SORRENTO THERAPEUTICS INC - SRNE STOCK NEWS

Sorrento Therapeutics (Nasdaq: SRNE) announced the FDA's clearance for a Phase 1 clinical trial of its allogeneic anti-CD38 Dimeric Antigen Receptor (DAR)-T cell therapy for relapsed or refractory multiple myeloma. This groundbreaking therapy aims to provide off-the-shelf treatment using Sorrento's proprietary KOKI technology, enhancing specificity and stability while reducing treatment delays. The CD38 DAR-T candidate has shown strong preclinical cytotoxic activity, setting the stage for a promising advancement in cancer therapy.

On July 15, 2021, China Oncology Focus, a subsidiary of Lee’s Pharm, enrolled the first patient in a Phase 3 study of Socazolimab for treating extensive-stage small-cell lung cancer. This clinical trial, authorized by the NMPA in March 2021, evaluates Socazolimab's efficacy combined with chemotherapy. Early Phase Ib results indicated a promising safety and efficacy profile. Socazolimab, licensed from Sorrento for Greater China, is a fully human anti-PD-L1 monoclonal antibody that aims to improve treatment outcomes in this aggressive cancer type.

Sorrento Therapeutics, Inc. (Nasdaq: SRNE) announced the approval to commence clinical trials for ESG-401, an anti-TROP-2 coupled to SN38, developed in partnership with Escugen Biotechnology. This novel ADC targets multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma, addressing significant unmet medical needs. Preclinical studies showed ESG-401's promising safety profile and efficacy, with low toxicity and extended tumor growth inhibition. Sorrento plans to file a US IND for ESG-401 by year-end.

Sorrento Therapeutics has initiated a large Phase 2 clinical trial in the UK for its intranasal COVIDROPS™ neutralizing antibody treatment, enrolling approximately 350 outpatients with mild or asymptomatic COVID-19. The trial, which uses a decentralized design, evaluates doses of 10 mg and 20 mg against placebo. Previous safety studies indicated a favorable safety profile. If results are positive, Sorrento plans to apply for Emergency Use Authorization across multiple regions, including the US and EU. The antibody is effective against various SARS-CoV-2 variants, including Delta and Alpha.

Sorrento Therapeutics has launched a new subsidiary in Mexico City, named Sorrento Therapeutics Mexico, aimed at developing COVID-19 related products. This includes receiving a permit from COFEPRIS to import the first 25 million units of COVI-STIX tests. The subsidiary will manage commercialization efforts and clinical trials for Sorrento's products in Mexico and Latin America. Dr. Henry Ji is the Chairman, while Héctor Sulaimán S. serves as CEO, signaling a strategic expansion into new markets.

Scilex Holding Company has completed enrollment for its SP-102 (SEMDEXA™) Phase 3 C.L.E.A.R. Trial, targeting lumbosacral radicular pain (sciatica). This trial involves 400 patients across 40 U.S. sites and aims to evaluate a non-opioid corticosteroid injectable. SP-102 received FDA Fast Track designation, with top-line data expected in Q4 2021. Previous trials indicated significant pain relief in patients. If approved, SP-102 could become a primary non-opioid option for sciatica, addressing a significant market need and replacing millions of off-label epidural steroid injections annually.

Sorrento Therapeutics (Nasdaq: SRNE) announced that its partner, Mabpharm Ltd, received approval from the China National Medical Product Administration for its infliximab biobetter antibody. Sorrento holds exclusive rights to market this product outside China, including in the US and Europe, where it plans to file a Biologics License Application (BLA) by the end of 2021. The biobetter has shown improved safety and lower immunogenicity compared to existing treatments and is effective for six autoimmune and inflammatory diseases. Global infliximab sales were $4.2 billion in 2020.

Sorrento Therapeutics has received FDA clearance to advance its Phase 2 trial for RTX aimed at treating moderate-to-severe osteoarthritis pain. The Phase 1b trial demonstrated RTX's safety and significant efficacy, with notable pain relief lasting over six months in patients with advanced OA. The drug targets a market projected to surpass $10 billion by 2025. The upcoming Phase 2 trial will evaluate various dosages of RTX against an active comparator, potentially supporting international registrations. Sorrento aims to identify the optimal Phase 3 dosage to further its clinical development program.

Sorrento Therapeutics (Nasdaq: SRNE) announced its receipt of Emergency Use Authorization (EUA) from COFEPRIS, allowing the import and commercialization of the COVI-STIX diagnostic test for SARS-CoV-2 in Mexico. The official registration number is “OFICIO: CAS/10720/2021.” A subsidiary, Sorrento Mexico Ltd, will facilitate the operations, with initial shipments expected in July 2021. COVI-STIX provides rapid results in approximately 15 minutes, enhancing Sorrento's position in the COVID-19 diagnostics market.