Biopharmaceutical company CureVac has announced a co-development and licensing agreement with The University of Texas MD Anderson Cancer Center to develop novel mRNA-based cancer vaccines.
mRNA-based vaccines against the coronavirus have become firmly established in medicine since the pandemic. Nevertheless, the technology is still at the beginning of its potential. Experts see a wide range of potential applications for this relatively new technology, particularly in infectious diseases and cancer.
German biotech CureVac has released preliminary data from its ongoing cooperation with UK drugmaker GSK on a new class of “transformative medicines” based on messenger mRNA.
CureVac and GSK have announced they are launching a Phase 1 clinical trial with their modified mRNA-based Covid 19 vaccine CV051, which would be recommended as a booster to protect against the omicron variant.
Pfizer and BioNTech are fighting back against CureVac’s lawsuit that asserts the makers of the Comirnaty-branded mRNA vaccine for Covid-19 infringed its patent.
Germany’s BioNTech is pushing back against allegations by compatriot CureVac that the company infringed its intellectual property in formulating its mRNA-based Covid-19 vaccine, Comirnaty, that it developed and marketed together with US drugs giant Pfizer.
In a vote of 21 in favor with one abstention, the US Food and Drug Administration’s advisory panel has recommended that the FDA approve Novavax’s Covid-19 vaccine Nuaxovid for emergency use. If the health agency agrees, it would be the fourth such shot available in the US, joining the mRNA products of Pfizer/BioNTech and Moderna and the viral vector shot of Johnson & Johnson’s pharma subsidiary Janssen.
Germany’s economics ministry has budgeted up to €2.9 billion ($3.14 billion) to ensure sufficient supply of mostly mRNA-based Covid-19 vaccines to be able to deal with the ongoing pandemic and any future outbreaks up to 2029.
CureVac is withdrawing its first-generation Covid-19 vaccine candidate, CVnCoV, from the current approval process with the European Medicines Agency. In a statement, the German biotech said the EMA had made it clear that there was no chance of the shot being approved before the second quarter of 2022. By this time, it expects candidates from the second-generation vaccine program it is pursuing with UK drugmaker GlaxoSmitKline (GSK) to have progressed to late-stage clinical development.
German biotech CureVac has canceled manufacturing contracts with two prospective partners for its Covid-19 vaccine CVnCoV while retaining others. The company said on Sept. 14 it would end the arrangements with Germany’s Wacker Chemie and Switzerland’s Celonic Group, but leave the deals with Rentschler Biopharma and Novartis intact.
CV2Cov, the next-generation Covid-19 vaccine under development by German biotech CureVac and UK drugs giant GSK, outperformed CureVac’s first-generation Covid shot in preclinical trials with non-human primates, the companies have reported.
Definitive results from CureVac’s 40,000-subject international Phase 2b/3 trial with its mRNA-based Covid-19 vaccine candidate, CVnCoV, have confirmed an earlier finding that it is only about 48% effective in preventing infection of any severity across the “unprecedented” 15 strains of the virus encountered during the tests with participants in Latin America and Europe.
In a stunning setback to the company’s ambitions of launching its mRNA-based Covid-19 vaccine in the third quarter, results from CureVac’s Phase 2b/3 trial showed the candidate branded CVnCoV to have an efficacy rate of only 47% against any severity of the disease.
German biotech CureVac’s protests against US export restrictions for ingredients it needs to make its Covid-19 vaccine CVnCoV seem to have borne fruit. News agency Reuters said the European Commission has persuaded Washington to temporarily waive some of the rules of the US Defense Production Act (DPA), which gives federal agencies the power to prioritize procurement orders related to national defense and to non-military crises.
US biotech Novavax has again delayed filing for approval of its protein-based Covid-19 vaccine at least until July this year, citing issues related to an assay needed to show that its manufacturing process is consistent across different sites. CEO Stanley Erck said the company now aims to submit data to regulators in the UK, US and EU in the third quarter of 2021 rather than in the second quarter as previously planned. The vaccine is currently in a rolling review with the European Medicines Agency (EMA).
The European Commission has confirmed rumors that it has initiated legal action against AstraZeneca for failing to meet contractual obligations for deliveries of Its Covid-19 vaccine. Health commissioner Stella Kyriakides said the action is being taken jointly with all 27 member states.
As one glitch after another at Covid vaccine suppliers upends deliveries, the German federal government is drawing up plans to build up production within its borders, federal health minister Jens Spahn said at a weekly news conference, thereby confirming remarks made by future vaccine commissioner Christoph Krupp in a pre-published newspaper interview.
A few weeks ago, Novartis said it was exploring ways to participate in the European Covid-19 vaccine manufacturing effort. In the meantime, it has been busy. On Mar. 4 the Swiss drugmaker signed an initial manufacturing agreement with CureVac to boost the German biotech’s overall vaccine capacity by 50 million doses in 2021 and 200 million doses in 2022.
German biotech CureVac has begun a rolling submission with the European Medicines Agency (EMA) for its mRNA-based Covid-19 vaccine candidate currently in Phase 2b/3 clinical trials with 35,000 people in Europe and Latin America.
Vaccines and treatments for Covid-19 continue to dominate global pharma market headlines. As the pandemic drags on, new issues continuously arise, some of them discouraging, such as the emergence of more and more virus mutants or production glitches that threaten to curb supply.
Members of the European Parliament (EP) at a Jan. 19 plenary debate on the EU’s strategy for Covid-19 vaccine procurement and deployment for the most part expressed support for the common approach to purchasing a common supply for the 27 member states. At the same time, they urged more solidarity in access to inoculation and transparency in contracts with pharmaceutical companies.
CureVac has agreed a collaboration with Bayer to speed up production and distribution of its Covid-19 vaccine candidate CVnCOV, which began clinical trials in December with a goal of 36,500 participants in Europe and Asia.
French family-owned CDMO Fareva has signed on to handle fill and finish manufacturing for German biotech CureVac’s mRNA-based Covid-19 vaccine candidate, CVnCoV, at the CDMO’s’ sites at Val-de-Reuil and Pau, both in France.
German biotech CureVac has started a Phase 2b/3 clinical trial of its Covid-19 vaccine candidate CVnCoV. Planned to enroll 36,500 participants in Europe and Latin America, the study is aimed at generating data to support approval of the company’s mRNA vaccine next year. A target date has not been disclosed.
Germany’s Wacker Chemie has signed a contract to manufacture the active substance for compatriot CureVac’s Covid-19 vaccine candidate CVnCoV. Under the terms, the biotech arm of the Munich-based chemical group will ramp up GMP production of the mRNA drug substance for the candidate at its Amsterdam site in the first half of 2021.
German biotech CureVac has signed a supply agreement with the European Commission to provide an initial 225 million doses of its mRNA-based Covid-19 vaccine, with an option for another 180 million doses.
After months of uncertainty and anxious glances across the water as potential Covid-19 vaccine manufacturers made deal after deal with other political blocs, the EU over the past four weeks has made rapid strides toward securing supplies for its 27 member states.
German biotech CureVac has more than tripled its market value to over $5 billion in an initial public offering launched on the US Nasdaq Global Market. Altogether 13.33 million shares changed hands at $16 each, the high end of the offered range. Separately, CureVac is raising €100 million in a private placement.
The European Investment Bank (EIB) has granted German biotech CureVac a €75 million loan to support its ongoing development of vaccines against infectious diseases, including its Covid-19 candidate CVnCoV.
