ActoBio Therapeutics Greenlighted by FDA to Commence a Phase Ib/IIa Trial with AG019 for the Treatment of Early Onset Type 1 Diabetes

A unique combination approach to oral tolerance made possible by L. lactis therapeutic protein delivery

GHENT, Belgium I March 29, 2018 I ActoBio Therapeutics, a wholly owned subsidiary of Intrexon Corporation (NYSE: XON) and innovative biotechnology company focused on a new class of orally delivered biopharmaceuticals, and Intrexon T1D Partners LLC, have been granted allowance by the U.S. Food and Drug Administration (FDA) for their Investigational New Drug (IND) application to initiate a Phase Ib/IIa study for the treatment of early onset type 1 diabetes (T1D) with AG019, an innovative disease-modifying approach to induce immune tolerance in T1D.  Currently no disease-modifying treatment for T1D is available, and standard of care is primarily based on exogenous insulin and diet regulation in combination with lifestyle modification.

AG019 is an oral capsule formulation composed of engineered L. lactis delivering the autoantigen human proinsulin and tolerance-enhancing cytokine IL-10. AG019 is designed to reduce T1D pathology by re-establishing immunological tolerance to islet antigens via the production of regulatory T-cells.  Preclinical tests in new-onset diabetes animal models demonstrated stable reversion to normoglycemia after treatment with AG019 (L. lactis expressing IL-10 and human proinsulin) in approximately 60% of mice.  The most effective treatment effects were seen for AG019 in combination with short-term treatment with an anti-CD3 monoclonal antibody with a maximum level of diabetic reversion of 89% when treatment started at early diabetes.  AG019 also preserved residual β-cell function, halted insulitis progression and increased the frequency of regulatory T cells. 

"With ActoBio's AG019, I see for the first time the prospect of a disease-modifying treatment for type 1 diabetes patients, mostly children and young adults.  The preclinical tests of AG019 showed a significant diabetes remission rate when treatment started at early stage.  It could be a real game changer in disease management, which currently exists in life-long insulin dependence and adapted lifestyle.  Together with my patients, my team is looking forward to participate in clinical studies to further develop this application," commented Prof. Chantal Mathieu, head of the Diabetes division of R&D at the Leuven University and head of Clinical and Experimental Endocrinology University Hospital Leuven Belgium.

"Pre-clinical tests with AG019 combined with an anti-CD3 mAb showed to be the most efficacious treatment. We and our partner are proud to achieve this important milestone in the development of what could be the first true disease-modifying treatment of type 1 diabetes. We soon will start the clinical trials in association with specialized institutes in Europe and North America," commented Pieter Rottiers, PhD, CEO of ActoBio Therapeutics.

About Intrexon Corporation
Intrexon Corporation (NYSE: 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.  Intrexon's integrated technology suite provides its partners across diverse markets with 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.

About ActoBio Therapeutics, Inc.
ActoBio Therapeutics, Inc. is pioneering a new class of microbe-based ActoBiotics® biopharmaceuticals that enable expression and local delivery of disease-modifying therapeutics.  The ActoBiotics® platform produces biologics through oral or topical administration with treatment applications across many diseases including oral, gastrointestinal, and autoimmune/allergic disorders.  This cost-effective approach is being developed to provide safer and more efficacious treatments than injectable biologicals.  ActoBio Therapeutics has a strong R&D pipeline with the latest stage candidate in Phase 2b and an extensive portfolio of candidates ready for clinical development across a number of potential indications.

About Intrexon T1D Partners
Intrexon T1D Partners is a private company organized to develop and commercialize products through the ActoBiotics® platform to treat type 1 diabetes.  The company is a 50/50 joint venture between ActoBio Therapeutics and a select group of external investors.

SOURCE: ActoBio Therapeutics

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