Covid-19 roundup: CureVac backs out of manufacturing contracts as demand dwindles; Despite PhII/III flop, biotech keeps looking for silver lining
CureVac terminated contracts with two companies who had signed on to help the German drug maker manufacture its mRNA Covid-19 vaccine in Europe, as potential demand for its shot has dwindled.
Contracts with Wacker for the manufacturing of mRNA drug substance and Celonic for the manufacturing and formulation of the mRNA drug substance for the drug, dubbed CVnCoV, are no more. The company has held on to existing agreements with Rentschler Biopharma and Novartis for mRNA production, and said that those will not be affected.
The company attributed the decision to what it called “the reduced short-term peak demand for vaccines following the first wave of the pandemic vaccination efforts,” in combination with change in demand for its candidate.
The announcement comes a few months after the company failed a pivotal Covid-19 vaccine trial, when it was only 48% effective. The company chalked up the failure to variants, specifically the Lambda variant out of Peru, although that argument found little traction with experts.
The company has said it’s still committed to seeking regulatory approval with the EMA. Meanwhile, vaccination rates in Europe have risen to the highest in the world, surpassing the United States.
“The development from a very high, short-term pandemic demand to broader availability of vaccines has led us to re-evaluate our immediate manufacturing capacity requirements in order to align the capacity with actual commercial and clinical capacity needs for CVnCoV,” COO Malte Greune said in a press release. “We would like to thank both our manufacturing partners for their dedication and effort in achieving our common goal to combat the pandemic with this key technology.”
Financial terms surrounding the cancellation weren’t disclosed, per an agreement between both sides, the press release said. — Josh Sullivan
Another therapy fails to help severe patients — but biotech isn’t giving up
More than a year after the pandemic sent a horde of biotechs into a frenzied campaign to repurpose their drugs for Covid-19, the search is still proving elusive.
RedHill Biopharma’s opaganib is the latest candidate to disappoint, as it failed to meet the primary endpoint — the proportion of patients breathing room air without oxygen support by Day 14 — of a Phase II/III study for severe patients.
All 475 patients in the trial were hospitalized with severe Covid-19 pneumonia. They were given either opaganib or placebo on top of standard of care.
But RedHill isn’t throwing in the towel just yet. Pointing to the drug’s “strong antiviral mechanism and effect against variants” observed in a previous Phase II study, execs say researchers are still analyzing the data to see if they can find silver linings such as subgroup benefits. Besides, they say, the drug appears to have good tolerability with balanced adverse events in the drug and placebo arms.
“While we are disappointed with the data not reaching statistical significance, we do see a trend that needs to be investigated that opaganib may provide benefit to patients earlier in the course of the disease,” said CEO Dror Ben Asher.
Touted as an oral, first-in-class sphingosine kinase-2 (SK2) selective inhibitor, opaganib is designed to target a key enzyme in human cells that viruses are believed to co-opt as they replicate.
The biotech is also testing RHB-107 (upamostat) in non-hospitalized symptomatic Covid-19 patients. — Amber Tong
12- to 15-year-olds now eligible for vaccine in UK
With a reduced disruption of education in mind, the British government has given the OK to adolescents ages 12 to 15 to receive the Covid-19 vaccine, the country’s health minister said in a statement.
Vaccinations will begin in England next week, and Scotland, Wales and Northern Ireland will set their own health policy.
“I have accepted the recommendation from the Chief Medical Officers to expand vaccination to those aged 12 to 15 — protecting young people from catching COVID-19, reducing transmission in schools and keeping pupils in the classroom,” health minister Sajid Javid said.
The Pfizer-BioNTech vaccine will be offered, as immunocompromised children in that age group were already eligible for that shot. — Josh Sullivan
On heels of manufacturing agreement for mRNA vaccine, Providence CEO trashes government
On Tuesday, Providence Therapeutics announced that it was teaming with the highly scrutinized Emergent Biosolutions to get help developing its mRNA Covid-19 vaccine candidate. Just a day earlier, its CEO went on television and trashed the Canadian government for its role in domestic vaccine production.
CEO Brad Sorenson went on the Bloomberg News Network and called out Prime Minister Justin Trudeau and his administration, saying he’s done the “absolute minimum” to support Canadian biotech, including Providence, while throwing money at foreign companies to get them to come to Canada.
“We could’ve been supplying vaccines to the world and we could’ve been adding to the solution as opposed to driving up prices and adding to the problem,” he said in an interview.
Last week, Resilience announced that it will start making mRNA for Moderna’s Covid-19 vaccine at its new site in Canada. The company landed a $163 million contract from the government of Canada, while Moderna also struck a deal for its own plant in August, and AbCellera got $125.6 million to help build its 130,000-square-foot facility to develop antibodies and offer preparedness for future pandemics.
“In March of 2020, we were one month behind Moderna,” he said. “Moderna received a billion dollars in support from Warp Speed and you can see where they’re at now. Providence received no support from the Canadian government until almost a year later and even then, we received $10 million, which is nominal at best.” — Josh Sullivan
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