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ActoBio Therapeutics(TM) Progresses AG019 to Next Stage of a Phase Ib/IIa Clinical Study for the Treatment of Type 1 Diabetes

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.

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 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 or follow us on Twitter at @Intrexon, on Facebook, and LinkedIn.

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

Local contact ActoBio Therapeutics

Kristoff Baeten

PR & Communications

T +32 474 88 1212


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SOURCE ActoBio Therapeutics, Inc.

ActoBio Therapeutics(TM) Progresses AG019 to Next Stage of a Phase Ib/IIa Clinical Study for the Treatment of Type 1 Diabetes

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Last Updated: 01-Jul-2019