On April 20, Microchip released an announcement that the Phase 2 trial of chidamide combined with envolimab in the treatment of non-small cell lung cancer (NSCLC) patients who have been treated with PD-1 inhibitors has been received from China.
New Drug Clinical Trial Application (IND) Acceptance Notice issued by the Drug Administration (NMPA).
This is another recent progress made by the Microchip Technology Innovation Product Pipeline after Sioroni was successively approved for clinical trials in China and the United States.
Chidamide: Combined with anti-PD-L1 antibody Phase 2 clinical acceptance, Chidamide, independently developed by Chipchip Biosciences, is the world's first subtype-selective histone deacetylase (HDAC) oral inhibitor, which is already in China Approved for the treatment of peripheral T-cell lymphoma and breast cancer indications, and is currently conducting pivotal phase 3 clinical trials in the indications of diffuse large B-cell lymphoma (DLBCL).
Envolimab (KN035) is a recombinant humanized PD-L1 single domain antibody Fc fusion protein injection that can be injected subcutaneously.
It has submitted a new drug application in China and has been included in the priority review.
The indication is standard treatment Failed microsatellite instability (MSI-H)/mismatch repair defect (dMMR) advanced colorectal cancer, gastric cancer and other advanced solid tumors.
According to the announcement, the NMPA accepted this time is an open, multi-center phase 2 clinical study of chidamide combined with envolimab in the treatment of NSCLC patients who have been treated with PD-1 inhibitors.
Previously, clinical studies have confirmed that Chidamide's unique mechanism of action is effective for NSCLC.
According to the results of the Phase 1b/2 clinical trial publicly disclosed at the Annual Meeting of the Association for Cancer Immunotherapy (SITC) in 2018, the objective remission rate of chidamide for patients with advanced non-small cell lung cancer reached 38%, and the disease control rate was 75%, indicating Chidamide has shown a preliminary but relatively clear combination effect in such patients.
Sioroni: successively approved for clinical trials in China and the United States
Chiauranib (CS2164) is a multi-target multi-pathway selective kinase inhibitor that can exert comprehensive anti-tumor effects through three active mechanisms, including: ①Inhibition of tumors by inhibiting cell cycle regulatory kinase Aurora B Cell cycle progression; ② inhibit tumor angiogenesis by inhibiting VEGFR and PDGFR related to angiogenesis; ③ inhibit tumor local immunosuppressive cell growth by inhibiting CSF1R related to immune cell proliferation and activation.
On April 16, Microchip released an announcement stating that a randomized, double-blind, controlled, multi-center phase 3 clinical trial of Cioroni combined with paclitaxel weekly therapy for platinum-refractory or platinum-resistant relapsed ovarian cancer (CHIPRO ) Has also been approved in China.
On the same day, the company also issued a press release stating that Cioroni has obtained FDA approval to start a phase 1b/2 clinical trial for the treatment of small cell lung cancer (SCLC) in the United States.
It is worth mentioning that Cioroni's previous clinical studies on small cell lung cancer and ovarian cancer have been included in the breakthrough treatment category in China.