Covid-19 roundup: After batting back at vaccine supplier, Inovio lines up a giant in its corner; Oxford spinout SpyBiotech begins PhI/II dosing for VLP-based vaccine
Inovio announced Tuesday morning that manufacturing giant Thermo Fisher has signed on to make their Covid-19 vaccine INO-4800 in 2021. The biotech — which has yet to get an OK on a vaccine after more than 40 years of operations — expects to be able to distribute 100 million doses to help end the Covid-19 pandemic, but first it has to get around a recalcitrant manufacturer that controls much of the IP used to make the biotech’s vaccines.
Inovio, never shy about accepting bragging rights, likes to note that its DNA platform approach to this massive problem can be addressed with a jab that doesn’t have to stay in the same freezing cold supply chain required by Pfizer/BioNTech and Moderna. That’s a major differentiation — provided it can make it to the market in time to rival the frontrunners.
Inovio plans to start a late-stage study of their vaccine this month, provided regulators sign off. That puts them well behind a group of leaders, with Pfizer out front with a promise to prove whether their mRNA vaccine from BioNTech works sometime next month.
A big roadblock also still lies along the manufacturing lane.
A few months ago a frustrated Inovio CEO Joseph Kim complained that their manufacturer was incapable of making commercial quantities and refused to transfer the IP necessary for others to do so. The company launched a bitter legal battle with VGXI, and a spokesperson for Inovio tells me today that the litigation is ongoing. He added that their attempt to gain an injunction was denied by the judge.
Inovio’s stock is up 10% Tuesday morning. — John Carroll
A ‘plug and display’ VLP player takes a shot at early-stage Covid-19 vaccine
A recent Oxford spinout has begun a new Covid-19 vaccine trial, and is taking a bit of a different approach than most other players.
SpyBiotech has launched a Phase I/II trial with the Serum Institute of India as a new partner, testing whether or not its virus-like-particle-based vaccine can prove safe and effective. They announced the first dosing of its patients Tuesday. The Serum Institute of India is running clinical development of the study, which will take place in Australia, and licensed SpyBiotech’s VLP technology. Financial terms of the deal were not disclosed.
“Traditionally speaking, genetically fusing large, complex antigens with VLPs is extremely difficult,” CEO and co-founder Sumi Biswas told Endpoints News. “With our technology, we’ve created this platform … which lets you plug and display different pathogen antigens.”
Right now, the companies have recruited “a few hundred” volunteers, Biswas said, and are researching how safe the candidate can be at different doses. It will be controlled against an adjuvant.
The company’s platform uses what Biswas called “superglue” protein technology that is derived from the strep family, splitting proteins into two parts — termed SpyCatcher and SpyTag. Despite the division, they retain their attractiveness and allow SpyBiotech to fuse them to other platforms and decorate them with VLPs.
In terms of its Covid-19 vaccine candidate, SpyBiotech is basing its efforts off the hepatitis B vaccine, splitting the protein to display the coronavirus spike rather than the hep B antigen. Attempting to take advantage of the hep B vaccine’s safety profile, Biswas is confident in the company’s efforts given its success at presenting other antigens on the same VLP in other proof-of-concept studies.
“The displaying process is very simple, and we have used the same hepatitis B VLP with that SpyCatcher to display a lot of complex antigens,” Biswas said. “What we’ve done differently for this is that, of course, the antigen is different, it’s the same SpyTag and you essentially mix the two and you’ve got very good display of the antigen on the surface of the VLP.”
Moving forward, Biswas said she expects data from the trial to come in sometime in October or November, and hopes to start the Phase III study before the end of the year.
Spun out of Oxford in 2017, SpyBiotech was initially based on research into the “superglue” phenomenon that showed promising results for a malaria vaccine. Since then, the biotech has focused mainly on its lead program, a vaccine candidate for human cytomegalovirus projected to start Phase I late next year.
Biswas hopes the technology will be useful in other indications too, as SpyBiotech has seen early positive results in oncology and other infectious diseases. But right now, the manufacturing advantage that VLPs have over other Covid-19 vaccine candidates gives SpyBiotech a leg up on the competition, Biswas says.
“The fact that the VLP carrier can be manufactured in large quantities and kept, and that manufacturing can be worked out in advance, it makes it suitable for use in these situations,” Biswas said. “In the unfortunate situation of Covid, at large, this is definitely even an accelerated proof point for that platform, and we’re really looking forward to exploiting this in other diseases.” — Max Gelman
Moderna slows down Phase III enrollment to ensure diversity
One of the leaders in the Covid-19 vaccine race has reportedly decided to pump the brakes slightly on its Phase III trial enrollment.
Moderna CEO Stéphane Bancel told CNBC in an interview Friday that the company would be decelerating enrollment in order to ensure that minority communities most at risk from the virus are sufficiently represented in the trial. As of Friday, about 20% of participants are Hispanic or Latino and around 7% are Black, Moderna reported.
“We believe we could have one of the best vaccines,” Bancel told CNBC. “We want to ensure we have data for all the people who could benefit and be protected.”
Bancel added that Moderna’s goal is for the trial population to match US Census numbers, which estimated in 2019 that around 18.5% of Americans are Hispanic or Latino, while 13.4% are Black.
Investors reacted poorly to the comments, sending the stock down around 8% immediately afterward, but then recovering to finish Friday down about 3.5%. In trading over the extended Labor Day weekend, Moderna was down another 4%.
Since the start of the year, Moderna shares have risen over 225%. Bancel has reported selling more than $40 million of his own stock over that time period. The company announced last Friday evening that it had enrolled more than 6,000 new volunteers in its Phase III trial over the previous week, bringing the total number to 21,411 out of an expected 30,000.
Pfizer, the only competitor ahead of Moderna in Endpoints News‘ Covid-19 vaccine race tracker, is up to about 23,000 enrolled patients in its Phase III, CEO Albert Bourla said last Thursday. That trial has reported 25% Hispanic or Latino volunteers and 8% Black volunteers. The company has said publicly that data could be available by the end of October, a projection on which Warp Speed chief Moncef Slaoui threw cold water. — Max Gelman
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