CureVac is playing catch-up to its messenger RNA (mRNA) peers in the race to develop a COVID-19 vaccine, but the company contends its technology could offer dosing advantages, and it now has $213 million in IPO cash to fund the human tests that could support that claim.
CureVac has sold more than 13.3 million shares for $16 apiece, the high end of its projected $14 to $16 per share price range. According to its IPO prospectus, the Tübingen, Germany-based company also raised additional cash through a separate agreement to sell €100 million (about $118 million) worth of shares, at the IPO price, to Dietmar Hopp. The billionaire SAP co-founder is the managing director of Dievini Hopp Biotech Holding, Curevac’s largest shareholder before the IPO.
CureVac is developing vaccines that use a patient’s cells to produce proteins that treat a disease or prompt an immune response to prevent one. The company’s technology is based on mRNA, molecules that carry the genetic instructions for making proteins. The mRNA is delivered to cells via a lipid nanoparticle.
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The goal is to get the cellular machinery to use these genetic instructions to churn out therapeutic proteins. It’s the same experimental approach that’s being pursued by Cambridge, MA-based Moderna and BioNTech of Mainz, Germany. But CureVac has been at this mRNA work for longer.
CureVac launched in 2000 based on the research of co-founders Ingmar Hoerr and Florian von der Mülbe. The company develops its therapeutic candidates with a proprietary technology called RNAoptimizer, which is used to design proteins, define the sequence of mRNA that codes for these proteins, and select the best formulations to deliver its mRNA medicines.
Much of the recent attention paid to CureVac has focused on its work on a COVID-19 vaccine. But the company’s technology faced its first human tests in cancer and rabies. The cancer vaccine candidate, CV8102, is in Phase I testing against four types of solid tumors. Rabies vaccine candidate CV7202 is also in Phase I.
“Everything we do in rabies, we can, at least in part, transfer to COVID,” Pierre Kemula, CureVac’s chief financial officer, told our sister publication Xconomy.
In early results so far, the rabies vaccine offered protection after two one microgram shots. A lower dose means each shot can be produced using less material, which lowers the production costs, Kemula said. Despite such a low dose, the vaccine was able to elicit an immune response. Protection from the vaccine lasted for six months, and as the study continues it’s possible it will reveal an even longer prophylactic effect, Kemula said. A lower dose could also reduce a vaccine’s risk of side effects. But Kemula said that that still needs to be demonstrated in clinical testing.
CureVac’s COVID-19 vaccine candidate started a Phase 1 study in June that is evaluating doses ranging from 2 micrograms to 8 micrograms. By comparison, the dose of Moderna’s mRNA vaccine candidate, mRNA-1273, is 100 micrograms. BioNTech COVID-19 vaccine candidate BNT162b2, in development under a partnership with Pfizer , is in Phase II/III testing at a dose of 30 micrograms. All three programs are evaluating mRNA candidates designed get cells to make the full spike protein of the novel coronavirus.
CureVac expects to report results from its Phase I study in the fourth quarter of this year, then proceed to a Phase IIb/III clinical trial. The Phase III portion of the study will enroll about 20,000 adults from Europe, Latin America, Africa, and Asia. CureVac won’t recruit any patients from the US or Canada.
“At this stage we see that there are many clinical trials in COVID in the US,” Kemula said. “Sites are busy. The US government has already purchased quite a lot of vaccines [via Operation Warp Speed]. When you do the balance, there seem to be other places that are more adequate.”
CureVac has not yet published any data about its COVID-19 research. Kemula said that all of the publicly available information about its vaccine is in the company’s IPO paperwork. The IPO comes weeks after the company struck up a partnership with GlaxoSmithKline that aims to develop mRNA vaccines and antibody drugs for infectious diseases—except for rabies and COVID-19.
Kemula said that the GSK alliance gives his company the opportunity to go after bigger disease targets than it would be able to do alone. But COVID was excluded from the deal because GSK already has partnerships with Sanofi and other companies. CureVac did not want to be the GSK’s second or third priority in COVID, so the company decided to continue developing its vaccine solo for now, he said.
Since its founding, CureVac has raised €1.03 billion (about $1.22 billion) combined in equity and debt financings, according to the IPO filing. Until the IPO, the most recent cash infusion was a €560 million ($640 million) equity financing last month. The IPO cash, combined with the proceeds from the private stock sale and the company’s cash on hand, will be deployed across CureVac’s mRNA pipeline. About $150 million is planned to take its COVID-19 vaccine candidate through the completion of Phase 3 testing, according to the prospectus. Another $50 million is earmarked for manufacturing.
CureVac also plans to spend $25 million on its cancer vaccine and $10 million for its rabies vaccine. Those sums are expected to support the completion of mid-stage testing for both programs. Another $65 million is set aside for further investment in its mRNA technology, and to advance programs in earlier stages of development.