Clover Biopharmaceuticals, a clinical-stage agency creating a Covid-19 vaccine with potential manufacturing and distribution benefits over different vaccine applied sciences, has raised $230 million because it prepares to advance its lead candidate into pivotal testing.
Chengdu, China-based Clover mentioned Tuesday that it expects to begin a world Section 2/3 scientific trial for its vaccine candidate, SCB-2019, within the first half of this yr. The corporate added that it has already began planning for the manufacturing of probably a whole lot of hundreds of thousands of vaccine doses.
The Clover Covid-19 vaccine is protein-based. SARS-CoV-2, the virus that causes Covid-19 an infection, is an enveloped RNA virus—the outer coating is dotted with spike proteins that bind to a receptor on the host cell. These spikes are trimeric, that means they’re shaped by three proteins.
Utilizing its Trimer-Tag know-how, Clover developed a trimeric spike protein that resembles the one discovered on the outer envelope of the novel coronavirus. The vaccine makes use of an adjuvant, an ingredient that enhances immune response, provided by Dynavax Applied sciences.
As a protein-based vaccine much like lots of the vaccines developed for influenza, shingles, and hepatitis B, Clover mentioned manufacturing can use manufacturing processes which are already properly established. The corporate added that this manufacturing might be quickly scaled as much as giant portions.
One other benefit of the Clover vaccines are the temperature necessities. The corporate mentioned its vaccines and adjuvant ought to be steady for lengthy durations at fridge temperatures of two to eight levels Celsius. At room temperature, Clover has mentioned its vaccines are steady for a minimum of two months. These temperature and storage necessities stand in distinction to messenger RNA vaccines, which should be distributed frozen and saved at temperatures properly under what medical-grade freezers can obtain. Final week, Pfizer and BioNTech asked the FDA to approve a change in the storage temperatures permitted as soon as vaccines attain a vaccination website.
The brand new financing follows publication in The Lancet earlier this month of peer-reviewed outcomes from an early-stage check of two Clover Covid-19 vaccine candidates. The 150-patient examine confirmed that the vaccines have been properly tolerated and protected. Each vaccines additionally induced neutralizing antibodies at ranges corresponding to or increased than these discovered within the blood of those that have recovered from Covid-19.
Clover mentioned that its analysis consists of vaccines that would handle a number of variants of the novel coronavirus. Along with supporting its Covid-19 vaccines, Clover mentioned the brand new capital will help plans to advance a number of applications into human testing later this yr. Different vaccines within the Clover pipeline embrace applications for rabies and influenza. The corporate additionally mentioned it plans to develop its manufacturing and capabilities.
GL Ventures and Temasek each led the Sequence C financing. Oceeanpine Capital, OrbiMed, and Delos Capital additionally invested. Clover mentioned it has raised greater than $400 million previously yr.
Clover additionally has financial support from the Coalition for Epidemic Preparedness Innovations (CEPI), which has dedicated to finance growth of the corporate’s Covid-19 vaccine candidate up by licensure with a complete funding of $328 million. A few of that money will fund the worldwide Section 2/3 examine. If the Clover vaccine is proven to be protected and efficient, it will be distributed by Covid-19 Vaccines International Entry, or COVAX, the World Well being Group’s initiative to make sure equitable vaccine entry all through the world.