Poultry industry's first engineered probiotic biologic moves into final development and regulatory stages for USDA conditional licensure and commercial scale-up
GREENFIELD, Ind., July 16, 2025 /PRNewswire-PRWeb/ -- BiomEdit, a pioneering animal health biotechnology company, today announced a significant milestone in the development of BE-101, its lead candidate for the prevention of mortality associated with necrotic enteritis (NE) in broiler chickens. The product has entered the final phase of the U.S. Department of Agriculture's (USDA) conditional licensure process and is advancing toward commercialization, expected in 2026.
BE-101, which will assume the brand name "Optavant™" upon full licensure, is the first-of-its-kind probiotic vectored antibody (pvAb™) product designed to neutralize Clostridium perfringens toxins – the major cause of NE associated productivity losses, disease and mortality, offering poultry producers a powerful, non-antibiotic solution to a disease that causes an estimated $6 billion in annual losses worldwide.
Recent progress includes:
- Completion and USDA approval of all required laboratory safety studies.
- Approval of pivotal efficacy study to establish a "reasonable expectation of effectiveness" for USDA conditional licensure.
- Acceptance of the Summary Information Format (SIF) and Risk Assessment, and start of the Federal Register Notice process, which precedes the field safety study.
- Completion of large floor pen NE challenge trials designed to simulate commercial conditions which demonstrated significant mortality reduction, feed conversion benefits and weight gain, showing BE-101's potential to address mortality and performance simultaneously.
To support upcoming commercialization, BiomEdit has selected Diamond Animal Health as its contract development and manufacturing organization (CDMO). Commercial scale-up activities are in progress.
"These approvals and study results represent a major inflection point for BE-101 and the entire BiomEdit platform," said Aaron Schacht, CEO of BiomEdit. "We're pleased to work closely with USDA to bring this novel solution to producers and to secure the right partner in Diamond Animal Health for commercial readiness."
"We're proud to support BiomEdit in the advancement of this truly innovative biologic platform," said Dean Warras, CEO of Diamond Animal Health. "The development of BE-101 represents the future of animal health solutions and will be a game changer for the poultry industry. At Diamond, we bring decades of experience in biologics development and manufacturing, and we're excited to apply that expertise to help bring Optavant™ to market at scale. This partnership exemplifies our commitment to working with leaders in innovation and to accelerating next-generation products that improve animal health and producer outcomes."
BiomEdit also announced the successful close of its Series B financing, led by Anterra Capital, with follow-on investment from Nutreco and new participation from AgriZeroNZ, Indiana's Elevate Ventures, and Betagro Ventures, among others. The oversubscribed round (~$18.4M) provides sufficient capital to fund BiomEdit through conditional licensure and into the commercial launch of BE-101.
In support of this next phase, BiomEdit has added two seasoned animal health industry executives:
- Kristin Bloink, DVM, MPH, has joined as Vice President of Development.
- Andrew Carlson has joined as Chief Commercial Officer.
In parallel, BiomEdit continues to build momentum across its broader pipeline. The company has secured over $1.7 million in new non-dilutive grants to support ongoing and new research programs, including:
- A USDA grant targeting Highly Pathogenic Avian Influenza (HPAI) with a novel biologic approach.
- A National Institutes of Health (NIH) award for early research into a human therapeutic application based on BiomEdit technology.
- A Global Methane Hub grant to investigate genetic systems in the rumen. This grant complements the previously awarded Gates Foundation grant of $4.5M received in 2023.
BiomEdit's methane-reduction platform is also advancing, with its first feed additive candidate now in in vivo evaluation for reducing enteric methane emissions while enhancing cattle productivity.
"We're pleased to invest in BiomEdit to accelerate the development of an effective methane mitigation solution for grazing cattle in New Zealand and around the world," said Wayne McNee, Chief Executive of AgriZeroNZ. "BiomEdit's poultry health product proves its unique, world-leading approach works, and our investment will support them to leverage this expertise to help farmers reduce methane emissions without compromising productivity and profitability."
"This is an exciting chapter for BiomEdit," said Schacht. "We are bringing a transformational poultry solution to U.S. broiler producers and pushing the frontiers of sustainable livestock production. In just three years since our founding, we are poised to deliver products to market, with new financing and investor support, as well as additional leadership well-suited for the opportunities and challenges ahead."
About BiomEdit
BiomEdit is an animal health microbial biotechnology company leveraging the power of the microbiome and synthetic biology to develop next-generation solutions for livestock and pet health. Founded in 2022, BiomEdit is backed by leading investors including Anterra Capital, Viking Global, Nutreco, AgriZeroNZ, Elevate, and Betagro Ventures, among others. www.biomedit.com
Media Contact
Julie Lawless, BiomEdit, 1 6155858561, [email protected], https://biomedit.com/
SOURCE BiomEdit
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