Shares of Moderna (MRNA) are on the rise on Wednesday after The New York Times reported that the company is among the five finalists selected by the Trump administration as the most likely to produce a vaccine for COVID-19. On the flip side, Inovio (INO) and Novavax (NVAX) are under pressure as the White House list doesn't include either company.
COVID-19 VACCINE FINALISTS: Five companies have been selected by the Trump administration as the most likely to produce a vaccine for the coronavirus, The New York Times' Noah Weiland and David E. Sanger reported, citing senior officials. The announcement of the decision will be made at the White House in the next few weeks, government officials said. The five companies are Moderna, AstraZeneca (AZN), Johnson & Johnson (JNJ), Merck (MRK) and Pfizer (PFE). By narrowing the field, the White House is betting it can identify the most promising vaccines at an early stage, speed along the process of determining which will work and ensure that the winner or winners can be quickly manufactured in large quantities, the publication added.
Moderna, Johnson & Johnson and AstraZeneca have already received a total of $2.2B in federal funding to support their vaccine programs. Their selection as finalists, along with Merck and Pfizer, will give all five companies access to additional government money, help in running clinical trials and financial and logistical support for a manufacturing base that is being built even before it is clear which if any of the vaccines in development will work, the authors noted.
WHAT'S NOTABLE: On May 25, Novavax announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX-CoV2373 includes Novavax' proprietary Matrix-M adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020. The Phase 1/2 clinical trial is being conducted in two parts.
The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX-CoV2373, both adjuvanted with Matrix-M and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol's two-dose trial regimen assesses two dose sizes with Matrix-M and without. The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety and COVID-19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVX-CoV2373 during the pandemic. The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations.
On May 20, Inovio had also announced the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating "robust" neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. The study was published in the peer-reviewed journal Nature Communications by Inovio scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine.
Kate Broderick, Inovio's Senior VP of R&D and Team Lead for COVID-19 vaccine development, said that the "positive preclinical results from our COVID-19 DNA vaccine not only highlight the potency of our DNA medicines platform, but also build on our previously reported positive Phase 1/2a data from our vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from a similarly designed vaccine INO-4700. The potent neutralizing antibody and T cell immune responses generated in multiple animal models are supportive of our currently on-going INO-4800 clinical trials."
A Phase 2/3 efficacy trial is planned to start in July/August, pending regulatory approval, the company noted.
PRICE ACTION: In afternoon trading, shares of Moderna have gained almost 2% to $60.73. Meanwhile, Inovio and Novavax have dropped about 13% and 15%, respectively.
