Receive our newsletter – data, insights and analysis delivered to you
  1. News
April 7, 2020

Inovio commences Phase I trial of DNA vaccine for Covid-19

Inovio Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application of its DNA vaccine candidate INO-4800 against Covid-19.

Inovio Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application of its DNA vaccine candidate INO-4800 against Covid-19.

Following the approval, the company has commenced a Phase I clinical trial of the vaccine candidate in healthy participants.

Inovio leveraged its DNA medicines platform to create the Covid-19 vaccine candidate. The company’s DNA medicines are designed to directly deliver optimised plasmids into cells intramuscularly or intradermally using its hand-held smart device Cellectra.

The Phase I trial will assess INO-4800 in up to 40 healthy adults at the University of Pennsylvania’s Perelman School of Medicine and at the Center for Pharmaceutical Research in the US. Screening of participants has been commenced at these sites.

Participants will be administered with two doses of INO-4800 four weeks apart. Initial immune responses and safety data are expected to be available in the coming months.

The vaccine candidate was subjected to preclinical testing in animal models, where it demonstrated encouraging immune response data, said the company.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

Further preclinical trials, including challenge studies, will be conducted along with the Phase I trial.

Inovio Pharmaceuticals president and CEO Dr Joseph Kim said: “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 I clinical testing.

“Our dedicated team of staff, partners and funders have been mobilised since the genetic sequence of the virus became available in early January and continues to work around the clock to ensure that we are rapidly advancing INO-4800 through this Phase I study towards planned efficacy trials.”

After obtaining Phase I preliminary safety and immunogenicity results, the company intends to launch Phase II efficacy studies of the Covid-19 vaccine candidate.

The company has already produced thousands of INO-4800 doses for Phase I and II trials. The aim is to generate one million doses by year-end for more trials and emergency use.

Related Companies

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU