Adverum Biotechnologies Provides 2018 Outlook
“In 2017, our newly-assembled team achieved our stated goal of transforming Adverum into a clinical-stage company,” said
Key Accomplishments for 2017
- Dosed the first patient in the ADVANCE Phase 1/2 trial for ADVM-043 in alpha-1 antitrypsin (A1AT) deficiency. The primary endpoint is safety and tolerability, and secondary endpoints include changes in plasma concentrations of both total and M-specific A1AT levels.
- Demonstrated long-term sustained expression of anti-VEGF protein in non-human primates following a single intravitreal injection of ADVM-022 for the treatment of wet age-related macular degeneration (wAMD).
- Appointed three highly-experienced new board members:
Eric G. Carter , M.D., Ph.D.,Richard N. Spivey , Pharm.D., Ph.D., andPatrick Machado , J.D. - Appointed Athena Countouriotis, M.D. as senior vice president and chief medical officer.
2018 Outlook - Planned Pipeline Milestones
ADVM-043 for A1AT Deficiency
- Report preliminary data from the ADVANCE Phase 1/2 clinical trial in the second half of 2018.
ADVM-022 for wAMD
- Report 12-month efficacy data in non-human primates in the first half of 2018.
- Complete Investigational New Drug (IND)-enabling preclinical studies.
- Submit an IND application to the
U.S. Food and Drug Administration (FDA ) in the second half of 2018.
ADVM-053 for Hereditary Angioedema (HAE)
- Complete IND-enabling preclinical studies.
- Submit an IND application to the
FDA in the second half of 2018.
Financial Guidance
Adverum’s cash, cash equivalents and marketable securities were
Upcoming Events
- Adverum plans to participate in the following upcoming conferences:
- ARM’s Cell & Gene Therapies State of the Industry Briefing in
San Francisco onJanuary 8, 2018 .Amber Salzman , Ph.D., president and chief executive officer of Adverum, will participate on the Gene Therapy: The Outlook for 2018 panel at 9:05 –9:50 a.m. PT - Cowen 38th Annual
Health Care Conference inBoston ,March 12 – 14, 2018 - Cowen 17th Annual Life Sciences Winter Meeting in
Colorado ,March 20 – 23, 2018
- ARM’s Cell & Gene Therapies State of the Industry Briefing in
About
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases. Adverum has a robust pipeline that includes product candidates designed to treat rare diseases alpha-1 antitrypsin (A1AT) deficiency and hereditary angioedema (HAE) as well as wet age-related macular degeneration (wAMD). Leveraging a next-generation adeno-associated virus (AAV)-based directed evolution platform, Adverum generates product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum has collaboration agreements with
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding plans related to Adverum’s product candidates, clinical studies, regulatory filings and the therapeutic and commercial potential of its product candidates, all of which are based on certain assumptions made by Adverum on current conditions, expected future developments and other factors Adverum believes are appropriate in the circumstances. Adverum may not consummate any of these plans or these product, clinical development or regulatory goals in a timely manner, or at all, or otherwise carry out the intentions or meet the expectations or projections disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that Adverum’s resources will not be sufficient for Adverum to conduct or continue planned development programs and planned clinical trials, the risk of a delay in the enrollment of patients in Adverum’s clinical studies or in the manufacturing of products to be used in such clinical studies, the risk that Adverum will not be able to successfully develop or commercialize any of its product candidates and the risk that Adverum will be delayed in receiving or fail to receive required regulatory approvals. Risks and uncertainties facing Adverum are described more fully in Adverum’s periodic reports filed with the
Contact for Adverum:Leone Patterson Chief Financial Officer 650-665-7222 lpatterson@adverum.com
Source: Adverum Biotechnologies, Inc.