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A nurse prepared to inject the Pfizer-BioNTech vaccine into a healthcare professional in Rome on Monday.
Filippo Monteforte / AFP via Getty Images
There is not enough of the Covid-19 vaccines approved
Pfizer,
BioNTech and Moderna, so it was good news
Novavax
and
Arcturus Therapeutics Holdings
were moving into the next stages of testing their vaccines.
But when Novavax (ticker: NVAX) said on Monday that it was starting its Phase 3 test in the U.S., the stock gave up 10% on the day to close at $ 116.85, although it recovered 2.9% on Tuesday. The reaction to the Arcturus news was even more pessimistic.
After Monday’s closing, Arcturus (ARCT) said it would conduct a Phase 2 test of its vaccine in Singapore. She released data from her initial clinical study of vaccines, which use messenger RNA technology along the lines of Pfizer (PFE), BioNTech (BNTX) and Moderna (MRNA) vaccines.
While analysts were studying Arcturus data, however, they found it meaningless. With a wave of downgrades on Tuesday morning, Arcturus shares ended the day at $ 42.36, down 54% from average volumes 15 times higher.
“It has been a crazy two days,” said Arcturus Chief Executive Joe Payne Barron’s after closing Tuesday.
Novavax started a Phase 3 study in the UK earlier this year, and the trail of 15,000 people is now fully enrolled. The company’s scientists are waiting to see what a difference appears in Covid’s case count between those receiving placebo injections and those receiving the Novavax vaccine,
The first tests of the injections generated impressive levels of virus neutralizing antibodies in the recipients. The vaccine contains protein particles similar to the spikes in the SARS-CoV-2 virus, which Novavax makes using a standard genetic engineering process.
As of this week, Novavax plans to enroll 30,000 volunteers in the US and Mexico for its Phase 3 study. Public health experts fear that recruiting for these placid-controlled Covid vaccine trails will become more difficult after US authorizations from vaccines from Pfizer / BioNTech and Moderna. When starting its main test now, Novavax is behind the start of developers like
Johnson & Johnson
(JNJ), even while Pfizer and Moderna increase production.
As an incentive, perhaps, Novavax plans to give the active vaccine to two-thirds of its volunteers and the placebo to one-third. Previous developers have split their assignments in half.
The disappointment with Arcturus’ Monday’s provisional Phase 1 data centers on the levels of antibodies generated by their injections. The company has hopes that its vaccine will stand out for providing immunity after just a single dose. But after the first of the two injections in the Phase 1 trial, the antibody levels were only comparable to the levels seen in patients who recovered from a Covid-19 infection. The second booster shot achieved only minimal improvement, noted Guggenheim analyst Seamus Fernandez, in a note on Tuesday.
The Guggenheim analyst maintained his Buy rating on Arcturus, but said in his note that the data “raised more questions than answers”. Rival vaccines, including Novavax’s, generated much higher levels of antibodies after two injections. Unless Arcturus can prove that a single dose of his vaccine is superior, Fernandez said, his product may not be a viable competitor.
Payne, the CEO of Arcturus, acknowledged that the moderate levels of antibodies seen after a single injection of the Arcturus vaccine were lower than those produced by two doses of rival vaccines. But he noted that the company’s interim data showed that a single dose was able to activate immune T cells against the SARS-CoV-2 coronavirus.
This could lead to useful immunity, said Ool Eng Eong. a professor of infectious diseases at the Duke-NUS medical school in Singapore, on an Arcturus conference call on Monday night,
Payne said Barron’s he hopes to hear from the U.S. Food and Drug Administration soon about whether Arcturus can start a Phase 2 test in the U.S.
Arcturus’ path to approval seems steep. It is clear that at least one large controlled Phase 3 trial will be required to obtain authorization in markets such as the USA or Europe. Arcturus hopes to start one in the second quarter, but Payne said it will have to be in some foreign jurisdiction where the unavailability of authorized Pfizer or Moderna vaccines makes it easier to recruit volunteers who can receive a placebo in an Arcturus trial.
He then hoped to offer the results of the Phase 3 test abroad for FDA authorization. “The FDA and all regulatory agencies understand the challenges of recruiting for a Phase 3 trial, if a vaccine is being distributed,” said Payne.
Arcturus shares had five downgrades after Monday’s data, including four that reduced it to Hold and one that reduced it to Sale.
At Raymond James, analyst Steven Seedhouse said in a note on Tuesday that he is withdrawing Arcturus from an Outperform to a Market Perform (the equivalent of a Hold), because single-dose levels of neutralizing antibodies were “below expectations “.
Data from the Phase 3 trial of the Pfizer-BioNTech and Moderna vaccines showed that the levels of neutralizing antibodies were correlated with Covid protection of the vaccines, noted Seedhouse. Therefore, with Arcturus’ provisional data only equal to that of Covid’s convalescent patients – instead of several times as large as other vaccines – investors will not be interested in Arcturus unless it can prove its one-dose advantage Phase 3 rehearsal, he waits.
Write to Bill Alpert at [email protected]