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A nurse administered a vaccine for Pfizer-BioNTech to a health worker in Rome on Monday.
Filippo Monteforte / AFP via Getty Images
There are not enough of the approved Covid-19 vaccines
Pfizer,
BioNTech and Moderna, so that was good news
Novavax
and
Arcturus Therapeutics Holdings
proceeded to the next stages of testing their vaccines.
But when Novavax (ticker: NVAX) said on Monday that it was starting the US phase 3 trial, the stock fell 10% on the day, to $ 116.85, although it recovered by 2.9% on Tuesday. The reaction to Arcturus’ news was even more shocking.
After Monday, Arcturus (ARCT) said it would conduct a Phase 2 trial of its vaccine in Singapore. It released data from the initial clinical study of the shots, using a messenger RNA technology in the line of vaccines from Pfizer (PFE), BioNTech (BNTX) and Moderna (MRNA).
However, after analyzing the Arcturus data, analysts found it unimpressive. With a wave of downgrades Tuesday morning, Arcturus shares ended the day at $ 42.36, down 54% from 15 times the recent average volumes.
“It’s been a crazy few days,” said Arcturus CEO Joe Payne. Barron’s after Tuesday’s closing.
Novavax started a Phase 3 study in the UK earlier this year and the route of 15,000 people is now fully enrolled. The company’s scientists are waiting to see what difference is shown in Covid cases between those who get placebo shots and those who get the Novavax vaccine.
Early trials of the shots yielded impressive levels of virus-neutralizing antibodies in recipients. The vaccine contains protein particles that look like the peaks of the SARS-CoV-2 virus, which Novavax makes through a standard genetic engineering process.
As of this week, Novavax aims to enroll 30,000 volunteers in the U.S. and Mexico for its Phase 3 study. Public health experts are concerned that recruitment for such placebo-controlled Covid vaccines will become more difficult following the US authorization of the Pfizer / BioNTech and Moderna vaccines. In the beginning of its central trial run, Novavax stands behind the earlier beginnings of developers such as
Johnson & Johnson
(JNJ), even as Pfizer and Moderna increase production.
As an incentive, Novavax may be planning to give the active vaccine to two-thirds of its volunteers, and the placebo to a third. The earlier developers divided their commissions in half and half.
The disappointment in Arcturus’ interim phase 1 data on Monday was based on the levels of antibodies caused by the shots. The company has nurtured the hope that its vaccine will stand out by providing immunity after just a single dose. But after the first of the two shots in the phase 1 trial, the antibody levels were only comparable to the levels seen in patients recovering from a Covid-19 infection. The second booster shot yielded only minimal improvement, Guggenheim analyst Seamus Fernandez noted in a Tuesday note.
The Guggenheim analyst maintains his Buy rating on Arcturus, but says in his note that the data ‘raises more questions than answers.’ Competitive vaccines, including one from Novavax, produced much higher levels of antibodies after two shots. Unless Arcturus can prove that a single dose of its vaccine is better, Fernandez said, the product could not be a viable competitor.
Payne, the CEO of Arcturus, acknowledged that the moderate antibody levels seen after a single ingestion of the Arcturus vaccine were lower than the two shots of competing vaccines. But he noted that the company’s interim data showed that a single dose could activate immune T cells against the SARS-CoV-2 coronavirus.
This can lead to useful immunity, Ool Eng Eong said. a professor of infectious diseases at Duke-NUS Medical School in Singapore, on a conference call from Arcturus on Monday night,
Payne tells Barron’s that he hopes to hear from the US Food and Drug Administration soon if Arcturus can start a Phase 2 trial in the US
Arcturus’ path to approval seems steep. At least one large, controlled Phase 3 trial will be required to seek permission in markets such as the US or Europe. Arcturus hopes to launch one in the second quarter, but Payne said it should be in a foreign jurisdiction where the unavailability of authorized Pfizer or Moderna vaccines makes it easier to recruit volunteers who may be a placebo in an Arcturus can get trial.
He then hopes to present the overseas Phase 3 trial results for FDA approval. “The FDA and all regulatory agencies understand the challenges of recruiting for a Phase 3 trial if a vaccine is distributed,” Payne said.
Arcturus shares received five downgrades after Monday’s data, including four that cut it to a Hold and one that cut it to a Sell.
On Raymond James, analyst Steven Seedhouse said in a Tuesday letter that he was dropping Arcturus from a better performance to a market performance (the equivalent of a Hold) because the single-dose doses of neutralizing antibodies were ‘overwhelming’.
The Phase 3 trial data from the Pfizer-BioNTech and Moderna vaccines showed that the levels of neutralizing antibodies were correlated with the Covid protection of the shots, Seedhouse said. With Arcturus’ interim data only equal to that of recovering Covid patients – instead of several times higher, like the other vaccines – investors will not be interested in Arcturus unless it has the benefit of one dose in a phase 3 study can prove. , he expects.
Write to Bill Alpert by [email protected]