Voormalig FDA-functionaris zal strategisch advies geven over wetenschappelijke, regelgevende en vaccinontwikkeling kwesties
LINCOLN, Neb.–(BUSINESS WIRE)– Adjuvance Technologies Inc., een privaat biofarmaceutisch bedrijf in de klinische fase dat de volgende generatie saponine-adjuvantia en vaccins voor infectieziekten en immuno-oncologie ontwikkelt, heeft vandaag aangekondigd dat Philip Krause, MD, de taak op zich zal nemen een strategische adviserende rol bij de organisatie bij de ontwikkeling van haar vaccinontwikkeling portfolio. Dr. Krause was onlangs de plaatsvervangend directeur van het Bureau voor Vaccinonderzoek en Beoordeling van het Center for Biologics Evaluation en Research van de Amerikaanse Food en Drug Administration (FDA).
Dr. Philip Krause to Provide Strategic Advice to Adjuvance
Former FDA official will provide strategic consulting on scientific, regulatory and vaccine development matters
LINCOLN, Neb.–(BUSINESS WIRE)– Adjuvance Technologies Inc., a privately-held clinical-stage biopharmaceutical company developing next generation saponin adjuvants and vaccines for infectious disease and immuno-oncology, today announced that Philip Krause, MD, will take on a strategic consulting role with the organization as it advances its vaccine development portfolio. Dr. Krause recently served as the Deputy Director, Office of Vaccines Research and Review of the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research.
“The deep scientific, regulatory and vaccine development experience that Phil brings to Adjuvance will be instrumental in efficiently developing our shingles vaccine candidate and our pipeline anchored on the next-generation saponin adjuvant TQL-1055,” noted Dr. Tyler Martin, Adjuvance CEO, President and Chairman. “I am thrilled to enhance the company’s expertise with such a well-respected scientist.”
Dr. Krause previously had a 30-year career in the FDA where he made major contributions in design of clinical trials, molecular virology and immunology, and the regulation and development of vaccines. He will provide strategic consulting on vaccine development, US and international regulatory affairs, clinical trial design and evaluation, virology and immunology and global health.
Dr. Krause said, “I look forward to this opportunity to provide advice and counsel to the Adjuvance leadership team on the development of their innovative saponin adjuvant platform, and their lead vaccine candidates.”
About TQL-1055: TQL-1055 is a rationally designed, semi-synthetic analogue of the QS-21 saponin adjuvant, which is used in the currently available shingles vaccine. Saponin adjuvants are potent immune stimulators and important components of licensed, currently marketed, and clinically advanced infectious disease vaccines. The usefulness of saponin adjuvants has been constrained by dose-limiting tolerability and manufacturing challenges. TQL-1055 is designed to have improved tolerability and to provide the same strong immune response as QS21 and has shown favorable tolerability in a Phase 1 clinical trial. Adjuvance is designing new combination adjuvants, with TQL-1055 as the foundation, to produce different types of immune responses.
About Shingles: Shingles (also known as herpes zoster) is a painful rash that develops, often on the face or torso, and has the potential complication of pain that can last for months or even years. Vaccination against shingles is recommended in the United States and many countries for older adults and people with weak immune systems, resulting in a market value of over $2.0 billion in 2020. Available shingles vaccines contain the saponin adjuvant QS-21 and the toll-like receptor (TLR) 4 agonist adjuvant monophosphoryl lipid A (MPL), known together as the AS01 adjuvant. The adjuvanted shingles vaccine is highly effective, but can cause short-term adverse events more intense than other vaccines. About 1 out of 6 people who got the available shingles vaccine experienced side effects that prevented them from doing regular activities. Symptoms went away on their own in about 2 to 3 days.
About Adjuvance Technologies: Adjuvance Technologies is a privately-held, clinical-stage biopharmaceutical company dedicated to making vaccines better 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 lead vaccine candidate against shingles aims to provide a better patient experience including improved tolerability for the recipient and the same protection against disease.
Headquartered in Lincoln, Nebraska, the company has received grant funding from the National Institutes 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.
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