GSK and CureVac forged their relationship during the Covid-19 pandemic, setting out to develop messenger RNA vaccines that could protect against the novel coronavirus and other infectious diseases. The collaboration has advanced three vaccine candidates into clinical testing, and now GSK is taking over their development, one of them for an infectious disease target that’s particularly hot right now.
Under terms of the restructured agreement announced Wednesday, GSK will now have full control of developing and manufacturing the avian influenza vaccine, currently in Phase 1 testing. It’s also getting a seasonal influenza vaccine and a Covid-19 vaccine, both in Phase 2 testing. GSK is paying €400 million (about $431.4 million) up front to obtain global rights to those programs. The British pharmaceutical giant could be responsible for up to €1.05 billion (about $1.01 billion) in additional payments if the vaccines achieve milestones. The new agreement replaces all financial terms of the previous R&D deal struck in 2020. Completion of this new agreement still requires antitrust and regulatory approvals.
CureVac’s vaccines stem from a technology platform designed to optimize the messenger RNA constructs that encode proteins that induce the desired immune response. However, the Germany-based company did not have luck with its first Covid-19 vaccine candidate, which failed to match up against newer coronavirus variants. The vaccine candidates headed to GSK employ a second-generation backbone that CureVac says improves the stability of the mRNA as well as its translation by a cell’s protein-making machinery. The intended result is increased and extended expression of the desired protein.
“These optimizations potentially allow for strong and early immune responses at low doses,” CureVac said in its annual report. “This supports the development of multivalent vaccines to target spreading Covid-19 variants or different influenza strains as well as combination vaccines against different viral diseases.”
In a note sent to investors, Leerink Partners analyst Mani Foroohar wrote that the restructured CureVac/GSK deal is logical, as vaccine development is a complex global business, and consolidating the programs within the pharma giant should streamline their development.
GSK is taking over development of the avian influenza program at an opportune time. A multi-state outbreak of bird flu in dairy cows is ongoing in the U.S. On Wednesday, the Centers for Disease Control and Prevention reported a fourth case of a human with a confirmed case of H5 bird flu. This latest case, involving a dairy worker, occurred in Colorado. The first reported case was in Texas followed by two in Michigan. The CDC said Wednesday that there is no known human-to-human spread and the current public health risk remains low. GSK faces potential competition in this indication. Earlier this week, the Biomedical Advanced Research and Development Authority awarded Moderna $176 million for Phase 3 testing of its mRNA vaccine candidate for bird flu.
Under CureVac’s restructured deal with GSK, the German company retains exclusive rights to additional preclinically validated infectious disease targets that remain undisclosed. CureVac is free to develop mRNA vaccines for these targets on its own or in partnership with others. The company added that its ongoing mRNA patent litigation against Pfizer and BioNTech is unaffected by the new agreement.
Major changes are coming for CureVac itself. Alongside the revised GSK agreement, CureVac announced a restructuring that will cut about 30% of its headcount “to create a leaner, more agile organization” focused on technology innovation and R&D. The layoffs will save €25 million (about $27 million) in personnel costs, the company said. Severance and related costs will result in a one-time restructuring charge of €15 million (about $16.2 million), which CureVac expects to record in the fourth quarter of this year.
CureVac said the cost savings combined with the money from GSK will extend its cash runway into 2028. In the near term, focus turns to other programs in its pipeline. A cancer vaccine candidate code-named CVGBM is in Phase 1 testing for glioblastoma. The company expects to report data in the second half of this year. By the end of next year, CureVac expects to have two more cancer vaccine candidates for solid tumors and blood cancers. The company aims to start Phase 1 tests for these vaccines by the end of 2026.
“The new GSK agreement not only provides substantial financing but also allows us to streamline our operations and focus on technology innovation, research, and development,” CureVac CEO Alexander Zehnder said in a prepared statement. “It enables us to prioritize our oncology programs and further leverage our technology in other areas where mRNA is uniquely suited to develop novel treatment approaches.”
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