Adjuvance Technologies Inc., a privately-held clinical-stage biopharmaceutical company developing saponin adjuvants and vaccines for infectious disease and immuno-oncology, announced that its adjuvant TQL-1055 was safe and well-tolerated with a co-administered pertussis vaccine. This is the first clinical trial of a candidate from the company’s adjuvant and vaccine portfolio.

“The usefulness of saponin adjuvants has been constrained by dose-limiting tolerability and manufacturing challenges. Our semi-synthetic molecule is designed to overcome these limitations,” said Tyler Martin M.D., Chief Executive Officer at Adjuvance. “These promising interim results demonstrate the potential of TQL-1055, including its ability to be used in a broader dose range without compromising its excellent tolerability.”

Interim data from the trial show that TQL-1055 was generally well tolerated across all dose levels, with an overall safety profile similar to a commercial pertussis vaccine. Solicited events reported by subjects included mild to moderate injection site reactions and mild or moderate systemic symptoms at a frequency similar to the commercial vaccine. No serious adverse events were reported.

The ongoing phase 1, randomized, double-blind, active-controlled, dose-escalation study is assessing the safety and immunogenicity of Pertussis Acellular Vaccine Adjuvanted with TQL-1055 (PAVA). It has fully enrolled 72 healthy adults 18-50 years of age and is evaluating six escalating dose levels from 25 to 800 mcg of TQL-1055, co-administered with a commercial pertussis vaccine. The primary endpoints of the study are safety and tolerability. Further data will be presented at IDWeek 2021.