Candidate: MK-7110 (formerly CD24Fc)
Type: Potentially first-in-class investigational recombinant fusion protein designed to modulate inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint.
2021 Status: DEVELOPMENT ENDS—Merck on April 15 discontinued development of MK-7110, saying it did not expect to bring the drug to market until at least the first half of 2022.
“Given this timeline and these technical, clinical and regulatory uncertainties, the availability of a number of medicines for patients hospitalized with COVID-19, and the need to concentrate Merck’s resources on accelerating the development and manufacture of the most viable therapeutics and vaccines, Merck has determined to discontinue development of MK-7110 for COVID-19,” Merck stated.
Roy Barnes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, added that the company has pivoted to advancing molnupiravir (MK-4482 or EIDD-2801), and on accelerating production of Johnson & Johnson’s COVID-19 vaccine.
Merck said February 25 that the FDA asked it for additional data beyond its Phase III trial (NCT04317040) to support an emergency use authorization of MK-7110. Based on that feedback, Merck said in its Form 10-K annual report for 2020, it no longer expects to supply MK-7110 in the first half of 2021 as once planned. Merck added that it was working to address FDA feedback.
In its Form 10-K, Merck also disclosed that it received full results in February 2021 from a Phase III trial that generated positive interim data in September 2020, and will be submitted for publication in the future. The interim data from 203 participants (75% of the planned enrollment) indicated 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 to placebo, as defined by the protocol. The risk of death or respiratory failure was reduced by more than 50%.
Merck & Co. said January 25 it will continue development of MK-7110 and another COVID-19 drug candidate, molupiravir (MK-4482), while halting development of two vaccine candidates against the virus, V590 and V591.
2020 Status: Merck added MK-7110 (formerly CD24Fc) to its COVID-19 arsenal when it purchased OncoImmune for $425 million in upfront cash, plus an undisclosed amount of additional payments tied to achieving regulatory and sales-based milestones. That acquisition was completed December 23, 2020.
Also in December, Merck signed an up-to-$356 million agreement with the U.S. government to supply it with 60,000 to 100,000 doses of MK-7110.
Merck has cited interim results generated in September from a Phase III trial (NCT04317040) that showed a greater than 50% reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19. Full results from the placebo-controlled study are expected in the first quarter, the company 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: