Lincoln, NE – October 4, 2021 – Adjuvance Technologies Inc., a privately-held, clinical-stage biopharmaceutical company developing next generation saponin adjuvants and vaccines for infectious disease and immuno-oncology announced that data from the first-in-human clinical trial of its TQL-1055 adjuvant were presented during the IDWeek 2021 scientific conference. The poster titled “Safety and immunogenicity of the semisynthetic saponin adjuvant TQL1055: preliminary results from a first-in- humans pertussis vaccine trial” will be presented by Dr. Sean Bennett, Chief Medical Officer.
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; study follow-up will continue through mid-2022.
About TQL-1055: TQL-1055 is a rationally designed, semi-synthetic analogue of the QS-21 saponin adjuvant. TQL-1055 is designed to have improved tolerability and provide the same strong immune response as QS-21. The efficient synthesis of TQL-1055 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. The usefulness of saponin adjuvants has been constrained by dose-limiting tolerability and manufacturing challenges. 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.
About IDWeek: IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). IDWeek is a recognized forum for peer-reviewed presentations of new research on scientific advances and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan.
Chief Executive Officer