ʻO ka spike protein binding assays a me ka neutralization assays me ka hoʻohana ʻana i nā maʻi e hōʻike ana i nā ʻano like ʻole a pau o ka hopohopo SARS-CoV-2 (VOCs) i hoʻopau ʻia me STI-9167, a ua ʻike ʻia kēia nAb e hoʻopaʻa me ka pilina kiʻekiʻe a hāʻawi i ka hana neutralizing ikaika loa (Omicron IC50 = 25 ng/ml). ʻO ka mea nui i ʻike ʻia, ʻokoʻa ʻo STI-9167 ke hoʻohālikelike ʻia i nā hoʻāʻo o SARS-CoV-2 nAbs i ʻae ʻia e EUA i loko o ka hoʻopaʻa ʻana a me ka neʻe ʻana o nā waiwai i mālama ʻia e kūʻē i ka ʻano Omicron a me Omicron (+R346K) e ulu nei, kahi ʻano o ka laina laina Omicron e ulu nui ana. hoʻopili i kahi hoʻololi protein R346K Spike hou. Hoʻohui ʻia, hāʻawi ʻia ʻo STI-9167 ma kahi haʻahaʻa haʻahaʻa (5mg/kg) e nā ala intranasal a i ʻole intravenous i hāʻawi i ka pale ikaika i nā hōʻailona lapaʻau o ka maʻi e ka Omicron variant i ka K18-hAce2 transgenic kiole kumu hoʻohālike o COVID-19, e pale ana i ke kaumaha. ka poho a me ka ho'ēmiʻana i nā titers virus i loko o ka māmā i nā pae undetectable.

"ʻO ka hanauna a me keʻano o ka STI-9167 nAb e hōʻike ana i ka hui nuiʻana ma waena o nā kānakaʻepekema o Mount Sinai a me Sorrento e hoʻoponopono i kahi pilikia olakino o ka honua," wahi a Domenico Tortorella, PhD, Professor of Microbiology ma Icahn Mount Sinai.

"Ua koho mākou i ka antibody STI-9167 mai nā pūʻulu nui o nā anti-SARS-CoV-2 spike neutralizing antibodies i kūkulu ʻia i kā mākou labs. Ua hōʻike ʻo ia i ka cross-neutralization maikaʻi loa e kūʻē i nā mea hoʻokaʻawale SARS-CoV-2 āpau a me nā ʻano hopohopo like ʻole, me nā ʻano like ʻole o Omicron a me Omicron (+R346K) hou, "i ʻōlelo ai ʻo J. Andrew Duty, PhD, Assistant Professor of Microbiology and Director of ka Center for Therapeutic Antibody Development ma Icahn Mount Sinai.

"ʻO nā nAbs i ʻae ʻia e EUA i kēia manawa ua hōʻemi nui ʻia a i ʻole nā hana hoʻopaʻa a me ka neutralization e kūʻē i ka omicron/omicron (+R346K) i lawa ʻole ai lākou e kākoʻo i nā pono lapaʻau o kēia manawa," wahi a Mike A. Royal, MD, JD, MBA, Luna Lapaʻau Nui ma Sorrento. "Pono nui ʻia nā nAbs ʻē aʻe i ka wā kokoke, ʻoi aku ka nui o ka poʻe pediatric i ʻike ʻia i ka nui o ka pilikia no ka maʻi omicron koʻikoʻi a me ka hale maʻi. Hāʻawi kā mākou intranasal COVIDROPS formulation i kā mākou nAbs i nā ala ea kiʻekiʻe kahi e ʻike nui ʻia ai ʻo Omicron a ulu, a ma ke ʻano he non-invasive, maʻalahi i ka mālama ʻana, kūpono ia no nā keiki. Ua hoʻomaka mākou e mālama i nā keiki me COVIDROPS (me STI-2099) ma Mekiko kahi e hoʻomau mau nei ka ʻano delta. Ma o nā haʻawina Phase 2 ma US, United Kingdom a me Mexico, ua ʻike mākou i kahi ʻano palekana palekana no ka lawe ʻana i ka intranasal o kā mākou nAbs a manaʻo i kahi hopena like me COVIDROP (me STI-9167).

"Ua loaʻa iā mākou ka ʻike me ka lawe ʻana i nā lāʻau lapaʻau COVID-19 i loko o ke keʻena a me ka hoʻonui ʻana i kekahi i ka Phase 2 a / a i ʻole ka hoʻomohala pivotal," wahi a Mark Brunswick, PhD, SVP a me ke poʻo o ka Regulatory Affairs and Quality ma Sorrento. "Ua kūpono mākou e hoʻopuka koke i ka COVISHIELD ma ke kahua IND a i loko o ke keʻena hauʻoli a manaʻo e waiho i kēia IND koʻikoʻi i ka mahina aʻe."

Ua ʻōlelo ʻo Kauka Henry Ji, Luna Hoʻokele a me Luna Nui o Sorrento, "ʻO ka hana a nā hui ma Sorrento a me Mount Sinai ua hāʻawi mai i kahi antibody kupaianaha me nā waiwai pale kūʻokoʻa a waiwai e kūʻē iā Omicron a me nā SARS-CoV-2 VOC āpau. ʻO kā mākou COVISHIELD neutralizing antibody ka mea maikaʻi loa i ka papa a me ka moho kiʻekiʻe loa no ka hakakā ʻana i ka Omicron maʻamau a me nā Omicron (+R346K) VOC. Ke hana ikaika nei mākou e hoʻonoho i kēia antibody no ka hoʻohana ʻana i nā maʻi maʻi COVID a ke hilinaʻi nei kā mākou ala e hāʻawi i kahi hopena lapaʻau kūpono ʻaʻole wale i ka wā kokoke akā ke hoʻomau nei ka maʻi maʻi.

Ua waiho ʻia kahi manuscript preprint ma Ianuali 19, 2022 a e paʻi ʻia ma ka pūnaewele ma biorxiv.org.

ʻO ka antibody neutralizing i wehewehe ʻia i hana ʻia i loko o nā hale hana ma Mount Sinai a laikini wale ʻia iā Sorrento Therapeutics. Loaʻa i nā lālā kumu o ka mauna ʻo Sinai a me nā kumu kula ʻo Mount Sinai kahi hoihoi kālā ma Sorrento Therapeutics.

He aha e lawe ʻia mai kēia ʻatikala:

Additionally, STI-9167 administered at a low dose (5mg/kg) by either the intranasal or intravenous routes provided strong protection against the clinical signs of infection by the Omicron variant in the K18-hAce2 transgenic mouse model of COVID-19, preventing weight loss and reducing virus titers in the lungs to undetectable levels.
Of noted significance, STI-9167 is unique when compared to tests of EUA-approved SARS-CoV-2 nAbs in that binding and neutralization properties are maintained against the emerging Omicron and Omicron (+R346K) variant, an increasingly prevalent Omicron lineage variant that encodes an additional R346K Spike protein mutation.
Our intranasal COVIDROPS formulation delivers our nAbs to the upper airways where Omicron is most likely to target and flourish, and as a non-invasive, easy to administer treatment, it is ideal for children.