Here’s the Dark Horse in the COVID Vaccine Race you’ll want to watch



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You would almost have to live in a cave to not hear about the major advances in the main coronavirus vaccines. Pfizer and BioNTech have already obtained UK authorization for their vaccine, BNT162b2, which could receive emergency use authorization in the US within weeks. So could ModernmRNA-1273.

There are other companies that could be on their heels. AstraZeneca hopes to get approvals for AZD1222 soon. Johnson & Johnson is expected to announce the results of the late-stage interim study for its vaccine candidate JNJ-78436735 in early 2021. Novavax plans to report the results of its advanced UK study on NVX-CoV2373 early next year and looks forward to launching an advanced stage study in the US in the coming weeks.

It’s completely understandable that these companies are the center of attention right now. However, there’s also a dark horse in the COVID vaccine race that you’ll want to watch – Arcturus Therapeutics (NASDAQ: ARCT).

Glass vial and ampoule with gray background

Image source: Getty Images.

Three big positives

Arcturus is currently evaluating the ARCT-021 vaccine candidate against COVID-19 in a phase 1/2 clinical study. Yes, that places the company well behind all of the others previously mentioned who have already advanced their vaccines to advanced stage testing. But there are three big positives for Arcturus’ vaccine that set it apart.

First, ARCT-021 uses a messenger RNA (mRNA) approach similar to BNT162b2 from Pfizer and BioNTech and mRNA from Moderna1273. This is important because these two mRNA vaccines have achieved considerable efficacy levels of 95% and 94%, respectively. These results bode well for the prospects that ARCT-021 will also prove to be very effective.

Second, the results of the interim phase 1/2 study of Arcturus show that a single dose of the vaccine may work well to prevent infection with the novel coronavirus. All of the current major COVID vaccine candidates require two doses, with the notable exception of JNJ-78436735 from J&J. This potentially gives Arcturus a significant competitive advantage if the ARCT-021 performs well in advanced stage testing.

Third, Arcturus expects to have a lyophilized (lyophilized) version of ARCT-021 ready before moving on to advanced stage studies. A freeze-dried powder form of the vaccine will not have the ultra-cold storage requirements that Pfizer and BioNTech’s BNT162b2 currently has.

The bottom line is that ARCT-021 could potentially solve all of the issues associated with major COVID-19 vaccines. A highly effective single dose mRNA vaccine that can be stored at standard refrigerator temperatures could be a huge winner.

The rest of the pipeline

As the infomercials say, “But wait! There’s more!” Arcturus also has several pipeline candidates based on its mRNA technology. If ARCT-021 proves to be safe and effective, it could translate into strong prospects for these other programs.

Arcturus is currently evaluating ARCT-810 mRNA therapy in a Phase 1 study targeting ornithine transcarbamylase deficiency, a genetic condition where ammonia builds up in the blood and can become toxic. He hopes to take the ARCT-810 to phase 2 testing in the first quarter of 2021.

The company’s pipeline includes three other preclinical programs. Two are experimental mRNA therapies targeting cardiovascular disease and cystic fibrosis. The LUNAR-FLU influenza vaccine candidate is perhaps the most intriguing of the three for investors. Arcturus plans to file for approval next year to take the candidate to clinical testing.

Novavax has announced its intention to explore the development potential of a combined influenza / COVID-19 vaccine for post-pandemic use. LUNAR-FLU potentially gives Arcturus the ability to follow the same path if ARCT-021 is successful.

Keep your eyes on Arcturus

It’s too early to know if ARCT-021 will deliver the late stage test results Arcturus is hoping for. And it’s far too early to make any predictions for the rest of the company’s pipeline.

However, so far two countries have seen enough promises for ARCT-021 to sign supply agreements with Arcturus. Israel signed an agreement with the company worth up to $ 275 million. Singapore has pledged to purchase up to $ 175 million of Arcturus’ COVID-19 vaccine, if all goes well in late stage testing.

The biotech stock has skyrocketed over 930% so far this year. Even with this impressive gain, Arcturus’ market cap is still less than $ 3 billion. Keep your eyes on Arcturus: this dark horse could become a big winner in the coronavirus vaccine race.



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