On December 5, 2022 -ImmuneOncia (CEO Heung Tae Kim) reported 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(Press release, ImmuneOncia Therapeutics, DEC 5, 2022, View Source [SID1234624816]).
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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 (Free ESMO Whitepaper) 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.