News | June 9, 2015

Goodwin Biotechnology And Aspyrian Therapeutics Collaborate On The Successful GMP Manufacturing And IND Submission For A Novel Antibody Drug Conjugate (ADC) Platform

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, Ph.D., 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."

About Goodwin Biotechnology, Inc.
Goodwin Biotechnology is a uniquely qualified CDMO that offers a Single Source Solution for our clients from cell line development, exploratory proof of concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and Biologic Drug Conjugates including Antibody Drug Conjugates (ADCs) for early and late stage clinical trials. By working with Goodwin Biotechnology, clients can enhance the value of their product candidates with clear development and manufacturing strategies, as well as a road map to meet the appropriate quality requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical development pathway in a cost-effective, timely, and cGMP compliant manner to enhance patients' lives. With over 20 years of experience as an independent integrated contract manufacturer, Goodwin Biotechnology has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multi-national biopharmaceutical companies. Based on the impressive track record, Goodwin Biotechnology was recently awarded Frost & Sullivan's Customer Value and Leadership Award for Best Practices in Mammalian Contract Manufacturing!  For more information, visit http://www.GoodwinBio.com.

About Aspyrian Therapeutics Inc.
Aspyrian Therapeutics Inc., a San Diego-based start-up biotechnology company, is developing a novel class of precision oncologic drugs for the treatment of solid tumors based on the Photoimmunotherapy platform licensed exclusively from the National Cancer Institute (NCI, USA). Photoimmunotherapy (PIT) utilizes cancer-selective antibodies conjugated to the molecule IRDye 700DX that is activated with a laser at the tumor site to induce rapid cancer cell destruction. The dual targeting resulting from in-tumor activation of a tumor-selective conjugate promises to deliver oncologists the ability to achieve locoregional tumor control with minimal damage to surrounding healthy tissues and structures. Importantly, laser activation can be accomplished on an outpatient basis by either external illumination or by needle placement of an optical fiber to illuminate a deep-seated tumor from within. The Company is currently working with a number of monoclonal antibodies with the potential to treat various types of cancers, including head and neck, esophageal, lung, brain, pancreatic, colorectal, breast and ovarian. For more information, visit www.AspyrianTherapeutics.com.

SOURCE: Goodwin Biotechnology, Inc.