Stablepharma publishes Phase 1 data for fridge-free Td vaccine SPVX02

Stablepharma says peer-reviewed Phase 1 results for SPVX02, a thermostable tetanus-diphtheria vaccine reformulation, have been published in eClinicalMedicine. The data support the candidate’s safety, immunogenicity and 24-month stability at 30°C as the company advances to Phase 2b testing in Manchester.

Why it matters: - SPVX02 could reduce dependence on the global cold chain, which drives vaccine waste, storage costs and distribution failures. - A room-temperature stable Td vaccine could expand access in places where refrigeration is unreliable or expensive. - Stablepharma also frames the platform as a possible lower-carbon alternative for temperature-sensitive medicines.

What happened: - Stablepharma announced that Phase 1 clinical trial results for SPVX02 have been peer reviewed and published in eClinicalMedicine, part of The Lancet family of journals. - SPVX02 is a room-temperature stable reformulation of a licensed tetanus-diphtheria vaccine. - The company says the vaccine uses Stablepharma’s StablevaX™ technology. - The publication follows a multicentre, blinded, randomized Phase 1 study in 60 healthy adults. - Study participants had been vaccinated against tetanus and diphtheria more than 10 years earlier.

The details: - SPVX02 is a lyophilised version of Tetadif, a WHO prequalified Td vaccine manufactured by BB NCIPD in Bulgaria. - The candidate is designed to stay stable at ambient temperatures and resist freezing. - Ongoing real-time stability studies show potency retention for at least 24 months at 30°C. - Analysis is continuing toward a 48-month target. - Stablepharma said no vaccine-related serious adverse events were observed in the Phase 1 trial. - Reactogenicity was predominantly mild to moderate. - By day 28, 100% of participants receiving SPVX02 reached protective antitoxin levels for both tetanus and diphtheria. - Stablepharma said the immune response mirrored licensed comparator vaccines. - Dr. Karen O’Hanlon, Stablepharma’s chief operating officer, said the results provide the first in-human evidence that an aluminium-adjuvanted vaccine can be reformulated into a fridge-free, freeze-resistant product without loss of efficacy. - Professor Saul Faust, who led the study at the University of Southampton and the NIHR Clinical Research Facility in Southampton, said larger studies will be needed to confirm the findings. - The healthcare sector accounts for 4.4% of global carbon emissions, or about two gigatons of CO₂, according to the company’s cited source. - Stablepharma said cold-chain failures continue to cause substantial vaccine wastage worldwide.

Between the lines: - The publication gives Stablepharma independent validation at a key step before larger efficacy and safety studies. - The data suggest thermostable vaccines could be easier to ship, store and deploy in routine immunization programs. - The environmental case is part of the pitch, not just the clinical one. - The company is positioning StablevaX™ as a platform, not only a single vaccine program.

What's next: - Stablepharma has started recruitment for a randomised, single-blind, non-inferiority Phase 2b trial. - The Phase 2b study will run at the Medicines Evaluation Unit in Manchester. - The trial will enroll 160 healthy adults ages 18 to 60. - Stablepharma says it sees potential for fridge-free formulations across other therapeutic areas, including oncology and anti-infectives. - More information is available from the company’s social media page.

The bottom line: - SPVX02 has cleared an important early clinical milestone, and the next test is whether larger studies can confirm that fridge-free performance holds up in broader use.