As SARS-CoV-2, the virus responsible for COVID-19, continues to spread globally, Needham analyst Alan Carr highlights that Gilead (GILD) and Moderna (MRNA) have the most advanced drug and vaccine programs in development, respectively. Under the Food and Drug Administration's Emergency Use Authorization, the analyst believes a drug treatment could become available this year and a vaccine in 2021.
DRUG COULD BE AVAILABLE THIS YEAR: Investment by industry toward the development of vaccines, antibodies and drugs for the infection has accelerated in the last couple of months as the WHO describes the COVID-19 crisis as a pandemic, a first for a coronavirus, Needham analyst Alan Carr wrote today in a research note to investors.
The analyst pointed out that Gilead and Moderna have the most advanced drug and vaccine programs in development, respectively. Results from two Chinese trials evaluating remdesivir, a Gilead drug initially developed for another coronavirus, are expected to be announced next month, he added, noting that clinical testing of the first vaccine for COVID-19, Moderna's mRNA-1273, began this week and results may be available in June.
In addition to standard development risks, he argued that investors should not overlook manufacturing timelines and capacity. Lastly, regulatory requirements for COVID-19 are unclear, but he noted that the Food and Drug Administration has the flexibility to allow access under Emergency Use Authorization. Carr believes EUA could allow for availability of a drug this year and a vaccine in 2021.
GILEAD'S TRIALS: Carr highlighted that two placebo-controlled trials testing remdesivir are underway in China, with results expected in April, 2020. Both are run by Chinese health authorities. Gilead has separately initiated two open-label Phase 3 trials evaluating two different dose regimens, he added, pointing out that one of the trials contains a standard of care arm. If the drug is successfully developed, Gilead intends to provide the drug at cost initially. The analyst also noted that management announced earlier this month that the company is manufacturing global supply at risk.
Meanwhile, all other drugs in clinical testing are also repurposed, including commercially available HIV drugs such as Abbvie's (ABBV) Kaletra and Johnson & Johnson's (JNJ) Prezcobix, Carr added.
MODERNA'S TRIALS: A Phase 1 immunogenicity trial of mRNA-1273 in 45 healthy volunteers was initiated by the NIH this week. The analyst believes a larger Phase 2 immunogenicity trial may be initiated in mid-2020. Although Moderna has limited additional manufacturing capacity at its Norwood facility, he noted that mRNA-1273 can be manufactured at large scale on a contract basis. The analyst assumes no vaccine, including mRNA-1273 will be available for use until 2021.
J&J and Sanofi (SNY) have also disclosed vaccine research efforts and GlaxoSmithKline (GSK) has contributed a vaccine adjuvant to a development collaboration, the analyst said. Additionally, he pointed out that mRNA vaccine company BioNTech (BNTX) plans to start a Phase 1 trial with collaborator Pfizer (PFE) in late April. Novavax (NVAX) plans to start clinical testing in May/June.
ANTIBODY PROGRAMS: Vir (VIR) has identified several candidates that bind SARS-CoV-2 and has announced collaborations with WuXi and Biogen (BIIB) to accelerate development and manufacturing, Carr noted. The analyst added that Regeneron (REGN) has identified several antibody candidates for clinical testing this summer. Because IL6 may be a driver of the inflammatory immune response in COVID-19 patients, Roche (RHHBY) and Sanofi are exploring utility of marketed IL6 mAbs Actemra and Kevzara.
Gilead
+3.23 (+4.34%)
Moderna
+1.11 (+3.93%)
AbbVie
-2.51 (-3.44%)
Johnson & Johnson
-2.8 (-2.05%)
Sanofi
-3.11 (-7.13%)
BioNTech
+29.71 (+44.95%)
Pfizer
-0.16 (-0.50%)
Novavax
+1.27 (+13.44%)
Biogen
-4.78 (-1.56%)
Regeneron
-4.5 (-0.91%)
Roche
+ (+0.00%)
GSK
-2.19 (-5.96%)
Vir Biotechnology
+1.26 (+2.52%)