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SEONGNAM, South Korea

ImmuneOncia (CEO Heung Tae Kim) announced the results of its Phase 2 NK/T-cell lymphoma clinical trial of IMC-001, a PD-L1 monoclonal antibody, at the Asian Congress of the European Society for Medical Oncology (ESMO Asia 2022) held in Singapore on December 4th, 2022.

The clinical data demonstrated that 6 out of 10 evaluable patients (60%) achieved an objective response, all of whom showed a complete remission (CR). Additionally, the administration has been continued in 4 of these 6 patients for over a year, which also indicates its outstanding safety (in terms of the long-term toxicity) and durable response.

Thanks to these achievements, the results of IMC-001 were selected for Mini Oral Session at ESMO Asia this year.

Professor Won Seog Kim of Samsung Medical Center, a presenter and Principal Investigator of IMC-001, commented, “The complete remission and response rate of 60% of IMC-001 significantly outperform currently available drugs for the treatment, and very rare adverse events of grade 3 or higher also eliminate concerns over the side effects, making it the best-in-class among PD-(L)1 drugs. These results are expected to satisfy the criteria for approval and lead to globalization of an immune checkpoint inhibitor developed by a Korean biotech.”

NK/T cell lymphoma is a rare cancer that occurs mostly in Asian countries such as China and Korea, and often treated with radiation and chemotherapy. NK/T cell lymphoma has a high recurrence rate of 75% within 2 years. Due to the absence of standard-of-care treatment for relapsed/refractory, it has high unmet needs. So far, no single immuno-oncology drug has obtained approval in this indication across the globe.

IMC-001 is a PD-L1 antibody, an immune checkpoint inhibitor that serves as the basis of the current immuno-oncology market. This antibody activates the anticancer functions of T cells by strongly inhibiting the binding between PD-1 expressed on T cells and PD-L1 expressed on the surface of cancer cells. Moreover, it can mediate ADCC (antibody-dependent cellular cytotoxicity) against tumor cells, as it maintains the Fc effector function using human IgG1.

Heung Tae Kim, CEO of ImmuneOncia said, “This achievement sets a new standard for the second-line treatment of NK/T-cell lymphoma, which has high unmet needs. This will be a momentum to secure more partnering opportunities in regions with a high incidence of NK/T-cell lymphoma, like China. ImmuneOncia is also preparing additional clinical trials to expand its indications in solid cancer.”

ImmuneOncia is a biotechnology company specializing in immuno-oncology drug development, jointly established by Yuhan Corporation of Korea and a Nasdaq-listed Sorrento Therapeutics in the US. In addition to IMC-001, ImmuneOncia has a wide range of new products in the pipeline, such as IMC-002, a CD47 antibody, and IMC-201, a bispecific antibody.

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