The saga of Merck and the COVID-19 treatment CD24Fc starts with a November 2020 company press release, “Merck inks $425M OncoImmune buyout to bag COVID-19 drug.” The OncoImmune drug, originally known as CD24Fc, is a fusion protein that has some data supporting use for severe or critical COVID-19 cases. Prior to the Merck’s deal, back in April 2020, OncoImmune started a trial to see if CD24Fc, “fortifies an innate immune checkpoint against excessive inflammation.” After the firm released interim phase 3 data in September, Merck paid $425 million upfront for the biotech firm, with the deal focused on CD24Fc. Back in November, Merck still had two vaccines and an antiviral (for moderate disease) in development, and the OncoImmune deal aimed to add a drug that may treat severe or critical COVID-19. Interim data from phase 3 testing by OncoImmune found that CD24Fc was correlated with “a 60% higher probability of improvement” and a “50% lower risk of death or respiratory failure” when compared to placebo. Although, there is mounting data accumulated for an ivermectin consideration (Merck is a producer of the generic product and in fact has given away billions of doses for humanitarian purposes).
Merck Makes $356 Million Deal with US Government
Moving forward to January 25, Biospace published the article, “Merck Shutters COVID-19 Vaccine Programs, Shifts Focus to Therapeutics.” At that time, due to poor response, the firm gave up on its vaccine candidates V590 and V591 and shifted attention to the therapeutics MK-4482 and MK-7110 (Merck’s new name for CD24Fc, also branded as SACCOVID™). The later is potentially a, “first-in-class recombinant fusion protein that modulates the inflammatory response to the SARS-CoV-2 virus.” Based on the interim data, Merck has made deals with the US government for manufacturing and distributing of this drug.
Merck’s Ivermectin Product Activity
Again, earlier in December of 2020, the Front Line Critical Care Alliance (FLCCC) presented to the Senate about the compelling findings of their meta-analysis combining dozens of randomized controlled trials and observational studies involving ivermectin and patients with at least mild COVID-19. By early January, the FLCCC and another meta-analysis author employed by UnitAid, a group affiliated with World Health Organization, Dr. Andrew Hill joined the FLCCC to present to the National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel. Just a week and days later, the apex research body slightly updated its recommendations—toward a slightly more neutral stance.
Merck Focuses on Potential Money Maker
As to MK-4482, phase 2/3 trials are ongoing and initial efficacy data should be out this quarter. A December 2020 press release from Merck further details deals with Uncle Sam. They indicate that they have agreements with the US government, “to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval,” or EUA from the FDA. Under the agreement, Merck will get up to $356 million for the manufacturing and supply of about 60,000-100,000 doses of MK-7100 through June 30, under Warp Speed auspices. And independently, Merck is investing to expand manufacturing of this new drug. Turning back to Merck’s press release, they note that this recombinant fusion protein targets the innate immune system. MK-7110 has been studied for the prevention of graft-versus-host disease (GVHD) in leukemia, now in phase 2, and a phase 3 trial of the drug as a prophylaxis for GVHD is underway.
What is MK-7100?
As noted in a Biospace piece, SACCOVID, or MK-7100 is an immunomodulator being investigated for its ability to target the innate immune system. This system of innate, or nonspecific, immunity is the system we were born with. It includes barriers that keep out antigens, and examples include the cough reflex, tear enzymes and skin oils, mucus with the ability to trap microbes, skin, stomach acid, and “innate humoral immunity” components, such as the interferon and interleukin-1 (which creates a fever). In September, the Pharmaceutical Business Review took a look at this treatment. They note that SACCOVID has shown “significant therapeutic efficacy” in the phase 3 data. Initial data from 203 subjects showed that, “severe or critical Covid-19 patients treated with SACCOVID witnessed speedy recovery and a significant reduction in disease progression to death or respiratory failure compared to patients securing placebo when used in combination with the standard of care (SOC).”
The SACCOVID study was partly funded by the National Cancer Institute. OncoImmune CEO and co-founder Dr. Yang Kiu notes, “The very large therapeutic effect of SACCOVID observed potentially represents a major breakthrough in Covid-19 therapy—We took a novel approach to fortify an innate immune checkpoint we discovered, having previously demonstrated efficacy in a nonhuman primate model for treating viral pneumonia, and applied this to SARS-CoV-2.” According to OncoImmune, its founders showed that the CD24-Siglec G axis moderates or regulates the severity of GVHD illness described above and that SACCOVID, “prevents GVHD in animal models of GVHD by interacting with Siglec G.” And compared with, e.g., T cell depletion, this treatment does not appear to suppress immune responses to the degree that the risk of infection is raised. They also highlight the ongoing phase 3 safety and efficacy testing for COVID-19 patients in the hospital. These trials are taking place at 17 centers nationwide, and the plan is to, “enroll over 270 patients and is near its enrollment target with topline readouts expected soon.”
What About Ivermectin?
As chronicled extensively on TrialSite, there is growing evidence that ivermectin is effective as both prophylaxis and early treatment for COVID-19. And, as outlined in our recent story, in part, Merck’s own first discovered the efficacy of the drug in the 1970s, and the firm has donated billions of doses since 1987 to fight river blindness, without any substantial safety issues. Despite this, the company just issued a press release asserting both that there is no good data for the efficacy of its branded ivermectin for COVID-19 and that there was inadequate safety data. Such concerns ring a bit hollow, given the over four billion doses they have (presumably safely) been donated and continue to donate.
The accumulating data would have already led to an emergency use authorization if it was a monetizable drug. With reports approaching 4,000 patients in ivermectin-based meta-analyses, even the World Health Organization (WHO) monitors the situation very closely. A very different position than Merck’s press release that absolutely no evidence for ivermectin efficacy exists.
Only time, data, and, ultimately the collectively agreed upon evidence will tell how this saga will impact the pandemic and society’s health. Some data points along the way point toward unfortunate and substantial bias in favor of expensive drugs over economical ones—across not just industry but also government. That’s why perhaps there is so much subtle pressure to classify those who discuss ivermectin studies as part of disinformation campaigns. Unfortunately, it could be the case that those carefully and meticulously supporting the perpetuation of disinformation campaigns are actually prominent members of industry and government that don’t stand pecuniary gain from letting lower cost competitors in the door. The reality is: all competitors seek a remdesivir story. But few have the chops, connectivity, brainpower, or fortune to face the confluence of forces that that particular drug’s maker, Gilead, had when Dr. Anthony Fauci declared that this was the “new standard.” The company has since gone on to generate just about $3 billion in revenue in the first nine months of the drug’s availability.
But what if the ivermectin studies turn out to be accurate—imagine if Merck would of have given away billions of more doses of this drug to help inhibit the pandemic till mass vaccination can truly help society transition out of the crisis—what would that have done to Merck’s brand?
Call to Action: TrialSite will track and monitor the progress of the Merck investigational products as well as the ivermectin data reading ongoing. Sign up for the newsletter for updates.