Sorrento Therapeutics Inc (SRNE)

[dia76ca]

A new powerpoint presentation about COVISHIELD is now on Sorrento website.
https://investors.sorrentotherapeutics.com/static-files/ef4904ac-5a52-48da-99cb-25e6b25bbb72
IT concludes with this slide information:
STI-9167 GMP Master Cell Bank generation completed
? IND-enabling preclinical safety and toxicology studies completed
• Phase 1 clinical trials planned in healthy individuals and infected patients for both intranasal formulation (COVIDROPS)
and intravenous formulation (COVISHIELD)
• IND submission in early February
? STI-9167 GMP Drug Product to supply Phase 1/2 studies formulated for intranasal and intravenous dosing has been F/F
? Already manufactured enough drug substance for 100,000’s of intranasal doses

Here is the BIG PICTURE:
"COVISHIELD (STI-9167) neutralizing antibody (nAb) was discovered by scientists from the Icahn School of Medicine at Mount Sinai (“Icahn Mount Sinai”) and further optimized and engineered by Sorrento scientists.

A preprint manuscript is published online at biorxiv.org: https://biorxiv.org/cgi/content/short/2022.01.19.476998v1

Sorrento has obtained worldwide exclusive license rights from Icahn Mount Sinai as previously announced on March 9, 2021 (https://investors.sorrentotherapeutics.com/news-releases/news-release-details/sorrento-and-mount-sinai-health-system-enter-exclusive-license).

Compared to available published literature and head-to-head experiments, STI-9167 nAb is a potentially “Best-in-Class” nAb against the Omicron variant of SARS-CoV-2 and the first reported nAb with high potency against Omicron (+R346K mutation) and has demonstrated highly potent neutralization activities in vitro (IC 50 of 25 ng/mL for Omicron live virus, 14.8 ng/mL and 23.9 ng/mL for Omicron and Omicron (+R346K mutation) pseudovirus, respectively), in addition to potent neutralizing activities against the SARS-CoV-2 virus and all of its variants of concern (VOCs).

STI-9167 nAb demonstrated strong protection in vivo following Omicron virus challenge in a preclinical model of COVID-19, preventing weight loss and reducing virus titers in the lungs to levels below the limit of detection.

GMP drug product manufacturing in support of large clinical development is in place at Sorrento GMP facilities.

Sorrento is evaluating in-house GMP manufacturing and is in negotiations with major global CMOs for commercial scale manufacturing to secure capacity to manufacture and supply tens of millions of doses. Sorrento currently has in-hand sufficient cGMP drug substance for 100,000’s of doses at the projected intranasal dose of STI-9199, the intranasal formulation of STI-9167.

INDs to be submitted in the US, UK and Mexico within a month for use as either a small volume intravenous push or intranasal instillation."