Sorrento Therapeutics Inc. (SRNE:NASDAQ) yesterday announced that it received a "study may proceed letter from the U.S. Food and Drug Administration (FDA) for its phase 1 clinical trial for COVI-GUARD™ (STI-1499) in hospitalized COVID-19 patients."
Sorrento stated that the letter from the FDA advised that the company may proceed with patient enrollment in the Phase 1 COVI-GUARD clinical study. The firm noted that it expects enrollment to gear up quickly and that it projects that this trial will be followed by larger trials targeting a potential Emergency Use Authorization (EUA) submission as early as the end of December 2020. The company noted that in anticipation of a potential EUA, it has already initiated cGMP manufacturing to produce 50,000 doses for this purpose.
The firm stated that the STI-1499 clinical program is being designed for rapid adaptive expansion in both the U.S. and Brazil.
The company indicated that it previously announced that "in preclinical studies, STI-1499 demonstrated 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies."
The firm explained that "STI-1499 was further evaluated in preclinical studies using multiple strains of SARS-CoV-2, including the highly contagious D614G variant and that in these preclinical studies the antibody has been 100% effective against the highly contagious D614G variant strain at similar doses to those observed in experiments with the USA-WA1/2020 strain."
The company pointed out that the highest proposed Phase 1 trial dose of 200 mg per patient is lower than other known SARS-CoV-2 targeted antibodies or antibody cocktails currently being evaluated in active clinical studies due to the potentially high potency of its STI-1499 antibody. The firm believes that this will aid in its ability to rapidly scale up manufacturing operations.
Sorrento is a clinical stage biopharmaceutical company based in San Diego, Calif., that concentrates its efforts on the development of new therapies to treat cancers. The company noted that "its multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms." These include fully human antibodies, clinical stage immuno-cellular therapies, antibody-drug conjugates and clinical stage oncolytic virus. The firm is also presently endeavoring to create potential antiviral therapies and vaccines against coronaviruses.
Sorrento has a market capitalization of around $2.1 billion with approximately 255.1 million shares outstanding and a short interest of about 28.8%. SRNE shares opened almost 26% higher today at $10.52 (+$2.16, +25.94%) over yesterday's $8.36 closing price. The stock has traded today between $9.05 and $10.60 per share and is currently trading at $9.34 (+$0.98, +11.66%).[NLINSERT]
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