ROCKVILLE, Md.--(BUSINESS WIRE)-- Trophogen Inc., a biotechnology company developing hormone and related growth factor analogs for human infertility, animal superovulation, and human cancers together with Advanced BioScience Laboratories Inc. (ABL), a biomedical contract research and manufacturing organization, today announced the signing of a contract manufacturing agreement between the two companies. The agreement includes the technology transfer and cGMP production of Trophogen’s recombinant, more potent/efficacious and longer acting human follicle-stimulating hormone (rhFSH) analog. The analog is the lead compound developed through Trophogen’s proprietary superagonist hormone technology platform originally licensed from the National Institutes of Health. The program is funded by a National Institute for Child Health & Human Development (NICHD) Phase 2 competitive renewal SBIR grant for $3 million over a 3 year period.
ABL will provide scale-up services, conduct an Engineering Run, and produce rhFSH under cGMP compliance for clinical studies scheduled in 2014.
"Trophogen is very pleased that the lead product of its large portfolio of more potent/efficacious and longer acting human and bovine recombinant superagonist analogs will be commercialized with ABL's expert assistance," said Dr. Bruce Weintraub, President and COO of Trophogen. “We look forward to working closely with ABL to bring this lead product to an IND and Phase 1/2 trial in 2014 and soon to begin clinical development of its other superagonist analogs as part of this collaboration."
“ABL is delighted to utilize our development expertise and cGMP manufacturing services within our recently commissioned manufacturing facility to support Trophogen’s lead product,” said Dr. Thomas VanCott, CEO of ABL. “We look forward to working closely with Trophogen to advance the rhFSH analog program into the clinic, and establish the basis for a long-term collaborative relationship.”
About Trophogen Inc.
Trophogen, Inc. is a U.S.-based biotechnology company founded in 2001 with series A funding from Toucan Capital, focusing on the development of human and bovine high affinity glycoprotein hormone and related growth factor superagonist analogs for human infertility and animal superovulation as well as targeted therapy and imaging of thyroid, ovarian, breast, prostate and testicular cancers. Trophogen was formed by two molecular endocrinologists who spent numerous years as academicians at the National Institutes of Health and the University of Maryland before striking out on their own to launch their first entrepreneurial endeavor. In addition to its venture capital support and this $3 million NICHD Phase 2 SBIR grant, Trophogen has received over $5 million from other NIH SBIR grants as well as over $2.5 million from various human and veterinary pharmaceutical co-development and licensing agreements. For more information about Trophogen please see www.trophogen.com.
Advanced BioScience Laboratories, Inc. (ABL) is a Maryland-based biomedical contract research and manufacturing organization dedicated to advancing the development of therapeutics, vaccines and other biologic products. ABL has extensive experience working with diverse organizations, including government and academic entities and commercial bio/pharmaceutical companies. Notable services include basic research, product design, process and assay development, preclinical in vivo models (including immunomonitoring), and Phase I/II cGMP biologics manufacturing. Since 2001 ABL has been a part of the Institut Mérieux, a group of four companies dedicated to developing translational science for better patient care globally. For more information on ABL and our services, please visit our website at www.ablinc.com.
Karen Dugard, Director of Operations
Andrew Arrage, Vice President, Business Development
KEYWORDS: United States North America Maryland
INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical