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To manufacture ADC candidate for Phase I trials
March 25, 2014
By: Kristin Brooks
Managing Editor, Contract Pharma
Goodwin Biotechnology, Inc. has entered an agreement with Aspyrian Therapeutics, Inc. for the technology transfer, process development, scale-up, and cGMP manufacture of an Antibody Drug Conjugate (ADC) candidate for Phase I trials. Aspyrian has licensed a new ADC technology platform, Near-infrared Photoimmunotherapy (PIT), from the National Cancer Institute, which allows for efficient and selective ablation of tumor cells while sparing damage to critical structures adjacent to the tumor. The payload in this ADC is inert until it is in the tumor and activated by near-infrared (NIR) light, therefore is designed to overcome the dose-limiting adverse effects that have hindered the development of conventional, toxin-loaded ADC systems. “We are pleased to have been selected to partner with Aspyrian Therapeutics for this leading edge ADC project,” said SooYoung Lee, Ph.D., chief operating officer at Goodwin Biotechnology. “This important project is a testament to our experience and expertise in bioconjugation that has been developed and refined over more than a decade. This initiative has been led by Muctarr Sesay, Ph.D., vice president of Process Development who is one of the pioneers in process development and cGMP manufacturing of many ADCs and biologic drug conjugates, which Goodwin has successfully manufactured for human clinical studies.” “The technical expertise that Goodwin Biotechnology offers in the field of bioconjugation, coupled with the responsiveness and flexibility they exhibited during the selection process, made them the obvious choice,” said Miguel Garcia-Guzman, Ph.D., chief scientific officer at Aspyrian Therapeutics. “Our mission is to leverage the potential of the PIT platform by developing a pipeline of proprietary and partnered ADC products, and this collaboration represents a critical milestone in this endeavor.”
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