Axplora

Goodwin Biotechnology, Inc. and Aspyrian Therapeutics, Inc. have entered in an agreement for the technology transfer, process development, scale-up, and cGMP manufacturing of a novel Antibody Drug Conjugate (ADC) for use in Phase I clinical trials.

Aspyrian Therapeutics has secured an exclusive license from the National Cancer Institute for a new ADC technology platform, Near-infrared Photoimmunotherapy (PIT). This technology allows for highly efficient and selective ablation of tumor cells while sparing damage to critical structures adjacent to the tumor. Because the payload in this unique ADC is inert until it is both in the tumor and activated by near-infrared (NIR) light, it overcomes the dose-limiting adverse effects that have hindered the development of conventional, toxin-loaded ADC systems.

Commenting on the project, SooYoung Lee, PhD, Chief Operating Officer at Goodwin Biotechnology, said “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, PhD, 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,” noted Miguel Garcia-Guzman, PhD, 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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Near-infrared Photoimmunotherapy (PIT) is based on three components:
– An antibody that binds to cell-surface antigens.
– The NIR IR700DX dye conjugated to the antibody via a stable linkage.
– NIR light dosimetry to activate the conjugate (cell killing occurs whether the conjugate is surface-bound or internalized).

Upon administration of non-ionizing NIR light, PIT induces rapid cell killing by localized disruption of cell membranes of only those cells targeted by the antibody conjugate. Importantly, unbound conjugates and free dye do not elicit any phototoxicity upon NIR irradiation. The combination of selective binding to surface antigens and organ-localized NIR activation permits highly efficacious disease-specific ablation, while sparing nearby healthy tissues and structures.

Published in: Goodwin Biotechnology, Inc website

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