Goodwin Biotechnology, Inc., a biological contract development and manufacturing organization (CDMO) that specializes in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing mammalian cell culture expression systems and bioconjugation technologies, has partnered with Aspyrian Therapeutics to successfully complete process development, scale-up, and cGMP manufacturing of their novel antibody drug conjugate (ADC). Based on achieving this critical milestone, Aspyrian Therapeutics recently submitted and has received FDA’s acceptance of an Investigational New Drug (IND) Application for RM-1929, their first-in-class, precision targeted therapy for cancer, and they will be initiating clinical studies shortly for the treatment of patients with recurrent head and neck cancer.

Aspyrian Therapeutics secured an exclusive license from the National Cancer Institute for the 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. Because the payload in this unique ADC is inert until it is both in the tumor and activated by a laser using visible light, it overcomes the dose-limiting adverse effects that have hindered the development of conventional, toxin-loaded ADC systems.

“The team at Goodwin Biotechnology takes great pride in partnering with our clients and advancing their biopharmaceutical candidates through the development phase and to file INDs,” said SooYoung S. Lee, Ph.D., Chief Operating Officer at Goodwin Biotechnology. “We have worked with numerous clients in the past and it always reinforces our drive and commitment when we’re able to add value to our clients and their product portfolio.”

“I have found that working with the team at Goodwin Biotechnology has been a great pleasure,” noted Miguel Garcia-Guzman, PhD, president and chief scientific officer at Aspyrian Therapeutics. “We were originally impressed by their expertise in Bioconjugation. This perception was reinforced by the flexible and solution-oriented approach to the complexity of our project. They treated our product as theirs as they orchestrated a flexible and well-run process. 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.”