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

• STI-3031 was discovered from Sorrento’s fully human G-MAB library.
• Currently, six G-MAB antibodies are in Phase 1b through Phase 3 clinical trials in immuno-oncology and COVID-19 indications.
• These clinical and pre-clinical G-MAB antibodies are expected to be the foundation for developing potent antibody drug conjugates (ADCs) and antibody drug nanoparticle albumin-bound (ADNAB) product candidates.
• G-MAB antibodies have also been used for the generation and production of both CAR-T and DAR-T cells for treating hematological cancer and solid tumors.

SAN DIEGO, April 27, 2021 (GLOBE NEWSWIRE) -- Over the last several months, Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") and its development partners have advanced into clinical development (Phase 1b through Phase 3 clinical trials) a number of fully human monoclonal antibodies (mAbs) for the treatment of COVID-19 and various cancers. This demonstrates the potential of the deep pipeline generated from Sorrento’s proprietary G-MAB library, invented by Dr. Henry Ji, the Chairman and CEO of Sorrento. This G-MAB library is based on the use of RNA transcription for amplification of the antibody variable domains from over 600 donors.  These donors were from both sexes and of multiple ethnicities, leading to a broad diversity of antibodies. In-depth analysis of deep sequencing DNA data showed that the G-MAB library contains more than 20 quadrillion (10¹⁶) distinct antibody sequences.  The G-MAB library has fostered the development of several early and late-stage oncology programs that are currently in Phase 2 and Phase 3 clinical trials and neutralizing mAbs currently in a Phase 2 clinical trial directed against the spike protein of COVID-19 viruses.

Two independent anti-PD-L1 mAbs are now in Phase 2 and Phase 3 clinical studies. A PD-L1 mAb (STI-3031, also known as IMC-001) was licensed to ImmuneOncia Therapeutics, Inc. (“ImmuneOncia”), a joint venture between Sorrento and Seoul-based Yuhan Corporation. IMC-001 has completed a Phase 1b study in patients with metastatic or locally-advanced solid tumors and is nearing completion of a Phase 2, open-label, “Neo-Chance” study in patients with resectable gastric cancer, esophageal cancer and liver cancer. ImmuneOncia has also started to enroll patients in a Phase 2 study in relapsed or refractory extranodal NK/T cell lymphoma, nasal type. Sorrento has filed an IND in the U.S. and received clearance from the FDA to proceed with a Phase 2a study for STI-3031 for advanced urothelial carcinoma.