D patients' lives. We believe that
AG019, alone or in combination with teplizumab, offers potential as
a new therapeutic option to address this high unmet need."
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 following
oral or topical administration with possible treatment applications
across many diseases including oral, gastrointestinal and
autoimmune/allergic disorders. 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 LinkedIn.
About Type 1 Diabetes (T1D)
T1D is an autoimmune
disease, which affects approximately 1.25 million Americans, of
which 200,000 are under the age of 20. Without a cure, these
numbers are predicted to grow to more than 5 million Americans in
2050. Recent estimates suggest T1D has a $14
billion annual economic impact, based on treatment cost and
lost wages.
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, 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:
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Investor
Contact:
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Corporate
Contact:
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Steven
Harasym
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Marie Rossi,
PhD
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Vice President,
Investor Relations
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Vice
President, Communications
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Tel: +1 (301)
556-9850
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Tel: +1 (301)
556-9850
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investors@dna.com
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publicrelations@dna.com
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Local contact
ActoBio Therapeutics
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Kristoff
Baeten
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PR &
Communications
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T +32 474 88
1212
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communications@actobio.com
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SOURCE ActoBio Therapeutics, Inc.