Sorrento Receives FDA Clearance to Proceed With Phase 2 Study for Sti-3031, an Anti-Pd-L1 Antibody, for Advanced Urothelial Carcinoma - Seite 2

A second antibody, Socazolimab, is licensed to Lee’s Pharmaceutical Holdings Limited in the Greater China territory, and has been cleared to begin a multicenter Phase 3 trial as a potential first-line treatment for patients with extensive-stage small-cell lung cancer. Professor Shun Lu (Shanghai Chest Hospital) is the Principal Investigator. Additionally, Phase 1b studies in several other indications have been completed for this product candidate, including: recurrent metastatic cervical cancer, advanced urothelial carcinoma, and high-grade osteosarcoma after adjuvant chemotherapy for maintenance. In addition, a Phase 1b/2 study has been initiated as a potential neoadjuvant treatment option for esophageal carcinoma. For cervical cancer, a pivotal study has been completed with a breakthrough therapy designation granted by the National Medical Products Administration (NMPA) in China. Sorrento intends to open an IND in the U.S. with the intent to have an end-of-phase 3 meeting or pre-NDA discussion with the FDA for various cancer indications.

Sorrento previously announced FDA clearance to commence a Phase 1b study in various relapsed or refractory solid tumors with an anti-CD47 antibody (STI-6643) (a CD-47 checkpoint inhibitor interacting with SIRPα). In preclinical studies, STI-6643 appears to have a beneficial toxicity profile (e.g., reduced hemolysis) without a priming mechanism while maintaining potent anti-tumor activity. Additionally, Sorrento licensed a separate promising anti-CD47 antibody (IMC-002) to ImmuneOncia, which has initiated a Phase 1b study in patients with metastatic or locally-advanced solid tumors and relapsed or refractory lymphomas.

Sorrento previously announced the formation of its subsidiary company - Adnab, Inc.,– which is focused on developing and commercializing ADNAB platform products for hematological malignancies and solid tumors based on an exclusive license from the Mayo Clinic. Sorrento intends to combine a variety of its proprietary mAbs in conjunction with the ADNAB technology platform, which was developed by Dr. Svetomir Markovic, M.D., Ph.D., and his research team at Mayo Clinic. This effort will potentially result in multiple next-generation ADNAB products. Since ADNABs can be designed to have one or two mAbs on the external surface, in addition to a chemotherapeutic payload, the cytotoxic payload can potentially be delivered preferentially to targeted cancer cell types. Sorrento expects to develop a number of innovative ADNABs in anticipation of filing INDs for clinical trials later in 2021.