With no Food and Drug Administration-approved vaccines or therapies for the disease, legacy drugmakers and small startups alike have stepped forward with plans to develop vaccines or treatments that target the infection caused by COVID-19.

Many of the companies that are initiating development in the U.S. have received funding from two organizations: the Biomedical Advanced Research and Development Authority (BARDA), which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health.  Additionally, international governments as well as foundations are funding developoment.

Here are some of the companies developing treatments or vaccines in the U.S. for COVID-19:

BioNTech SE specifies their major offering areas as Therapeutic Development, Cancer Medicine, Patient-Specific Immunotherapy, Tailored Therapeutics, Antibody Therapeutics, Cell and Gene Therapy, Peptide Manufacturing
Services, Drug Research Services, and In Vitro Diagnostic Devices. From their roots in Mainz, Germany, they are driven to become the leading global biotechnology company for individualized cancer medicine. Last week, Pfizer (linked below) announced it would help develop and distribute BioNTech SE’s COVID-19 vaccine candidate, which BioNTech plans to put into clinical trials in late April.

Pfizer Inc. specifies their major offering areas as Internal Medicines for Cardiovascular and Metabolic Diseases (CVD), Rare Diseases Prevention & Cure, Vaccines and Immunization Development, Oncology, Inflammation and Immunology Research, Therapeutic Research & Development, and Anti-infectives. Pfizer is working with BioNTech on a vaccine for COVID-19. Pfizer and BioNTech for several years have said they would partner to develop mRNA-based influenza vaccines.

Gilead Sciences Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. While Gilead’s primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions, they are currently testing remdesivir as a treatment for mild to moderate forms of pneumonia in people with the virus.

GlaxoSmithKline 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. They also 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.

Heat Biologics Inc. is a clinical-stage company focused on developing its proprietary “ImPACT” (Immune Pan-Antigen Cytotoxic Therapy) adjuvant technology for use in a number of oncology and infectious disease indications. Heat Biologics previously announced it is developing a vaccine for the novel coronavirus with the University of Miami Miller School of Medicine. It disclosed 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.

Inovio Pharmaceuticals Inc. is bringing IMMUNO-INGENUITY™ to life and is reshaping the future of treating and preventing cancer and infectious diseases. Inovio’s platform is achieving what no other approach has before: utilizing DNA and next-generation antigen sequencing and delivery to activate the immune system. Another CEPI grantee, awarded $9 million, Inovio has said it already began preclinical testing and small-scale manufacturing.

Johnson & Johnson is a multinational corporation founded in 1886 that develops medical devices, pharmaceutical and consumer packaged goods. Their major offering areas include Consumer Healthcare Products, Pharmaceuticals, Medical Devices, and Diagnostics. On Feb. 11, Johnson & Johnson said it was 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. Last week, 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.

Moderna Inc. develops messenger RNA therapeutics. It provides in vivo drug modality that produces human proteins or antibodies inside patient cells. It has strategic option agreements with AstraZeneca and Alexion Pharmaceuticals and strategic collaborations with Karolinska Institutet, Institut Pasteur, Karolinska University Hospital, and Merck. Moderna received funding from CEPI in January to develop an mRNA vaccine against COVID-19. Last month, it said it had shipped the first batch of mRNA-1273 to the NIAID for a Phase 1 clinical trial in the U.S.

Novavax Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, they produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. They specify their major offering areas as Infectious Disease Prevention Products Development, Recombinant Nanoparticle Vaccine Technology, and Matrix-M Adjuvant Technology. Novavax announced in February it had several vaccine candidates in preclinical animal studies and plans to initiate a Phase I clinical study by June.

Regeneron Pharmaceuticals Inc. is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. They have therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. 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.

Roche Holding AG is a research and medical healthcare company whose offerings include Biotechnology, Pharmaceuticals, Research & Development, Healthcare, and Diagnostics Solutions. Roche’s Actemra was first approved in 2010 as a rheumatoid arthritis drug. The Swiss drugmaker has initiated a Phase 3 clinical trial evaluating Actera as a treatment for patients with COVID-19 who have been hospitalized with severe pneumonia. Roche expects to begin enrolling around 330 patients in early April, in the U.S. and elsewhere in the world.

Sanofi  is a leading global healthcare company that discovers, develops, produces and markets innovative therapies to help protect health and enhance people’s lives. Along with the other U.S. affiliates, Genzyme, Sanofi Pasteur, Merial, and Chattem, they work to prevent and treat the diseases they know about today, as well as those they may face tomorrow. 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.

Takeda Pharmaceutical Company Ltd. operates as a research-based pharmaceutical company. They plan 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. Like Johnson & Johnson, Takeda plans to examine whether other therapies, both experimental or with regulatory approval, may have treatment potential.

Vaxart Inc. is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform and specifies its major offering areas as Oral Recombinant Vaccines Manufacturing and Prophylactic and Therapeutic Vaccine Research & Development. Vaxart was one of the first companies to announce plans to develop a vaccine in January. In March, the company announced Emergent BioSolutions will help develop and manufacture its oral vaccine candidate.

Vir Biotechnology Inc. is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Their major offering areas include Biotechnical Research, Immunology, and identifying the limitations of the immune system in combating a particular pathogen. 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.

You can also find the full list of vaccines and therapeutics put out by the World Health Organization that may be candidates for Covid-19 here: DRAFT landscape of COVID-19 candidate vaccines – 20 March 2020

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