Candidates: Two versions of a human monoclonal antibody.

Category: ANTIBODY

Types: Monoclonal antibody versions engineered through Vir’s platform and designed to neutralize SARS-CoV-2 live virus by binding to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (SARS). That, according to VIr, indicates that the epitope is highly conserved, and thus makes it harder for escape mutants to develop.

Each version has a half-life extending alteration to potentially extend the time over which the antibody provides protection.

One version has been developed with a second “vaccinal” mutation designed to increase short-term potency; the other version doesn’t have that mutation. The mutation allows the antibody to function both as a therapeutic and a vaccine, Vir says. The lead candidates are among additional antibodies identified by Vir that bind to different sites, and therefore could be used in combination with the lead development candidates.

Status: Vir Biotechnology on March 25 said it intended to move “as soon as possible” both versions of its lead antibody candidate into human Phase I/II trials, after two separate labs confirmed that the antibody neutralized SARS-CoV-2. The trial is expected to start within 3–5 months.

“The candidate could have implications for not only the current pandemic, but may have utility in the future both as a vaccine, and a therapeutic should other coronaviruses emerge,” Cowen analyst Phil Nadeau wrote.

To save development time, Vir said, it transferred the lead development candidate at-risk to WuXi Biologics and Biogen, both of which joined Vir in announcing COVID-19-focused collaborations in recent weeks. Vir announced its partnership with Biogen in March, and with WuXi the previous month. The WuXi partnership is a development and manufacturing collaboration to advance and produce human monoclonal antibodies to treat COVID-19. Should the antibodies receive regulatory approvals, WuXi Biologics has rights to commercialize therapies in Greater China and Vir, in all other markets worldwide.

Vir’s novel antibodies will have extended half lives through Xencor’s Xtend™ Fc technology, to which Vir has licensed non-exclusive rights under a technology license agreement announced March 25 by Xencor.

The company added that it is continuing to search for additional antibodies from survivors of SARS-CoV-2, SARS-CoV-1, and other coronaviruses.


COVID-19: 200 Candidates and Counting

To navigate through the >200 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:

● ANTIVIRAL
● VAX
● ANTIBODY
● RNA

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