No let-up in Covid-19 vaccine trials

A project from SK Bioscience and Glaxo started phase 3 this week, but it is far from the only late-stage candidate.

Spotlight

If you thought the Covid-19 vaccine race was over, think again. An analysis by Evaluate Vantage shows that numerous trials have started this year, some groups clearly believing that there is still room for more players, particularly outside the big western markets.

The latest company to take the plunge was South Korea’s SK Bioscience, whose GBP510, which uses Glaxosmithkline’s adjuvant, went into phase 3 this week. SK is taking an unusual approach, testing the project’s safety and immunogenicity versus Astrazeneca’s Vaxzevria, but a few others are also going down this route.

The charts below capture only industry-sponsored studies of vaccines that are currently unapproved, or are only approved for Covid-19.

Whether immunogenicity data will be enough for regulators is still an open question. Both the FDA and the EMA currently ask for at least one phase 3 efficacy trial; however, nations that are struggling to get access to jabs might be less picky.

SK seems to be aiming at the developing market, saying it hopes to deliver its vaccine, if approved, via Covax, the scheme working on worldwide vaccine access.

Vantage has found two other late-stage studies looking at immunogenicity: Valneva’s UK trial of VLA2001, and Medigen Vaccine Biologics’ study in Paraguay of MVC-COV1901; the latter is already approved in Medigen’s home market of Taiwan, despite controversy over a lack of supporting data.

Outside US

The table below shows that other several countries could also soon have domestically developed shots, including Iran and Vietnam.  

Inovio appears to have given up on the US for now. The Innovate trial of the group’s DNA-based candidate INO-4800 has been on FDA hold for some time now; Inovio said during its second-quarter call that it did not plan to enrol any US patients into the phase 3 portion of the study, and would instead focus on Latin America, Asia and Africa.

The group plans to seek BLA approval in the US if Innovate succeeds – which seems a long shot given that the phase 2 portion of the study found unimpressive neutralising antibody levels, according to a preprint.

Meanwhile, the mRNA player Arcturus has been cagey about its plans, saying only that its candidate ARCT-021 had been “selected by a global entity for inclusion in a multinational phase 3 vaccine trial”.

While the list below is dominated by small names, two big pharma groups stand out: Sanofi and Glaxo, both of which famously missed the first wave of Covid-19 vaccines, finally took their project into phase 3 in May.

The companies said they would also evaluate the vaccine as a booster, “regardless of the initial vaccine platform received”. This seems like a sensible move, as most of the market for second-wave vaccines, at least in the US and Europe, looks likely to be for boosters.

Still, the incumbents are already getting in on the act here, too, with Moderna and Pfizer/Biontech recently submitting booster applications to the FDA for Spikevax and Comirnaty respectively.

The agency plans to hold an advisory committee meeting to discuss Pfizer and Biontech’s request on September 17, three days before the US government’s plan to start offering booster shots begins.

Update on the second wave of late-stage Covid-19 vaccines
Project Description Developer(s) Update
GBP510 Nanoparticle (2 doses)  SK Bioscience/Glaxo Ph3 safety/immunogenicity study vs Astra's Vaxzevria started Aug 2021
MVC-COV1901 Protein subunit vaccine (2 doses) Medigen Vaccine Biologics/Dynavax Ph3 immunogenicity study vs Astra's Vaxzevria began in Paraguay Aug 2021
INO-4800  DNA (2 doses) Inovio/Advaccine Innovate ph3 began in Brazil Aug 2021; FDA hold remains
SpikoGen Protein subunit vaccine (2 doses) Cinnagen/Vaxine Ph3 study began in Iran Aug 2021
Nanocovax Recombinant protein (2 doses)  Nanogen Biopharmaceutical Ph3 study began in Vietnam Jun 2021
Covid-19 vaccine project Recombinant protein (2 doses)  Sanofi/Glaxo  Ph3 study began in US, Japan & S. America May 2021
VLA2001 Inactivated virus (2 doses) Valneva/Dynavax Ph3 UK Cov-Compare immunogenicity study vs Astra's Vaxzevria began Apr 2021
CoVLP Plant-derived coronavirus-like particle (2 doses) Medicago/Glaxo  Ph3 study began in Canada, US, UK & S America Mar 2021
COVID-19 S-Trimer Trimerised fusion protein (2 doses)  Clover/Dynavax Ph2/3 OUS Spectra study began Mar 2021 
GRAd-COV2 Gorilla adenoviral vector (1/2 doses) Reithera Ph2/3 Italian Covitar study began Mar 2021
UB-612 Peptide-based vaccine (2 doses) Vaxxinity Ph2/3 study not yet recruiting
ARCT-021  Self-amplifying mRNA (1 dose) Arcturus "Selected by a global entity" for inclusion in ph3 trial
NVX-CoV2373 Recombinant nanoparticle (2 doses) Novavax (Glaxo to support manufacture of 60m doses for UK)  EUA application delayed until Q4 2021
CVnCoV mRNA (2 doses) Curevac (Glaxo to support manufacturing and co-develop next-gen multi-valent candidates) Ph2/3 Herald study disappointed
Source: Evaluate Pharma & clinicaltrials.gov.

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