[Seoul Market Wrap] HLB Innovation's CAR-T Therapy Achieves 60% Complete Remission in Blood Cancer Trials with Zero Reported Immune Toxicities

Response rate 80%, complete response maintained for 12 months… No CRS or neurotoxicity including high-risk lymphoma patients… Results of 1 billion high-dose clinical trials to be revealed in December

HLB Innovation's (024850) next-generation CAR-T treatment achieved a complete response rate of 60% in blood cancer clinical trials. One patient maintained a complete response up to 12 months after treatment, and no cases of major immunotoxicity, such as cytokine release syndrome (CRS) or neurotoxicity (ICANS), were reported. In preclinical trials for solid tumors, faster tumor control and lower levels of cytokine production were confirmed than existing CAR-Ts.

According to HLB Innovation, the interim results of the phase 1 clinical trial 'CELESTIAL-301' of Verismo's blood cancer CAR-T treatment 'SynKIR-310' were included in the official abstract of the American Society of Hematology (ASH 2026) released on the 4th. The study was selected for an oral presentation at the ASH annual conference to be held in New Orleans, USA on December 13th.

#### Including high-risk lymphoma… Maintain complete remission for 12 months

SynKIR-310 is a CAR-T treatment targeting the CD19 protein on the surface of cancer cells, and is being developed for patients with relapsed or refractory B-cell non-Hodgkin lymphoma who have received at least two previous treatments.

As of July 14, there were 6 patients treated in the first two dose groups. Among these, 4 out of 5 patients for whom efficacy could be evaluated showed a response to treatment, recording an objective response rate (ORR) of 80%. Three patients achieved complete response (CR) with no signs of cancer, resulting in a complete response rate of 60%.

The median time to treatment response was 1 month. One patient who achieved complete response maintained the response 12 months after treatment, and the median duration of complete response has not yet been reached.

The median patient age was 72 years. All three patients with aggressive lymphoma had double or triple hit genetic characteristics, and all patients had stage 3 or 4 disease. The median number of previous treatments was 2nd, and high-risk patients with difficult treatment were included.

No major immunotoxicity was observed in the safety evaluation. Cytokine release syndrome (CRS) and immune effector cell-related neurotoxicity syndrome (ICANS) did not occur in all six treated patients, and no treatment-related serious adverse reactions or dose-limiting toxicities (DLTs) were reported.

Grade 4 neutropenia and leukopenia occurred in 1 patient each. Of the total patients, three received treatment in an outpatient setting.

This clinical trial will be conducted by gradually increasing the number of administered cells and evaluating safety and appropriate dosage. 100 million doses were administered to Cohort 1, 300 million doses were administered to Cohort 2, and Cohort 3 was designed to administer 1 billion doses, which is 10 times the first dose group.

Verismo plans to disclose additional clinical results and pharmacokinetic/pharmacodynamic (PK/PD) analysis data of Cohort 3 at the ASH oral presentation in December. Changes in treatment response and safety due to dose expansion are also major targets to confirm.

#### Direct comparison with existing CAR-T… Expanding research on blood cancer and solid cancer

At this ASH, Verismo will also present two preclinical studies comparing the anti-cancer effectiveness and safety of KIR-CAR technology with existing CAR-T as posters.

The first study dealt with dual-target KIR-CAR technology that simultaneously targets CD19 and CD20. This is to respond to the problem of cancer cells reoccurring after treatment with existing CD19-targeted CAR-T as they lose or change target antigens, and cytokine production is significantly reduced compared to the existing single-chain dual-target CAR-T.

In the second study, blood cancer treatment SynKIR-310 was directly compared with existing single-chain CD19 CAR-T. In preclinical models of leukemia and lymphoma, SynKIR-310 showed faster tumor regression and high tumor suppression effects, and the amount of cytokine production was actually reduced.

Following blood cancer, research results showing the characteristics of KIR-CAR technology were also published in solid cancer. In the preclinical study of 'SynKIR-110', a solid tumor treatment drug that Verismo will present at the Society of Immuno-Oncology (SITC 2026), it was confirmed to have a faster tumor control effect than the existing CD28 and 4-1BB-based single-chain CAR-T.

In particular, compared to CD28-based CAR-T, the amount of cytokine production was lower at about 1/10th for IFN-γ and about 1/30th for TNFα and IL-2. TNFα and IL-2 decreased by approximately 96.7%. T cells infiltrating tumor tissue also showed low expression of exhaustion-related markers TIM3, LAG3, and PD1.

Differences in normal lung tissue were also confirmed. The accumulation of CAR-T cells observed in the comparison group did not appear in animals administered SynKIR-110. However, these results were confirmed at the preclinical stage, and the toxicity reduction effect has not been proven in actual patients.

Verismo's KIR-CAR is a multi-chain method that separates cancer cell recognition and T cell activation signals. It was designed to reduce excessive immune responses and early exhaustion of T cells by utilizing the natural killer (NK) cell-derived signaling protein DAP12.

Currently, SynKIR-310 is undergoing phase 1 clinical trials targeting blood cancers, and SynKIR-110 is targeting mesothelin-expressing solid cancers such as mesothelioma, ovarian cancer, and bile duct cancer.

Brian Kim, CEO of Verismo, said, "Based on the initial anti-tumor activity and safety results confirmed in this clinical trial, we will continue to verify the clinical potential of the KIR-CAR platform in the fields of blood cancer and solid cancer."