FISHERS, IND. (February 15, 2024) – BiomEdit, an emerging animal health biotechnology company, today announced the advancement of a first-of-its-kind engineered bacteria product into full pivotal development. The product candidate – CPerf LLV* (BE-101) – is a probiotic vectored antibody (pvAb) biological and was specifically engineered to combat the damaging effects of necrotic enteritis in broiler chickens. The company is targeting conditional licensure by the United States Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) in 2026.
Necrotic enteritis stands as one of the most economically devastating diseases in the poultry industry, causing annual losses estimated at $6 billion worldwide, with individual outbreaks resulting in mortality rates as high as 50%. Treating necrotic enteritis effectively remains a challenge. Antibiotics are often used reactively, after outbreaks occur, highlighting the need for preventive solutions. CPerf LLV* (BE-101) will offer an efficient-to-deliver, novel, non-antibiotic, biological approach to combating necrotic enteritis in poultry.
“We are very encouraged by the progress of CPerf LLV* (BE-101) and the positive results observed in our recent studies,” said Aaron Schacht, CEO at BiomEdit. “This represents a significant step forward in our mission to offer transformational solutions for poultry health and productivity.”
CPerf LLV* (BE-101) represents a paradigm shift in the tools available to poultry producers and veterinarians in the fight against necrotic enteritis. As a pvAb technology, CPerf LLV* (BE-101) is an engineered bacterial consortium that delivers protective biomolecules directly to the chicken’s gut. The engineered bacteria act as “probiotic vectors,” supporting gut health, while simultaneously expressing antibodies that neutralize toxins produced by the Clostridium perfringens (C. perfringens) bacteria responsible for the damaging effects of necrotic enteritis.
Regulatory Pathway for Approval: In BiomEdit’s collaboration with the USDA CVB, the Agency determined that the novelty of the antibody expression technology engineered into safe commensal Lactobacillus delivery strains establish eligibility for the conditional licensure pathway.
“As first-time innovations combining microbiome science and synthetic biology like CPerf LLV* (BE-101) emerge, it’s critical to work closely with regulatory authorities to ensure safe and efficacious products and efficient approvals,” said Emily Helmes, vice president of Regulatory at BiomEdit.
Pivotal studies are currently underway and completed studies have already demonstrated consistent and promising results. Five positive studies encompassing nearly 2,000 birds show significant reductions in necrotic enteritis-related mortality. BiomEdit has recently commenced efforts for a Series B capital raise targeting sufficient funds to advance CPerf LLV* (BE-101) to market and progress an exciting pipeline of several additional novel animal health projects.
About BiomEdit: BiomEdit is an emerging animal health biotechnology company that leverages a unique platform combining the leading science of the microbiome with synthetic biology to innovate novel animal health products. Founded through a strategic partnership in 2022 between Elanco Animal Health (NYSE: ELAN) and Ginkgo Bioworks (NYSE: DNA), the company was born from a carve-out of technology and assets from Elanco combined with access to Ginkgo’s leading cell programming platform technology.
