Adverum Biotechnologies Completes Patient Enrollment for INFINITY Phase 2 Trial of ADVM-022 in DME and Provides 2021 Business Outlook

-- INFINITY Phase 2 trial fully enrolled; data expected in 2H21 --

-- First pivotal trial planned for ADVM-022 in wet AMD in mid-2021; regulatory agency discussion planned 1Q21 --

-- New commercial GMP manufacturing facility expected to be production-ready by YE23 --

REDWOOD CITY, CA, USA I January 11, 2021 I Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the completion of patient enrollment in the INFINITY Phase 2 trial to evaluate a single intravitreal injection of ADVM-022, for the treatment of diabetic macular edema (DME). The company will provide a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 10:50 a.m. ET. The live webcast will be accessible under Events and Presentations in the Investors section of the company's website.

“2021 is an exciting year for Adverum as we build on the tremendous progress we have made to advance ADVM-022, a potential one-time intravitreal injection gene therapy for VEGF-driven retinal diseases, into a pivotal trial for wet AMD and in Phase 2 for DME. ADVM-022 has the potential to help millions of patients at risk of losing their vision,” said Laurent Fischer, M.D., chief executive officer at Adverum Biotechnologies. “Our investigators understand the potentially transformative clinical data emerging for ADVM-022, and we have seen rapid enrollment of patients in our clinical trials. In INFINITY, we began patient enrollment during the COVID-19 pandemic, and in less than six months, we recently completed patient enrollment. We look forward to sharing data from this trial in the second half of 2021. We are grateful to the participants and investigative sites. As we move through 2021, we are in a strong position with an expert team, a promising lead therapy, and expanding manufacturing capabilities which will enable us to continue to deliver on our mission to bring novel gene therapies to patients as quickly as possible.”

Arshad M. Khanani, M.D., M.A., principal investigator in the INFINITY trial, and director of clinical research at Sierra Eye Associates, said, “Currently, patients with DME require frequent, long-term anti-VEGF intravitreal injections, which during COVID-19 is even more challenging and in many parts of the world actually impossible. ADVM-022 is a single in-office intravitreal injection therapy that has shown promising efficacy and safety for over two years in patients with wet AMD in the OPTIC trial. In INFINITY, we are excited to study ADVM-022 in our patients with DME, who are often of working age and need a more durable treatment over the long course of their disease. ADVM-022 has the potential to be a transformative treatment for patients with DME.”

Dr. Fischer continued, “We are also incredibly excited about our investment in a new GMP commercial manufacturing facility in North Carolina announced last week to support our expected commercialization for the first in-office gene therapy for wet AMD and DME.”

Our Focus in 2021

ADVM-022 in wet AMD:

  • Present longer-term data from OPTIC Phase 1 trial, including additional anti-VEGF protein expression data, in the first quarter of 2021
  • First pivotal study trial planned for ADVM-022 in wet AMD in mid-2021 following regulatory agency discussion planned for the first quarter of 2021
  • Continue to follow OPTIC patients who reached 2-years post treatment with ADVM-022 in a 3-year extension study

ADVM-022 in DME:

  • Present clinical data from INFINITY Phase 2 trial in the second half of 2021

Adverum GMP Manufacturing:

  • Begin build-out of new GMP commercial manufacturing facility in North Carolina with multiple production suites with 4000L total capacity, expected to be production-ready by the end of 2023 with further expansion capabilities to support the future commercialization of ADVM-022
  • Process development scale up from current 200L suspension to 1000L suspension

About Adverum Biotechnologies
Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

SOURCE: Adverum Biotechnologies

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