Sorrento Therapeutics Preclinical Data of Neutralizing Antibodies Against SARS-CoV-2
- In preclinical studies, both STI-1499 and STI-2020 demonstrated potent neutralizing activity against SARS-CoV-2 virus isolates, including the emerging Spike D614G variant virus.
- Both STI-1499 and STI-2020 demonstrated protective activities against SARS-CoV-2 infection in Syrian golden hamsters.
- At day 5, STI-2020 at 500 µg reduced virus load in hamster lungs to undetectable levels in 100% of animals tested, whereas STI-1499 at 2,000 µg reduced virus load below the detection limit in 60% of animals tested and showed a 10-fold reduction in the remaining 40% of animals.
Sorrento Therapeutics (SRNE) has released preclinical data reporting on COVI-GUARD™ (STI-1499) and COVI-AMG™ (STI-2020 – Affinity Matured COVI-Guard) neutralizing antibodies (nAbs) against SARS-CoV-2 as well as a D614G virus variant infection in a preprint publication.
- Both STI-1499 and STI-2020 demonstrated potent neutralizing activities against SARS-CoV-2 virus infection in preclinical models.
- STI-1499 nAb has been cleared by the FDA for a Phase 1 clinical trial in hospitalized COVID-19 patients.
STI-2020 is an affinity-matured version of the COVI-GUARD nAb. It demonstrated a greater than 50-fold increase in potency in vitro experiments.
Both STI-1499 and STI-2020 have shown 100% in vitro neutralization of SARS-CoV-2 at concentrations of 6 µg/ml and 78 ng/ml, respectively in a preclinical cell-based assay. The neutralization activity at these concentrations protected against both SARS-CoV-2 and the highly contagious Spike D614G isolate.
Dr. Slobodan Paessler’s laboratory at the University of Texas Medical Branch at Galveston (UTMB) generated promising preclinical animal data for STI-1499 and STI-2020 nAbs in a Syrian golden hamster model infected with SARS-CoV-2.
A Few Highlights of the Data from the Most Recent STI-2020 Study:
- Hamsters infected with SARS-CoV-2 and then treated with a single dose of 500 µg STI 2020 started gaining weight within 48 hours of STI-2020 administration, as compared to control animals that steadily lost weight for 5 days before recovery.
- At day 5, STI-2020-treated (500 µg) hamsters had gained 5% weight, versus a weight loss of about 10% for the control animals (15% difference).
- At day 5, all STI-2020-treated (500 µg) hamsters (5 out of 5 analyzed animals) had an undetectable viral load in lungs as compared to the lungs of animals in the control group, where more than 1,000 infectious viral particles per gram of tissue were readily detected.
Based on interspecies allometric scaling methods, the 500 µg single dose of STI-2020 administered to the hamsters in the preclinical studies would be equivalent to a human dose of less than 100 mg of antibody. In contrast to other currently-used dosing regimens requiring grams of antibody per patient for treating COVID-19, this antibody could be highly potent at a very low dose. COVI-AMG could potentially be administered as a simple rapid injection for the treatment of COVID-19 patients.
From the Chairman and CEO of Sorrento Therapeutics
Dr. Henry Ji, Chairman and CEO of Sorrento, said, “We believe that the results for STI-1499 and STI-2020 are truly remarkable. Based on the preclinical testing we have conducted to date, STI-2020 is our most promising SARS-CoV-2 antibody so far. The potency of both nAbs and their ability to mitigate SARS-CoV-2 infection from the lungs in a Syrian golden hamster model is very impressive, strongly supporting further development of these antibodies. STI-1499 has been cleared by the FDA for a Phase 1 clinical trial in hospitalized COVID-19 patients. STI-2020 has the potential to be utilized for both early and late therapeutic interventions, as well as for prophylaxis, with the potential of having a low efficacious dose, which could enable efficient manufacturing and ultimately result in higher affordability for patients.”
Sorrento has received FDA clearance for its Phase 1 clinical trial for STI-1499 in hospitalized COVID-19 patients and it intends to submit an IND for STI-2020 as soon as possible.
This good news is boosting Sorrento Therapeutics’ stock after days of stock pressure. The stock closed yesterday at $10.15, UP $0.51. Today it closed at $11.60, UP $1.45.
Recently, Sorrento’s management was complaining that a group of bearish investors was putting pressure on the stock. If that’s true we hope to hear the officials’ opinions regarding the firm’s complaint.
Sorrento Therapeutics news is exciting and we hope it will be confirmed in the upcoming human clinical trials.