Abclon is showing strong performance. The announcement of the Phase 1 clinical trial results for the CAR-T therapy 'AT101' at the American Society of Clinical Oncology (ASCO) and the ongoing inquiries for technology licensing appear to be influencing the stock price. Expectations are rising as AT101 has demonstrated better efficacy than existing treatments with annual sales exceeding 1 trillion KRW.
As of 12:14 PM on the 9th, Abclon is trading at 24,150 KRW, up 19.55% from the previous day.
The AT101 clinical trial targeted patients with various hematologic cancers, including relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which is untreatable with conventional anticancer drugs, as well as follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL). The possibility of expanding indications was also confirmed. The Phase 1 trial involved a total of 12 patients: 6 in the low-dose group, 3 in the medium-dose group, and 3 in the high-dose group.
AT101 is administered to patients only once. The direct indicators to confirm efficacy are complete remission rate (CR) and objective response rate (ORR). The overall results of the Phase 1 trial, including all three dosage groups, showed a CR of 66.7% and an ORR of 91.7%.
Kymriah, the first product launched on the market, showed a CR of 40% and an ORR of 52% in its Phase 2 trial (JULIET). Yescarta, which joined the blockbuster drug ranks with sales exceeding 1 trillion KRW last year, showed a CR of 58% and an ORR of 83% in its Phase 1/2 trial (ZUMA-1).
On the 5th (local time), Professor Yoon Deok-hyun, head of the CAR-T Center at Seoul Asan Medical Center, presented the final results of Abclon's CAR-T therapy 'AT101' Phase 1 trial at ASCO held in Chicago, USA.
In an interview with the media, Professor Yoon stated, "The Phase 2 dosing for AT101 was concluded to be an infusion of 5 million T cells per kilogram of body weight," adding, "Since 100% of patients in the medium and high-dose groups responded, it is promising to look forward to the Phase 2 trial of AT101."
Based on the clinical outcomes of AT101, Abclon will conduct over 20 technology licensing meetings at BioUSA held in Boston, USA.
Researcher Ha Tae-gi from Sangsangin Securities explained, "It appears that Abclon will leverage the differences and advantages of its proprietary humanized antibody (h1218 antibody), which binds to a different epitope than Kymriah, Yescarta, Tecartus, and Breyanzi," adding, "There is a high possibility of pursuing global technology licensing starting in the second half of this year." He also mentioned, "Additionally, new CAR-T therapies are under development," and "Discussions are ongoing for joint development of new CAR-T therapies with the University of Pennsylvania in the USA besides AT101."
All CD19-targeting CAR-T therapies currently use the mouse-derived FMC63 antibody. Abclon is the first in the world to use the h1218 humanized antibody.
Abclon is paying special attention to the patent strategy for AT101. To commercialize through global big pharma or for overseas technology transfer, they have conducted FTO (Freedom to Operate) patent infringement analyses. They have completed patent registrations in Korea, the USA, Japan, and Canada and are pursuing a continuous patent acquisition strategy. They plan to actively promote at BioUSA.
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