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CPerf LLV* (BE-101) — The first-of-its-kind engineered bacterial biologic1
Clostridium Perfringens Alpha Toxin and NetB Antibody Fragment, Live Limosilactobacillus Vector or CPerf LLV* (BE-101) is an engineered probiotic that helps reduce mortality associated with necrotic enteritis (NE) in poultry. NE is one of the industry’s most costly diseases caused by Clostridium perfringens. It is the first conditionally licensed product from our Programmable Veterinary Biologics™ platform.
The problem
Necrotic enteritis costs the poultry industry an estimated $6B annually.
The shift to antibiotic-free production has made necrotic enteritis harder to control, and costlier to ignore.
The solution
CPerf LLV* is a non-antibiotic approach engineered against Clostridium perfringens toxins to reduce the impact of necrotic enteritis (NE) in broiler chickens with the expected result of lower NE-associated mortality and other NE-related losses.
Now available to U.S. producers under USDA conditional license.
The first-of-its-kind engineered bacterial biologic for poultry to achieve USDA conditional licensure.1
What it means for broiler production.
Demonstrated 48.7% reduction in NE-associated mortality in broiler chickens, from 13.1% in challenged controls to 6.6% in birds receiving CPerf LLV* in a pivotal study reviewed by USDA Center for Veterinary Biologics (CVB) supporting conditional licensure.
Improved broiler weight gain and feed conversion were observed in a controlled study of subclinical NE published in npj Biofilms and Microbiomes, a Nature portfolio journal, for probiotic-delivered nanobodies targeting alpha toxin and NetB of C. perfringens as compared with treatment groups of prophylactic antibiotics and the parent probiotic strains. Systemic factors contributing to the observed performance differences were analyzed and confirmed in situ expression of the nanobodies and provided mechanistic data.
Fits antibiotic-free and no-antibiotics-ever programs.
Designed to act in the gut of the chicken and engineered against C. perfringens toxins, a primary driver of NE-related disease, mortality and productivity losses.
Reasonable expectation of efficacy in terms of reduced NE-associated mortality from necrotic enteritis in a challenge trial. Effects on growth performance and feed efficiency have been observed in research studies but were not reviewed by USDA.
How CPerf LLV* is administered
Two applications, and no daily protocol to manage.
CPerf LLV* is applied as a spray at the hatchery. Chicks ingest the strains during natural preening, and the strains colonize the intestinal tract. A second dose is delivered through the water system at 13 days, anticipated to last through the growth cycle, with no continuous in-feed program to manage.
The colonized strains produce and secrete nanobodies that were engineered against C. perfringens toxins before they damage the gut wall, so the product supports healthier guts allowing the birds to grow to their genetic potential.
“This is an exciting chapter for BiomEdit. We are bringing a transformational poultry solution to U.S. broiler producers and pushing the frontiers of sustainable livestock production.”
Aaron Schacht, CEO, BiomEditOther products in our pipeline
BE-105 | Obesity & Diabetes (Cats)2
Oral biologic for chronic weight management and metabolic health and first demonstration that microbial biologics can potentially deliver systemic peptide pharmacology.
BE-122 | Inflammatory Bowel Disease (Dogs)2
Oral biologic to help treat inflammatory bowel disease (IBD) in dogs, offering a potential alternative or complement to chronic corticosteroid therapy.
The subject product is licensed conditionally by USDA. The approved claim is: This product has shown a reasonable expectation of efficacy for passive immunity of healthy chicks against Clostridium perfringens. Duration of passive immunity has not been determined. The license is conditional; efficacy and potency have not been fully demonstrated. Product use is subject to federal and state regulatory requirements. The subject product is covered by one or more U.S. patents, including U.S. Patent Nos. 12,599,637 and 12,427,174. Additional U.S. and foreign patents may be pending.
1 USDA has issued a conditional license for the product CPerf LLV* in accordance with regulation 9 CFR 102.6.
2 Pipeline candidates (BE-105, BE-122) are experimental products in research, have not been approved by the FDA or USDA, and are not available for commercial sale. Pipeline information is subject to change as technical, clinical, and regulatory evaluations evolve.
Curious what’s next after CPerf LLV*?
*Clostridium Perfringens Alpha Toxin and NetB Antibody Fragment, Live Limosilactobacillus Vector