CanSino Biological, Moderna, and INOVIO Lead COVID-19 Vaccine Race; 42 Other Candidates in Pre-Clinical Stage

CanSino Biological, Moderna, and INOVIO Lead COVID-19 Vaccine Race; 42 Other Candidates in Pre-Clinical Stage

According to WHO, as of March 20, two vaccine candidates were in Phase I clinical trial, and 42 others were in preclinical development. This information is supplemented by an April 7, 2020 Motley Fool article with more recent developments, which is focused on vaccine trials by companies with at least $200 million in market capitalization. According to the Fool, many companies, “had vaccine platforms targeting other coronaviruses such as MERS and SARS. This enabled them to rapidly prototype experimental vaccines for immunizing against the novel coronavirus that causes COVID-19.” The article lists 12 companies with products in development with the designated market cap, one clinical and 11 pre-clinical. 

INOVIO Uses DNA Plasmids in COVID-19 Vaccine Trial

One late-breaking study that did not make the WHO list is by INOVIO. In a press release from April 6, they announced that the FDA had approved the application for its DNA vaccine “INO-4800” with first Phase I dosing to begin that day. The INOVIO research is being conducted in, “Philadelphia, PA (at the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research), where screening of potential participants has already begun.” Pablo Tebas, who is an “infectious disease specialist and professor of Medicine at the Hospital of the University of Pennsylvania,” is the Principal Investigator of the study. 

INOVIO notes that a “DNA medicine” is generally made of optimized plasmids, the later being made of “small circles of double-stranded DNA” created or organized by computer sequencing technology and designed to produce an immune reaction. They also assert that their DNA medicines are superior in that they “deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA[.]” INOVIO’s President and CEO is Dr. J. Joseph Kim. 

Moving on, WHO’s above-mentioned “DRAFT landscape of COVID-19 candidate vaccines,” describes two studies in clinical evaluation and 42 studies in preclinical evaluation. Here is an overview of the Phase I studies: 

CanSino/Beijing Institute of Biotechnology Using Adenovirus Type 5

Of the two vaccine studies already in human trials, the first is, “A phase I clinical trial for recombinant novel coronavirus (2019-COV) vaccine (adenoviral vector),” as described on the Chinese Clinical Trial Registry. The developers are CanSino Biological Inc. and the Beijing Institute of Biotechnology. According to its website, CanSino was started in Tianjin, China in 2009; it now has more than 450 employees, one approved vaccine for Ebola virus disease (Ad5-EBOV), and 16 vaccine candidates in the product pipeline. 

The platform for the CanSino product is a NonReplicating Viral Vector, and the vaccine uses an Adenovirus Type 5 Vector. According to Science Direct, “Adenovirus type 5 is one of the most extensively studied and characterized adenovirus and is the one used most frequently in generating recombinant adenoviruses.”  

Moderna/NIAID Test mRNA Product at Three Sites

The second WHO-listed Phase I trial uses messenger RNA (mRNA) as a vaccine candidate. Per the NIH, the work is sponsored by Moderna (founded in 2010 in Cambridge, Massachusetts; founding investor Flagship Pioneering) and the National Institute of Allergy and Infectious Diseases (NIAID). Study locations include the Emory Vaccine Center/The Hope Clinic, Decatur, Georgia (recruiting); National Institutes of Health – Clinical Center – Vaccine Research Center Clinical Trials Program, Bethesda, Maryland (not yet recruiting); and the Kaiser Washington Vaccine and Treatment Evaluation Unit (recruiting) in Seattle, Washington. The actual start date was March 3, 2020, with an estimated primary study completion date of June 1, 2021. According to the NIH’s RePORT, one key site for the study is Kaiser Washington Vaccine and Treatment Evaluation Unit. The Project Leader and Senior Scientific Investigator is Lisa Jackson.   

42 Vaccine Candidates in Pre-Clinical

As noted by WHO, there were 42 Pre-Clinical studies in the works when they prepared their March report. For your convenience, the following is the March 20, 2020 “Draft landscape,” which also includes the Phase I trials: 

PlatformType of candidate vaccineDeveloperCoronavirus targetCurrent stage of clinical  evaluation/regulatory status- Coronavirus candidateSame platform for non-Coronavirus candidates
Non- Replicating Viral VectorAdenovirus Type 5 VectorCanSino Biological Inc.and Beijing Institute of BiotechnologyCOVID-19Phase 1 ChiCTR2000030906Ebola
RNALNP-encapsulated mRNAModerna/NIAIDCOVID-19Phase 1NCT04283461multiple candidates
PlatformType of candidate vaccineDeveloperCoronavirus targetCurrent stage of clinical  evaluation/regulatory status- Coronavirus candidateSame platform for non-Coronavirus candidates
DNADNA plasmid vaccine Electroporation deviceInovio PharmaceuticalsCOVID-19Pre-ClinicalLassa, Nipah HIVFilovirus HPVCancer indications ZikaHepatitis B
DNADNATakis/Applied DNA Sciences/EvvivaxCOVID-19Pre-Clinical
DNADNA plasmid vaccineZydus CadilaCOVID-19Pre-Clinical
InactivatedFormaldehyde- inactivated + alumSinovacCOVID-19Pre-ClinicalSARS
Live Attenuated VirusDeoptimized live attanuated vaccinesCodagenix/Serum Institute of IndiaCOVID-19Pre-ClinicalHAV, InfA, ZIKV, FMD, SIV, RSV, DENV
Non- Replicating Viral VectorMVA encoded VLPGeoVax/BravoVaxCOVID-19Pre-ClinicalLASV, EBOV, MARV, HIV
Non- Replicating Viral VectorAd26 (alone or with MVA boost)Janssen Pharmaceutical CompaniesCOVID-19Pre-ClinicalEbola, HIV, RSV
Non- Replicating Viral VectorChAdOx1University of OxfordCOVID-19Pre-Clinicalinfluenza, TB, Chikungunya, Zika, MenB, plague
Non- Replicating Viral Vectoradenovirus- based NasoVAX expressing SARS2-CoVspike proteinAltimmuneCOVID-19Pre-Clinicalinfluenza
Non- Replicating Viral VectorAd5 S(GREVAX™platform)GreffexCOVID-19Pre-ClinicalMERS
Non- Replicating Viral VectorOral Vaccine platformVaxartCOVID-19Pre-ClinicalInfA, CHIKV, LASV, NORV; EBOV, RVF, HBV, VEE
Protein SubunitDrosophila S2 insect cell expression system VLPsExpreS2ionCOVID-19Pre-Clinical
Protein SubunitS proteinWRAIR/USAMRIIDCOVID-19Pre-Clinical
Protein SubunitS-TrimerClover Biopharmaceuticals Inc./GSKCOVID-19Pre-ClinicalHIV, REV Influenza
Protein SubunitPeptideVaxil BioCOVID-19Pre-Clinical
Protein SubunitS proteinAJ VaccinesCOVID-19Pre-Clinical
Protein SubunitIi-Key peptideGenerex/EpiVaxCOVID-19Pre-ClinicalInfluenza, HIV, SARS- CoV
Protein SubunitS proteinEpiVax/Univ. of GeorgiaCOVID-19Pre-ClinicalH7N9
Protein SubunitS protein (baculovirus production)Sanofi PasteurCOVID-19Pre-ClinicalInfluenza, SARS-CoV
Protein SubunitFull length S trimers/ nanoparticle + Matrix MNovavaxCOVID-19Pre-ClinicalRSV; CCHF, HPV, VZV, EBOV
Protein Subunitgp-96 backboneHeat Biologics/Univ. Of MiamiCOVID-19Pre-ClinicalNSCLC, HIV, malaria, Zika
Protein SubunitMolecular clamp stabilized Spike proteinUniversity of Queensland/GSKCOVID-19Pre-ClinicalNipah, influenza, Ebola, Lassa
Protein SubunitS1 or RBDProteinBaylor College of MedicineCOVID-19Pre-ClinicalSARS
Protein SubunitSubunit protein, plant producediBio/CC-PharmingCOVID-19Pre-Clinical
Protein SubunitSubunitVIDO-InterVac, University of SaskatchewanCOVID-19Pre-Clinical
Protein SubunitAdjuvanted microsphere peptideUniversity of SaskatchewanCOVID-19Pre-Clinical
Replicating Viral VectorMeasles VectorZydus CadilaCOVID-19Pre-Clinical
Replicating Viral VectorMeasles VectorInstitute Pasteur/Themis/Univ. of Pittsburgh Center for Vaccine ResearchCOVID-19Pre-ClinicalWest nile, chik, Ebola, Lassa, Zika
Replicating Viral VectorHorsepox vector expressing S proteinTonix Pharma/Southern ResearchCOVID-19Pre-ClinicalSmallpox, monkeypox
RNALNP-encapsulated mRNA cocktail encoding VLPFudan University/ Shanghai JiaoTong University/RNACure BiopharmaCOVID-19Pre-Clinical
RNALNP-encapsulated mRNAencoding RBDFudan University/ Shanghai JiaoTong University/RNACure BiopharmaCOVID-19Pre-Clinical
RNAmRNAChina CDC/Tongji University/SterminaCOVID-19Pre-Clinical
RNAmRNAArcturus/Duke-NUSCOVID-19Pre-Clinicalmultiple candidates
RNAmRNABioNTech/Fosun Pharma/PfizerCOVID-19Pre-Clinical
RNAsaRNAImperial College LondonCOVID-19Pre-ClinicalEBOV; LASV, MARV, Inf (H7N9), RABV
VLPPlant-derived VLPMedicago Inc.COVID-19Pre-ClinicalFlu, Rotavirus, Norovirus, West Nilevirus, Cancer
UnknownUnknownUniversity of HongKongCOVID-19Pre-Clinical
UnknownUnknownMIGAL GalileeResearch InstituteCOVID-19Pre-Clinical
UnknownUnknownDoherty InstituteCOVID-19Pre-Clinical
UnknownUnknownTulane UniversityCOVID-19Pre-Clinical