AAVogen Inc., a biotech company that is developing gene therapeutics for muscle wasting disease, welcomes Lawson Macartney, DVM/PhD as the newest member of its Science Advisory Board.
Dr. Macartney is a 25-year veteran of the pharmaceutical industry and currently chairs the Board of Directors for Viking Therapeutics. He has also held senior leadership positions at Ambrx, ScoutBio, Shire, GlaxoSmithKline and AstraMerck.
“Lawson is an incredible asset to the company and has immediately contributed to our development program,” said Dan Rodgers, founder and Chief Executive Officer of AAVogen.
“He possesses intimate knowledge of gene therapy science and manufacturing. He also understands the commercialization challenges unique to the field,” added Rodgers. “His expertise provides a much-needed industry perspective to an already renowned Science Advisory Board.”
AAVogen also completes another milestone by holding an FDA pre-IND meeting for AVGN7.
AVGN7 is an AAV-based gene therapeutic for muscle wasting disease and is being developed for treating cancer cachexia. Preclinical studies indicate that AVGN7 rapidly enhances muscle mass, muscle strength and exercise capacity. It also prevents muscle wasting in animal models of cancer cachexia.
“The FDA provided a straight forward roadmap to IND filing,” said Heather Hsu, Chief Business Officer, “consistent with our development plans.”
The Center for Biologics Evaluation and Research or “CBER” of the FDA regulates gene therapy products. CBER was well represented at the meeting and provided comments on AVGN7 preclinical development, manufacturing and clinical testing. These welcomed comments resulted in AAVogen making minor adjustments to the established development plan that will support the IND filing and initiation of clinical trials. These revisions overall will result in AAVogen saving substantial time and money.
“Obtaining clear and executable advice from the FDA is critical at any stage of development,” said Rodgers, “but especially for a small start-up such as AAVogen. We also can’t overestimate the importance of saving time and money. This could mean, after all, that we start clinical trials sooner and without having to focus so much of our efforts on fund raising, which is our current top priority.”
More information about AAVogen, AVGN7 and muscle wasting disease is available at www.aavogen.com. Additional information about the AAVogen product pipeline and investing in AAVogen is also available on the website and can be obtained by contacting Dr. Rodgers at danrodgers@aavogen.com.