News
| The Second American Ind Of The Year! The Self-Developed Dual Antibody Was Approved By FDA To Enter Clinical Practice |
| 2022-11-07 |
SIM0237, an anti-PD-L1 /IL-15 bisecific antibody, was approved by the US Food and Drug Administration (FDA) for the treatment of locally advanced unresectable or metastatic solid tumors. This is also the second US IND approval of our own research project this year. In addition, the application for clinical trials of SIM0237 in China was accepted by the National Medical Products Administration of China on October 10, 2022.
Dr Bijoyesh Mookerjee, chief medical Officer for Oncology at Sonics, said: PD-1/PD-L1 immune checkpoint inhibitors (ICI) have shown strong efficacy in a variety of tumors, but many patients fail to benefit or develop resistance. By combining anti-PD-L1 antibody with IL-15 cytokine as a bisspecificity molecule, and the IL-15 terminal is specially designed for inactivation, we are expected to further improve the efficacy, reduce toxicity, and improve the tolerance of patients with locally advanced or metastatic solid tumors.
IL-15 is an immune-activating cytokine that promotes the expansion and activation of NK cells and CD8+ T cells. In previous molecular studies of the same type, IL-15, when combined with anti-PD-L1 /PD-1 antibodies, showed promising clinical antitumor benefit in patients with advanced malignancies that had failed or relapsed, including immune checkpoint inhibitor therapy. Therefore, dual-target drugs targeting both IL-15 and PD-1/PD-L1 may have good clinical antitumor activity and potential efficacy in patients with relapsed/refractory tumor after tumor immunotherapy.
About SIM0237 SIM0237 is an anti-PD-L1 mab and IL-15/IL-15Rα fusion protein developed based on the pioneer protein engineering technology platform. It can block the PD1/PD-L1 immunosuppressive pathway by binding PD-L1 and activate the immune system through IL-15. Thus, it plays a dual synergistic role of relieving immune suppression and activating immune system to play an anti-tumor role. SIM0237 is designed by special protein engineering, and the IL-15 terminal is inactivated, which increases the tolerance and exposure to anti-PD-L1 antibody. Therefore, SIM0237 may have better efficacy and safety than similar molecules. Preclinical studies have shown that SIM0237 is superior to PD-L1 monotherapy and IL-15 monotherapy in mouse tumor model, and has high potential for clinical development. |