Goodwin Biotechnology, Inc. Completes GMP Manufacturing of Neogenix Oncology, Inc. Monoclonal Antibody for Upcoming Clinical Trials
- Category: Antibodies
- Published on Wednesday, 28 January 2009 01:00
- Hits: 1530
Neogenix Oncology AND Goodwin Biotechnology announced today that the first phase of manufacturing of the Neogenix therapeutic monoclonal antibody, NPC-1C, had been completed, and that GMP grade product had been delivered to Neogenix in preparation for Phase I/II clinical trials planned for the first half of the year
GREAT NECK, NY, & PLANTATION, FL, USA | January 28, 2009 | Neogenix Oncology, Inc. (Neogenix) and Goodwin Biotechnology Inc. (GBI) announced today that the first phase of manufacturing of the Neogenix therapeutic monoclonal antibody, NPC-1C, had been completed, and that GMP grade product had been delivered to Neogenix in preparation for Phase I/II clinical trials planned for the first half of the year.
Neogenix is a cancer therapeutics and diagnostic company focused on developing innovative new products for the diagnosis and management of a broad range of cancers. The company’s portfolio includes monoclonal antibodies that recognize cancer-specific immunogenic proteins (tumor-associated antigens) derived from specific tumor systems. Neogenix monoclonal antibodies are of value in that they define the immunogenic tumor protein as both a diagnostic marker and as a therapeutic target for tumor destruction.
NPC-1C is a novel monoclonal antibody intended for the treatment of advanced pancreatic cancer, and is the first of these products to enter development. Anti-tumor activity has been demonstrated both in-vitro ADCC assays and recently completed animal studies.
An Important Milestone
“Completion of this phase of development with NPC-1C represents an important milestone for our company,” said Philip M. Arlen, MD, Neogenix President and Chief Medical Officer. “The team at Goodwin has done an excellent job in delivering a high quality antibody that with FDA approval, will allow us to enter our Phase I/II trials.”
Commented Stephanie Finnegan, CEO of GBI, “While it is never easy to bring a novel molecule from the research bench into human clinical trials, the professionalism, scientific skills, good business practices and partnering spirit of the Neogenix team have facilitated our work immensely. Our team has been highly motivated to perfect the clinical manufacturing of a promising therapy for what is a devastating disease. It has been a privilege to work with Neogenix on this break-through project.”
About Neogenix Oncology Inc.
Founded in 2004, Neogenix Oncology, Inc., headquartered in Great Neck, NY, is a research-driven biopharmaceutical company that develops and commercializes innovative diagnostics and therapeutics for the management of serious and difficult to treat cancers. Neogenix’s pipeline is derived in part from the Hollinshead library of clinically tested vaccines, with the potential to develop products for a wide range of cancers, including colorectal, prostate, lung, ovarian, squamous, and others. The company conducts its research and development work in its laboratories in Great Neck, NY and in Rockville, MD. For more information, please visit the company's website at www.neogenixoncology.com.
About Goodwin Biotechnology Inc.
GBI is one of the earliest contract manufacturing organizations (CMO), specializing in process development and cGMP compliant mammalian cell culture of bio-therapeutics for pre-clinical through Phase III clinical trials. The company and its predecessor, The Goodwin Institute for Cancer Research have been operating in the biologics CMO sector since the early 1980’s. GBI's clients include small to midsized biotech companies, renowned cancer research institutes and various branches of the U.S. government
SOURCE: Neogenix Oncology, Inc.