Sorrento Therapeutics, Inc. (Nasdaq: SRNE) announced that it is filing an investigational new drug application (IND) for COVI-GUARD (STI-1499) for hospitalized COVID-19 patients today.
- IND filing today for STI-1499 (COVI-GUARD™) for hospitalized COVID-19 patients.
- The initial trial is expected to be followed by pivotal trials with a goal of potentially receiving an EUA (Emergency Use Authorization) as early as the end of this year.
- Animal model data (Syrian Golden Hamsters infected with SARS-CoV-2) confirm the neutralizing profile and high potency of this antibody, expected effective dose in human to be at least 5 times lower than current known antibodies being assessed in other active trials.
- Additional in-vitro experiments demonstrated the complete virus neutralizing property of STI-1499 against the highly contagious D614G SARS-CoV-2 variant.
- 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 has previously received guidance from the FDA in response to a pre-IND meeting package and believes it has addressed all questions and followed the recommendations from the agency for all sections of the IND.
As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% neutralizing effect (in vitro) of the antibody and that a low dose prevented SARS-CoV-2 from infecting healthy cells in such preclinical in vitro studies.
Animal data generated by Dr. Paessler’s laboratory at the University of Texas Medical Branch at Galveston (UTMB) in Syrian Golden Hamsters infected with SARS-CoV-2, justify the IND filing and continued clinical development. This established model, while limited, is the most predictive animal model currently available for this disease. The data were presented to federal agencies and will be published as soon as possible in a scientific journal.
The highest proposed dose (200 mg per patient) in the phase 1 safety trial is a much lower dose than currently being tested for other known antibodies in active clinical studies. The potentially higher potency of the antibody may allow for faster scaled manufacturing (availability to patients) and potentially a lower cost per dose as compared to other known antibodies currently being evaluated.
STI-1499 antibody has also been evaluated in preclinical studies against multiple strains of SARS-CoV-2, including the highly contagious D614G mutant, the current dominant strain globally. In such preclinical studies, the antibody has been 100% effective against the highly contagious D614G mutant strain at a low dose.
More information about the phase 1 clinical trial can be found on www.clinicaltrials.gov (NCT# 04454398).