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 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 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, chief operating officer, Goodwin Biotechnology.

“I have found that working with the team at Goodwin Biotechnology has been a great pleasure,” said Miguel Garcia-Guzman, president and chief scientific officer, 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.”