The Coalition for Epidemic Preparedness Innovations (CEPI) said that it would fund a SARS-CoV-2 vaccine under development by Sichuan Clover Biopharmaceuticals Inc., of Chengdu, China.

CEPI, of Oslo, Norway, will invest up to $328 million in Clover’s COVID-19 S-Trimer vaccine program, Joshua Liang, CEO at Clover Biopharmaceuticals, told BioWorld.

CEPI´s commitment to fund phase II/III trials of Clover´s vaccine represents a a step forward in the funding of the project. CEPI already invested $69.5 million to get the vaccine through phase I trials and the results should be published soon. Both CEPI and Clover have high hopes for the vaccine.

“We are confident about the upcoming full results from our phase I study, because preliminary results from the trial suggest the vaccine is safe and well-tolerated, and high levels of neutralizing antibodies against SARS-CoV-2 have been observed,” said Lian.

According to Clover, data from preclinical studies has been promising and demonstrated that S-Trimer, in combination with adjuvants from Glaxosmithkline plc, of London, or Dynavax Technologies Corp., of Emeryville, Calif., induces strong immune responses in animal models, with levels of neutralizing antibodies at, or higher, than levels observed in human convalescent sera from patients that were previously infected with COVID-19 and recovered.

Phase I studies are ongoing and are randomized, observer-blind and placebo-controlled. The peer-reviewed publication in which results are to be published is yet to be determined, Clover told BioWorld.

CEPI’s latest funding is conditioned on the phase I trials showing that the vaccine is safe and effective.

“The clinical development and manufacturing progress of Clover’s S-Trimer vaccine candidate are very promising so far, so I am pleased to extend our partnership with Clover through to potential licensure of the vaccine,” said CEPI CEO Richard Hatchett.

“CEPI’s expanded investment will fund critical late-stage clinical trials to establish the efficacy of the vaccine, in parallel to scaling up the manufacturing process with the goal of making potentially hundreds of millions of doses of this vaccine available to those who need it through Covax, if it is proven to be safe and effective,” he explained.

Covax is a multilateral initiative to purchase and secure the distribution of COVID-19 vaccines among participant countries. Most countries have signed up, but the U.S. has not.

CEPI has a portfolio of nine SARS-CoV-2 vaccine candidates, of which eight have entered clinical trials.

The coalition is highly focused in China´s COVID-19 vaccine developments and established a representative office in Shanghai back in April.

“CEPI is seeking to cooperate broadly in China on COVID-19 vaccine development and build robust collaborations to prevent and control other potential infectious disease outbreaks in the future,” it said.

Seeking a diverse patient population

Clover’s phase II/ÏII vaccine trials are expected to be conducted worldwide. The company is eyeing several jurisdictions currently affected by the pandemic.

“Because the development of a COVID-19 vaccine is an urgent need globally, it is important to demonstrate that our vaccine is safe and effective in diverse populations,” said Liang. “It is important that we conduct the study in countries that have sufficient numbers of COVID-19 cases.... We have been evaluating study sites across Asia, Latin America, Europe and Africa.”

Clover’s phase II and phase III clinical trials will be as large as those of other biotech companies with advanced development programs in terms of participants.

“We will disclose the specific countries and sites when we are able to do so,” he said. “The phase II/III study will recruit tens of thousands of participants, expected to be similar in size to other publicly disclosed efficacy studies for COVID-19 vaccines.”

Clover´s vaccine is based on a proprietary Trimer-Tag technology developed by the Chinese company.

“Preserving the native-like structure of the SARS-CoV-2 S protein in a vaccine candidate is critical for inducing the desired protective immune response. Clover’s S-Trimer preserves the native trimeric structure of the S protein by utilizing our proprietary Trimer-Tag technology,” Liang explained.

“The S-Trimer vaccine candidate is a protein-based subunit vaccine. Protein-based vaccines have already been tried and proven to be safe and effective (influenza, hepatitis B, etc.), and their production can be rapidly scaled-up to large quantities using well-characterized manufacturing processes.”