Calder Biosciences announces clinical supply agreement with Biodextris to evaluate its lead RSV vaccine candidate as part of a Phase 1 clinical trial
2023 BIO International Convention
BOSTON, June 6, 2023 /PRNewswire/ - Calder Biosciences Inc., a molecular engineering and clinical manufacturing-stage biotechnology company pioneering its 3D-Vaxlockä platform technology to engineer and develop novel protein subunit vaccines, today announced a clinical supply agreement with Biodextris Inc.
Under the agreement, Calder Biosciences will evaluate DT-preF, its lead candidate in the development of a vaccine to prevent acute lower respiratory infections caused by the Respiratory Syncytial Virus (RSV), as part of a Phase I clinical trial that will include an efficacy read-out. Preclinical studies are designed to assess the toxicity and tolerability of the lead candidate vaccine. The preclinical study will begin in Nov and the Phase 1 clinical study will begin in H1 2024.
Calder Biosciences' CEO, Chris Marshall, remarks: "We are truly excited to be working with the Biodextris team to bring our RSV vaccine candidate into production, featuring our novel manufacturing process. This represents the first of a series of conformationally locked protein subunit vaccines with greatly improved safety and potency."
"We are delighted to have signed this agreement with Calder Biosciences. It represents an important contract for Biodextris, as this work will be the first to be carried out by our production and development teams in our new industrial-scale vaccine and biologics development, manufacturing and packaging plant (CDMO)" says Alain Carrier, General Manager of Biodextris. The new Biodextris biomanufacturing centre (cGMP) and its analytical capabilities was developed with the support of the governments of Quebec and Canada and Investissement Québec.
Today's announcement was made at the 2023 BIO International Convention, which is being held in Boston, MA, from June 5 to 8.
About Biodextris Inc.
Founded in 2015, Biodextris is a subsidiary of Clean Biologics SAS, which provides clinical manufacturing process analysis and development services and quality control testing for clients in the vaccine and biologics industries. The company is staffed by experienced biologics development scientists, and key team members have worked together in medium and large vaccine development and manufacturing companies for almost twenty years. The Biodextris team provides its extensive pharmaceutical company expertise in a more personal and interactive setting to clients of various sizes. The company develops, manufactures, and tests a wide range of biological products for vaccine, pharmaceutical, and other applications. Biodextris has the experience and expertise to develop high-quality, robust, and marketable products, while acting with the flexibility and sense of urgency required by small organizations. For more information biodextris.com
About Calder Biosciences Inc.
Founded in 2018, Calder Biosciences is a New York City-based, privately held, clinical manufacturing-stage biotechnology company with financial backing from SOSV, a global venture capital firm. Calder is developing next-generation protein subunit vaccines. Calder's proprietary 3D-Vaxlockä technology locks proteins in the conformation that most prominently exposes sites of vulnerability and elicits substantially amplified and focused, neutralizing antibody responses, along with strong T cell responses. These responses are expected to improve both protection and safety. Better stability also substantially reduces cold chain requirements and spoilage. Calder's lead, 3D-Vaxlock'd RSV vaccine is entering clinical development. For more information: calderbiosciences.com