Covid-19 roundup: CureVac expands cache to $1.3B as coronavirus race heats up; Russian scientists publish early data to back up vaccine
The money just keeps on pouring in for CureVac.
Following a series of high-profile deals and an IPO raise totaling nearly $1 billion in recent weeks, the biotech announced another cash injection Friday, netting about $300 million (€252 million) from the German government to support its mRNA Covid-19 vaccine candidate. In addition to developing the vaccine, the money will be used to rapidly ramp up production.
The funding was granted after CureVac applied to a German government program to accelerate vaccine R&D back in July. Payments are contingent on reaching predefined milestones, with an expected funding of up to €103 million in 2020 and up to €149 million in 2021.
“Given the significant costs related to the development of a safe and effective vaccine, as well as to the extension of the manufacturing capacity, we believe that this grant can substantially support our efforts to produce and develop a safe and effective vaccine in high volume as quickly as possible,” CEO Franz-Werner Haas said in a statement.
CureVac stock $CVAC jumped slightly at the news, up around 4% in early Friday trading.
Friday’s announcement is the latest in a long string of big fundraising from the company, which for years was privately fronted by German billionaire Dietmar Hopp. Its most recent round, prior to going public a few weeks ago, brought in a whopping $640 million from main investors GSK and Germany in late July.
That was soon followed by the IPO, which raised $213 million, and an additional share purchase by Hopp for $118 million. After raising nearly $1 billion in the span of three weeks, and now with this new German grant in hand, CureVac is now valued at around $10 billion.
The news also came shortly after Hopp commented earlier Friday about his desire for CureVac to produce 100 million doses of its vaccine candidate by the end of the year, according to Reuters. Though the vaccine is expected to gain regulatory approval by next spring or summer, a limited authorization could come through for those with high-risk jobs.
CureVac’s mRNA vaccine rivals, Moderna and BioNTech, are also likely to beat the biotech to market, Hopp said, and it ranks 12th in Endpoints News’ Covid-19 vaccine race tracker.
“We can’t win this race,” Hopp said. “But we want to win the race to produce the best vaccine and here we have good chances.”
CureVac is just one of several companies researching how messenger RNA can be applied to potential Covid-19 vaccines. Though the technology has never been approved for vaccine use before, investors are funneling billions of dollars on the hopes of a breakthrough, opening the door to a whole new pipeline of drugs across the industry. — Max Gelman
Russia’s registered vaccine shows promising results in early trial, scientists report
Almost a month after Russia registered the world’s first Covid-19 vaccine, the whole world is finally getting a glimpse of some early human data.
The study, published in the Lancet, gives all the positive signs: Among 76 volunteers in two Phase I/II studies, the vaccine — dubbed Sputnik V — appeared safe, and neutralizing antibodies were detected in all participants. T cell responses were also there, with proliferation of both CD4+ and CD8+ types.
“Similar to these studies before it, Logunov and colleagues’ studies are encouraging but small,” concluded an accompanying editorial. “The immunogenicity bodes well, although nothing can be inferred on immunogenicity in older age groups, and clinical efficacy for any COVID-19 vaccine has not yet been shown.”
None of the studies, so far, have been deemed sufficient to support vaccine licensure, and Russia’s surprise announcement had stirred up disbelief and mockery in the US, where officials have reportedly turned down Russia’s offer to collaborate on the vaccine, saying “There’s no way in hell the US tries this on monkeys, let alone people.”
On the other hand, China has opened up access to experimental jabs for certain populations such as military personnel, medical workers and more recently aviation staffers.
Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, the vaccine comprises two vector components, recombinant adenovirus type 26 (rAd26) and recombinant adenovirus type 5 (rAd5), carrying the gene for the SARS-CoV-2 full-length spike glycoprotein. After an initial safety test, investigators administered rAd26 and rAd5 sequentially in a prime-boost regimen.
In total, 40 participants were given this regimen, designed to alleviate concerns about pre-existing immunity to adenoviruses. Some received the frozen formulation, while others got the lyophilized version — which Lancet reviewers Naor Bar-Zeev and Tom Inglesby considered a strength of the study.
Compared to the frozen formulation, the lyophilized (freeze-dried) could mean stability within existing cold chains without causing the hurdle that’s facing players like Pfizer and BioNTech.
Another strength, they noted, is a high standard for measuring neutralization.
“With this (publication) we answer all of the questions of the West that were diligently asked over the past three weeks, frankly with the clear goal of tarnishing the Russian vaccine,” Kirill Dmitriev, the head of the Russian Direct Investment Fund (RDIF), told Reuters. The sovereign wealth fund has backed the vaccine candidate. “All of the boxes are checked,” he told Reuters. “Now… we will start asking questions of some of the Western vaccines.”
But Bar-Zeev and Inglesby also noted limitations with the Russian data. In the frozen vaccine portion of the trial, for instance, the group included young military personnel who could be healthier than the general public. Older adults are also absent from the group, which was also overwhelmingly white.
“Clearly, much more remains to be learned from the phase 3 randomised trial planned to include 40 000 civilian volunteers and, hopefully, broadly inclusive of groups at risk,” they wrote. — Amber Tong
Novo looking at diabetes drugs to treat severe Covid-19 cases
Novo Nordisk is investigating whether an existing drug class used to treat diabetes can provide new treatment options for severe cases of Covid-19.
Mads Krogsgaard Thomsen, the Danish drugmaker’s CSO, told Bloomberg News in an interview Friday that GLP-1 drugs could prove effective in treating Covid-19. Studies have shown that individuals afflicted with diabetes, as well as those with obesity, often show more serious symptoms from coronavirus infections.
“The early indication is that the GLP-1 class is actually beneficial in Covid-19,” he told Bloomberg. “That’s not unexpected because this is the class of agents that target the risk factors for bad Covid-19 outcomes.”
Thomsen pointed to new research suggesting that young people who contract Covid-19 are at risk of developing type 1 diabetes, an autoimmune disorder, as another reason for the new focus. Rather than a patient’s own immune system attacking beta cells in the pancreas, coronavirus destroys the body’s insulin producers.
A small study out of France earlier this week also illustrated the links between Covid-19, weight and diabetes, estimating that only one out of 10 patients who end up in intensive care are in a range of healthy weight.
Novo is the biggest diabetes drug producer in the world and has a slate of GLP-1 drugs on the market, such as Ozempic for type 2 diabetes and Saxenda for obesity. Ozempic raked in $1.64 billion in global 2019 sales, up from $264 million in 2018, and is expected to surpass $3 billion in 2020. Saxenda is also on pace for a $1 billion haul this year.
On the whole, the GLP-1 market totaled $11.3 billion last year. This included sales of blockbusters Trulicity, from Eli Lilly, and Bydureon, from AstraZeneca. — Max Gelman
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Social image: Franz-Werner Haas, CureVac
