No Let-Up in Covid-19 Vaccine Trials

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September 03, 2021 No let-up in Covid-19 vaccine trials

Madeleine Armstrong

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

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

Ph3 safety/immunogenicity study Nanoparticle (2 GBP510 SK Bioscience/Glaxo vs Astra's Vaxzevria started Aug doses) 2021

Ph3 immunogenicity study vs MVC- Protein subunit Medigen Vaccine Biologics/Dynavax Astra's Vaxzevria began in COV1901 vaccine (2 doses) Paraguay Aug 2021

Innovate ph3 began in Brazil Aug INO-4800 DNA (2 doses) Inovio/Advaccine 2021; FDA hold remains

Protein subunit SpikoGen Cinnagen/Vaxine Ph3 study began in Iran Aug 2021 vaccine (2 doses)

Recombinant Ph3 study began in Vietnam Jun Nanocovax Nanogen Biopharmaceutical protein (2 doses) 2021

Covid-19 Recombinant Ph3 study began in US, Japan & S. vaccine Sanofi/Glaxo protein (2 doses) America May 2021 project

Ph3 UK Cov-Compare Inactivated virus (2 VLA2001 Valneva/Dynavax immunogenicity study vs Astra's doses) Vaxzevria began Apr 2021

Plant-derived Ph3 study began in Canada, US, CoVLP coronavirus-like Medicago/Glaxo UK & S America Mar 2021 particle (2 doses)

COVID-19 Trimerised fusion Ph2/3 OUS Spectra study began Clover/Dynavax S-Trimer protein (2 doses) Mar 2021

GRAd- Gorilla adenoviral Ph2/3 Italian Covitar study began Reithera COV2 vector (1/2 doses) Mar 2021

Peptide-based UB-612 Vaxxinity Ph2/3 study not yet recruiting vaccine (2 doses)

Self-amplifying "Selected by a global entity" for ARCT-021 Arcturus mRNA (1 dose) inclusion in ph3 trial

Recombinant NVX- Novavax (Glaxo to support EUA application delayed until Q4 nanoparticle (2 CoV2373 manufacture of 60m doses for UK) 2021 doses)

Curevac (Glaxo to support CVnCoV mRNA (2 doses) manufacturing and co-develop next- Ph2/3 Herald study disappointed gen multi-valent candidates)

Source: Evaluate Pharma & clinicaltrials.gov.