Background: On March 17, Pfizer announced that it would help develop and distribute BioNTech SE’s Covid-19 vaccine candidate, though the deal excludes China. BioNTech plans to put the vaccine candidate into clinical trials in late April, in Germany and the U.S. It is testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China. Pfizer and BioNTech for several years have said they would partner to develop mRNA-based influenza vaccines.
YTD Performance: 104%
Background: Vir said Feb. 25 it is collaborating with Shanghai-based WuXi Biologics to test monoclonal antibodies as a treatment for Covid-19. If the treatment is approved, WuXi will commercialize it in China, while Vir will have marketing rights for the rest of the world. The preclinical company is run by George Scangos, the former CEO of Biogen. It later announced a partnership with Biogen to help develop and manufacture its monoclonal antibodies as a potential treatment for Covid-19. Biogen will handle clinical manufacturing of Vir’s antibodies, the company said.
YTD Performance: Vir 324.9%; Biogen’s 4.9%
Stage: Phase 3 clinical trials
Background: Gilead is a longtime drugmaker best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine. Along with U.S. trials, Gilead is conducting a randomized, controlled clinical trial in Wuhan, testing remdesivir as a treatment for mild to moderate forms of pneumonia in people with the virus. The trial was given the go-ahead by China’s Food and Drug Administration in February.
YTD Performance: Shares of Gilead are up 13.4%.
Type: Pandemic adjuvant platform for vaccines
Name: AS03 Adjuvant System
Background: GSK is another leading vaccine maker, having brought to market vaccines for human papillomavirus (HPV) and the seasonal flu, among others. On Feb. 3, it said the CEPI-funded University of Queensland will have access to the British drugmaker’s vaccine adjuvant platform technology, which is believed to both strengthen the response of a vaccine and limit the amount of vaccine needed per dose. On Feb. 24, GSK said that Clover Biopharmaceuticals Inc., a Chinese biotechnology company, is also using its adjuvant technology in combination with its vaccine candidate, Covid-19 S-Trimer, in preclinical studies. Dr. Thomas Breuer, chief medical officer for GSK Vaccines, is leading work on vaccines and the adjuvant platform.
YTD Performance: 23.5%.
Background: Heat Biologics has previously announced that it is developing a vaccine for the novel coronavirus with the University of Miami Miller School of Medicine. It disclosed March 17 in a financial filing that its Covid-19 vaccine candidate had been added to the World Health Organization’s “draft landscape” of 41 candidate vaccines. The company also recently joined the Alliance for Biosecurity, which may help it “secure government funding to support its rapid development, production, and distribution” of its Covid-19 vaccine, according to Maxim Group analysts.
YTD Performance: 19%.
Type: DNA-based vaccine
Stage: Human Trials
Background: Another CEPI grantee, awarded $9 million, Inovio has said it already began preclinical testing and small-scale manufacturing.
YTD Performance: 124.6%.
Background: On Feb. 11, J&J said it is working with BARDA to test its vaccine candidate, with both organizations providing funding for research and development and the public-health organization funding the Phase 1 trials. Similar to GSK, J&J’s AdVac and PER. C6 technologies are used to improve the development process for a vaccine and were also used to develop J&J’s experimental Ebola vaccine. “We are also in discussions with other partners, that if we have a vaccine candidate with potential, we aim to make it accessible to China and other parts of the world,” Dr. Paul Stoffels, J&J’s chief scientific officer, said in a statement. On March 13, J&J said it started preclinical testing on multiple candidates in collaboration with Beth Israel Deaconess Medical Center in Boston, and it aims to have a vaccine candidate by the end of the month. J&J also said in February that it partnered with BARDA on a project that aims to screen existing antiviral medications, including experimental or approved therapies, that may be effective against Covid-19.
YTD Performance: Down -7.5%.
Type: RNA-based vaccine
Stage: Human Trials
Background: Moderna received funding from CEPI in January to develop an mRNA vaccine against Covid-19. On Feb. 24, it said it had shipped the first batch of mRNA-1273 to the NIAID for a Phase 1 clinical trial in the U.S.
YTD Performance: 51.4%.
Name: Hydroxychloroquine (HCQ), sold under the brand name Plaquenil
Background: Hydroxychloroquine (HCQ) is a medication used to prevent and treat malaria in areas where malaria remains sensitive to chloroquine.
Mylan NV said Thursday it was restarting production of a medication to treat malaria — hydroxychloroquine sulfate tablets — that could potentially treat Covid-19 if it’s approved by the federal government.
The World Health Organization has listed it as a drug under investigation for treatment against the novel coronavirus, although it isn’t approved for that use in the United States. It is also used to treat rheumatoid arthritis and lupus erythematosus. Mylan said that it restarted production at its Morgantown, West Virginia, plant of the medication and has enough active pharmaceutical ingredient to start supply in mid-April and provide at some point after the ramp-up to 50 million tablets that could treat 1.5 million Covid-19 patients.
YTD Performance: Down −25.75%
Background: Novavax, a preclinical biotechnology company, announced Feb. 26 it had several vaccine candidates in preclinical animal studies, and that it plans to initiate a Phase I clinical study by June. In March the company it had received $4 million from CEPI to develop a Covid-19 vaccine and that Emergent BioSolutions Inc. EBS, 10.966% would support contract development and manufacturing for the experimental vaccine.
YTD Performance: 165.6%.
Name: No name yet
Background: On Feb. 4, Regeneron announced it is working on developing monoclonal antibodies as treatments for Covid-19. The company’s VelocImmune platform uses genetically-engineered mice with humanized immune systems in preclinical testing. “We are aiming to have hundreds of thousands of prophylactic doses ready for human testing by end of August,” a spokesperson said. Christos Kyratsous, VP of infectious disease R&D and viral vector technology, is running the project.
YTD Performance: 29.8%.
Name: No name yet
Background: Starting Feb. 18, Sanofi is working with BARDA to test a preclinical vaccine candidate for severe acute respiratory syndrome (SARS) for Covid-19 using its recombinant DNA platform. It has a long history of producing vaccines in its Sanofi Pasteur business and acquired this candidate through its 2017 acquisition of Protein Sciences for $750 million. The French drugmaker previously worked with the organization on flu vaccines. Scientists in Meriden, Ct., are working on the vaccine; David Loew, Sanofi Pasteur’s EVP, is leading the project.
YTD Performance: 14.4%.
Background: The Japanese drugmaker said March 4 it plans to test hyperimmune globulins for people who are at high risk for infection. As part of its research, which will be performed in Georgia, Takeda said it would need access to plasma from people who have recovered from Covid-19 or those who have received a vaccine if one is developed. Dr. Rajeev Venkayya, president of Takeda’s vaccine business, is the co-lead of the company’s Covid-19 response team. Like J&J, Takeda plans to examine whether other therapies, both experimental or with regulatory approval, may have treatment potential.
YTD Performance: 29.0%.
Background:Vaxart was one of the first companies to announce plans to develop a vaccine when it did so Jan. 31. In March the clinical-stage company announced that Emergent BioSolutions will help develop and manufacture its oral vaccine candidate. “We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the roll-out of a large vaccination campaign,” Vaxart CEO Wouter Latour said in a March 18 news release. The company plans to start a Phase 1 clinical trial in the U.S. in the second half of 2020, a company executive said.
YTD Performance: 516.3%.
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