Intrexon said today it will acquire ActoGeniX for $60 million, in a deal that combines the companies’ technologies to create new oral biologic drugs for a variety of disease targets.
The deal joins Intrexon’s UltraVector® platform and integrated technology suite—part of a synthetic biology approach the company dubs “Better DNA®”—with ActoGeniX’s TopAct™ platform.
UltraVector is used toward development of cellular and gene therapies for cancer, orphan genetic disorders, blindness, infectious diseases, tissue repair, as well as synthetic biology-mediated production of APIs. The platform uses a modular method allowing users to design and build standard genetic components into gene programs and DNA vectors.
According to Intrexon, UltraVector applies assembly-line manufacturing processes to DNA fabrication and create complex DNA sequences from a standardized inventory of parts using automated techniques. This allows for functional screening and new solution development to be produced quickly and cost-effectively.
TopAct is designed to enable molecular engineering of food-grade microbes (Lactococcus lactis) that in turn generate biologically-contained ActoBiotics™ for in-situ expression and secretion of new biotherapeutic proteins and peptides—including cytokines, enzymes, hormones, and monoclonal antibodies to the oral and gastrointestinal tract.
According to ActoGeniX, ActoBiotics can selectively deliver a vast number of biological and small molecule effectors to the oral and gastrointestinal tract, opening opportunities that cannot be achieved through customary delivery mechanisms like injectable medicines. ActoBiotics have the potential to generate one or more targeted biologic therapies against oral, gastrointestinal, metabolic, allergic, and autoimmune diseases—and at a cost comparative to small molecules, the companies said.
“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,” Intrexon Chairman and CEO Randal J. Kirk said in a statement. “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.”
Added ActoGeniX CEO Bernard Coulie, M.D., Ph.D.: “Together with Intrexon, our collective technologies have the potential to revolutionize treatment for an array of diseases through cost effective and efficacious biological therapies.”
ActoGeniX brings to the combined company a fully-scalable, validated cGMP manufacturing process, as well as two clinical-stage compounds to Intrexon’s portfolio: AG013, designed to deliver a therapeutic peptide for 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, while the Phase I PK study of AG014 indicated that the compound is safe and well tolerated while providing prolonged gastrointestinal exposure.
According to Intrexon, 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. 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 of type 1 diabetes have been published in the Journal of Clinical Investigation as well as the journal Diabetes.
In December 2013, ActoGeniX launched a collaboration with Stallergenes to develop first-in-class oral allergy treatments following a successful Proof of Principle study. ActoGeniX is eligible for Under that deal, ActoGeniX is eligible for upfront, preclinical, clinical, regulatory, and commercial milestone payments totaling up to €75 million (about $85.5 million) per allergen, as well as tiered royalties on net sales of future products.
ActoGeniX also has preclinical programs for the targeted modulation of the human microbiome, whose imbalances have been linked to numerous areas of disease.
Intrexon agreed to pay ActoGeniX stockholders approximately $30 million in cash and $30 million in Intrexon common stock. The deal is set to close during the first quarter of this year, subject to customary closing conditions.