-=Sorrento Therapeutics (SRNE) receives FDA clearance to proceed with Phase 1 clinical trial of Covid drug

• Update Feb 22, 2023: Sorrento is embroiled in a legal battle with NantCell. After losing in court in December 2022, Sorrento filed for Chapter 11 bankruptcy. 

 Sorrento Therapeutics receives FDA clearance to proceed with Phase 1 clinical trial of STI-1499 (COVI-GUARD) neutralizing antibody in COVID-19 positive patients

Co announced that it received a study may proceed letter from the FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized COVID-19 patients.

As Sorrento previously announced, 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.

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.

Animal data generated in Syrian Golden hamsters infected with SARS-CoV-2 was presented to the FDA in support of a post-exposure human treatment dose for the IND. The effective dose in the hamster model translates to a projected total dose of approximately 160mg for a human patient.

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 STI-1499 clinical program is being designed for rapid adaptive expansion, including international sites in Brazil to supplement the US program.

=Sorrento Therapeutics (SRNE) : collaboration with Celularity in therapy development for coronavirus infection

Sorrento Therapeutics announces collaboration with Celularity to initiate emergency allogeneic NK cell therapy development for coronavirus infection

Sorrento Therapeutics has initiated a clinical and manufacturing collaboration with Celularity, a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Sorrento owns 25% of Celularity, and the companies have a longstanding relationship. The objective of the collaboration is to expand the therapeutic use of Celularity's CYNK-001, an allogeneic, off-the-shelf, placental-derived Natural Killer (NK) cell therapy, to the treatment and prevention of coronavirus infections.

Under the contemplated collaboration, Sorrento and Celularity would assess CYNK-001 as a potential novel therapy for the treatment and prevention of coronaviruses, focusing in particular on the newly emerged 2019 Novel Coronavirus (2019-nCoV). In addition, Sorrento would utilize current existing capacity in its cGMP cell therapy manufacturing facilities in San Diego, California to supplement Celularity's new cGMP facility in Florham Park, New Jersey. The combined capacity would support the rapid scale-up and sustained production of the novel cell therapy.

Sorrento is already in contact with leading scientists and local Chinese experts to discuss the clinical validation and logistics requirements to fast-track CYNK-001 cell therapy available in China for this particularly urgent indication.

=Long trade : Sorrento Therapeutics (SRNE) +25% (12/17)

• Dec 15:  #3; vol. 2.6M