Delnova Unveils Partnership With Pace Life Sciences To Boost Capabilities

 


DelNova's strategic partnership with Pace® Life Sciences marks a significant step towards advancing the clinical development of ReViVox®, their lead candidate designed to address the unintended outcomes of botulinum neurotoxin (BoNT) treatments like Botox®. Pace® Life Sciences, a Contract Development and Manufacturing Organization (CDMO), will provide comprehensive services including contract CMC development, clinical trial materials manufacturing, and regulatory compliance to support DelNova in achieving this critical goal.

This collaboration is driven by DelNova's unwavering commitment to mitigating unwanted side effects arising from BoNT therapy, encompassing renowned US brands like BOTOX®, DYSPORT®, XEOMIN®, and JEUVEAU®.

Pace® Life Sciences will play a pivotal role by offering the essential expertise needed to complete the investigational new drug (IND) research necessary for future FDA submissions, covering crucial aspects like formulation, kinetics, and stability.

DelNova's proactive approach extends to actively pursuing funding, both dilutive and non-dilutive, exemplified by a recent application submitted to the Small Business Innovation Research (SBIR) program.

Moreover, through this strategic partnership, DelNova gains the valuable capacity to manufacture small Good Manufacturing Practice (GMP) batches of ReViVox® for clinical studies. Pace® Life Sciences, with its extensive presence across the US and a specialized CDMO facility in San Diego, brings invaluable expertise in complex drug delivery, formulation, and sterile fill-finish GMP manufacturing to the table.

DelNova's CEO and Founder, Mary Gardner, in collaboration with Frank Tagliaferri, PhD, Vice President of Pharmaceutical Development at Pace® Life Sciences, combine decades of pharmaceutical development experience to drive this groundbreaking effort. Importantly, ReViVox® has the potential to be the pioneering product addressing the unmet medical need of reversing unwanted paralysis induced by BoNTs, drawing significant interest from medical practitioners worldwide.

Pace® Life Sciences remains dedicated to providing comprehensive contract services, supporting efficient program advancement in the pharmaceutical, biopharmaceutical, and gene therapy industries. Their network of CDMO sites, including GMP analytical testing laboratories and manufacturing support service centers, underscores their commitment to efficiently advancing client programs through the clinic to commercialization. Their mission revolves around delivering superior and reliable services that result in positive customer experiences across all channels of their business.

Meanwhile, DelNova's ReViVox®, designed specifically for the rescue of complications caused by off-target muscle paralysis following aesthetic and medical neurotoxin therapies, such as botulinum toxins type A (e.g., Botox®), is attracting considerable attention from medical practitioners worldwide. This growing interest validates the pressing need for a product that addresses this industry void and has the potential to revolutionize the field.

Read More - https://www.techdogs.com/tech-news/pr-newswire/delnova-unveils-partnership-with-pace-life-sciences-to-boost-capabilities

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