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.
About Pertussis: Commonly known as whooping cough, pertussis is a respiratory illness that spreads from person to person. Vaccination against pertussis occurs throughout life and is recommended in many countries for all children and adults. Reported annual cases of pertussis in the United States have increased 10-fold between the 1970s and 2010s, revealing the need for more effective vaccines and vaccination.
About TQL-1055: TQL-1055 is a rationally designed, semi-synthetic analogue of the saponin adjuvant QS-21 that is designed to have improved tolerability and provide the same strong immune response as QS-21. Adjuvance has retained the desirable properties of, and eliminated several challenges with QS-21. TQL-1055 is a semi-synthetic molecule whose efficient synthesis uses raw material from leaves and branches of the Quillaja saponaria tree, making it available in greater quantities than the source material for other saponin adjuvants. TQL-1055 has shown favorable tolerability and a strong immune response in a clinical trial. With TQL-1055 as the foundation, Adjuvance is designing new combination adjuvants to produce different types of immune responses.
About saponin adjuvants: Saponin adjuvants are potent immune stimulators and important components of licensed and clinically-advanced infectious disease vaccines including those against shingles, malaria, COVID-19 and influenza. Saponin adjuvants have also been studied in immuno-oncology applications. Existing saponin adjuvants are limited by poor clinical tolerability and inefficient manufacturing requirements. The natural source material in most saponin adjuvants is extracted from the inner lining of the bark of the Quillaja saponaria tree, resulting in a terminal harvest.
About Adjuvance Technologies: Adjuvance Technologies is a privately held clinical-stage biopharmaceutical company dedicated to empowering health through fundamental breakthroughs in adjuvant design, vaccine development, and manufacturing. Adjuvance creates and manufactures next generation proprietary adjuvants as the foundation of its vaccine pipeline and for other developers through licensing partnerships. Our vaccine candidates in pertussis and herpes zoster aim to provide a better experience for the recipient and the same protection against disease.
Headquartered in Lincoln, Nebraska, the company has received grant funding from the National Institute of Health (NIH) and closed a Series A investment by Morningside Venture Investments. For more information, visit www.adjuvancetechnologies.com and connect with us on Twitter and LinkedIn.