2023-06-07 13:45:00
[바이오타임즈] AbClon (174900) announced on the 7th that it had confirmed the safety and efficacy of AT101, a CAR-T drug under development, in the phase 1 clinical trial for hematologic cancer. The company disclosed these results at the 2023 American Society of Clinical Oncology (ASCO).
AT101’s clinical trials include not only relapsed and refractory DLBCL (diffuse large B cell lymphoma) that cannot be treated with existing anticancer drugs, but also FL (follicular lymphoma) and MCL (mantle cell lymphoma) mantle cell lymphoma. ), MZL (marginal zone lymphoma), and other hematological malignancies are selected as clinical targets, confirming the possibility of expanding indications. Phase 1 clinical trial was conducted on a total of 12 patients, consisting of 6 in the low-dose group, 3 in the medium-dose group, and 3 in the high-dose group.
AbClon’s Cati treatment AT101 is administered to a patient only once, and the indicators that can directly confirm its effectiveness are the complete response rate (CR) and objective response rate (ORR). The overall results of clinical phase 1, including all three dose groups, showed a CR of 66.7% and an ORR of 91.7%.
It is explained that the safety indicators of AT101 clinical trials are also noteworthy. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are the most frequently mentioned side effects of using CARTI treatment. In the case of AT101, there was 1 case each with grade 3 or higher in CRS and ICANS, showing a grade 3 or higher incidence rate of 8.3%.
Kymriah, which entered the market first, showed a CR of 40% and an ORR of 52% in phase 2 clinical trials (JULIET), and cytokine release syndrome and neurotoxicity of grade 3 or higher were 22% and 12%, respectively. Yescarta, which achieved more than KRW 1 trillion in sales last year and joined the ranks of blockbuster drugs, showed a CR of 58% and an ORR of 83% in the phase 1/2 clinical trial (ZUMA-1), CRS and ICANS of grade 3 or higher. were 11% and 32%, respectively. In addition, Yescarta’s CRS and ICANS show a high incidence rate of 93% and 67%, respectively.
Regarding the persistence of the efficacy of AT101, the patients in the low-dose group who received the first treatment continued to maintain the CR even following one year of treatment.
Earlier this year at AACR, AT101 used the h1218 antibody developed independently by AbClone, thereby demonstrating differential anticancer efficacy as a result of non-clinical results from all other commercialized Carti products (Kymria, Yescarta, etc.) that have no choice but to use the same antibody, FMC63. It has been announced that it has In particular, it was confirmed that the drug effectively acts on CD19 mutant cells, which have been reported in patients with recurrent CATI. AT101 has technological innovations that are different from existing CATI treatments, such as ▲improvement of immunogenicity through humanization of antibodies ▲unique drug efficacy enhancement mechanism ▲product production stabilization through automation in the manufacturing process.
“We confirmed the efficacy and safety of AT101 in this phase 1 clinical trial,” said an official from AbClon. AbClon is expected to conduct phase 2 clinical trials in September.
Also, AbClon is paying special attention to AT101’s patent strategy. FTO patent infringement analysis was conducted for commercialization or overseas technology transfer through global big pharma, and patent registration is being completed in Korea, the United States, Japan, and Canada, and a strategy for securing patents is ongoing. It plans to actively promote it by participating in this Bio USA.
[바이오타임즈=최진주 기자] news@biotimes.co.kr
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