SB-REG-KMAS is an innovative veterinary biological drug candidate developed by Sanford Biotech based on its own research and preclinical studies and scientific publications, for the treatment of mastitis in dairy cows. The active substance is a suspension of live, allogeneic mesenchymal stem cells (MSCs) derived from adipose tissue, prepared in the form of a sterile suspension for intravenous and intra-arterial administration.
SB-REG-KMAS comes in the form of a sterile MSC suspension ready for use after thawing – ‘off-the-shelf’, which allows the veterinarian to quickly apply the preparation on the farm or in a field clinic.
It is estimated that mastitis affects 20–35% of dairy cows in Europe, and each case of the disease results in measurable losses: a drop in productivity, the need to withdraw milk from the market, and the costs of antibiotic therapy, as well as the culling of cows in the event of recurrence (approximately 10% per year).
Standard treatment of mastitis is mainly based on antibiotic therapy, during which milk from infected cows must beexcluded from commercial sale throughout the entire treatment and withdrawal period, resulting in significant economic losses. In cases of chronic or recurrent infections, cows are culled from the herd (approx. 10% annually), which increases milk production costs.
MSC cells have anti-inflammatory and regenerative properties, including:
As a result, cows return to full milk production more quickly and the risk of culling is significantly reduced.
SB-REG-KMAS is Europe's first cell therapy project for dairy cattle in the treatment of mastitis. This disease generates losses exceeding EUR 2 billion annually in the European Union, creating significant commercial potential for effective and safe biological therapies. The product is planned to be implemented in a B2B model – through distribution to large farms, dairy cooperatives and agricultural producer groups that seek to reduce culling costs and increase herd productivity.
The introduction of SB-REG-KMAS biological cell therapy shortens the recovery period, reduces the use of antibiotics by 40–60%, and thus significantly reduces production losses and culling costs. The project's business model assumes B2B sales to large farms, milk producer groups and dairy cooperatives, with the possibility of integrating the therapy system with preventive programmes and digital herd monitoring.
From an investor's point of view, SB-REG-KMAS represents a high return on investment (ROI) segment in the veterinary industry – the market for cell therapies for farm animals remains virtually untapped. It is predicted that by 2030, the value of the market for biological preparations for cattle in Europe will exceed EUR 1.5 billion, and products that reduce antibiotic therapy will become part of the EU's Farm to Fork strategy.
Sanford Biotech plans to develop SB-REG-KMAS as a licensing platform, enabling regional partners to obtain licences in the form of co-manufacturing or technology transfer, which increases scalability and reduces CAPEX costs. Combined with the growing demand for One Health and ESG-compliant therapies, the project has significant commercial potential and long-term portfolio value.