Covid-19 roundup: An mRNA player gets a boost out of the latest round of animal data; PhaseBio pulls the plug on treatment trial
The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.
Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.
Neutralizing antibodies started to develop 3 weeks after the first vaccination and strongly increased after the second vaccination. The impact of different dosing schedules for the two-injection (prime and boost) regimen was investigated at 2µg with 1, 2, 3, or 4 weeks between the first and second vaccination. The data showed induction of IgG1 and IgG2a binding antibodies 7 days after the first vaccination. Titers increased after the second vaccination, showing higher response levels with longer injection intervals.
The biotech posted the study in pre-print on bioRxiv, with a planned publication in a peer-reviewed journal, so there’s no objective review of what they found. In it, researchers note:
By termination on day 49, all sera 96 derived from animals vaccinated on d0/28 were able to neutralise 50% of infecting virus (100 TCID50) in 97 cell culture at a dilution of 1:5120.
Even at this stage of the game, though, with the Pfizer/BioNTech and Moderna vaccines being tested in large pivotal studies, animal data can still get a rise out of the investor class. CureVac took advantage of its new listing on Nasdaq to add an 8% bump to its share price, enhancing their roughly $9 billion market cap.
CureVac made the leap to Nasdaq over the summer as the executive crew mapped out a short path that they believe puts them in contention for rolling out a vaccine in the near term to fight the pandemic. Their fundraising efforts quickly pieced together a $1 billion raise, with an initial $16 price on the stock. It’s now more than $50 a share.
Fortunes will be made — and lost — in the months to come. But for today, CureVac is counting itself among the winners. — John Carroll
PhaseBio shuts down Covid-19 trial due to ‘evolving’ landscape, poor interim readout
A biotech conducting a clinical-stage trial looking to study its experimental drug in Covid-19-related ARDS was shut down Friday morning.
PhaseBio had been researching whether or not its pemziviptadil program, primarily being studied in pulmonary arterial hypertension, could have an effect on hospitalized Covid-19 patients. But the company said that due to the “evolving Covid-19 treatment landscape,” as well as FDA guidance and a less-than-stellar interim readout, it will be ending the trial.
The company said it had recently submitted a new trial protocol for Covid-19 in response to that changing landscape, but regulators returned with questions about the likely need for additional trials with enough patients to adequately assess the mortality risk.
Investors did not appear pleased with the news as the market opened Friday, with PhaseBio shares $PHAS down about 6% at the opening bell.
PhaseBio had planned for an enrollment of 70 in each of its treatment arms. The total was determined to be unlikely to be big enough, and the need for an entirely new trial measuring mortality rates also proved too difficult to enroll.
Furthermore, the interim readout was accelerated to include only the first 25 patients treated with pemziviptadil. In both the 40 mg and 100 mg doses, PhaseBio did not see anything indicating that the program would meet its primary endpoint, though it noted that a larger sample size would be needed to draw a definitive conclusion. Nevertheless, the trial was halted.
PhaseBio’s Phase IIb study in pulmonary arterial hypertension will resume enrollment, the company added. It had been paused due to Covid-19 complications as well as PhaseBio steering resources toward its ARDS study.
In response to the Covid-19 pandemic, vast amounts of time and energy have been spent trying to find effective treatments and vaccines for the disease. There are nearly 4,000 trials listed on the US government’s website, and thus far only 24 have been terminated — less than 1%.
Just Thursday, Gilead’s Veklury became the first fully approved Covid-19 treatment and only three therapies have even received emergency use authorization: Veklury, convalescent plasma and hydroxychloroquine. The latter’s EUA has since been revoked. — Max Gelman
Biotech execs rally around Anthony Fauci as Trump bites back
Days after President Donald Trump waged a verbal attack on Anthony Fauci, calling him a “disaster” and an “idiot,” 9 industry leaders published a letter in support of the NIAID director and agencies such as the CDC and FDA.
The authors of the letter, published in Nature, include: Ron Cohen, president and CEO of Acorda Therapeutics; Cedric Francois, president and CEO of Apellis Pharmaceuticals; John Crowley, chairman and CEO of Amicus Therapeutics; Paul Hastings, president and CEO of Nkarta Therapeutics; Rachel King, CEO of GlycoMimetics; Ted Love, president and CEO of Global Blood Therapeutics; John Maraganore, CEO of Alnylam Pharmaceuticals; Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization; and Jeremy Levin, chairman and CEO of Ovid Therapeutics and chairman of the Biotechnology Innovation Organization.
They called members of the CDC, FDA and NIH the country’s “‘United Armed Forces’ against COVID-19,” and Fauci an “American hero.”
“However, we are concerned that various parties in this critical coalition have come under politically motivated attacks,” they wrote.
On Sunday, Fauci said in an interview with 60 Minutes that the White House has limited his media appearances, and called the Trump campaign’s framing of his comments in an ad “outrageous.”
In response, Trump said: “People are tired of hearing Fauci and all these idiots, all these people that have gotten it wrong.” He claimed, without evidence, that more people would’ve died if he had followed Fauci’s advice.
The president has previously accused a “deep state” at the FDA of intentionally delaying a vaccine and therapeutics, and fought the agency on stricter guidance for Covid-19 vaccine EUAs.
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
“Not only are these attacks completely unjustified, but they also risk intimidating and demoralizing the very people we all are relying on to help end the COVID-19 nightmare. As such, they are irresponsible and pose danger to us all,” industry leaders wrote in their letter published Thursday.
Earlier this week, the independent Government Accountability Office launched an investigation into the White House’s influence on the CDC and FDA. The news came a week after Democratic Senators Patty Murray, Gary Peters and Elizabeth Warren wrote to the GAO, citing incidents in which they accused the Trump administration of pressuring the agencies.
“Many of our colleagues and friends are working as part of Operation Warp Speed; we stand united with them, with the many good people at FDA, CDC and NIH, and with Dr. Fauci, in upholding the high scientific, medical and ethical principles that will allow us to defeat COVID-19,” the Nature letter concludes. — Nicole DeFeudis
Peru PM says country will not sign vaccine deal with AstraZeneca
Pharma companies have been making deals with governments all over the world to supply their potential Covid-19 vaccines, but one country has decided to reject an agreement with one big vaccine developer.
Peru’s prime minister Walter Martos announced in a news conference Thursday that his government would not sign a vaccine purchase contract with AstraZeneca, per a Reuters report. Martos said the British drugmaker did not provide enough data from its studies and offered fewer doses than other companies developing vaccines.
“The other labs have caught up with us accordingly, however AstraZeneca has not,” Martos said, per Reuters. “They were offering us a very low quantity of vaccines compared with other laboratories that are offering us large quantities at lower costs,” he said.
AstraZeneca has been one of the frontrunners of the Covid-19 vaccine race, currently placing 3rd in Endpoints News’ tracker. However, their Phase III trial came to a global halt in early September after a British volunteer developed what was thought to be a rare spinal inflammation disorder.
Studies have since resumed in the UK, South Africa, Brazil, India and Japan, but remain on hold in the US. On Tuesday, Reuters reported that the US portion of the trial could resume soon, perhaps by the end of the week.
Also earlier this week, a healthy volunteer died in AstraZeneca’s Brazil study, the country’s health agency said. The individual was reportedly in the placebo group of the trial and testing will continue unencumbered. Oxford University, working with the firm to create the vaccine, said in a statement “there have been no concerns about safety of the clinical trial.” — Max Gelman
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