INOVIO Pharmaceuticals (NASDAQ: INO), a biotechnology company designing DNA medicines, received approval from Mexico’s national health regulatory agency to advance its COVID-19 vaccine candidate to Phase 3 clinical trials.
This is the latest advancement in the company’s global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), for its DNA vaccine candidate for COVID-19, INO-4800. INOVIO also recently announced approvals for Phase 3 clinical trials in Brazil and the Philippines.
INOVIO is headquartered in Plymouth Meeting, PA but it has a local presence with its Research & Development Center and Device Engineering & Manufacturing Facility in Sorrento Valley.
The company’s President and CEO, J. Joseph Kim, Ph.D. said INOVIO is excited about this advancement in their global trials as they help evaluate their vaccine candidate in the fight against the COVID-19 pandemic.
“With the virus threatening to become an endemic threat worldwide, while millions of people around the globe remain unvaccinated, we are committed to supporting the international public health response,” Kim said.
In addition to COVID-19 vaccine development, the public company designs DNA medicines to treat and protect people from infectious diseases, cancer and diseases associated with HPV.
DNA Vaccine Candidate
Kate Broderick, Ph.D. has been leading INOVIO’s innovation of a COVID-19 vaccine right here in San Diego as the company’s senior vice president of R&D.; Currently, the company has approximately 320 employees and over the past year, INOVIO has added about 100 people to its team.
Broderick explained that some of the key differences that set their DNA vaccine candidate apart is its thermostability, the type of immune response it generates and its potential to serve as an effective booster vaccine.
Two out of the three COVID-19 vaccines available in the United States are mRNA-based vaccines which elicit an antibody response from the immune system.
Similarly, INOVIO’s DNA-based vaccine delivers instructions to the skin cells about what the infection looks like. On top of that, the DNA vaccine also activates the immune system’s T-Cells, which fight and destroy the targeted pathogen.
She explained that antibodies are like a lock and key in the sense that they look for a specific infection to target, whereas T Cells are a bit more flexible in their response to infection and play an important role in addressing the challenge of coronavirus variants.
“As [SARS-CoV-2 is] continuing to change we really think these T cells are going to be critical in sort of mitigating the risk of the virus mutating and changing,” Broderick said.
Additionally, the thermostability of the DNA vaccine means that it can be stored around room temperature, whereas mRNA vaccines require extreme cold storage, and thus can make for an accessible vaccine option for rural areas.
Global Vaccination Effort
At this point in the coronavirus pandemic, Americans have had the opportunity to get the COVID-19 vaccine for free through public vaccination sites, at doctors’ offices or even the drug store.
However, this is not the case globally where only 2% of the population in low-income countries have received at least one vaccine dose as of Sept. 9, according to data from Our World in Data, World Bank and the United Nations.
Another aspect of INOVIO’s global trials is that it evaluates the vaccine candidate in diverse populations, which Broderick said was a strategic decision to make sure it is effective for a variety of people.
The company’s vaccine was designed back in January of 2020, and the biggest marker of success for Broderick is the data showing that it remains effective against the multiple variants that have cropped up so far.
“Ensuring that the vaccines that we’re producing now are able to really mitigate the risk of those new variants that we don’t know about yet is absolutely crucial and so far we’ve been able to do that and so I feel that’s been a real marker for success for our development so far,” Broderick said.
CEO: J. Joseph Kim, Ph.D.
HEADQUARTERS: Plymouth Meeting, PA
BUSINESS: Biotech company designing DNA medicines to treat and protect people from infectious diseases, cancer and diseases associated with HPV.
EMPLOYEES: Approx. 320 employees
STOCK: INO (NASDAQ)
REVENUE: $7 million (2020)
NOTABLE: INOVIO is conducting Phase 3 trials for its COVID-19 vaccine candidate in Mexico, Brazil and the Philippines.