Inovio Pharmaceuticals is an American

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used ...

company focused on the discovery, development, and commercialization of synthetic DNA products for treating

cancer Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...

s and

infectious disease An infection is the invasion of tissues by pathogens, their multiplication, and the reaction of host tissues to the infectious agent and the toxins they produce. An infectious disease, also known as a transmissible disease or communicable di ...

s. In April 2020, Inovio was among some 100 companies, academic centers, or research organizations developing a

vaccine A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified.

candidate for treating people infected with

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was identified in Wuhan, China, in December 2019. The disease quickly ...

, with more than 170 total vaccine candidates in development (June 2020).

Technology

The Inovio technology is based on inserting engineered DNA into cells, where it becomes transcribed into mRNA and translated into proteins. The proteins encoded by the DNA elicit

immune response An immune response is a reaction which occurs within an organism for the purpose of defending against foreign invaders. These invaders include a wide variety of different microorganisms including viruses, bacteria, parasites, and fungi which could ...

to antigens from cancers and

virus A virus is a submicroscopic infectious agent that replicates only inside the living cells of an organism. Viruses infect all life forms, from animals and plants to microorganisms, including bacteria and archaea. Since Dmitri Ivanovsk ...

es, by stimulating the production of

T cell A T cell is a type of lymphocyte. T cells are one of the important white blood cells of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell r ...

s and antibodies that aid recovery. The technology can be "targeted" to specific types of cancer and immune diseases, such as those produced by a virus. During a meeting of the White House Coronavirus Task Force in March 2020, CEO, Joseph Kim, said that Inovio scientists had designed a vaccine candidate (INO-4800) for the COVID-19 coronavirus in January, in three hours, after the virus'

genetic sequence A nucleic acid sequence is a succession of bases signified by a series of a set of five different letters that indicate the order of nucleotides forming alleles within a DNA (using GACT) or RNA (GACU) molecule. By convention, sequences are us ...

was first published. Shareholders sued Inovio in August 2020, claiming it exaggerated evidence of its coronavirus vaccine's efficacy in order to boost its stock price.

License of electroporation device

In 2006, Inovio licensed "certain patented technology relating to the delivery of gene-based therapeutics into

skin Skin is the layer of usually soft, flexible outer tissue covering the body of a vertebrate animal, with three main functions: protection, regulation, and sensation. Other animal coverings, such as the arthropod exoskeleton, have different de ...

", as well as patents "involving the delivery of genes or drugs via ''

ex vivo ''Ex vivo'' (Latin: "out of the living") literally means that which takes place outside an organism. In science, ''ex vivo'' refers to experimentation or measurements done in or on tissue from an organism in an external environment with minimal ...

'', intratumoral and

intramuscular Intramuscular injection, often abbreviated IM, is the injection of a substance into a muscle. In medicine, it is one of several methods for parenteral administration of medications. Intramuscular injection may be preferred because muscles have ...

electroporation Electroporation, or electropermeabilization, is a microbiology technique in which an electrical field is applied to cells in order to increase the permeability of the cell membrane, allowing chemicals, drugs, electrode arrays or DNA to be introd ...

... The ''ex-vivo'' patents are relevant to the delivery of genes to dendritic and

stem cells In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type of ...

Licence of US7328064B2

Sometime after its publication in February 2008, Inovio was assigned a patent for "an apparatus hat providesfor injecting a fluid into body tissue, the apparatus comprising: a hollow needle; and a fluid delivery means, wherein the apparatus is adapted to actuate the fluid delivery means in use so as to automatically inject fluid into body tissue during insertion of the needle into the said body tissue."

Cellectra injection device

To facilitate use of its potential products, Inovio manufactures a proprietary injection device, called "Cellectra", which the company describes as providing a "brief electrical pulse to reversibly open small pores in the

cell Cell most often refers to: * Cell (biology), the functional basic unit of life Cell may also refer to: Locations * Monastic cell, a small room, hut, or cave in which a religious recluse lives, alternatively the small precursor of a monastery ...

to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as

mRNA In molecular biology, messenger ribonucleic acid (mRNA) is a single-stranded molecule of RNA that corresponds to the genetic sequence of a gene, and is read by a ribosome in the process of synthesizing a protein. mRNA is created during the ...

." The small device, which runs on "AA" batteries, is designed for use in the field under the difficult conditions of an epidemic. In June 2020 – in anticipation of the Inovio COVID-19 vaccine candidate becoming successful – the US Department of Defense invested million to further develop Cellectra as a handheld device and to preorder an undisclosed number of the devices.

Vaccine development

In a 2016 dose-escalation Phase I clinical trial to assess safety after

injection in healthy adults, the Inovio vaccine candidate, INO-4700 (also called GLS-5300) for development against

Middle East respiratory syndrome Middle East respiratory syndrome (MERS) is a viral respiratory infection caused by ''Middle East respiratory syndrome–related coronavirus'' (MERS-CoV). Symptoms may range from none, to mild, to severe. Typical symptoms include fever, cough, ...

(MERS) coronavirus, proved to be safe with only mild symptoms and no

adverse effect An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a " side effect", when judged to be secondary to a main or therapeutic effect. The term compl ...

s. The trial also demonstrated

immunogenicity Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted: * Wanted immunogenicity typically relates to vaccines, where the injectio ...

by dose-independent immune responses detected in more than 85% of subjects after two vaccinations that were durable a year later. In 2016, Inovio was involved, along with their partners GeneOne Life Science, in an attempt to control the

Zika Zika fever, also known as Zika virus disease or simply Zika, is an infectious disease caused by the Zika virus. Most cases have no symptoms, but when present they are usually mild and can resemble dengue fever. Symptoms may include fever, red ...

virus outbreak in

Miami Miami ( ), officially the City of Miami, known as "the 305", "The Magic City", and "Gateway to the Americas", is a coastal metropolis and the county seat of Miami-Dade County in South Florida, United States. With a population of 442,241 at ...

. In fact, they "were the first to initiate a human Zika DNA vaccine trial... orthe safety, tolerability, and

of GLS-5700 in 40 healthy adults. The trial's estimated completion date is November 2017." Then in

Puerto Rico Puerto Rico (; abbreviated PR; tnq, Boriken, ''Borinquen''), officially the Commonwealth of Puerto Rico ( es, link=yes, Estado Libre Asociado de Puerto Rico, lit=Free Associated State of Puerto Rico), is a Caribbean island and unincorporated ...

, where a Zika emergency had been declared, they did a study with 160 previously healthy adults using their proprietary "Cellectra-3P" technology. Preliminary results for the Miami trial were self-reported at the end of 2017. In February 2020 after receiving details of the

of the coronavirus, Inovio announced that it had produced a preclinical DNA-based vaccine as a potential therapy for

. Inovio is in competition to develop a coronavirus vaccine with numerous other companies, which were conducting preclinical or early-stage human research on more than 170 vaccine candidates, as of late June. In April 2020, Inovio began a Phase I trial of the COVID-19 vaccine candidate, INO-4800. In May 2021, Inovio announced the results of preclinical studies on a "pan-SARS-CoV-2" DNA vaccine (INO-4802) and plans to initiate phase I/II studies. The vaccine incorporates common overlapping mutations from several SARS-COV-2 variants of concern isolated from several different countries including Brazil and India.

Partnerships

In January 2020, the

Coalition for Epidemic Preparedness Innovations The Coalition for Epidemic Preparedness Innovations (CEPI) is a foundation that takes donations from public, private, philanthropic, and civil society organisations, to finance independent research projects to develop vaccines against emerging ...

(CEPI) announced it would grant of up to $9 million to Inovio for development of a vaccine against

SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a ...

. Inovio has partnerships to develop its COVID-19 vaccine candidate with CEPI, the South Korean National Institute of Health, and the International Vaccine Institute.

Clinical research

Inovio is collaborating with Beijing Advaccine Biotechnology Co., a Chinese biotech firm, in order to speed its acceptance by regulatory authorities in China, with plans to begin human

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...

s of a candidate vaccine in China during the first half of 2020. Inovio has partnerships with manufacturers to scale up production of a vaccine if preliminary efficacy trials are successful. In April 2020, the company began human Phase I safety studies of its lead vaccine (INO-4800) in the United States, and a Phase I-II trial in South Korea, to test for immunization against the COVID-19 virus. In April 2021, the US Department of Defense discontinued funding of future phase III trials of INO-4800. The company is planning to conduct phase III trials outside the United States. On 9 July it decided to conduct phase 3 trials in partnership with Beijing based Advaccine Pharmaceutical company. In early June, Inovio partnered with the International Vaccine Institute and Seoul National University,

South Korea South Korea, officially the Republic of Korea (ROK), is a country in East Asia, constituting the southern part of the Korean Peninsula and sharing a land border with North Korea. Its western border is formed by the Yellow Sea, while its eas ...

, to advance human research on INO-4800 in a Phase I-II safety and efficacy trial to be conducted on 120 participants at Seoul National University Hospital beginning in June. The trial is funded by the

and supported by the Korea Centers for Disease Control and Prevention and the Korea National Institute of Health.

History

Inovio was formerly known as Electrofect, which was founded in

Oslo, Norway Oslo ( , , or ; sma, Oslove) is the capital and most populous city of Norway. It constitutes both a county and a municipality. The municipality of Oslo had a population of in 2022, while the city's greater urban area had a population of i ...

in 1999. The company was renamed to Inovio in October 2001.

References

External links

Inovio Pharmaceuticals website
{{authority control Companies listed on the Nasdaq Health care companies based in Pennsylvania Companies based in Montgomery County, Pennsylvania Biotechnology companies of the United States Biotechnology companies established in 1983 COVID-19 vaccine producers 1998 initial public offerings Medical research