DelNova has announced a strategic partnership with Pace® Life Sciences to serve as their contract development and manufacturing organization (CDMO). This collaboration is aimed at advancing DelNova's candidate Rescue Drug, ReViVox®, designed to address unwanted side effects that may occur after Botulinum Neurotoxin (BoNT) therapy, including well-known US brands like BOTOX®, DYSPORT®, XEOMIN®, and JEUVEAU®.

Pace® Life Sciences brings essential expertise to support DelNova in completing investigational new drug (IND)-enabling research for future FDA submissions. This includes work on formulation, kinetics, and stability. DelNova is actively seeking funding opportunities, both dilutive and non-dilutive, including an application submitted to the Small Business Innovation Research (SBIR) program.

Furthermore, through this partnership with Pace® Life Sciences, DelNova gains the capability to manufacture small Good Manufacturing Practice (GMP) batches of drug products for clinical studies. Pace® Life Sciences, with its specialized CDMO facility in San Diego, excels in complex drug delivery, formulation, and sterile fill-finish GMP manufacturing.

Mary Gardner, CEO and Founder of DelNova, and Frank Tagliaferri, PhD, Vice President of Pharmaceutical Development at Pace® Life Sciences, are enthusiastic about this collaboration. They bring extensive pharmaceutical development expertise to DelNova's efforts. Currently, there is no available product to reverse unwanted paralysis induced by BoNTs, making ReViVox® potentially the first of its kind to address this medical need.

Pace® Life Sciences is a comprehensive provider of contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services for the pharmaceutical, biopharmaceutical, and gene therapy industries. DelNova's ReViVox® is poised to address complications arising from off-target muscle paralysis following aesthetic and medical neurotoxin therapies, filling a crucial void in the industry.

This partnership underscores the commitment of both companies to advance medical solutions and improve patient outcomes in the field of neurotoxin therapy.

More Information : https://www.techdogs.com/tech-news/pr-newswire/delnova-unveils-partnership-with-pace-life-sciences-to-boost-capabilities
Comments (0)
No login
Login or register to post your comment