Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe


Sorrento Receives FDA Clearance to Proceed with Phase 1 COVID-19 Neutralizing Antibody Trial

Share on Stocktwits


Sorrento Therapeutics shares traded more than 10% higher after the company reported it received FDA approval to proceed with its Phase 1 clinical trial of STI-1499 (COVI-GUARD) Neutralizing Antibody in hospitalized COVID-19 patients.

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%).


1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe