3:53 PM
 | 
Feb 22, 2018
 |  BC Innovations  |  Product R&D

Shooting for the universe

CureVac brings a new modality -- RNA -- to the race for a universal flu vaccine

CureVac AG is bringing a new modality to the race for a universal flu vaccine with an mRNA program backed by a grant from the Bill & Melinda Gates Foundation. While the company believes its approach can yield a product with a cost structure and supply chain relevant for the developing world, it faces a steady pipeline of clinical compounds based on conventional modalities.

Last week, CureVac announced it received backing from Gates for a universal flu vaccine and a vaccine against malaria. The funding comes three years after Gates made a $52 million equity investment in CureVac to support development of the company’s RNA platform and construction of an industrial-scale GMP facility.

Daniel Menichella, CBO of CureVac and CEO of its U.S. CureVac Inc. subsidiary, told BioCentury the company expects to select a clinical candidate by the end of 2020, and said Gates’ help goes beyond funding and includes coordination with academics that could help selection of an optimal vaccine design.

He would not disclose the amount of either of the new grants, although he told BioCentury the flu vaccine award is “sizable.”

The need for a universal flu vaccine has been heightened by this year’s harsh flu season. According to the CDC, the current vaccine provides only 36% protection.

A Feb. 15 statement from FDA Commissioner Scott Gottlieb highlighted the challenges of depending on seasonal vaccines, which include prediction of which strain will be dominant, the ability of the virus to mutate as it circulates, and efficacy differences among different manufacturing approaches. For example, for unknown reasons, cell-based vaccines against the H3N2 strain provided better protection than egg-based vaccines this year.

“RNA is relatively easy to scale up quickly and there is a degree of precision about it.”

Anthony Fauci, NIAID

Momentum for moving away from seasonal vaccines is starting to mount. “Ultimately, developing a universal flu vaccine that provides protection against many different strains of flu from year-to-year would be ideal,” wrote Gottlieb, although he noted that such a solution is likely “several years away.”

On the same day, Sen. Ed Markey (D-Mass.) introduced a bill to make a $1 billion commitment to NIH over five years for research towards a universal influenza vaccine, with the goal of creating lifetime protection from the disease.

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has a universal flu vaccine in Phase I testing, and at least 10 companies and institutions outside of CureVac have universal flu vaccines in preclinical to Phase II testing (see “An Expanding Universe”).

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