OncoSec Medical (NSDQ:ONCS) and Inovio Pharmaceuticals (NSDQ:INO) announced that they are testing potential COVID-19 vaccines after the latter received investigational new drug clearance from the FDA.
Inovio received an IND nod, while OncoSec’s is pending, but both companies are pursuing a first-in-human Phase 1 clinical trial for their vaccines, according to separate news releases.
OncoSec is using its existing product candidate, Tavo, in combination with an immunogenic component of the SARS-CoV-2 virus that was developed by researchers at NIH’s National Institute of Allergy & Infectious Diseases (NIAID) and licensed to the company.
With this combination, OncoSec is developing a novel, DNA-encodable investigational vaccine called CORVax12, and it is designed to act as a prophylactic vaccine to prevent COVID-19. It is slated to drive a coordinated vaccine response, capable of drawing upon the innate, adaptive humoral and adaptive cellular arms.
Providence Cancer Institute, a part of Providence St. Joseph Health, is set to pursue the Phase 1 trial and, pending FDA IND approval, will evaluate the vaccination of healthy adult volunteers with OncoSec’s next-generation Apollo generator technology.
“Previous vaccine efforts against coronaviruses, including the SARS coronavirus, have focused on the S glycoprotein, which facilitates interaction with the host cell through binding to the ACE2 receptor,” said Dr. Rom Leidner, Providence Cancer Institute head & neck cancer program co-medical director and principal investigator on the planned study.
“Given the structural similarities between ACE2-receptor binding domain of the SARS-CoV-2 and SARS-CoV viruses, we would like to explore whether a similar strategy with OncoSec’s CORVax12 may hold potential as an effective vaccine. Importantly, we believe the delivery of CORVax12 using OncoSec’s electroporation system may allow for highly effective DNA transfer to drive this investigational vaccine,” Leidner said in a news release.
After winning an IND nod, Inovio is set to begin testing its INO-4800 DNA vaccine candidate in a Phase 1 trial, with the first dosing taking place earlier this week.
The Phase 1 study is slated to enroll up to 40 healthy adult volunteers in Philadelphia and Kansas City, M0., where screening of potential participants has already begun. Study supplies for the vaccine arrived at the sites last week.
Each participant is set to receive two doses of INO-4800 four weeks apart, with the initial immune responses and safety data expected to come in late in the summer.
Inovio said its COVID-19 vaccine’s preclinical results were consistent with its completed Phase 1 study for Middle East Respiratory System (MERS), in which the vaccine was well-tolerated and induced high levels of antibody responses in 95% of subjects and generated broad-based T-cell responses in nearly 90% of study participants.
The company intends to advance INO-4800 to Phase 2 efficacy studies as soon as possible once it attains initial data from the Phase 1 study. It already has manufactured thousands of doses for the vaccine and is working to scale up INO-4800 manufacturing to have 1 million doses available by year-end.
“This is a significant step forward in the global fight against COVID-19,” Inovio president & CEO J. Joseph Kim said in a news release. “Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 clinical testing.”