M. Peter Marinkovich, MD, on Developing B-VEC, First Approved Derm Gene Therapy

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The associate professor of dermatology at Stanford University discussed his experiences investigating and helping to develop Vyjuvek, approved for treating DEB.

“My experience with B-VEC started in 2017at the SID meeting there in Portland, Oregon. And I was approached by Suma Krishnan who had this really interesting vector, and she wanted me to test it and help her develop it. I saw what she had, this HSV-1 vector, I thought it looked really cool. And so I worked with her, first we started some preclinical studies towards the end of 2017.”

Krystal Biotech’s beremagene geperpavec (B-VEC) became the first approved gene therapy in the dermatology field in May 2023 under the name Vyjuvek. The therapy was approved for the treatment of dystrophic epidermolysis bullosa (DEB) now a bit over 6 months ago, and CGTLive spoke with some experts involved in its development to look back at the work done on B-VEC and their future outlook with the therapy and gene therapy in general within the dermatology field.

One of these experts is M. Peter Marinkovich, MD, an associate professor of dermatology at Stanford University, and an investigator on the GEM trials that B-VEC was evaluated in. Marinkovich, who became involved with the development of B-VEC pretty early on, gave an overview of the therapy’s fast timeline of development - about 5 years from the start to approval. Marinkovich spoke about his experience prescribing B-VEC since its approval and its impact on patients with DEB. He also shared the learning process he went through and the lessons he learned about working with the FDA while working toward B-VEC's approval, and stated that the process had made him a better clinical researcher.

REFERENCE
FDA approves first topical gene therapy for treatment of wounds in patients with dystrophic epidermolysis bullosa. News release. FDA. May 19, 2023. Accessed May 19, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-topical-gene-therapy-treatment-wounds-patients-dystrophic-epidermolysis-bullosa
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