Providence Cancer Institute at Providence St. Joseph Health is pursuing a first-in-human phase I clinical trial of CORVax12, a novel DNA-encodable, investigational vaccine, which is intended to act as a prophylactic vaccine to prevent coronavirus disease 2019 (COVID-19), according to OncoSec, the vaccine’s developer.
The CORVax12 vaccine approach combines the co-administration of tavokinogene telseplasmid (interleukin-12 plasmid; IL-12; TAVO) with a DNA encodable version of the SARS-CoV-2 spike or “S” glycoprotein, which was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center to enhance immunogenicity of the component.
“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,” principle investigator for the planned study Rom Leidner, MD, co-medical director of the head and neck cancer program at Providence Cancer Institute and assistant member at the Earle A. Chiles Research Institute, said in a press release. “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.”
Investigators have already filed an investigator-initiated investigational new drug (IND) application with the FDA and have designed a clinical trial protocol that will assess the vaccination of healthy adult volunteers utilizing the company’s next-generational, investigational APOLLO generator technology for the first time, pending FDA clearance for APOLLO to enter the clinic. The trial will also include extensive immune monitoring.
OncoSec will supply the vaccine and its investigational APOLLO electroporation device to Providence and does not currently anticipate any additional capital commitment. Moreover, the company indicated that they will contribute manufacturing, preclinical, and prior clinical information and data for tavokinogene telseplasmid, along with manufacturing data for the APOLLO technology, to support the possible FDA allowance of Providence’s IND. Providence will hold the IND though, if cleared by the FDA, and perform the preclinical and clinical development work.
“During a pandemic such as COVID-19, any opportunity to find a medical solution should be fully investigated,” Christopher Twitty, chief scientific officer of OncoSec, said in a press release. “We are excited to extend our deep expertise in IL-12 based immunotherapies along with an innovative vaccine candidate in support of the clinicans at Providence and their exploration of our CORVax12 vaccine to address this crisis. We hope to make a meaningful impact on COVID-19 as well as gaining a deeper understanding of its associated immunobiology.”
Tavokinogene telseplasmid has already been assessed as a potential treatment for multiple cancer indications, either as a monotherapy or in combination with leading checkpoint inhibitors. Further, results from recently completed studies of the IL-12 plasmid have demonstrated a local immune response and, subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, justifying additional development.
OncoSec Collaborates with Providence Cancer Institute to Conduct First-in-Human Trial of OncoSec’s CORVax12, an Investigational Vaccine to Prevent COVID-19, Combining an Enhanced “Spike” DNA Sequence and TAVO [news release]. San Diego, CA and Pennington, NJ. Published April 6, 2020. prnewswire.com/news-releases/oncosec-collaborates-with-providence-cancer-institute-to-conduct-first-in-human-trial-of-oncosecs-corvax12-an-investigational-vaccine-to-prevent-covid-19-combining-an-enhanced-spike-dna-sequence-and-tavo-301035810.html. Accessed April 6, 2020.