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Inovio Pharmaceuticals is Carving a Niche in the Immunotherapy Market

28 Jan Inovio Pharmaceuticals is Carving a Niche in the Immunotherapy Market

Inovio Pharmaceuticals (NASDAQ: INO), 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.

J Joseph Kim, President/CEO of Inovio Pharmaceutials, believes that the Company can rise to the challenge of developing a vaccine for Coronavirus even faster, with Inovio using the DNA sequence of the new coronavirus strain, which was made public on January 11, 2020, to design and construct a potential vaccine and advancing it to animal testing process in a very short span of time. 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 for developing the new coronavirus vaccine.

In addition to the Coronvirus vaccine program, the Company’s pipeline consists of a phase 3 clinical candidate for Brain cancer and two phase 2 candidates in immune-oncology.

Inovio Pharmaceuticals (NASDAQ: INO)

Market Cap: $532.05M; Current Share Price: 5.60 USDChart
Data by YCharts

According to the World Health Organisation (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 2000 people and claimed 56 lives. 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.

A special WHO Committee opined that it was too early to declare a public health emergency of international concern (PHEIC), stating that the special committee will reconvene soon to assess the situation. However 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 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.

Image Source: Company

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).

Image Source: Company

Invoio is collaborating with AstraZeneca (NYSE: AZN) 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 (NYSE: QGEN), to co-develop liquid biopsy based pretreatment test to guide patient seclection 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.

Image Source: Company

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.

Risk Assessment

  • The Company has a strong balance sheet with cash and short-terms investments totaling $93.8 M, which it believes to be sufficient to support its pipeline and development activities. The Company has ample funding support through its association with organization such as BARDA, CEPI and its commercial collaborations with other major pharma, biotechnology Companies. The Company has received over $170 million in non-dilutive funding since 2019 from the CEPI, DARPA, NIH and Bill and Melinda gates foundation.
  • The Company has a robust intellectual property rights portfolio with over 1000 issued and pending patents that offer it protection and add value to its pipeline.
  • Inovio is also making a foray into the diagnostics area with its tie up with QIAGEN; the Company believes that the Commercialization of a CDx test together with VGX-3100 could enhance market adoption. The collaboration aims to create an accurate test that would increase absolute efficacy of VGX-3100 among HPV-infected women who have progressed to HSIL/Cervical Pre-Cancer as per the Company.
  • The Company is also seeking to extend its pipeline by targeting a novel orphan/rare disease indication, namely INO-3107, for the treatment of Recurrent Respiratory Papillomastosis (RRP). The Company has upcoming catalysts in the form of phase 3 for its lead asset VGX-3100, the efficacy data from which is likely to be published in Q4, 2020. Additionally the Company is expecting to release the data from its Phase 2 checkpoint-combination programs Glioblastoma and HPV-Related Cancers in 2020.
  • Inovio immunotherapy platform offers the advantage of an “off-the-shelf” product that does not require cold-chain storage and can be stored for over a year at room temperature. The platform also offers rapid and scalable manufacturing that is cost-effective and can be produced in bulk quantities.
  • 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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