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Regulation

Trump receives Regeneron COVID-19 mAb, EUA could be imminent

Trump’s treatment with Regeneron mAb could affect testing of the COVID-19 therapy

Trump’s treatment with Regeneron mAb could affect testing of the COVID-19 therapy.

Oct 2, 2020 | 11:48 PM GMT

President Donald Trump received an infusion of Regeneron’s investigational COVID-19 mAb cocktail Friday after receiving a diagnosis of infection with SARS-Cov2 and exhibiting symptoms, the White House said.

Trump was taken to the Walter Reed National Military Medical Center near Washington after receiving the infusion, the White House said.

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said it provided the mAb “in response to an Individual Patient Investigational New Drug (IND) application” from Trump’s physicians. 

The announcement is likely to trigger a tsunami of requests to access the mAb from Regeneron and COVID-19 mAbs that are being developed by Eli Lilly and Co. (NYSE:LLY) and AbCellera Biologics Inc., Vir Biotechnology Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), and other companies.

Compassionate use requests, and publicity over the confidence Trump’s physicians have implicitly expressed in the therapy, could disrupt ongoing mAb trials. Patients may be reluctant to be randomized to a placebo-controlled trial.

Regeneron said in a statement that its “current priority is to maintain a sufficient supply of REGN-COV2 in order to conduct rigorous clinical trials that fully evaluate its safety and efficacy. In addition to the clinical trial supply and product being manufactured under an agreement with the U.S. government, there is limited product available for compassionate use requests that have been approved under rare, exceptional circumstances on a case-by-case basis.”

Earlier in the day, HHS Secretary Alex Azar told a House of Representatives subcommittee about “very promising early data” from antiviral COVID-19 mAb programs and hinted that emergency use authorizations could be imminent. 

“We could be weeks to a month or two away from issuing an emergency use authorization for antibody treatments,” said Azar to the House select subcommittee on the coronavirus crisis. 

Data delivered

The hearing occurred four days after Regeneron presented initial Phase I/II/III data for REGN-COV2 and two weeks after Eli Lilly reported Phase II data for LY-CoV555, both in COVID-19 outpatient settings.

The biotech’s descriptive analyses had demonstrated REGN-COV2 led to nominally significant reductions in viral load through day 7 in the first 275 patients in the double-blind study. The data also suggested the two-mAb cocktail may provide more benefit to patients who are negative for anti-SARS-CoV-2 mAbs or have high viral levels at baseline; and showed the two-mAb cocktail numerically lowered time to symptom alleviation.

On a conference call on Tuesday, Regeneron President and CSO George Yancopoulos said the data suggest REGN-COV2 could benefit hospitalized patients, who have higher baseline viral loads than outpatients. He also noted that some individuals with high viral loads are asymptomatic carriers, and suggested the cocktail could lower transmission (see “Regeneron’s COVID-19 mAb Cocktail”).

On Sept. 16, Lilly reported interim Phase II data showing the middle of three doses of LY-CoV555  met the co-primary endpoint of reducing viral loads at day 11 from baseline levels. Low and high doses missed the viral load endpoint.

Lilly VP of Immunology Ajay Nirula told BioCentury at the time that the high dose’s failure to significantly reduce nasopharyngeal SARS-CoV-2 levels at day 11 weren’t particularly meaningful because, by that point, most patients in all cohorts, including the placebo groups, had low or undetectable levels (see “Lilly’s COVID-19 mAb”).

Both companies also found that rates of medically attended visits, including ER visits and hospitalizations, are generally low in outpatient populations and went down with treatment. REGN-COV-2 led to a trend toward fewer visits: 6/182 (3.3%) in both treatment cohorts combined vs. 6/93 (6.5%) for placebo.

In Lilly’s trial, 5/302 (1.7%) patients given LY-CoV555 were hospitalized or visited the ER vs. 9/150 (6%) for placebo; the pharma did not say whether the difference was statistically significant.

Both candidates are also in Phase II/III or III trials to treat hospitalized COVID-19 patients and to prevent COVID-19.

Lilly gained rights to LY-CoV555 in March via a deal with AbCellera. The Vancouver, B.C.-based biotech discovered the candidate using blood from an individual who recovered from COVID-19. It 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”).

The pharma is also testing the clinic a second antiviral COVID-19 mAb, JS016 (LY-CoV016), in collaboration with Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877) (see “China’s First COVID mAb in Clinic”).

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