03 Feb 5 Companies Striving to Develop a Vaccine for the Novel Coronavirus (nCoV)
According to the World Health Organization (WHO), Coronovirus (CoV) is a family of viruses that cause illnesses ranging from common cold to lethal diseases such as the Middle East Respiratory Syndrome (MERS-CoV), Severe Acute Respiratory Syndrome (SARS-CoV) and a new strain of CoV named, novel coronavirus (nCoV). The virus is Zoonotic as they are transmitted from animals to humans, with there being many known strains that have not yet infected humans. The infection manifests in the form of respiratory symptoms, cough, fever, shortness of breath and can take the form of pneumonia, severe acute respiratory syndrome, kidney failure and even death.
WHO had identified a new type of coronavirus, namely 2019 novel coronavirus (2019-nCoV) in China in early January 2020, which has so far infected 7711 confirmed and 12167 suspected cases throughout the country, out of which 1370 are severe and 170 people have died, while 124 people have recovered and been discharged from hospital as per a statement from WHO. The disease which originated from the Chinese city of Wuhan, has spread to other countries with three cases being reported from France, four cases in Australia, and three cases from the U.S so far. According to the US Centers for Disease Control and Prevention (CDC), there are nearly 60 patients under observation in over 20 states in the U.S.
The WHO has declared the Coronavirus outbreak as a Public Health Emergency of International Concern (PHEIC) as more cases are reported around the world as the virus continues to spread beyond Wuhan, China. The notice allows members of the United Nations to take preemptive measures to contain the spread of the virus, including measures such as sealing borders, cancelling flights, proactively screen and quarantine suspected cases etc. Hong Kong has declared the highest level of citywide emergency, while China has cancelled its Chinese New Year Celebrations, declared school breaks and placed travel restriction in order to curb the spread of the disease.
There is no definite cure for treatment or eradication of CoV, with treatment being limited to alleviation of symptoms, and providing support and care to patients. Scientists have been able to sequence the virus genetic code; spurring organizations around the world into action, with the researchers at the US National Institutes of Health are already working on a therapeutic. Organizations like CEPI are supporting initiatives to develop a vaccine by proving funding support.
Inovio Pharmaceuticals (NASDAQ: INO)
Market Cap: $453.05M; Current Share Price: 4.53 USD
Data by YCharts
Inovio’s Pharmaceuticals, a late-stage biotechnology Company developing DNA-based immunotherapies and vaccines to combat cancer and infectious diseases, announced the grant of up to $9 million by the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a vaccine for coronavirus 2019-nCoV, a deadly new strain of Coronavirus that has originated in Wuhan, China. The Grant is in addition to the award of nearly $ 56 million from CEPI to the Company in April 2018, for developing vaccines for Middle East Respiratory Syndrome (MERS) and Lassa fever.
The Company had earlier developed a vaccine for “Zika Virus”, in association with its partners, and advanced the vaccine from “bench to human testing” in just seven months, making it the fastest vaccine development on record in recent decades, according to the Company. The Company intends to begin the first human tests in the U.S by early summer, hoping to capitalize on the relaxation of testing norms, in the event of a potential outbreak situation. The Company will be collaborating with the Wistar Institute, VGXI and Twist Biosciences Corp (NASDAQ: TWST) for developing the new coronavirus vaccine.
Inovio Pharmaceuticals is focused on developing DNA-based immunotherapy and monoclonal therapies to fight cancer and infectious diseases. The Companies immunotherapy enables a patient’s immune system to produce functional antibodies and killer T cells that are capable of combating cancer and infectious diseases. The technology helps identify strains and variants of a target cancer or virus, assess gene sequence of selected antigens, create an optimal consensus sequence for the antigen and insert a synthetic consensus sequence for each antigen into a separate DNA plasmid to manufacture SynCon Immunotherapy. The therapy can then be delivered into the muscle or skin using its Cellectra Device which causes the immune system to produce protective antibodies and killer T Cells to fight the infectious cells or cancer.
The Company’s proprietary CELLECTRA allows plasmid construct to be delivered via intramuscular or intradermal. It is an advanced transfection delivery that helps increase immunotherapy cellular intake and promotes antigen expression leading to CD8+ T cell activation and antibody response. Inovio has a diverse pipeline of candidates such as VGX-3100 meant for the treatment of Cervical Dysplasia, Vulvar Dysplasia and Anal Dysplasia (In collaboration with ApolloBio (China Exclusivity)). Furthermore the Company is developing INO-3107 for the treatment of Recurrent Respiratory Papillomatosis (RRP), INO-5401 for the treatment of Glioblastoma, INO-5151 for Prostate Cancer (In association with Regeneron and Parker Institute for Cancer Immunotherapy).
Invoio is collaborating with Astra Zeneca to for the development and commercialization of MEDI0457, a PD-L1 checkpoint inhibitor to be used in combination with durvalumab, intended for the treatment of metastatic HPV-related SCCHN. The Company is actively seeking strategic partnership and collaborations to fund and develop its platform of infectious diseases. In addition the Company had entered into agreement with QIAGEN, to co-develop liquid biopsy based pretreatment test to guide patient selection for VGX-3100, a potential first-in-class treatment for HPV Infection of the Cervix and the first non-invasive treatment for cervical pre-cancer.
Additionally its partner funded development pipeline has various candidates such as PENNVAX-GP, a HIV therapeutic being developed in association with NAID. The Company is seeking additional funding from DARPA for the phase 2 development of INO-4201, a potential vaccine for Ebola.
Moderna, Inc. (NASDAQ: MRNA)
Market Cap: $6.84B; Current Share Price: 20.51 USD
Data by YCharts
Moderna is developing an mRNA vaccine for the treatment of the novel coronavirus (2019-nCoV), in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) and the National Institutes of Health (NIH). The Company uses its proprietary mRNA platform to discover and create novel solutions across indications such as prophylactic vaccine development, personalized cancer vaccine, intra-tumoral immune-oncology and localized regenerative medicine to name a few.
The Collaboration also includes the National Institute of Health’s Vaccine Research Center (VRC), a part of the National Institute of Allergy and Infectious Diseases (NIAID) which are working with Moderna to design the vaccine. NIAID will conduct IND-enabling studies and a Phase 1 clinical study in the U.S as per a Company statement. Additionally the Company has had six positive Phase 1 clinical readouts in its prophylactic vaccines modality and moved two additional programs into development.
The Company has developed a unique mRNA sequence that codes for a protein, and encompasses knowledge of mRNA biology, chemistry, formulation & delivery, bioinformatics and protein engineering to address unmet needs in critical areas.
The Platform offers great flexibility and wide applicability; by changing the sequence of the genetic code it can combine different mRNA sequences for different proteins in a single mRNA medicine. It has a drug design studio, which can develop mRNA within a very short period of time, using a proprietary Sequence Designer module, bioinformatics algorithms and its modular synthesis robotics, making it a pioneering Digital Biotech Company™.
The Company has built a robust and diverse network of strategic collaborations with pharmaceutical and biotechnology organisation, in addition to government entities and research organisations to leverage its mRNA platform for drug discovery and development. Some of its collaborations are with Astra Zeneca, Merck, Vertex, BARDA, DARPA and Bill and Melinda gates foundation.
Novavax Inc (NASDAQ: NVAX)
Market Cap: $266.45M; Current Share Price: 7.62 USD
Data by YCharts
The Company is working on a vaccine for the deadly virus by leveraging its experience in developing candidates that offer protection against Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Novavax will use its proprietary “ recombinant nanoparticle” technology along with its Matrix-M adjuvant to create a potential vaccine to combat the virus.
Novavax has extensive experience of working with Coronaviruses, including preclinical work that encompasses severe acute respiratory syndrome coronavirus. The Company will be using the genetic sequence of the new coronavirus to develop its vaccine candidate. The technology used for the development of the potential vaccine has already been validated in its lead clinical program, namely Resvax, an RSV vaccine and a phase III Nanoflu vaccine.
The Company was recently granted Fast Track Designation for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older by the U.S. Food and Drug Administration (FDA). The candidate is currently being evaluated in a pivotal phase 3 clinical trials to study its immunogenicity and safety compared to the quadrivalent formulation of Fluzone. The results from the study are expected to be announced by the end of Q3, 2020 and will act as the basis for its U.S. biologics license application (BLA) and future licensure of NanoFlu using the FDA’s accelerated approval pathway.
In addition its pipeline consists of ResVax, a respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (RSV F Vaccine), an Ebola GP vaccine and a combination influenza / RSV F Vaccine for older adults.
BioCryst Pharmaceuticals (NASDAQ: BCRX)
Market Cap: $439.07M; Current Share Price: 2.85 USD
Data by YCharts
BioCryst has an FDA approved antiviral drug Rapivab, which is used for the treatment of acute uncomplicated of flu in patients who are two years and older. The Company has another drug in its pipeline, namely Galidesivir, which has demonstrated the potential to fight numerous families of viruses including Coronavirus. The drug is currently undergoing phase I clinical study and has passed safety tests in humans. The candidate was primarily developed for treating Ebola but is also active against coronaviruses, according to the Company.
Galidesivir (BCX4430) is a nucleoside RNA polymerase inhibitor, which is capable of disrupting the viral replication and the ability to fight multiple threats at once. The candidate is being developed as a broad-spectrum antiviral under the Animal Rule for the treatment of viruses that pose a threat to health and national security. The drug has demonstrated survival benefits against multiple serious pathogens including Ebola, Marburg, Yellow Fever and Zika viruses and has been able to establish a safety and tolerability in humans. In addition, the candidate has been able to show broad-spectrum activity in vitro against more than 20 ribonucleic acid (RNA) viruses belonging to nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses as per the Company.
Galidesivir is being developed in association with U.S. Government Agencies such as the National Institute of Allergy and Infectious Diseases (NIAID) and has received funding amounting to $39.5 million. Furthermore the Company is also collaborating with Biomedical Advanced Research and Development Authority (BARDA) for the development of galidesivir as a potential treatment for diseases caused by RNA pathogens, including filoviruses.
The Company’s pipeline consists of Berotralstat (BCX7353) for prevention of Hereditary angioedema (HAE) attacks, BCX9930 Oral Factor D Inhibitor for Complement-mediated Diseases and BCX9250 Oral ALK-2 Inhibitor for Fibrodysplasia Ossificans Progressiva (FOP).
VIR biotechnology (NASDAQ: VIR)
Market Cap: $2.92B; Current Share Price: 26.63 USD
Data by YCharts
The Company is evaluating the safety, efficacy and potential of its previously identified anti-coronavirus monoclonal antibodies, or mAbs, in treating 2019-nCoV. The mAbs were discovered by leveraging its antibody platform earlier from the survivors of an infection and may hold the key to treating and preventing the occurrence of Coronavirus. The Company is working on isolation of new mAbs specific to the virus on a war footing, while its scientists explore the application of whole genome CRISP-based screening capabilities to zero-in on the host receptors for the infection.
VIR has four current technology platforms that have the ability to stimulate and enhance the immune system. The Company’s antibody platform identifies rare antibodies from survivors of infectious diseases, which are capable of treating evolving or existing untreatable pathogens through direct pathogen neutralization and immune system stimulation. Additionally its T Cell platform leverages the immunology of human cytomegalovirus, or HCMV as a delivery vector for treatment of infections by pathogens that are refractory to current vaccine technologies.
The Company’s innate immunity platform targets host proteins as a means of creating host-directed therapies with high barriers to resistance, while its siRNA platform harnesses the power of siRNA to inhibit pathogen replication and eliminate microbial immune countermeasures.VIR ‘s pipeline is focussed on targeting infectious diseases such as HBV (VIR-2218) and (VIR-3434), Influenza (VIR-2482), HIV(VIR-1111) and TB(VIR-2020).
VIR has strategic collaborations with leading companies and organizations such as Alnylam pharmaceuticals (NASDAQ: ALNY), Brii Biosciences, Bill & Melinda gates foundation to name a few.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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