COVI-AMG (plutavimab) / Sorrento - LARVOL DELTA

Unbiased approach to identify and assess efficacy of human SARS-CoV-2 neutralizing antibodies. (PubMed, Sci Rep) - "STI-2020 and STI-5041 were protective when administered intravenously or intranasally in the golden (Syrian) hamster model of COVID-19 challenged with the WA-1 strain or Beta variant. The ability to administer nAbs intravenously and intranasally may have important therapeutic implications and Phase 1 healthy subjects clinical trials are ongoing."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Prevalence of reproductive tract infections including sexually transmitted infections among married women in urban and peri-urban mid to low socioeconomic neighbourhoods of Delhi, North India: an observational study protocol. (PubMed, BMJ Open) - "This study protocol has been approved by the ethics review committees of the WHO and Society for Applied Studies (SAS/ERC/RHR-RTI/STI/2020)...The findings will be published in peer-reviewed journals and disseminated through scientific conferences. CTRI/2020/03/023954."

Journal • Observational data • Gynecology • Infectious Disease • Vaginitis

Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19 (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Sorrento Therapeutics, Inc. | N=280 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Sorrento Therapeutics, Inc. | N=500 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19 (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Sorrento Therapeutics, Inc. | N=209 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms (clinicaltrials.gov) - P2; N=500; Recruiting; Sponsor: Sorrento Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19 (clinicaltrials.gov) - P2; N=280; Recruiting; Sponsor: Sorrento Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

Brazilian Protocol for Sexually Transmitted Infections 2020: epidemiological surveillance (PubMed, Epidemiol Serv Saude) - "This article summarizes the chapter on epidemiological surveillance of sexually transmitted infections (STI) that forms part of the Clinical Protocol and Treatment Guidelines (PDCT) for Comprehensive Care for People with STI 2020), published by the Health Surveillance Secretariat of the Ministry of Health of Brazil...The PCDT-IST 2020 was developed based on scientific evidence and validated in discussions with specialists. Epidemiological and clinical aspects are addressed, as well as guidelines for health service managers regarding programmatic and operational management of these diseases, guidelines for health professionals on screening, diagnosing and treating people with STIs and their sex partners, in addition to strategies for surveillance, prevention and control actions."

Clinical • Journal • Infectious Disease

Sorrento Receives US FDA Clearance to Proceed With Phase 1 Study for STI-2099 (Intranasal COVIDROPS) in Healthy Volunteers and Outpatient Treatment for Newly Diagnosed COVID-19 Positive Patients (GlobeNewswire) - "Initial trials are expected to be followed by a Phase 2 trial in both mild and moderate COVID-19 patients, either as a stand-alone nasal application or as a combination nasal and intravenous administration....It has received clearance from the FDA for its Investigational New Drug application (IND) for its Phase 1 study of the safety and pharmacokinetics of intranasal (IN) STI-2099 (COVIDROPS) in both healthy volunteers and patients with mild COVID-19....Sorrento is currently evaluating an intravenous formulation of this potent antibody, STI-2020 (IV)...This small volume IV-push formulation is being tested against the dominant strain of the SARS-CoV-2 virus in the U.S. as well as the emerging UK variant."

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

Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19 (clinicaltrials.gov) - P2; N=280; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 (clinicaltrials.gov) - P1/2; N=0; Withdrawn; Sponsor: Sorrento Therapeutics, Inc.; N=50 ➔ 0; Not yet recruiting ➔ Withdrawn

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

Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19 (clinicaltrials.gov) - P1/2; N=209; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

"@PressSec can you advice how Sorrento Therapeutics DARPA funded STI-2020 and StemCell will be available to us ? @US_FDA" (@shrey_shreyans)

Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms (clinicaltrials.gov) - P2; N=500; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

"We need sti-2020 for the antibody and cure .. @US_FDA needs to understand and expedite progress doe Sorrento Therapeutics.. why only big pharma ??" (@shrey_shreyans)

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

Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trials for STI-2020 (COVI-AMG) in Healthy Volunteers and in Newly Diagnosed COVID-19 Patients (GlobeNewswire) - "Sorrento Therapeutics, Inc....announced today FDA acceptance of its Investigational New Drug (IND) application for its Phase 1 clinical trials for intravenous (IV) STI-2020...The FDA has been requesting...for activity against antibody drug-resistant SARS-CoV-2 variants, including the E484K, F490S, Q493R and S494P mutations....Binding affinity of STI-2020 against each of the variants is similar to or better than that observed for wild-type SARS-CoV-2....STI-2020 demonstrated similarly strong binding affinities to the currently dominant D614G variant and the mink-associated N439K variant as compared to that for wild-type SARS-CoV-2. To expedite development toward a potential EUA submission, Sorrento is planning on initiating dosing in a healthy population."

IND • Preclinical • Infectious Disease • Novel Coronavirus Disease

DARPA and JPEO Award Contract to SmartPharm, a Subsidiary of Sorrento, for Development of Rapid Countermeasure Against COVID-19 Using Gene-Encoded Neutralizing Antibodies (GlobeNewswire) - "SmartPharm Therapeutics, Inc....announced today that it has been awarded a contract from the Defense Advanced Research Projects Agency...The contract would provide SmartPharm up to USD $34 million for development through Phase 2 clinical studies of a gene-encoded antibody ('Gene MAb')...Sorrento will seek further funding in support of the COVID Gene MAb program toward EUA (emergency use authorization) approval and large-scale manufacturing pending successful clinical studies....SmartPharm/Sorrento team will produce plasmid DNA encoding the SARS-CoV-2 neutralizing antibody STI-2020 (COVI-AMG™)."

Financing • Infectious Disease • Novel Coronavirus Disease

Sorrento Announces FDA IND Filing Today for COVI-AMG Neutralizing and High Potency Antibody Against SARS-CoV-2 (GlobeNewswire) - "Sorrento Therapeutics, Inc....announced today that it is filing an investigational new drug application (IND) for intravenous (IV) COVI-AMG (STI-2020) to treat COVID-19 patients with mild symptoms and to evaluate safety and pharmacokinetics in healthy volunteers....Sorrento has initiated cGMP manufacturing to produce 100,000 doses, expected to be available early next year, in anticipation of a potential EUA. In order to speed up development toward EUA submission, Sorrento is also planning on initiating dosing in a healthy population in order to rapidly generate safety and pharmacokinetic results."

Commercial • IND • Infectious Disease • Novel Coronavirus Disease

Sorrento Announces That Intranasal Administration of COVI-AMG Neutralizing Antibody Prevented COVID-19 Disease Progression in Infected Hamsters Following SARS-CoV-2 Infection (GlobeNewswire) - "Sorrento announced the enhancement of the clinical potential of this antibody by releasing in vivo data of intranasal COVI-DROPS (STI-2099)....The 500 µg single dose of STI-2020 (IV) or STI-2099 COVI-DROPS (IN) administered to the hamsters in the preclinical studies would be equivalent to a human dose of approximately 45 mg of antibody....Sorrento is in the final stages of cGMP manufacture of both forms of the antibodies and anticipates submitting IND filings for both intravenous STI-2020 and intranasal COVI-DROPS STI-2099 in November 2020."

IND • Preclinical • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 (clinicaltrials.gov) - P1/2; N=50; Not yet recruiting; Sponsor: Sorrento Therapeutics, Inc.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • CXCL8 • IL10 • IL6