Goodwin to manufacture ADC for Aspyrian

Aspyrian Therapeutics has selected CDMO Goodwin Biotechnology to complete process development, scale-up, and cGMP manufacturing of their novel antibody drug conjugate (ADC).  

The selection of Goodwin comes as Aspyrian recently submitted and has received FDA's acceptance of an Investigational New Drug (IND) application for the recurrent head and neck cancer therapy RM-1929.

The deal comes as over the last two years, Goodwin has manufactured monoclonal antibodies for Actinium Pharmaceuticals and Alethia Biotherapeutics, and has done other fill/finish work for Panacea Pharmaceuticals.

David Cunningham, director of communications at Goodwin, told us that all of the company’s manufacturing work is done at its facility in south Florida, where the company offers a variety of bioconjugation services and technologies.

The deal also follow’s Aspyrian’s securing of an exclusive license from the National Cancer Institute for its new ADC technology platform, Near-Infrared Photoimmunotherapy (PIT), which permits highly efficient and selective ablation of tumor cells while sparing damage to critical structures adjacent to the tumor.

Miguel Garcia-Guzman, President and Chief Scientific Officer at Aspyrian Therapeutics, said: "This is our company's first IND submission and securing the IND was a crucial milestone for our company. It speaks about the quality, timeliness, and process economics that Goodwin Biotechnology puts into every aspect of their work."