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Sorrento Pops 28% On FDA Nod To Kick Off Covid-19 Antibody Trial
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Sorrento Pops 28% On FDA Nod To Kick Off Covid-19 Antibody Trial

Shares in Sorrento are surging 28% in Thursday’s pre-market session after the biotech company said it received US regulatory clearance to start a Phase 1 trial for its Covid-19 neutralizing antibody candidate.  

The US Food and Drug Administration (FDA) has given Sorrento (SRNE) the go-ahead to proceed with patient enrollment for its Phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized Covid-19 patients. The initial trial is expected to be followed by large-scale trials targeting a potential Emergency Use Authorization (EUA) submission as early as before the end of this year, the company said.

Sorrento disclosed that the highest proposed dose (200 mg per patient) in the Phase 1 trial is a lower dose than currently being tested for other known SARS-CoV-2 targeted antibodies or antibody cocktails in active clinical studies.

“The potentially high potency of STI-1499 antibody may allow for rapid scaling up of manufacturing operations,” the company said in a statement.

In preclinical studies, STI-1499 demonstrated 100% in vitroneutralizing effect against SARS-CoV-2, preventing infection of healthy cells. Sorrento said that STI-1499 was further evaluated in preclinical studies using multiple strains of SARS-CoV-2, including the highly contagious D614G variant. 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.

On a year-to-date basis, Sorrento shares have had a stellar journey soaring 147% sparked by investor hopes for its Covid-19 candidates. Back in July, Sorrento inked a licensing deal with Columbia University giving it rights to COVI-TRACE, a fast, one-step diagnostic test that samples saliva and can detect the SARS-CoV-2 virus in 30 minutes. (See SRNE stock analysis on TipRanks).

Dawson James analyst Jason Kolbert late last month reiterated a Buy rating on the stock with a $21 price target (150% upside potential).

“Sorrento plans to accelerate the development of multiple candidates for in vivo gene-encoded expression of Sorrento’s antibodies, starting with Sorrento’s previously announced STI-1499, or COVI-GUARD,” Kolbert wrote in a note to investors. “If clinical trials are successful, a single administration of STI-1499dpi (DNA plasmid injection) could allow the recipient’s own muscle cells to produce the antibody for a prolonged period of time after a single injection, potentially providing extended protection against Covid-19 for periods of time that might provide an alternative to vaccines.”

“Manufacturing of DNA plasmids (in bacterial fermenters) can be done with Sorrento’s in-house cGMP capabilities for a fraction of the cost associated with traditional antibody manufacturing,” the analyst added.

Overall, only one other analyst has rated the stock recently with a Buy rating, which provides Sorrento with a Moderate Buy consensus. At $25.50, the average analyst price target indicates another 205% upside potential in the shares over the coming year.

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