Stablepharma doses first patient in Phase 2b SPVX02 trial

Stablepharma has started dosing in a 160-patient Phase 2b trial of SPVX02 in Manchester, UK, the final clinical step before potential commercialization of its fridge-free tetanus-diphtheria booster. The study will test whether the vaccine matches the licensed comparator on immune response, safety and tolerability while supporting the company’s thermostable vaccine platform.

Why it matters: - Stablepharma is trying to remove refrigerated storage from a routine booster vaccine, which could cut cold-chain costs, reduce waste and make distribution easier. - The Phase 2b readout is the last clinical hurdle before potential commercialization of SPVX02. - If successful, Stablepharma could use the same platform across other vaccines and temperature-sensitive medicines.

What happened: - Stablepharma dosed the first participant in a Phase 2b clinical trial of SPVX02 on 6 October 2026. - The study is running in Manchester, UK. - The trial will enroll 160 healthy adults. - Participants will be randomized 1:1 to receive a single dose of SPVX02 or Tetadif®, the licensed WHO-prequalified tetanus-diphtheria comparator vaccine. - The study is single-blind and non-inferiority designed.

The details: - SPVX02 is a thermostable, lyophilised tetanus-diphtheria booster vaccine developed with Stablepharma’s StablevaX™ technology. - The vaccine is designed to remain stable at temperatures up to 30°C and resist freezing. - Ongoing real-time stability studies have shown potency retention for at least 6 months at 40°C and for 24 months at 30°C. - The primary objective is to assess whether post-boost immune responses are non-inferior to Tetadif®. - The trial will also evaluate safety and tolerability over 28 days after dosing. - Eligible participants must have previously received a primary tetanus and diphtheria vaccination. - The study protocol is SPL-SPVX02-02, with IRAS ID 1014057. - Stablepharma said the Phase 1 results published in eClinicalMedicine, part of The Lancet family of journals, showed a strong safety profile and immune responses comparable to licensed Td vaccines. - Stablepharma said the Phase 1 publication provided the first published human evidence that an aluminium-adjuvanted vaccine can be reformulated into a fridge-free, freeze-resistant product without affecting safety or immune performance.

Between the lines: - Stablepharma is positioning SPVX02 as more than a single product and as proof of concept for a broader thermostable vaccine and drug platform. - The company is also targeting biologics, anti-infectives, oncology products and other medicines that depend on refrigeration. - Chief Executive Officer Özgür Tuncer said the Phase 1 publication provided independent validation of the science behind SPVX02 and that Phase 2b is the final critical step toward commercialization. - Chief Operating Officer Dr. Karen O’Hanlon said the trial is meant to generate the evidence needed to move SPVX02 forward while showing the platform’s broader potential. - The chief investigator said the study is designed to provide robust clinical evidence on immunogenicity, safety and tolerability versus Tetadif®.

What's next: - Stablepharma will track immune responses and safety outcomes for 28 days after dosing. - The company will use the Phase 2b results to determine whether SPVX02 can advance toward commercialization. - Stablepharma will continue broader development of its StablevaX™ platform for vaccines, biologics and other temperature-sensitive pharmaceutical products. - More information is available in the company’s social media page.

The bottom line: - Stablepharma has moved its fridge-free Td vaccine into the final clinical stage, and the next data readout will determine whether the platform can become a commercial alternative to conventional refrigerated vaccines.