Pharmaceutical companies are working on diagnostic tests, vaccines, and drugs to treat the coronavirus
With the spread of the coronavirus in focus around the world, here is a rundown of pharmaceutical companies working on diagnostic tests, vaccines, and drugs to treat the coronavirus.
On February 26, Novavax (NVAX) announced progress in its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19. Novavax has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing, which is expected to begin by the end of spring 2020. Novavax created the COVID-19 vaccine candidates using its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike protein. Novavax expects to utilize its proprietary Matrix-M adjuvant with its COVID-19 vaccine candidate to enhance immune responses.
On February 25, The National Institutes of Health's National Institute of Allergy and Infectious Diseases announced it was sponsoring a clinical trial of Gilead Sciences' (GILD) remdesivir to evaluate the safety and efficacy in hospitalized adult patients diagnosed with coronavirus. The study will be a series of 2-arm comparisons between different investigational therapeutic agents and a placebo. The primary objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in patients hospitalized with coronavirus.
On February 24, Moderna (MRNA) announced that it has released the first batch of mRNA-1273, the company's vaccine against the novel coronavirus, for human use. Vials of mRNA-1273 have been shipped to the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health to be used in the planned Phase 1 study in the U.S. mRNA-1273 is an mRNA vaccine against the novel coronavirus encoding for a prefusion stabilized form of the Spike protein, which was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center. Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations.
On February 24, Co-Diagnostics (CODX) announced that its Logix Smart Coronavirus COVID-19 Test has obtained regulatory clearance to be sold as an in vitro diagnostic for the diagnosis of SARS-CoV-2 in markets that accept CE-marking as valid regulatory approval.
On February 18, Johnson & Johnson (JNJ) announced that its Janssen unit will expand its existing partnership with the Biomedical Advanced Research and Development Authority, or BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services, to seek treatment solutions for COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2, also known as 2019-nCoV. "This latest collaboration will enhance Janssen's ongoing work with global partners to screen a library of existing antiviral molecules, with the aim of identifying compounds with promising antiviral activity against SARS-CoV-2. The expanded partnership with BARDA builds on Johnson & Johnson's multipronged response to the COVID-19 outbreak. These efforts, in addition to the ongoing development of a potential vaccine candidate, bring hope of finding a solution against COVID-19 for communities in greatest need in China and around the world," the company stated.
Also on February 18, Sanofi Pasteur, the vaccines global business unit of Sanofi (SNY), said it would leverage previous development work for a SARS vaccine which may unlock a fast path forward for developing a COVID-19 vaccine. Sanofi will collaborate with BARDA, part of the Office of the Assistant Secretary for Preparedness and Response, "expanding the company's long-standing partnership with BARDA."
On February 4, Regeneron (REGN) announced an expanded agreement with the U.S. Department of Health and Human Services, or HHS, to develop new treatments combating the novel coronavirus.
On February 2, Reuters reported that GlaxoSmithKline (GSK) was collaborating with the Coalition for Epidemic Preparedness Innovations to contribute toward the effort of developing a vaccine for the coronavirus outbreak. The company said it would make its "adjuvant platform technology" available for developing a vaccine against the 2019-nCoV virus, the report noted, citing a statement from GSK and CEPI.
On January 30, NanoViricides (NNVC) confirmed that it was working on developing a treatment for 2019-nCoV, as it was called at the time. "We have already initiated a program for developing a treatment for the 2019-nCOV," said Anil Diwan, executive chairman of the company, adding, "Our platform technology enables possibly the most rapid pathway for new drug development against viral diseases. Of course, we will need support from governmental and international agencies such as the US CDC, WHO, and Chinese CDC to successfully develop these treatments, and, if developed, to get them to the patients in the fastest possible time. At this time, the company does not have a collaboration with any of these agencies, and we have not been contacted by any of these entities or asked to develop a treatment for this virus. We had collaborations with the CDC and USAMRIID in the past. The company intends to pursue a relevant collaboration for testing of our drug candidates soon." The new 2019-nCoV is known to be closely related to the SARS-CoV of 2002-2003 epidemic. In fact it has been shown to use the same cell surface receptor as SARS-CoV, namely ACE2. "We have already found some lead candidate ligands in our chemical library that can bind to the SARS-CoV spike protein in the same fashion as it binds to the cognate receptor, ACE2, using molecular modeling tools," explained Dr. Diwan, adding, "We believe this means we may already be significantly ahead in developing a potential treatment for the new Wuhan virus."
Also on January 30, Inovio (INO) announced that it was collaborating with Beijing Advaccine to advance the development in China of INO-4800, Inovio's vaccine against the recently emerged strain of coronavirus. Inovio recently announced that it is developing INO-4800 through Phase 1 human testing in the U.S. to evaluate safety and immunogenicity with the support of an initial grant up to $9M from the Coalition for Epidemic Preparedness Innovations, or CEPI. Inovio plans to rapidly develop INO-4800 against the new coronavirus and has already started preclinical testing and preparations for clinical product manufacturing. The goal of this collaboration is to leverage Advaccine's expertise to run a Phase 1 trial in China in parallel with Inovio's clinical development efforts in the U.S. Inovio and Advaccine will also work together to attract additional grant funding and further collaborations with larger vaccine companies in China to increase the speed of future testing of INO-4800.
Additionally, a number of companies have estimated the impact of the coronavirus on their businesses, with many updating their first quarter and fiscal year 2020 outlooks. Follow this link for a previous summary The Fly compiled of those companies.