COVI-GUARD (STI-1499) / Sorrento, Mount Sinai - LARVOL DELTA

SARS-CoV-2 monoclonal antibodies with therapeutic potential: Broad neutralizing activity and No evidence of antibody-dependent enhancement. (PubMed, Antiviral Res) - "These findings confirm that SARS-CoV-2 has already escaped some mAbs, and identify a mAb candidate that may neutralize multiple SARS-CoV-2 variants. They also suggest that risk of ADE in macrophages may be low with SARS-CoV-2 D614, and LALA Fc change impacts neither viral neutralization nor Ab clearance."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Sorrento to Present Data Demonstrating STI-2020 Preserves Binding Against UK B.1.1.7 SARS-CoV-2 Mutated Spike Protein (GlobeNewswire) - "Sorrento Therapeutics, Inc....announced that it will be presenting preliminary results from an ongoing SARS-CoV-2 mutation surveillance program...Dr. Robert Allen, Senior Vice President...will be presenting data from the SARS-CoV-2 Spike protein variant screening program at PepTalk 2021 today and on Thursday of this week. Disclosed data will provide evidence of maintained binding potency by STI-2020 in in vitro assays...This is highly clinically relevant as it might signify that the STI-2020 antibody currently in clinical trials is not anticipated to behave differently against the new virus variant...Additional neutralizing antibodies were identified that bind strongly to the B.1.1.7 and B.1.351 spike proteins and are under further analyses..."

Preclinical • Review • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19 (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: Sorrento Therapeutics, Inc.; N=33 ➔ 0; Recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • CXCL8 • IL10 • IL6

Sorrento to Host a R&D Day to Showcase COVID-19 Product Pipeline (GlobeNewswire) - "Sorrento Therapeutics, Inc....announced it will host a R&D Day conference call and simultaneous webcast on October 13th, 2020 focusing on its comprehensive multi-modal approach to COVID-19. R&D Day Agenda: Clinical Stage Products (cleared Phase 1 or Phase 2): STI-1499 (COVI-GUARDTM neutralizing antibody (nAb) against SARS-CoV-2 and its D614G Variant); STI-5656 (Abivertinib for reducing cytokine storm and associated ARDS: acute respiratory distress syndrome); Pre-Clinical Stage Products of high interest: STI-2020; COVI-SHIELDTM; STI-2030; STI-4398; STI-3333; STI-2099."

Clinical • Cytokine storm • Live event • Preclinical • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19 (clinicaltrials.gov) - P1; N=33; Recruiting; Sponsor: Sorrento Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • CXCL8 • IL10 • IL6

"$SRNE STI-1499 and STI-2020 Pre Print Released! @AndyBiotech @InsidrFinancial @MaxRiskCapital @RobLansinger @ACInvestorBlog https://t.co/NmQDPIwuf8" (@1BioBioom)

Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trial of STI-1499 (COVI-GUARD) Neutralizing Antibody in COVID-19 Positive Patients (GlobeNewswire) - "Sorrento Therapeutics, Inc....announced today that it received a study may proceed letter from the FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499)....Animal data generated in Syrian Golden hamsters infected with SARS-CoV-2 was presented to the FDA in support of a post-exposure human treatment dose for the IND. The effective dose in the hamster model translates to a projected total dose of approximately 160mg for a human patient....The STI-1499 clinical program is being designed for rapid adaptive expansion, including international sites in Brazil to supplement the US program."

IND • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Sorrento Announces FDA IND Filing Today for COVI-GUARD Neutralizing and High Potency Antibody Against SARS-CoV-2 (GlobeNewswire) - "Sorrento has initiated cGMP manufacturing to produce 50,000 doses, expected to be available by the end of this year, in anticipation of a potential EUA; Sorrento Therapeutics, Inc....announced that it is filing an investigational new drug application (IND) for COVI-GUARD (STI-1499) for hospitalized COVID-19 patients today....The highest proposed dose (200 mg per patient) in the phase 1 safety trial is a much lower dose than currently being tested..."

Commercial • IND • Infectious Disease • Novel Coronavirus Disease

"$SRNE Announces FDA IND Filing Today for COVI-GUARD Neutralizing and High Potency Antibody Against SARS-CoV-2" (@BioStocks)

Infectious Disease • Novel Coronavirus Disease

Study to Evaluate STI-1499 (COVI-GUARD) in Hospitalized Patients With COVID-19 (clinicaltrials.gov) - P1; N=32; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.; N=24 ➔ 32

Clinical • Enrollment change • Infectious Disease • Novel Coronavirus Disease

Sorrento Enters Into Letter Of Intent To Acquire SmartPharm And Develop Pipeline Of Gene-Encoded Therapeutic Antibodies, Starting With Neutralizing Antibodies To Treat COVID-19 and Cancer Therapeutics (PRNewswire) - "Sorrento Therapeutics, Inc....and SmartPharm Therapeutics, Inc....announced today the signing of a letter of intent for Sorrento to acquire SmartPharm....The transaction is expected to close in August 2020....Sorrento plans to accelerate the development of multiple candidates for in vivo gene-encoded expression of Sorrento's antibodies, starting with Sorrento's previously announced STI-1499, or COVI-GUARD...with an IND submission targeted for August 2020. The initial clinical trial for STI-1499 is expected to be in ICU patients to ensure safety and potentially allow a preliminary look at efficacy."

IND • M&A • Infectious Disease • Novel Coronavirus Disease

A Randomized Placebo-controlled Study to Evaluate STI-1499 (COVI-GUARD) in Hospitalized Patients With COVID-19 (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease