COFEPRIS granted emergency use approval for Sorrento Therapeutics Inc (NASDAQ: SRNE)’s COVI-STIX under OFICIO: CAS/10720/2021.
On June 14, 2021, Sorrento received an import permit from COFEPRIS for its COVI-STIX. The company will establish its subsidiary – Sorrento Mexico Ltd, in Mexico to manage the commercial operations.
It will use COVI-STIX to identify SARS-CoV-2 virus nucleocapsid antigen in nasopharyngeal or nasal samples of patients.
Commercial launch in July
Sorrento expects to unveil the COVI-STIX test soon in Mexico. The company will begin its first commercial shipment in July 2021.
Signs multi-year R&D accord
Sorrento signed CRADA (Cooperative Research and Development Agreement) with NAMRU-3. As per the pact’s terms, NAMRU-3 will engage in clinical validation and surveillance aspects, whereas Sorrento offers technical expertise.
Sorrento will also provide access to its products to contain SARS-CoV-2 and emerging threats. NAMRU-3 will ensure readiness through deterring, detection, and responding quickly to infectious diseases by integrating with partners across the US Africa Command, European Command, and Central Command.
They will engage in the research of infectious diseases and guides the DoD (Department of Defense). Both firms will also ensure US Armed Forces’ medical readiness.
Initially, both firms will concentrate on clinical diagnostic validation/ surveillance for COVITRACK/ COVISTIX Diagnostics besides COVI-AMG/ COVIDROPS outpatient neutralizing antibody cure.
Sorrento’s CEO, Henry Ji, is pleased to collaborate with NAMRU-3 to efficiently and rapidly assess/ deploy its products in various parts worldwide to satisfy the urgent need.
Sorrento develops best-in-class solutions using its G-MAB antibody library to contain the spread of the SARS-CoV-2 virus and its variants. These developments include low-cost, simple, and sensitive diagnostics like COVITRACK, COVISTIX, rescue therapies, and potent neutralizing antibodies such as COVIDROPS and COVI-AMG.
The UK regulatory agency permits COVI-DROPS Phase 2 trials
The UK regulatory agency – MHRA (Medicines and Healthcare products Regulatory Agency) approved Sorrento to conduct a phase 2 clinical trial of COVI-DROPS to evaluate its efficacy. Sorrento received the approval in less than a month after submitting the rolling application with supporting data from a trial conducted in the US to MHRA.
The company did not report any adverse side effects in the clinical trial of COVI-DROPS in a healthy subject.
Sorrento will recruit 350 subjects with COVID-19 for the phase 2 efficacy clinical trial.
It will administer COVI-DROPS as an intranasal instillation. The antibody works against the SARS-CoV-2 virus and its other variants.
