SORRENTO THERAPEUTICS INC - SRNE STOCK NEWS

Sorrento Therapeutics, Inc. (Nasdaq: SRNE) has submitted an Emergency Use Authorization (EUA) Application to the FDA for its COVI-STIX rapid diagnostic test aimed at detecting SARS-CoV-2 virus nucleocapsid antigen in nasal samples. Results from COVI-STIX can be obtained in as little as 15 minutes, with positive detection as quick as two minutes for samples with high viral loads. Sorrento is focused on developing therapies for cancer and coronavirus treatments, including various antiviral therapies and diagnostic solutions.

The FDA has approved Sorrento Therapeutics' Investigational New Drug application for Phase 1 clinical trials of STI-2020 (COVI-AMG) in healthy volunteers and mild COVID-19 patients. This monoclonal antibody is designed for high potency, potentially requiring less volume for effective dosing. Preclinical studies showed STI-2020's strong binding to multiple SARS-CoV-2 variants. The trials aim to evaluate safety and efficacy, with plans for rapid enrollment and subsequent pivotal trials for Emergency Use Authorization submission.

Sorrento Therapeutics (SRNE) has received a Clinical Laboratory Improvement Amendments (CLIA) license from California, enabling it to conduct clinical sample testing. The company plans to offer three diagnostic tests for SARS-CoV-2, including an EUA-approved RT-PCR test, COVI-STIX, and COVI-TRACE. These tests will provide rapid results, with the RT-PCR test reporting within three hours and the other two tests within 20 to 30 minutes. Sorrento aims to generate revenue from clinical testing, enhance flexibility, and reduce costs by processing samples in-house.

Sorrento Therapeutics (NASDAQ: SRNE) announced Dr. Henry Ji, Chairman and CEO, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference. A pre-recorded presentation will be available, and one-on-one virtual meetings with select investors will occur from November 30 to December 3, 2020. For further details, investors can access the recorded presentation via the provided link, which will expire after 90 days. Sorrento emphasizes that its statements about future performance are forward-looking and subject to risks.

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) announced a contract from DARPA for up to $34 million to develop a gene-encoded antibody, Gene MAb, aimed at providing rapid protection against SARS-CoV-2. This funding will support Phase 2 clinical studies of STI-2020-encoded Gene MAb, which can be administered via intramuscular injection. The Gene MAb approach could offer significant advantages, such as storage at refrigerator temperatures, addressing cold chain challenges faced by existing COVID-19 vaccines. Sorrento plans to seek additional funding for emergency use authorization and scaling production.

Sorrento Therapeutics (Nasdaq: SRNE) has filed an IND for STI-2099 (COVI-DROPS™) aimed at evaluating safety and pharmacokinetics in healthy volunteers and mild COVID-19 patients. Following this phase 1 trial, a phase 2 study is planned for both mild and moderate cases, using either a stand-alone nasal application or a combination with intravenous administration. Prior preclinical studies showed a 100% neutralizing effect of STI-2099 against COVID-19 in animal models, demonstrating potential for early outpatient treatment.

SRNE has submitted an IND filing for STI-2020 (COVI-AMG™) aimed at treating mild COVID-19 symptoms. This includes a safety and pharmacokinetic study in healthy volunteers. Following these initial trials, pivotal trials may lead to a potential Emergency Use Authorization (EUA). Preclinical data from gold Syrian hamsters infected with SARS-CoV-2 shows a strong neutralizing effect. This engineered antibody boasts ultra-high potency, requiring a lower effective dose for humans, facilitating a simple IV-push administration for outpatient treatment.

Sorrento Therapeutics (Nasdaq: SRNE) announced positive results from an IND-enabling study of its intranasal COVI-DROPS (STI-2099), demonstrating reduced COVID-19 disease severity in infected hamsters. The study revealed that intranasal administration showed earlier weight recovery and shorter disease duration compared to intravenous COVI-AMG (STI-2020). Sorrento plans to file IND applications for both therapies in November 2020 and initiate clinical trials to assess safety and efficacy in COVID-19 patients.

Sorrento Therapeutics (Nasdaq: SRNE) has announced the clearance to proceed with Phase 2 clinical trials of Abivertinib in Brazil and the U.S., targeting COVID-19 patients. The Brazilian study aims to enroll 400 hospitalized patients, focusing on various disease stages. The rapid enrollment is facilitated by a partnership with Synova Health, enabling access to numerous medical centers. The U.S. trial will have a different protocol, concentrating on severe cases. This strategic alignment may accelerate recruitment and reduce costs for both trials.