Belgium's ActoGeniX to Join Intrexon Bringing New Generation of Orally Delivered Biotherapeutics

Intrexon Corporation has entered into a definitive agreement to acquire ActoGeniX, a European clinical-stage biopharmaceutical company forging a new frontier in cellular therapeutics. The proprietary TopAct platform developed by ActoGeniX enables the molecular engineering of food-grade microbes (Lactococcus lactis) to generate biologically-contained ActoBiotics for in situ expression and secretion of novel biotherapeutic proteins and peptides including cytokines, enzymes, hormones, and monoclonal antibodies to the oral and gastrointestinal tract. This groundbreaking class of orally available biopharmaceuticals has the potential to facilitate targeted therapies against oral, gastrointestinal, metabolic, allergic and autoimmune diseases.

Intrexon's exclusive channel collaborators currently use the company's suite of technologies in cellular and gene therapies for cancer, orphan genetic disorders, blindness, infectious diseases, tissue repair, as well as synthetic biology-mediated production of APIs. The addition of the ActoGeniX platform brings two more clinical-stage assets to the Intrexon portfolio, and complements the broad collection of tools available for current and future partners to enable innovative solutions for the next generation of biotechnology. ActoBiotics offer the unique ability to deliver a vast number of biological and small molecule effectors selectively to the oral and gastrointestinal tract opening a pipeline of opportunities that cannot be achieved through customary delivery mechanisms like injectable medicines. By focusing on biopharmaceuticals with known pharmacological activity, documented efficacy and established safety profiles, the development risk for existing and potential partners is substantially lower than for newly discovered drug compounds.

"Together with Intrexon, our collective technologies have the potential to revolutionize treatment for an array of diseases through cost effective and efficacious biological therapies," said Bernard Coulie, CEO of ActoGeniX.  "Our validated cGMP manufacturing process is fully scalable, and the expertise of both companies will further advance our distinctive ability to deliver one or multiple biologics through an ActoBiotic at a cost of goods comparative to small molecules."

"Oral administration of potent protein-based biopharmaceuticals with high selectivity and low inherent toxicity combined with targeted distribution permits ease of administration for patients with gastrointestinal disorders.  With intervention focused at the site of pathology, these novel biotherapies have the potential to provide therapeutic effect beyond current treatment regimens," added William J. Sandborn, Chief, Division of Gastroenterology, Professor of Medicine, University of California, San Diego.

ActoGeniX's clinical-stage products include AG013, which delivers a therapeutic peptide for the prevention and attenuation of oral mucositis, and AG014, which secretes anti-TNF-alpha Fab to treat inflammatory bowel disease with localized delivery minimizing systemic exposure. Data from the AG013 Phase IB trial were published in the journal Cancer, and the Phase I PK study of AG014 indicated the product is safe and well tolerated while providing prolonged gastrointestinal exposure. Other ActoBiotics under development have shown positive efficacy data in animal models for allergic diseases, type 2 diabetes, as well as autoimmune disorders such as celiac disease and type 1 diabetes. With respect to type 1 diabetes, data on the effect of an ActoBiotic expressing the anti-inflammatory cytokine IL-10 combined with the auto-antigens pro-insulin or GAD-65 in an animal model have been published in the Journal of Clinical Investigation as well as Diabetes. ActoGeniX recently partnered with Stallergenes to develop first-in-class class oral allergy treatments after a successful Proof of Principle study, and it also has preclinical programs for the targeted modulation of the human microbiome whose imbalances are implicated in many disease areas.

"Utilization of living biofactories, whether through adoptive T-cell therapies, autologous fibroblast platforms, or food-grade microbes, is one of the principal objects of the engineering of biology, which we aspire to lead at Intrexon. The outstanding team at ActoGeniX is a welcome addition to assist us in this endeavor," commented Randal J. Kirk, Chairman and CEO of Intrexon. "While the applications of this novel platform are substantial and readily apparent within the Health segment, its utility across our Food, Animal Health, and Consumer sectors has us equally excited."