In a flurry of catch-up following the coronavirus outbreak in China, a number of biopharma companies have announced development within the last few weeks to address the ever-spreading infection known as COVID-19.

While most potential therapies are in the preclinical and discovery stage, a few, such as Foster City, Calif.-based Gilead Sciences Inc.’s remdesivir and Hangzhou China-based Ascletis Pharma Inc.’s ASC-09 and ritonavir, are in phase III. Data collected from Cortellis and BioWorld show a total of 30 potential COVID-19 candidates in development, most of which were reported in February.

Aside from the two phase III candidates, Tokyo-based Fujifilm Holdings Corp.’s favipiravir, which is approved for influenza in Japan and Ebola virus in Guinea, entered clinical development for COVID-19 this month. Aim Immunotech Inc.’s rintatolimod, which is approved in various countries for chronic fatigue syndrome, also is a candidate being studied.

Nearly 30 other products in development for coronavirus, just not specifically COVID-19, are within the Cortellis database. Companies are announcing their efforts to fight COVID-19 every day. Gaithersburg, Md.-based Novavax Inc. said on Feb. 26 that a vaccine candidate was derived from coronavirus spike protein and would be boosted by its Matrix-M adjuvant. It plans to enter a phase I trial in late spring. One day earlier, San Francisco-based Vir Biotechnology Inc. signed a global development collaboration with Wuxi Biologics, of Shanghai, to produce human monoclonal antibodies to treat COVID-19.

According to the World Health Organization, China has reported nearly 80,000 cases and more than 2,700 deaths. Outside of China, there have been about 2,800 cases in 37 countries, including 44 deaths. While it is too soon to know whether COVID-19 will reach pandemic proportions., the U.S. CDC has suggested it will likely spread to the U.S. since the virus is already moving to countries outside of China.

Biopharma products in development for COVID-19

Drug Active companies Status Details
Favipiravir Fujifilm Holdings Corp.; Fujifilm Toyama Chemical Co. Ltd.; Medivector Inc.; Zhejiang Hisun Pharmaceutical Co. Ltd. Launched Avigan approved for influenza in Japan and Ebola in Guinea; Zhejiang began a clinical trial in February 2020 in China to study it for emergency use for COVID-19
Rintatolimod Aim Immunotech Inc. (formerly Hemispherx Biopharma Inc.); GP Pharm SA; Goethe University Frankfurt Launched Approved for chronic fatigue syndrome in various countries; entered discovery for coronavirus in February 2020
ASC-09 + ritonavir (oral tablet) Ascletis Pharma Inc. Phase III A fixed-dose combination of HIV-1 protease inhibitors ASC-09 and ritonavir, to treat HIV and COVID-19; initiated a phase III trial in China in February 2020
Remdesivir Gilead Sciences Inc. Phase III Prodrug of GS-441524 that targets the viral RNA-dependent RNA polymerase in development for Ebola, Nipah virus and COVID-19; agent is formulated using Captisol technology from Ligand Pharmaceuticals Inc.
BDB-1 Beijing Defengrei Biotechnology Co., a subsidiary of Staidson (Beijing) Pharmaceutical Co., Ltd. Phase II

Anti-C5a monoclonal antibody that received approval in February 2020 for clinical trials in China for COVID-19

Brilacidin Innovation Pharmaceuticals Inc. Phase II Exploring its lead defensin mimetic candidate, brilacidin, as a treatment for the COVID-19; potential treatment also for otitis media or externa, skin diseases, Middle East respiratory syndrome coronavirus and severe acute respiratory syndrome coronavirus
INO-4800 Beijing Advaccine Biotechnology Co Ltd; GeneOne Life Science Inc; Inovio Pharmaceuticals Inc Preclinical DNA vaccine for Middle East respiratory syndrome (MERS) coronavirus infection and COVID-19; as of January 2020, Inovio planned to initiate phase I trials in the U.S. and China for COVID-19
CYNK-001 Celularity Inc.; Sorrento Therapeutics Inc. Preclinical A cryopreserved successor product to PNK-007 in development for multiple myeloma and other cancers; in January 2020, Sorrento entered discussions on how to fast-track development in China for COVID-19
SARS-CoV-2 vaccine Chongqing Zhifei Biological Products Co. Ltd.; Institute of Microbiology, Chines Academy of Sciences Preclinical In January 2020, Chongqing Zhifei planned to carry out the vaccine preparation process and the Institute of Microbiology planned to evaluate the efficacy of the vaccine; in February 2020, the vaccine entered the animal experimental stage
Matrix-M adjuvant and COVID-19 vaccine Novavax Inc. Preclinical Vaccine using its recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein; is assessing candidates in animal models and will begin clinical trials by the end of spring 2020
S-protein/ACE2 targeted prophylactic polypeptide (inhalant) Sichuan Kelun Pharmaceutical Co. Ltd. Preclinical Polypeptide targeting SARS-CoV-2 spike protein (S-protein) and angiotensin-converting enzyme 2 (ACE2) cellular receptor for the potential prevention of COVID-19; in February 2020, preclinical data in primates showed good biological activity and safety; clinical trials were planned
ChAdOx1 nCoV-19 The Jenner Institute Preclinical Vaccine consisting of the replication-deficient simian adenovirus vector ChAdOx1 encoding spike protein antigen to prevent COVID-19; by February 2020, the vaccine had been constructed and manufacturing for clinical doses was planned
Umbilical cord-derived mesenchymal stem cells (intravenous) Wuhan Hamilton Biotechnology Co. Ltd. Preclinical Wuhan is investigating human umbilical cord-derived mesenchymal stem cells for the potential intravenous treatment of COVID-19; in February 2020, a clinical trial was planned in China
Dendritic cell vaccine Beijing Dingcheng Taiyuan Biotechnology; Betta Pharmaceuticals Co. Ltd. Discovery Universal dendritic cell vaccine for the potential prevention and treatment of COVID-19; in February 2020, development was ongoing in China
Precision-driven treatment Beroni Group; Tianjin University Discovery Developing a rapid detection method and precision-driven treatment of COVID-19 caused by SARS-CoV-2 infection using nanobody-based technology
Recombinant subunit-trimer vaccine Clover Biopharmaceuticals Inc. Discovery A recombinant trimeric Spike-protein (S-Trimer) subunit vaccine, using it's Trimer-Tag technology delivered through a vector, for prevention of COVID-19; in February 2020, preclinical studies using Glaxosmithkline plc's pandemic vaccine adjuvant technology with the vaccine were planned
Live-attenuated vaccine Codagenix Inc.; Serum Institute of India Ltd. Discovery A live-attenuated vaccine for prevention of COVID-19; by February 2020, Codagenix had designed numerous candidate genomes and planned to grow and evaluate the vaccine viruses in vivo prior to clinical trials
SARS-CoV-2 mRNA vaccine Curevac AG Discovery An mRNA vaccine for prevention of COVID-19; in January 2020, the project was in the discovery/planning stage
Monoclonal antibodies and vaccine Dyadic International Inc.; The Israel Institute for Biological Research Discovery C1 gene expression platform to express gene sequences and targets developed by IIBR into both an rVaccine candidate and monoclonal antibodies; expanded collaboration in February 2020
SARS-CoV-2 vaccine (injectable) Fudan University; ID Pharma Co. Ltd. Discovery A vaccine, using ID Pharma's Sendai virus vector, for prevention and treatment of COVID-19; in February 2020, early research was underway
Z-VacciRNA Guanhao Biotech Co. Ltd.; Zy Therapeutics Inc. Discovery A series of mRNA vaccine as a freeze drying powder injection using Zy's technology, for prevention of COVID-19; in February 2020, it was at discovery stage
Antibodies Immunoprecise Antibodies Ltd. Discovery Identified candidates through discovery platforms B Cell Select and DeepDisplay and Talem Therapeutic's access to the transgenic animal platform OmniAb for direct generation of human antibodies
SARS-CoV-2 vaccine Medigen Biotechnology Corp.; National Institutes of Health Discovery A vaccine for prevention of COVID-1; in February 2020, preclinical studies in animals were planned in Taiwan
mRNA-1273 Moderna Therapeutics Inc. Discovery An mRNA vaccine that encodes viral spike (S) protein, for prevention of COVID-19; in January 2020, National Institute of Allergy and Infectious Diseases planned to conduct IND-enabling studies and a U.S. phase I trial
Anti-SARS-CoV-2 program Nanoviricides Inc. Discovery An anti-nCoV nanoviricide program, by using company's nanoviricide technology, for treatment of COVID-19; in January 2020, company started preparations to test candidates in cell cultures against certain known BSL2 coronaviruses, including ones that use the ACE2 receptor; company was seeking to outlicense
Antibodies Regeneron Pharmaceuticals Inc. Discovery Human monoclonal antibodies developed using its VelociSuite technologies for treatment of COVID-19; in February 2020, development of a vaccine was planned
Protein subunit vaccine Sanofi Pasteur Discovery Protein subunit vaccine consisting of antigens found on the surface of SARS-CoV-2, created using its egg-free, recombinant DNA baculovirus expression platform technology, for prevention of COVID-19; in February 2020, Sanofi planned to advance a preclinical candidate
Coronavirus vaccine (oral, enteric-coated tablet) Vaxart Inc. Discovery Recombinant protein vaccine using replication-incompetent adenovirus type 5 (Ad5) vector, as part of its VAAST platform, for the oral prevention/treatment of coronavirus
Protein subunit vaccine (molecular clamp) University of Queensland Discovery Subunit vaccine using its molecular clamp vaccine platform to stabilize the viral protein for prevention of COVID-19; Glaxosmithkline plc and Seqirus GmbH are providing access to their pandemic vaccine adjuvant technologies; as of February 2020, preclinical studies were planned
SARS-CoV-2 targeting human monoclonal antibodies Vir Biotechnology Inc. Discovery Antibodies that target SARS-CoV-2 spike protein that the virus uses to enter cells through the cellular receptor ACE2 for treatment and/or prevention of COVID-19; in February 2020, two antibodies were identified; company formed a collaboration with Wuxi Biologics

Source: Cortellis and BioWorld

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