Delnova Unveils Partnership With Pace Life Sciences To Boost Capabilities
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.
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