Kaidi Therapeutics Highlights 100% ORR with KD-496 Dual-Targeting CAR-T at ESMO 2025 in IPO Filing

Oct 22, 2025 11:08 CST Updated 11:08

KAEDI

Developer of Novel Cell Therapies

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Nanjing Kaidi Biotechnology Co., Ltd. independently developed the KD-496 CAR-T Cell Injection (Product Code: KD-496, an autologous CAR-T cell therapy product targeting NKG2DL/CLDN18.2 double-positive solid tumors, NCT0634860). Its preliminary clinical data made a striking appearance at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting, titled "A Phase I Trial of KD-496, a CLDN18.2/NKG2DLs Dual Targeting CAR-T, in Subjects with Gastrointestinal Cancers," Poster Number 945P. The innovative value of "breaking through the treatment bottleneck of gastrointestinal tumors with dual targets" has attracted significant attention in the industry.

KD-496 is the world's first CAR-T solid tumor therapeutic drug targeting both CLDN18.2 and NKG2DL.The product has made a breakthrough with patients suffering from advanced gastrointestinal tumors and launched a clinical exploration titled "A Single-Center, Open-Label, Single-Arm Clinical Study on the Safety and Efficacy of KD-496 CAR-T in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors," led by Professor Lin Shen from Peking University Cancer Hospital. Focusing on the key pain points in solid tumor treatment, it has opened a new direction for CAR-T to overcome solid tumors.

From March 2024 to April 2025, six patients (aged 43-73 years) with NKG2DL/CLDN18.2 double-positive gastric and pancreatic cancer who failed traditional treatments received KD-496 CAR-T cell therapy (three cases in the low-dose group and three cases in the medium-dose group). Grade 3 treatment-related adverse events included anemia (33%) and leukopenia (50%). One case of cytokine release syndrome (CRS) reached grade 3; no grade 4/5 CRS or neurotoxicity was observed.

Highlights of Efficacy:In evaluable subjects: gastric cancer patients (n=4),Achieved 75% Objective Response Rate (ORR); In two patients with pancreatic cancer, an overall objective response rate (ORR) of 50% was achieved.Notably, the ORR for patients with gastric cancer and pancreatic cancer in the medium-dose group reached 100%.Among them, one subject with pancreatic cancer has completed the D240 follow-up after infusion and is still in the follow-up period, with continued PR.

These preliminary data strongly confirm the anti-tumor activity of KD-496 CAR-T therapy in gastrointestinal tumors, especially gastric cancer and pancreatic cancer. Nanjing Kaidi Biotechnology Co., Ltd. will continue to deepen its research, actively advancing the safety and efficacy studies of higher-dose KD-496 CAR-T formulations. It hopes that through more in-depth clinical exploration, it can provide new treatment options for patients with advanced gastric cancer and pancreatic cancer, extending the benefits of innovative therapies to more cancer patients. Meanwhile, investment institutions interested in the solid tumor CAR-T field are sincerely invited to discuss cooperation opportunities to jointly promote the innovation process in cancer treatment.

Source: Kaidi Medical

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