Kumho HT Confirms Partial Response in Phase 1 Clinical Trial of Immuno-Oncology Drug... "Global Big Pharma Attention"

Kumho HT recently announced on the 11th that it attracted attention from major pharmaceutical companies attending the European Society for Medical Oncology Asia Congress (ESMO Asia Congress) held in Singapore by presenting the interim results of the Phase 1 clinical trial of its immuno-oncology pipeline 'DNP-002'. DNP-002 not only secured successful interim clinical data in terms of safety, efficacy, and pharmacodynamic characteristics but also confirmed partial response, suggesting that various collaborative projects with global pharmaceutical companies are expected to be promoted in the future.

The Phase 1 clinical trial of DNP-002 was conducted at Seoul Asan Medical Center and the National Cancer Center on 36 patients with solid tumors who had no remaining treatment options. The clinical drug dose was gradually increased in six steps from 0.01 mg/kg to 1.0 mg/kg, evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, and preliminary anticancer effects of DNP-002.

In the Phase 1 trial, DNP-002 was found to cause a dose-dependent decrease in neutrophils. Although ‘DLT (dose-limiting toxicity)’ was observed in subjects receiving high doses, a therapeutic dose that maximizes anticancer effects while minimizing side effects was established. Additionally, DNP-002 showed statistically significant increases in peripheral blood inflammatory cytokines and T cell activation.

Regarding efficacy, among 16 subjects evaluated for antitumor effects, one showed a ‘partial response’ and six showed ‘stable disease’. The partial response was observed in an esophageal cancer patient, whose tumor size decreased by up to 69% compared to baseline and was maintained for over 30 weeks. Tumor reduction effects were also confirmed in one endocrine cancer patient and one sarcoma patient.

DNP-002 is an antibody therapeutic targeting ‘CEACAM’, recognizing ‘CEACAM1’, ‘CEACAM5’, and ‘CEACAM6’ among the CEACAM family. Among these, the main target CEACAM6 is overexpressed not only in tumors but also in neutrophil-derived myeloid-derived suppressor cells (MDSCs), allowing simultaneous targeting of tumors and immunosuppressive cells.

A Kumho HT official stated, “The antitumor effects, including partial response, were observed at cohort 2 (0.03 mg/kg), which is a safe dose. Due to DNP-002’s T cell activation properties, synergistic effects are expected when combined with immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors.”

He added, “Professor Tan from the Singapore National Cancer Center, who attended the conference, commented that most existing anticancer research targeting CEACAM is biased towards ‘CEACAM5’, but this clinical study demonstrated that CEACAM6, the main target of DNP-002, is a clinically useful target.”

The European Society for Medical Oncology Asia Congress is a platform for sharing the latest cancer research results, clinical trials, and treatment strategies focusing on multidisciplinary oncology in Asia. This year, it was held in Singapore from the 6th to the 8th, with major global top-tier pharmaceutical companies such as Amgen, Merck, Pfizer, Novartis, and AstraZeneca participating in large numbers.

The European Society for Medical Oncology published Kumho HT’s research achievements in the ‘ESMO Daily Reporter’ (Studies show two promising new immune-related targets in cancer).