Shares of Inovio Pharmaceuticals (INO) and Moderna (MRNA) moved higher on Friday ahead of a report this Sunday on CBS's 60 Minutes by Bill Whitaker about the race to make a vaccine for the COVID-19 coronavirus.
60 MINUTES: Bill Whitaker of CBS's 60 Minutes is expected to discuss on Sunday the race to develop a safe and effective drug and vaccine to treat the COVID-19 coronavirus. According to the preview of Sunday's report, the clinical trial is up and running in the middle of the outbreak and is the fastest clinical trial many have seen coming to fruition.
WHAT'S NOTABLE: The FDA will allow private companies to begin marketing coronavirus test kits directly to the public, in a move to ease a shortage of test kits, The Wall Street Journal's Thomas M. Burton reported this week. The FDA will review the accuracy of test data submitted by the manufacturers retroactively, which FDA Commissioner Stephen Hahn says has risks, but is warranted by the severity of the pandemic. On Thursday, Stephen Hahn, the Commissioner of Food and Drugs, said in a press conference from the White House that a trial being conducted of a vaccine against the novel coronavirus could take 12 months.
INOVIO NEWS: Last week, Inovio announced the receipt of a $5M grant to accelerate a coronavirus vaccine delivery device. The grant from the Bill & Melinda Gates Foundation will help accelerate the testing of a proprietary smart device for intradermal delivery of a vaccine to treat the coronavirus that causes COVID-19. INO-4800 is in preclinical studies and is planned to advance into Phase 1 clinical trials in the U.S. in April with up to $9M funding from CEPI, the company said, adding that it plans to accelerate the testing and scale up of the Cellectra 3PSP devices to support large scale manufacturing of INO-4800 doses by the end of 2020. The Cellectra 3PSP device is designed specifically for a COVID-19 type pandemic scenario, it said. Inovio's San Diego Device Manufacturing facility will build initial quantities and demonstrate the design and scale up of manufacturing processes which can then be transferred to additional contract manufacturers for increased capacity. At the time, Inovio President and Chief Executive Officer J. Joseph Kim said in a statement that the "evolving situation following the outbreak of COVID-19 has allowed us to further showcase INOVIO's technology capabilities and versatility in fighting emerging infectious diseases. We are very grateful for both the financial and moral support from CEPI to take steps toward tackling this global pandemic. Our DNA medicine platform has been selected among a small group of important vaccine technologies for rapidly impacting emerging infectious diseases outbreaks such as COVID-19, having already advanced INO-4700, our vaccine candidate against MERS-CoV, another coronavirus, to a Phase 1/2a clinical trial."
MODERNA NEWS: Meanwhile, as SARS-CoV-2, the virus responsible for COVID-19, continues to spread globally, Needham analyst Alan Carr highlighted that Moderna and Gilead (GILD) have the most advanced drug and vaccine programs in development, respectively. Under the FDA's Emergency Use Authorization, the analyst believes a drug treatment could become available this year and a vaccine in 2021. 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.
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.
OTHER VACCINE PLAYERS: Other vaccine players include Novavax (NVAX), BioNTech (BNTX), Applied DNA Sciences (APDN), AbbVie (ABBV), GlaxoSmithKline (GSK) and Tonix Pharmaceuticals (TNXP). J&J (JNJ) and Sanofi (SNY) have also disclosed vaccine research efforts and GlaxoSmithKline has contributed a vaccine adjuvant to a development collaboration, the analyst said. Additionally, he pointed out that mRNA vaccine company BioNTech plans to start a Phase 1 trial with collaborator Pfizer (PFE) in late April. Novavax plans to start clinical testing in May/June.
Additionally, 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.
PRICE ACTION: In late morning trading, shares of Inovio are up nearly 3% to $6.69, while Moderna shares gained about 3% to $29.14.
Inovio
+0.2 (+3.09%)
Moderna
+0.5 (+1.78%)
Novavax
-1.59 (-13.73%)
BioNTech
-13.95 (-23.60%)
Applied DNA Sciences
-0.87 (-15.54%)
AbbVie
-2.43 (-3.42%)
GSK
+0.37 (+1.10%)
Tonix Pharmaceuticals
+0.3953 (+71.30%)
Gilead
-1.44 (-1.83%)
Johnson & Johnson
-3.88 (-3.05%)
Sanofi
-1.2 (-2.95%)
Pfizer
-0.9 (-2.96%)
Vir Biotechnology
-3.99 (-9.32%)
Regeneron
-21.82 (-4.44%)
Biogen
+0.93 (+0.32%)
Roche
+ (+0.00%)