Covid-19 roundup: Inovio finally gets PhII rolling — but there's still a clinical hold; Low cost vaccine enters PhI/II in India
Inovio has managed to convince the FDA to sign off on a Phase II trial of its Covid-19 vaccine. But the Phase III portion remains clamped by a partial clinical hold more than a month after it was first imposed.
The little biotech said that regulators still have remaining questions about the device that will be used to deliver its candidate, INO-4800, directly into the skin. The plan is “to resolve the remaining device questions during the conduct of Phase 2 segment and prior to the start of the Phase 3 segment of the trial,” according to a statement.
CEO Joseph Kim gushed over the news with characteristic fervor, hailing the initiation of Phase II as a “pivotal milestone” and highlighting the fact that the Department of Defense will fund the trial.
But over 40 years in the vaccine business — with no approved products to show for it — Inovio has consistently fallen short of its promises. Having started out early with a DNA vaccine that Kim said took only 3 hours to come up, nabbed a grant from CEPI and later gotten the DoD on board with $71 million, the company had promised that a late-stage study should be set to go in the summer.
Instead, a bigger legal feud with its contract manufacturer dragged Inovio way behind the frontrunning pack of big-name players like Pfizer/BioNTech, Moderna, AstraZeneca and J&J. Then came the disclosure, late September, that the FDA wasn’t sure its delivery device is quite ready for prime time.
Inovio said the FDA has now reviewed enough non-clinical data, device information and interim Phase I safety and immunogenicity as well as trial plans to give the green light.
The Phase II portion will enroll around 400 participants in the US as part of a dose-confirming exercise.
Like Pfizer/BioNTech and Moderna — both of which pronounced stellar vaccine effectiveness within the past few days — Inovio’s vaccine will be given in a two-dose regimen. But INO-4800 promises to do away with the frozen cold chain requirements, remaining stable at room temperature for more than a year.
If it proves efficacious in trials, that is.
Shares of the Plymouth Meeting, PA-based company, which were hammered when the partial hold was disclosed, climbed 12.92% in pre-market trading.
Indian vaccine maker kicks off trial for Baylor’s low-cost candidate
Years after Peter Hotez and his team at the Baylor College of Medicine were forced to shelve a potential vaccine for SARS due to a lack of funding, a new candidate they’ve developed against SARS-CoV-2 is going into the clinic.
Hyderabad-based Biological E, which licensed the subunit vaccine from BCM Ventures, has started a Phase I/II trial in India, where the jab will be boosted by an adjuvant from Dynavax.
To be injected in two intramuscular shots 28 days apart, the vaccine candidate consists of the receptor binding domain of the spike protein — rather than the whole spike protein, which is the target of both Pfizer/BioNTech and Moderna’s inoculations. In the new study, three dose levels will be tested among 360 healthy volunteers between 18 and 65 years old.
“This vaccine represents an urgent biotechnology innovation for ensuring health equity and combating the COVID-19 pandemic,” said Hotez, dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children’s Hospital Center for Vaccine Development.
Results are expected by February.
Baylor began working with Biological E back in August, when India became the third-leading nation in Covid-19 cases, to transfer the technology needed to scale up manufacturing of its vaccine within the country. As the vaccine is produced using a known yeast-based expression technology, the hope was the pharma company could leverage its past experience to push forward an affordable vaccine option.
Narender Dev Mantena, a director of BioE Holdings who’s heading up the vaccine initiative, previously said they expect to make “several hundred million doses available annually.”
Pfizer/BioNTech vaccine likely to roll out in UK by Christmas
Britain will be ready to roll out the vaccine developed by Pfizer and BioNTech within two weeks, according to health minister Matt Hancock, reiterating a timeline he’s plotted in recent days.
“We’re working very closely with the company,” he told BBC TV. “We’ll be ready to roll it out as soon as it comes, we’ll be ready from the first of December…, but more likely is that we may be able to start rolling it out before Christmas.”
Pfizer and BioNTech have struck a deal to supply the UK with 30 million doses of its mRNA jab — vials that Hancock has said he’s ready to fly in from Belgium if border disputes arise due to Brexit.
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