The US FDA Allows Sorrento Therapeutics Inc (NASDAQ:SRNE) To Conduct Phase 2a Clinical Study Of STI-3031 To Cure Advanced Urothelial Carcinoma

Sorrento Therapeutics Inc (NASDAQ:SRNE) and its partners advanced fully human mABs (monoclonal antibodies) into clinical development to treat cancers and COVID-19. 

Sorrento’s CEO, Henry Ji, invented the proprietary G-MAB library. The company developed innovative formulations based on the G-MAB library. 

The G-MAB library uses RNA transcription to amplify antibody variables collected from more than 600 female and male donors and multiple ethnicities. Therefore, the G-MAB library comprises over 20 quadrillion unique antibody sequences. 

Sorrento used the G-MAB library to develop several late-stage and early-stage oncology programs that undergo phase 3 and phase 2 clinical trials. The neutralizing mAbs are undergoing phase 2 clinical studies to eliminate COVID-19 spike protein.

Two separate anti-PD-L1 mAbs (STI-3031) are undergoing Phase 2 and 3 clinical studies. ImmuneOncia Therapeutics, Inc obtained a license for STI-3031. 

ImmuneOncia Therapeutics, Inc is a JV between Yuhan Corporation based in Seoul and Sorrento. The phase 1b clinical study of STI-3031 is completed in patients with LA (locally advanced) or solid metastatic tumors. 

An open-label and Phase 2 clinical study of STI-3031 in patients with liver cancer, esophageal cancer, and resectable gastric cancer is nearing completion. ImmuneOncia began enrolling patients in phase 2 clinical studies in refractory or relapsed extranodal NK/T cell lymphoma. 

Receives US FDA approval for STI-3031 Phase 2a clinical study

Sorrento received the approval of the US FDA to carry out the phase 2a clinical studies of STI-3031 to treat patients with advanced UC (urothelial carcinoma). 

Sorrento licensed its second antibody – Socazolimab, to Greater China-based Lee’s Pharmaceutical Holdings Limited. Socazolimab is cleared to commence phase 3 multi-center clinical studies led by Professor Shun Lu to treat patients with extensive-stage SLC (small-cell lung cancer).

The company already completed the phase 1a clinical studies for this drug to treat indications like high-grade osteosarcoma, advanced urothelial carcinoma, and recurrent MCC (metastatic cervical cancer). It also initiated Phase 1b/2 clinical trial to cure esophageal carcinoma. 

Clinches a deal to takeover ACEA Therapeutics

Sorrento signed an agreement to takeover ACEA Therapeutics, a late-stage oncology company, on April 5, 2021. Major assets of ACEA are the next generation inhibitor – AC0939, brain-penetrating, and next-generation BTK inhibitor – AC0058, and next-generation dual EGFR mutant – Abivertinib.

The company expects to complete the merger in Q2 2021.