DPhil. Sunyoung Kim, CSO of ViroMed,
"Our gene therapy research is sailing
through, and we are preparing for commercial production."
Looking ahead to BLA in 2021 … discussing
licensing out opportunities with big pharmas
Korea – DPhil. Sunyoung Kim (pictured), first generation bio-venture company
ViroMed’s CSO and R&D Director, announced on September 5th that
preparations for the commercialization of VM202,
the company’s flagship gene therapy medicine, are cruising along, full speed
ahead. “Over the last six months,” he said, “we’ve brought a significant number
of new hires onboard. I would say we were concentrating entirely on research thus
far, and now we’ve just stepped into the production stage.” The company is
currently conducting phase III trials for diabetic peripheral neuropathy and
diabetic non-healing ischemic foot ulcers, as well as phase II trial for Lou
Gehrig’s disease, all in the US.
Some 30 new employees have joined ViroMed this year to date—marking an overall
staff increase of nearly 30%. This past
July, the company also hired Dr. Jun T. Park as Vice President. Dr. Park came
to ViroMed directly from eleven years as a reviewer at the US FDA overseeing
new drug development and approval, who now oversees licensing & regulatory
affairs at ViroMed. CSO Kim explained that “all hires this year are coming in
as department heads or higher,” and that the company is “focusing particularly on
strengthening expertise in quality management, clinical management, and process
development.” Establishing new facilities for new drug production has been underway
as well. Late last month, Reyon Pharmaceutical, which holds the manufacturing
rights to VM202 substance, began construction of a new factory in Chungju,
Korea, which will produce VM202 drug substance.
The company is also working to expand the therapeutic range of VM202 targeting PDPN.
This past July, the US FDA approved ViroMed’s another phase III trial of VM202
targeting painful diabetic peripheral neuropathy (PDPN).
Nearly 60 to 70 percent of PDPN
patients are not benefiting from existing medications, and as such, if VM202’s
efficacy is confirmed, the size of its addressable market is expected to be
worth close to KRW 10 trillion. The company is anticipating to submit a BLA
around 2021 once the PDPN trials are complete. CSO Kim noted that “ViroMed has
been discussing licensing out opportunities with multiple global pharmaceutical
ViroMed is Korea’s first venture company situated within a university. CSO Kim
originally founded ViroMed in 1996 with two fellow researchers. The company
then became the first in the country to undertake gene therapy clinical trials,
the first in the world to reach phase III trials for diabetic peripheral
neuropathy and foot ulcers, among others—making ViroMed one of the top forces
in the field of gene therapy treatment worldwide. Of the three DNA-based gene
therapy treatments currently in phase III in the US, two belong to ViroMed.
ViroMed is also developing treatment for neurological and vascular diseases
using gene therapy. “By 2025, our new drug candidates currently under
development will be in globally conducted phase III trials,” said CSO Kim.
Translated by English Editor
Original text in Korean: 김선영 바이로메드 R&D 총괄 사장 "유전자치료제 연구 '순항'… 생산 준비단계 들어갔다" | IT/과학 | 바이오 | 한경닷컴