Latest vaccine news from Novavax, Arcturus, Disappoints Street

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There are not enough of the approved Covid-19 vaccines

Pfizer,

BioNTech and Moderna, so that was good news

Novavax

and

Arcturus Therapeutics Holdings

went on to the next stages of testing their vaccines.

But when Novavax (ticker: NVAX) said on Monday that it was entering its US Phase 3 trial, the stock gave up 10% on that day to close at $ 116.85. It rose 1% during early trading on Tuesday. The response to the news from Arcturus was even more bleak.

Following Monday’s shutdown, Arcturus (ARCT) said it will conduct a phase 2 study of its vaccine in Singapore. It released data from its first clinical study of the shots, which use messenger RNA technology along the lines of Pfizer (PFE), BioNTech (BNTX) and Moderna (MRNA) vaccines.

However, when analysts studied Arcturus’s data, they found it unimpressive. With a wave of downgrades on Tuesday morning, Arcturus stock fell 52% from Monday’s close to $ 43.93.

Novavax started a Phase 3 study in the UK earlier this year and that pathway of 15,000 individuals is now fully enrolled. The company’s scientists are waiting to see what difference emerges in the number of Covid cases between those who receive placebo injections and those who receive the Novavax vaccine,

Early trials with the shots yielded impressive levels of virus neutralizing antibodies in the recipients. The vaccine contains protein particles that resemble the spikes of the SARS-CoV-2 virus, which Novavax produces through a standard genetic engineering process.

Beginning this week, Novavax aims to enroll 30,000 volunteers in the US and Mexico in its Phase 3 trial. Public health experts are concerned that recruitment for such placebo-controlled Covid vaccine traces will become more difficult, following the US authorizations of the vaccines by Pfizer / BioNTech and Moderna. By starting the crucial trial now, Novavax is lagging behind the earlier start of developers such as

Johnson & Johnson

(JNJ), even as Pfizer and Moderna ramp up production.

As an incentive, Novavax may plan to give the active vaccine to two-thirds of its volunteers and the placebo to a third. The earlier developers divided their assignments half and half.

The disappointment in Monday’s interim Phase 1 data from Arcturus centers on the levels of antibodies generated by its recordings. The company has fueled hope that its vaccine will stand out by providing immunity after just a single dose. But after the first of two shots in the phase 1 study, antibody levels were only comparable to those seen in patients recovered from Covid-19 infection. The second booster shot yielded only a minimal improvement, Guggenheim analyst Seamus Fernandez noted in a note from Tuesday.

The Guggenheim analyst maintained its Buy rating on Arcturus, but said in his note that the data “ raised more questions than answers. ” Rival vaccines, including those from Novavax, produced much higher levels of antibodies after two injections. Unless Arcturus can prove that a single dose of its vaccine is superior, Fernandez said, its product may not be a viable competitor.

Other analysts were less forgiving. Arcturus stock got five downgrades after Monday’s data, including four bringing it back to a Hold and one bringing it back to a Sell.

At Raymond James, analyst Steven Seedhouse said in a note on Tuesday that he is dropping Arcturus from an Outperform to a Market Perform (the equivalent of a Hold) because the single dose levels of neutralizing antibodies were “underwhelming.”

The Phase 3 trial data from the Pfizer-BioNTech and Moderna vaccines showed that levels of neutralizing antibodies were correlated with the Covid protection of the shots, Seedhouse noted. So with Arcturus’ interim data equal only to recovering Covid patients – rather than several times higher like the other vaccines – investors won’t take any interest in Arcturus unless it can prove its benefit from one dose at a stage 3 study, he expects.

Write to Bill Alpert at [email protected]