Gallant Announces First-of-Its-Kind Partnership with MWI Animal Health to Deliver Anticipated FDA-Conditionally Approved Stem Cell Therapy into Veterinary Clinics 

Agreement establishes first ultra-low temperature cold chain in veterinary medicine ahead of anticipated potential first FDA-approved, off-the-shelf stem cell therapy 

SAN DIEGO – (February 27, 2026) – Gallant, an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced a landmark fulfillment agreement with MWI Animal Health (MWI), part of global healthcare company Cencora, to create the first-ever ultra-low temperature cold chain for veterinary medicine. This comes as Gallant advances toward delivering the potential first-ever FDA-approved off-the-shelf veterinary stem cell therapy, pending conditional approval by the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM). 

Together, the companies are laying the foundation for a new category of veterinary care. 

The first expected product from Gallant’s pipeline is sonruvetcel injectable suspension—a potential first-in-class, uterine-derived allogeneic mesenchymal stromal cell (MSC) therapy for cats with refractory feline chronic gingivostomatitis (rFCGS). Partnership with MWI will enable reliable delivery of veterinary stem cell therapies requiring storage at -80°C. 

“Breakthrough science only matters if we can safely and reliably put it into the hands of veterinary professionals,” said Dr. Linda Black, DVM, Ph.D., CEO of Gallant. “With MWI, we are pairing regenerative medicine innovation with world class supply chain management. This partnership helps ensure that, once approved, veterinarians can conveniently access an FDA-regulated, off-the-shelf stem cell therapy with confidence in its quality and integrity.” 

“This partnership demonstrates how distribution innovation can unlock clinical innovation,” said Julia Loew, CCO at MWI Animal Health. “Stem cell therapies require precision handling. By investing in ultra-low temperature logistics tailored to veterinary practice, we are ensuring that this category of innovation can be delivered to clinics in the exact state intended, ready for safe and effective use.” 

Under the agreement, MWI will develop and deploy a scalable, ultra-low temperature fulfillment model. It will support nationwide availability through overnight shipping from MWI’s Edwardsville, Kansas, distribution center, helping to ensure access for clinics across the continental United States and in noncontiguous U.S. markets, including Alaska, Hawaii and Puerto Rico. 

The companies expect the partnership to serve as a model by establishing infrastructure that can support Gallant’s broader pipeline of disease-modifying therapies targeting inflammatory and degenerative conditions in companion animals. 

Expanding the Spectrum of Care 

Recent survey data conducted by Gallant, in collaboration with the American Animal Hospital Association (AAHA), found that nearly 95% of veterinary professionals believe stem cell therapy will become a standard treatment option within the next decade. 79% say they are likely to use or recommend stem cell therapy in the future, and 93% report they would be more likely to offer regenerative therapies in-house if they were off-the-shelf and delivered through a simple IV protocol. 

The Gallant–MWI partnership directly addresses veterinary professionals’ expectations and practice needs by pairing an anticipated FDA-regulated, donor-derived stem cell therapy with a clinic-friendly fulfillment model. 

About Gallant 

Gallant is an animal health biotechnology company creating a new category of veterinary medicine with a pipeline of off-the-shelf, ready-to-use stem cell therapies targeting the root causes of disease in pets. Led by pioneers in veterinary regenerative medicine with deep expertise in development, manufacturing and commercialization, Gallant is making regenerative medicine accessible to everyday practice. Learn more at www.gallant.com. 

Luna Bioscience’s Recent Research Discoveries Advance Development of Leptospirosis Rapid, Point-of-Care Diagnostic Tests and Recombinant Protein Vaccines

Researchers from Yale University, in collaboration with Luna Bioscience, Inc., have unveiled a revolutionary diagnostic method that detects leptospiral Virulence-Modifying (VM) proteins in the blood and urine of infected animals, paving the way for early diagnosis, supporting vaccine development and improved understanding of leptospirosis pathogenesis. “This is the first systemic bacterial disease mediated by a toxin (such as tetanus, botulism, diphtheria) that has the potential for rapid antigen/antibody detection by a novel test, with direct implications for similar test development for other veterinary diseases,” says research team leader Dr. Joseph M. Vinetz.

The research has led to the development of monoclonal antibody (mAb)-based capture immunoassay and antibody/antigen detection-based diagnostic tests. These assays directly detect VM proteins and animal antibody responses to these proteins, a recently identified family of leptospiral proteins crucial for disease pathogenesis. The findings are detailed in a paper published in the September 29 online issue of Microbiology Spectrum.  https://doi.org/10.1128/spectrum.00018-25 

“We have long known that leptospirosis severely impacts multiple organ systems in dogs, leading to conditions like jaundice, acute kidney injury, and pulmonary haemorrhage,” said Dr. Vinetz. Furthermore, in livestock, rapid diagnosis in individuals and herds promises to improve animal health. “Our discovery of these VM proteins as circulating exotoxins gives us a specific target for both diagnostics and potential therapeutic interventions.”

The assay’s success in detecting VM proteins lays the groundwork for developing rapid, inexpensive lateral flow diagnostics suitable at point of care, for both veterinary and human use. Such tools are particularly crucial for resource-limited settings where leptospirosis is most prevalent.

This study was supported by the National Institutes of Health and the America’s Foundation, with significant contributions from Luna Bioscience, Inc.

For further information, please contact:

Carla Devillers, CEO, Luna Bioscience, Inc.

  carla@lunabioscience.com    +1 (917) 545-7262

Dr. Joseph M. Vinetz
Section of Infectious Diseases, Department of Internal Medicine
Yale University School of Medicine

joseph.vinetz@yale.edu

Yale University Office of Public Affairs & Communications

public.affairs@yale.edu


About Luna Bioscience:

Luna Bioscience, Inc. is a spin-out from Yale University developing solutions for animals and humans to emerging global infectious diseases through novel vaccines, diagnostics and therapeutics. Luna has been supported by a series of peer-reviewed NIH small business grants, a testament to the rigorousness and clinical relevance of its translational science.

About Yale School of Medicine:
Yale School of Medicine, founded in 1810, is a world-renowned center for biomedical research, education, and advanced health care. It ranks among the top medical schools in receipt of research funding from the National Institutes of Health and is a vital part of Yale University.

Source:
Chaurasia R, Jacobs A, Tang J, Dong S, Vinetz JM. Development of Leptospiral Virulence-Modifying Protein Detection Assay: Implications for Pathogenesis and Diagnostic Test Development. Microbiology Spectrum. 2025, embargo release date, 9-29-2025


MORE on LUNA BIOSCIENCE:

Luna Bioscience has established robust data providing a pathway for collaborating with a major development partner for vaccine and rapid diagnostic test development for leptospirosis in dogs and food-producing animals.

Luna’s co-founder and chief executive Carla Devillers told XYZ media outlet that the industry’s top players are interested in the firm’s leptospirosis vaccine and diagnostics, as Luna’s R&D developments are a major improvement on the currently available vaccines that are based on whole killed bacteria. Further, Devillers said that the advent of rapid diagnostics will enable improved case identification, driving further novel leptospirosis vaccine development.

The New Haven, Connecticut-based start-up is working on a universal one-shot leptospirosis vaccine that can provide long-term protection against all Leptospira species and serovars– current vaccines tend to be for 2-5 serovars at a duration of 6-12 months. Luna also believes its recombinant protein approach can produce vaccines with a low cost of goods in comparison to currently marketed products.

The start-up’s advisory board includes animal health industry experts such as Dr. Judy Jarecki-Black (former global head of intellectual property at Merial) and Dr. Fabian Kausche (previously head of global R&D at Boehringer Ingelheim Animal Health as well as chair of PetMedix).