Inovio Pharmaceuticals is planning to launch a late-stage study in the US of its investigational COVID-19 vaccine in the second quarter of 2021, according to the Financial Post.
In September 2019, the US Food and Drug Administration (FDA) placed a temporary hold on Inovio’s mid-to-late stage trial investigating its vaccine candidate INO-4800.
At that time, the hold was put in place because the FDA had ‘additional questions’ regarding the phase 2/3 trial of INO-4800, as well as the delivery device to be used in the trial.
Inovio’s chief executive officer Joseph Kim told the Financial Times that he expects the company will answer all regulatory questions raised by the FDA with regards to the vaccine delivery system by the second quarter.
He added: “We [Inovio] expect to complete mid-stage trials in March and project [that] we will be able to start late-stage trials in second quarter of this year.”
Inovio’s COVID-19 vaccine candidate is composed of optimised DNA plasmids, which are delivered directly into cells intramuscularly or intradermally using its proprietary hand-held CELLECTRA device.
The CELLECTRA device provides a brief electrical pulse to reversibly open small pores in the local skin area cells, which Inovio says increases product delivery by ‘a hundred-fold’.
When the DNA plasmids are delivered, they instruct cells to produce the targeted antigen, which is then processed naturally and triggers specific T-cell and antibody-mediated immune responses.
On Monday, Inovio also announced that it has signed a collaboration and licence agreement for INO-4800 with Chinese biotech Advaccine Biopharmaceuticals Suzhou.
As part of this agreement, Advaccine will gain exclusive rights to develop, manufacture and commercialise INO-4800 within Greater China, including Mainland China, Hong Kong, Macao and Taiwan.
Advaccine will pay Inovio $3m upfront as well as a total of $108m upon the achievement of certain development and sales-based milestones for INO-4800 within Greater China.
Inovio and Advaccine are already working together on the clinical development of INO-4800 in China, with an ongoing phase 2 trial having recently completed enrolment.
“Inovio’s partnership with Advaccine enables us to leverage their deep expertise, capabilities and network across the region – making it possible to rapidly produce and, if and when approved, distribute our vaccine candidate to more people across Greater China,” said Kim.
“This agreement also provides Inovio with an Asian manufacturing partner with a near-term focus on INO-4800 and a long-term manufacturing resource potentially for other Inovio products,” he added.