Adjuvance Technologies Announces First Clinical Results of its Next-generation Saponin Adjuvant
24.8.2021 17:00:00 EEST | Business Wire | Press release
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210824005212/en/
Contact information
Investors
Tyler Martin
Chief Executive Officer
+1 402-817-5050
Media
Melissa Malhame
mmalhame@adjuvancetechnologies.com
+1 531-530-1287
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ningbo FEED Meeting Confirms Full Confidence in Q1 2027 FID for Allied Biofuels’ US$6.1 Billion Presidential Decree-Backed SAF and e-SAF Project18.9.2026 18:38:00 EEST | Press release
Allied Biofuels has held a major Front-End Engineering Design (FEED) meeting at Sinopec’s office in Ningbo, China, bringing together Allied Biofuels, Sinopec Engineering Group Co., Ltd. of China, Topsoe A/S of Denmark, Sasol South Africa Limited, and Plug Power of the United States — the principal international engineering and technology providers supporting its US$6.1 billion Presidential Decree-backed Sustainable Aviation Fuel (SAF) and e-SAF project in Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918708077/en/ FEED Meeting - Ningbo, China At the joint FEED meeting of the project’s core engineering and technology stakeholders, the discussions established clear alignment on engineering responsibilities, technology interfaces, design deliverables, project integration and the coordinated execution programme required to advance the project through FEED. All stakeholders working on the project expressed full co
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli ® (Relacorilant)18.9.2026 15:00:00 EEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu ® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 15:00:00 EEST | Press release
Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In DES
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca ® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 13:58:00 EEST | Press release
Alfasigma S.p.A, a global pharmaceutical company with a focus on innovation in rare disease and specialty care in areas where there is significant unmet patient need, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), an oral, once-daily JAK1 preferential inhibitor, for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy. Following this positive opinion, the application is now referred to the European Commission (EC) for final action. The EC’s decision is expected in the next weeks. “At present, half of people living with axSpA fail to adequately respond to treatment, leaving them with years of preventable struggle with persistent pain and other impactful symptoms,” said Daniele D'Ambrosio, Chief Development Officer, Alfasigma. “This
IMPACT Therapeutics and Pharmanovia Announce Positive CHMP Opinion for Senaparib, as a Potential First-Line Maintenance Treatment of Advanced High-Grade Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer18.9.2026 13:38:00 EEST | Press release
For business and medical media only This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918325771/en/ Stephan Eder, CEO, Pharmanovia IMPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality mechanisms, together with global specialty pharmaceutical company Pharmanovia, today jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a Marketing Authorisation (MA) for the medicinal product Sepalna® (senaparib) intended for the maintenance treatment of advance epithelial ovarian, fallopian tube and primary peritoneal cancer. Following the CHMP’s recommendation for approval, senaparib will be submitted to the European Commission (EC) for final decision. Once approved by the EC, senaparib will
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom