Candidate: Anti-SARS-CoV-2 monoclonal antibodies for the treatment of COVID-19
Types: Fully human monoclonal antibodies targeting immutable sites confirmed as 98.71% to 99.29% conserved over the entirety of all 1 million coronavirus isolates. Enzolytics says it has confirmed that the analyzed sites are conserved sites not only on the initial virus strains but also existing in the Delta and Lambda variants, as well as in the Alpha, Beta and Gamma variants.
2021 Status: Samsung to Produce Antibodies—Samsung Biologics will provide end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Enzolytics’ anti-SARS-CoV-2 monoclonal antibodies to treat SARS-CoV-2, as well as antibodies to treat HIV, the companies said October 7. The value of the partnership was not disclosed.
Enzolytics and Samsung Biologics also agreed to continue talks for producing other monoclonal antibodies being developed by Enzolytics.
The Enzolytics protocol offers the opportunity to implement artificial intelligence (AI) analysis and provides a platform for creating multiple fully human monoclonal antibodies targeting conserved immutable sites on the viruses and offering a cure for the viruses. A stable cell line will be manufactured with support from Samsung Biologics’ R&D Center in San Francisco. Its related clinical trial materials will be manufactured at Samsung Biologics headquarters in Incheon, South Korea.
“Active Production” of Antibodies—Enzolytics said August 25 that it was in “active production” of anti-coronavirus fully human monoclonal antibodies in its Texas lab that were designed to target multiple specific epitopes on the SARS-CoV-2 virus.
The company said its process for producing monoclonal antibodies against infectious diseases began with conducting an AI analysis of the epitope sequences to identify conserved sites with a conservativeness of up to 99%. In the case of COVID-19, the Company initially analyzed 50,512 CoronaVirus isolates and has now analyzed over 1 million isolates resulting in the identification of 19 conserved, immutable sites.
Following the production of multiple monoclonal antibodies in its Texas lab, the monoclonal antibodies will be processed at CRO/CDMO labs contracted by the Company where the sequencing of the antibodies will be determined using denovo mass spectrometry. Peptide sequences will also be determined using PCR. Once the sequencing of the antibodies is determined, the antibodies will be produced using recombinant protein technology in FDA-approved Cho cell lines to create pharmaceutical-grade material for animal and clinical trials.
These follow-on steps will be conducted in specialized CRO/CDMO labs under the Company’s guidance and pursuant to contracts, Enzolytics added.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: