Inovio Pharmaceuticals, a Pennsylvania biotech company has commenced a clinical trial for a new vaccine targeting COVID-19 called INO-4800. The study commences at University of Pennsylvania and Center for Pharmaceutical Research in Missouri.
Preclinical data, which was submitted to global regulatory authorities and submitted as part of the investigational new drug (IND) application show promising immune response results across multiple animal models. Additional preclinical trials including challenge studies continue in parallel with the new Phase I clinical trial. The study will be conducted at two sites including University of Pennsylvania and the Center for Pharmaceutical Research in Kansas City, Missouri.
The open-label study has been designed to evaluate the safety, tolerability and immunological profile of their investigational vaccine product called INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.
The study started April 3 and will end November 2020. With up to 40 participants in Philadelphia and Missouri receiving the first inoculations with two study arms. Each participant will receive two doses of INO—4800 four weeks apart, and the initial responses and safety data from the study are expected by late summer the company reported in a press release.
The Research Sites
What is INO-4800?
The vaccine contains a tiny part of the SARS-CoV-2 genetic sequence and once injected into the body it triggers the immune system to recognize the infectious pathogen. In a WGNTV news cast, Dr. Kate Broderick, Senior Vice President of Research and Development at Inovio and the vaccine’s lead developer, noted, “It provides the body basically a template, a poster, of what the virus looks like.” She continued, “So when the virus, or if the virus should infect you, your body already knows exactly what the bad guy looks like.” In this way, the Chicago news outlet compares it to a “Most Wanted” poster and the outlaw is SARS-CoV-2.
How does it Work?
A discussed in Precision Vaccination, INO-4800 is a DNA vaccine candidates matched to SARS-CoV-2. It is delivered via Inovio’s proprietary platform hand-held smart device called CELLECTRA. The biotech company calls it a “one-of-a-kind platform,” offering optimized DNA into cells, where they are translated into proteins that activate an individual’s immune system to produce targeted T cell and antibody response. The technology involves a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter. Upon entry, the plasmids being replicating, thereby strengthening the body’s own natural response mechanisms.
As it turns out, DNA medicines are made up of optimized DNA plasmids which are small circles of double-stranded DNA. The company uses a computer sequencing technology to actually synthesize or reorganize in order to produce a specific immune response in the body.
The company strives to grow the therapeutic range of monoclonal antibodies with its DNA-encoded monoclonal antibody technology known as dMAb. With dMAb, Inovio encodes DNA to express monoclonal antibody. The effort: generate a compelling in vivo monoclonal antibody production via injections of DNA plasmid into the patient. Their ultimate goal involves the vision to produce in vivo production of therapeutic antibodies while not interfering or modifying the patient’s own DNA.
Inovio Pharmaceuticals focuses on rapidly bringing to market precisely designed DNA medicines to treat, cure and protect people from diseases associated with HPV, cancer, and infectious diseases. According to their literature, they are the first and only company to have clinically demonstrated that a DNAM medicine can be delivered directly into cells in the body via their proprietary smart device to safely product a robust immune response to destroy and clear high-risk HPV 16 and 18, which are responsible for 70% of cervical cancer and 90% of anal cancer and 69% of vulvar cancer.
Business & Finance
Publicly traded, the company trades at $8.12 with a $1.1 billion market capitalization. Much like many biotech ventures, they operate at continuous losses—in this case nearly $120 million in projected losses. Annual reports can be accessed here.
Lead Research/Investigator Contacts
Barbara Bradshaw, Program Manager, Center for Pharmaceutical Research
Eileen Donaghy, Program Manager, University of Pennsylvania