Appclon announced on the 22nd that it has submitted a research abstract to present the Phase 1 follow-up data of AT101 at an overseas clinical conference scheduled for June.
The chimeric antigen receptor T-cell (CAR-T) therapy AT101 previously presented its Phase 1 results at ASCO last year. If the presentation of follow-up data is confirmed at the overseas clinical conference, the company plans to announce the follow-up results for the Phase 1 subjects.
Appclon conducted the Phase 1 trial of AT101 on a total of 12 patients. Among them, all 6 patients who received medium to high doses achieved complete remission (CR). In the low-dose group of 6 patients, 3 achieved complete remission and 1 achieved partial remission (PR), resulting in an objective response rate (ORR) of 92%. The commercialized CAR-T therapies Kymriah and Yescarta showed complete remission rates of 29% and 51%, respectively.
A company representative stated, “Despite the high objective response rate, existing CAR-T therapies have limited durability of efficacy, making progression-free survival (PFS) and overall survival (OS) critical factors. AT101 is expected to gain a technological advantage as long-term follow-up data appear positive.”
They added, “Although four global CAR-T therapies have been launched, technology licensing-out (LO) is expected to be possible focusing on strengths such as efficacy, durability, and the possibility of cross-administration. The amendment of the Advanced Regenerative Bio Act, which marks the beginning of commercialization for cell and gene therapies, is also a positive factor.”
According to the Advanced Regenerative Bio Act, treatments for serious diseases such as life-threatening cancers with no alternative therapies are eligible for expedited review. AT101 is currently undergoing a Phase 2 clinical trial involving 82 patients at seven institutions in Korea.
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