ViroMed said it would conduct a phase 1 clinical trial on CAR-T (chimeric antigen receptor T-cell) therapy, a new cancer-targeting immunotherapy, in the U.S. market by 2020-2022. The Korea-based biotech venture last year entered into an exclusive license agreement with Nasdaq-listed Bluebird bio to develop CAR-T therapies.
CAR-T therapies enable T-cells in the blood to selectively target cancer cells and attack them. ViroMed developed four CAR genes, which often appear in solid cancer and blood cancer, and transferred a technology for one of the genes to the U.S. firm.
Besides the VM801 that went under the license agreement with Bluebird bio in 2015, ViroMed said it was preparing all-phase clinical trials on VM802.
ViroMed CEO Kim Yong-soo expressed his will to develop CAR-T therapies at the “New Drug Pipeline Tracking Day” event, hosted by Mirae Asset Daewoo Securities, in Yeouido, Seoul.
“We’re doing the optimization of genes for CAR-T in blood cancer and solid cancer. We have finished the work for one gene, and we’re working on the other two now,” Kim said. “By 2022, we will make at least three genes ready for CAR-T clinical trials and seek a value increase through technology transfer or raising the phases of clinical trials.”
He also said ViroMed aimed to lead the U.S. gene therapy market with VM202 pipelines that are on two phase-3 clinical trials in the U.S. – VM202-DPN for patients with painful diabetic neuropathy and VM202-PAD for those with chronic non-healing ischemic foot ulcer in diabetes. Among the 16 drugs under the phase-3 clinical trials in the U.S., VM202 is a rare therapy with good marketability and hard clinical data, Kim said.
“Among the phase-3 clinical trials (related to gene therapy), nine are targeting cancer, three for genetic diseases, and four for chronic diseases. Their targets are small, lowering the chance of developing a blockbuster drug. But VM202 targets chronic diseases, which raises its marketability,” he said. “The 16 drugs on the phase-3 clinical trials are those with sales potentials within the next three to four years.”
Kim also said that his company would make two drug candidates that have a higher value than VM202 by 2025. The company will select target diseases for pIKO and pMUN genes, which were genetically modified by ViroMed to maximize treatment, and test them in U.S. clinical trials by 2020-2021. Named as experimental codes, pIKO is effective on vascular and neurological diseases, and pMUN, on muscular and nervous system diseases, Kim noted.
“By 2025, ViroMed aims to become the company that posts the largest sales per gene therapy. It is an achievable goal,” he said.
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