September 30, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Audentes Therapeutics Inc., headquartered in San Francisco, announced yesterday that it had added three executives to its leadership team.
Natalie Holles will step in as the senior vice president and chief operating officer. Prior to joining Audentes, Holles was senior vice president of corporate development at Hyperion Therapeutics She was at Hyperion from 2013 through its acquisition by Horizon Pharma in May of this year. She has also consulted to many privately-held biopharmaceutical companies on executive strategy and business development.
Thomas Soloway joins Audentes as senior vice president and chief financial officer. Most recently, Soloway was senior vice president and chief financial officer of Ascendis Pharma A/S, a biopharma company in Denmark. He participated in a successful initial public offering (KPO) to the NASDAQ. Before that, Soloway co-founded Transcept Pharmaceuticals, Inc. , where he started as senior vice president of operations and chief financial officer, eventually rising to executive vice president and chief operating officer.
Kevin Baker will be senior vice president of preclinical development. Prior to Audentes, Baker was vice president of preclinical development at Five Prime Therapeutics, Inc. Before that, he was associate director of protein therapeutics at Human Genome Sciences, Inc. (HGS). Baker has extensive experience in advancing drugs into clinical studies.
On Sept. 1, Audentes announced it was buying Cardiogen Sciences, Inc., a Palo Alto, Calif.-based company that focuses on drugs to treat inherited heart arrhythmias. Audentes focuses on developing and commercializing adeno-associated virus (AAV) gene therapies for rare diseases. It currently has three products in development, AT001 for X-Linked Myotubular Myopathy (XLMTM), AT002 for Pompe disease, and AT003 for CASQ2 subtype of Catecholaminergic Polymorphic Ventricular Tachycardia (CASQ2-CPVT).
In December 2014, Audentes closed on a $42.5 million Series B financing round led by Deerfield Management and joined by Sofinnova Ventures, Venrock and existing investors OrbiMed, 5AM Ventures and Versant Ventures.
Analyst speculate that the particular strengths of these three executive appointments point toward a potential IPO.
Gene therapy has been a tricky technology to make viable, and there’s very little basis for reimbursement. Other companies in this area include bluebird bio and Avalanche Biotechnologies . In June of this year, Avalanche’s stock plunged after doubts were raised concerning the design of its Phase II trial for wet age-related macular degeneration.
Although the Phase IIa trial met its 12-month primary endpoint, showing the drug was well tolerated and had a favorable safety profile, analysts tore into the study’s secondary efficacy endpoints at a conference call. There were particular concerns over the number of rescue injections performed and the measurements of retinal thickness. They also questioned the study’s design, that it did not show a statistically significant difference between the control arm and the AVA-101 patients.
Avalanche’s traded for $40.79 on June 11. After the report and conference, it sold for $18.75. It’s currently trading for $8.39.
The connection between Avalanche and Audentes is the gene therapy platform, both of which employ an adeno-associated viral vector. That isn’t to indicate that the two companies have identical platforms, however, but it may, according to the San Francisco Business Times, give investors pause should Audentes actually go public. That, of course, will depend on the results of its own clinical trials and the actuality of an IPO, which is currently just speculation. The three new executives clearly have experience in this area.
“It takes great people to build a great company and to achieve ambitious goals,” said Matthew Patterson, Audentes’ president and chief executive officer in a statement. “We are honored to have Natalie, Tom and Kevin join our team at this exciting time in our company’s growth, as their shared passion for our mission of serving patients with rare diseases combined with their proven leadership experience will greatly strengthen our ability to achieve our vision of becoming a leading gene therapy company.”