On December 5, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the results of a Phase II NK/T-cell lymphoma study of IMC-001, a PD-L1 monoclonal antibody licensed to ImmuneOncia Therapeutics, LLC ("ImmuneOncia") (Seongnam, South Korea) (Press release, Sorrento Therapeutics, DEC 5, 2022, View Source [SID1234624798]). ImmuneOncia is a biotechnology company specializing in immuno-oncology drug development, jointly established by Yuhan Corporation of Korea and Sorrento. 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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The Phase II NK/T-cell lymphoma study was selected for an oral presentation at the Asian Congress of the European Society for Medical Oncology (ESMO Asia 2022) in Singapore on December 4th, 2022. The clinical data demonstrated that in patients with heavily treated NK/T-cell lymphoma, 6 of 10 evaluable patients (60%) not only achieved an objective response, but all 6 patients with an objective response also achieved a complete remission with IMC-001. Additionally, 4 of these 6 patients stayed on treatment for over a year, which provides encouraging indication of long-term IMC-001 treatment safety and durable efficacy.
NK/T-cell lymphoma is a rare cancer that is most prevalent in Asian countries, including China and Korea, and is typically treated with a regimen of radiation and chemotherapy. NK/T-cell lymphoma has a high recurrence rate of 75% within two years. Due to the absence of standard-of-care treatment for relapsed/refractory cases, NK/T lymphoma represents a high unmet medical need and significant market opportunity. To date, no single immuno-oncology drug has obtained approval in this indication.
Professor Won Seog Kim of Samsung Medical Center, the presenter and Principal Investigator of the IMC-001 study, commented, "The complete remission and response rate of 60% of IMC-001 significantly outperformed currently available drugs for the treatment, and very rare adverse events of grade 3 or higher also limit concerns over the side effects, making it a leader among PD-L1 drugs. We expect these results to satisfy the criteria for approval."
Heung Tae Kim, Chief Executive Officer of ImmuneOncia said, "This achievement sets a new standard for the second-line treatment of NK/T-cell lymphoma, which has high unmet needs. ImmuneOncia is preparing additional clinical trials to expand its indications in solid cancer."
Henry Ji, Ph.D., Chief Executive Officer of Sorrento commented, "We expect to leverage these data to create momentum to secure additional partnership and co-development opportunities for IMC-001 in regions with a high incidence of NK/T-cell lymphoma, such as China, as well as in other indications."
IMC-001 is a PD-L1 antibody, a fully human 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.