Animal Health biotech BiomEdit announced the advancement of a first-of-its-kind engineered bacteria product into full pivotal development. The product candidate – BE-101 – is a probiotic vectored antibody (pvAb™) biological and was specifically engineered to combat the damaging effects of necrotic enteritis in broiler chickens.
FISHERS, Ind., Feb. 15, 2024 /PRNewswire-PRWeb/ -- 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 – 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. BE-101 will offer an efficient-to-deliver, novel, non-antibiotic, biological approach to combating necrotic enteritis in poultry to address poultry producers' expectations for a next-generation solution.
"We are very encouraged by the progress of 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. By offering this novel biologic approach for producers to combat necrotic enteritis, we can help them avoid and reduce the use of antibiotics while supporting their achievement of poultry production goals."
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, 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. BiomEdit and CVB's recent alignment on licensing plan requirements for BE-101 paves the way for future pvAb™ approaches targeting different diseases and marks a significant advancement for the development of novel biotherapeutics in animal health.
"As first-time innovations combining microbiome science and synthetic biology like 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. "We appreciate the collaboration with CVB on BE-101."
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. The company is now focused on completing additional efficacy studies, scaling up and optimizing manufacturing, formulation and delivery studies, and conducting necessary safety studies to support regulatory submission.
BiomEdit recently commenced efforts for a Series B capital raise targeting sufficient funds to advance 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 to address challenges in livestock production and pet health. 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. BiomEdit is a private venture funded by Anterra Capital, Viking Global Investors, Ferment, and Nutreco Ventures. In 2022, BiomEdit was recognized by S&P Global Animal Health as Best Start-up in Animal Health and CEO Aaron Schacht as 2023's Visionary CEO in its annual animal health industry awards. In November 2023, BiomEdit received a $4.5M grant from the Bill & Melinda Gates Foundation to accelerate research and development of a portfolio of novel microbiome-based solutions to reduce methane emissions that also enhance feed efficiency for beef and dairy cattle. The company also announced a first-of-its-kind collaboration with Athian, the world's first cloud-based carbon marketplace for the livestock industry, to develop sustainability protocols and products in parallel. For more information, visit www.biomedit.com.
Wade B., Keyburn A. L., Seemann T., Rood J. I., Moore R. J. (2015). Binding of Clostridium perfringens to Collagen Correlates with the Ability to Cause Necrotic Enteritis in Chickens. Vet. Microbiol. 180 (3-4), 299–303. doi:10.1016/j.vetmic.2015.09.019
https://www.merckvetmanual.com/poultry/necrotic-enteritis/necrotic-enteritis-in-poultry
Media Contact
Julie Lawless, BiomEdit, 1 6155855861, [email protected], www.biomedit.com
SOURCE BiomEdit
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