FDA tells Merck to show more data for its OncoImmune COVID-19 drug as EUA pushed back

Merck's site in Upper Gwynedd, PA
Merck hit an FDA emergency use authorization snag for a COVID-19 drug candidate it bought from OncoImmune. (Montgomery County Planning Commission/CC BY-SA 2.0)

Merck will no longer be able to supply an experimental COVID-19 drug from its $425 million buyout of OncoImmune to the U.S. government under a $356 million contract as the FDA has demanded more data, delaying its supply.

The U.S. Big Pharma, which has already ditched a vaccine program for COVID-19 from a recent buyout, has now run into trouble with a COVID drug from its November acquisition of OncoImmune.

This med, now known as MK-7110 (formerly CD24Fc) was initially used in allogeneic hematopoietic stem-cell transplant patients. But the biotech believed it could be used to help certain COVID-19 patients, and, as evidence of the effect of SARS-CoV-2 accrued, OncoImmune spied an opportunity to use CD24Fc to treat the sickest COVID-19 patients.

RELATED: Merck inks $425M OncoImmune buyout to bag COVID-19 drug

OncoImmune began a clinical trial in April to test the theory that CD24Fc fortifies an innate immune checkpoint against excessive inflammation.

This was enough to grab the attention of Merck, which spent $425 million to buy the company and the drug late last year, with OncoImmune later reporting top-line findings from an interim efficacy analysis of a phase 3 study of 203 participants (75% of the planned enrollment) showing that selected hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status compared with placebo, as defined by the protocol.

The risk of death or respiratory failure was reduced by more than 50%. Merck says full results from this phase 3 study, “which were consistent with the topline results,” were seen by the company this month.

RELATED: Merck cans both its COVID-19 vaccines due to weak clinical data

Merck also signed an agreement with the U.S. government in December last year worth $356 million for a manufacturing and supply deal of around 60,000 to 100,000 doses of MK-7110 by the end of June.

But, now, there’s a major snag. In a 10-k filing with the Securities and Exchange Commission on Thursday, Feb. 25 (and not via a press release), the Big Pharma said: “Merck received feedback from the FDA that additional data, beyond the study conducted by OncoImmune, would be needed to support a potential EUA application. Based on this FDA feedback, Merck no longer expects to supply the U.S. government with MK-7110 in the first half of 2021.”

Merck said it is “actively working with FDA to address the agency’s comments.” It did not give an updated timeline for the supply deal nor the emergency use authorization process.