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 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 Korean biotech.”
NK/T cell lymphoma is 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.