Inovio's Covid-19 vaccine studies just hit a brick wall at the Pentagon. Are other hopefuls in trouble?
Inovio received some harsh news from the Pentagon on Friday regarding its Covid-19 vaccine program, and it could prove foreboding to other mid-stage players in the space.
The US Department of Defense has scuttled funding for Inovio’s Phase III Covid-19 vaccine trial, Inovio said in a press release, but will continue to fund the study’s Phase II segment. Friday’s move comes as a result of a growing availability of authorized vaccines in the US, Inovio said the department communicated to them. Endpoints News has reached out to DoD for comment.
“The decision results from the changing environment of COVID-19 with the rapid deployment of vaccines,” DoD said, per Inovio. “This decision is not a reflection of the awardee or product, rather a fast-moving environment associated with the former Operation Warp Speed on decisions related to future products.”
Inovio hustled to reassure investors that the funding withdrawal did not stem from their vaccine candidate itself, dubbed INO-4800, saying in its statement that the decision was unrelated to the program’s data or partial clinical hold that’s been in place since last September. Furthermore, the company’s release led with the seemingly innocuous note on how they’re planning for a Phase III trial to take place predominantly outside the US.
But most didn’t seem to be assuaged, as Inovio $INO shares were crushed early Friday. The stock was down more than 30% at points in pre-market trading, and opened down 25%.
Inovio’s support had come from the department’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. The office’s point over vaccine availability could prove as a warning sign for other government-backed Covid-19 projects that haven’t yet hit the market. According to the latest CDC numbers, more than 135 million Americans have received at least one vaccine dose, accounting for 52% of the population over 18.
Those figures come largely as a result of the Pfizer/BioNTech and Moderna vaccines, which were the first two to receive EUAs in the US after their Phase III data read out last November. Of the nearly 219 million doses administered so far, about 114 million have come from Pfizer/BioNTech and 95 million from Moderna.
An additional 8 million doses of the one-shot J&J vaccine have also been given, and that shot’s rollout hold is expected to be lifted as early as Friday. And Novavax has previously said it expects its own EUA to come as soon as next month, further complicating matters for Inovio and other Covid-19 shots from small players in late-stage development.
INO-4800 is a DNA-based vaccine candidate composed of an optimized DNA plasmid, Inovio says. The approach differs from the major vaccine players’ strategy of using mRNA (Pfizer and Moderna), adenoviruses (J&J and AstraZeneca) and protein-based delivery (Novavax). Inovio had released some early-stage data on their candidate just last week, saying T cell responses were “fully maintained” against the coronavirus variants that emerged in the UK, South Africa and Brazil when compared to responses to the original Wuhan, China strain. They noted that the samples were collected from varying timepoints from when their Phase I trial participants were immunized.
It’s been a troubled few months for Inovio, which has seen its Covid-19 vaccine program stuck in neutral ever since the FDA slapped a partial hold on its Phase III trial in late September. Regulators had raised questions over the program’s device used to inject the vaccine into the skin, and Inovio said in March that it is planning to respond to the agency next month.
In a 10-K filing at the time, Inovio admitted its vaccine efforts may end up being fruitless, writing, “We do not know whether our planned Phase 3 clinical trial will begin on time or be completed on schedule, if at all.”