Abera Bioscience has concluded the last toxicological study with Ab-01.12 and received the final report, demonstrating that the vaccine is well-tolerated, has a good safety profile, and none of the tested doses resulted in lasting side effects.

“These are gratifying results and a significant milestone for both our vaccine platform and the vaccine candidate. We are working to secure funding for the clinical Phase 1 study for Ab-01.12 in a way that is advantageous for our shareholders,” says Maria Alriksson, CEO of Abera Bioscience.

Abera’s universal pneumococcal vaccine has undergone a two-part toxicological program, with the vaccine administered intranasally four times at 14-day intervals. The first part, involving multiple doses and administrations, was conducted in the spring, with the company announcing positive results in April 2023.

The company has received the final report indicating that the vaccine, at all doses, is well-tolerated and does not exhibit any lasting adverse effects.”

During the summer, a larger study with a similar design was conducted. All collected data, including a comprehensive range of toxicological parameters in line with regulatory requirements such as clinical observations, histopathological evaluation, and clinical chemistry, have now been analyzed and evaluated. The company has received the final report indicating that the vaccine, at all doses, is well-tolerated and does not exhibit any lasting adverse effects.

“The results from the toxicological studies are a crucial part of the development program, demonstrating that the vaccine has a good safety profile when administered intranasally. At the same time, we observe a robust immune response both systemically and locally in the nose, which is promising for the upcoming clinical trials. We look forward to bringing a vaccine to market that provides protection and prevents transmission,” says Mats Lundgren, CSO at Abera Bioscience.

Photo of Maria Alriksson: Abera