Phase I start marks first for anti-SARS-CoV-2 mAbs, first for AbCellera

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A COVID-19 mAb from Eli Lilly and AbCellera has become the first against the virus to start human trials and is also the Vancouver-based company’s first product to enter the clinic. While the Phase I study of Ly-CoV555 is assessing safety, its evaluation in hospitalized COVID-19 patients leaves room for exploratory observations that may hint at efficacy.

Eli Lilly and Co. (NYSE:LLY) announced Monday it had dosed the first patients in the Phase I J2W-MC-PYAA study, a randomized, placebo-controlled trial evaluating safety and PK/PD of Ly-CoV555. Data are due by the end of this month.

If the mAb against the SARS-CoV-2 spike is safe, Lilly plans to proceed to Phase II testing in non-hospitalized COVID-19 patients. The pharma will also test the mAb in a preventative setting in vulnerable populations that historically have not been optimal candidates for receiving vaccines, such as the elderly and immunocompromised individuals.

Ly-CoV555 is the first candidate out of AbCellera Biologics Inc.’s partnership with Lilly, which began in March. The two had already been in discussions regarding a collaboration on multiple targets when SARS-CoV-2 emerged, at which point they focused the deal’s initial scope on the emerging pandemic. The pair expanded the deal two weeks ago to discover antibodies for up to eight additional targets selected by the pharma.

AbCellera discovered Ly-CoV555, along with hundreds of other potentially virus-neutralizing mAbs, using blood from an individual who recovered from COVID-19.

The company, which said it took less then three months to go from screening to human studies, has been developing its pandemic response capabilities since 2018, when it signed a deal with the U.S. Defense Advanced Research Projects Agency (see “AbCellera, Vir Find Partners”).

AbCellera co-founder and CEO Carl Hansen previously told BioCentury the company’s goal is to enable its partners to go from ideation through discovery, optimization and development to the clinic within a year, and that the process typically takes at least three years. The company raised $105 million last week in a series B round, with participation from Lilly, to speed the path to the clinic by expanding its R&D capabilities (see “Fresh of Lilly Deal, AbCellera Readies to Deploy $105M”).

Separately, Celltrion Inc. (KSE:068270) announced Monday plans to begin human testing in July of its COVID-19 antiviral antibody CT-P59. At least three more companies plan to bring virus-neutralizing mAbs into the clinic this summer, including Lilly, which is developing JS016 with Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877).

The other two are Vir Biotechnology Inc. (NASDAQ:VIR), which is partnered with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN)(see Table: “mAbs Against SARS-CoV-2”).

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