Vaccines from CureVac, Imperial enter the clinic as PDS finds a partner for its product

The WHO halted, for a second time, the hydroxychloroquine arm of its SOLIDARITY trial

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CureVac and Imperial announced trial starts for their COVID-19 vaccines this week. A third vaccine, from PDS Biotech and Farmacore, is expected to start a Brazilian Phase I trial.

The trial starts come as the European Commission launches an EU-wide procurement strategy to ensure equitable access to COVID-19 vaccines on the continent. The commitment aims to meet European demand before making vaccines available globally (see “EU Lays Out Strategy”).

Two days after the German government took a 23% stake in CureVac AG, Germany and Belgium cleared the biotech to start a Phase I trial of its COVID-19 vaccine.

The trial will enroll 168 healthy volunteers ages 18-60 to receive 2-8 µg doses of the mRNA vaccine (see “Germany Takes Stake in CureVac”).

While the deal comes amid concerns about the potential for vaccine nationalism, Germany won’t have exclusive rights or first access to CureVac’s vaccine, Christof Hettich told BioCentury. He is a co-founder and managing director of CureVac’s majority shareholder dievini Hopp BioTech holding.

Slated to begin testing this week is an RNA vaccine from Imperial College London, which could be available as early as spring 2021.

The Phase I/II study will enroll 300 healthy volunteers to receive two doses of the vaccine; the second shot will be administered four weeks after the initial dose.

The first part of the trial will enroll 15 participants ages 18-45 to assess safety and determine the optimal dose.

Imperial has partnered with Morningside Ventures to form VacEquity Global Health to develop and distribute the vaccine in the U.K. and low- and middle-income countries.

The partners expect to publish results from the trial once safety data are available.

A third vaccine is poised to enter the clinic.

PDS Biotechnology Corp. (NASDAQ:PDSB) partnered with Farmacore Biotechnology Ltd. on Wednesday to develop a COVID-19 vaccine that combines T cell-activating nanotechnology from the former and a recombinant SARS-CoV-2 protein from the latter.

The partners plan to begin a Phase I trial in Brazil, with financial support from the country’s government. They also aim to start U.S. trials.

Separately, Sanofi (Euronext:SAN; NASDAQ:SNY) said Tuesday it will invest €610 million ($687.3 million) to create a new production site and research center for vaccines in France.

Of the total, €490 million will go towards building the vaccine production facility in Neuville sur Saône; €120 million will be allotted for a R&D center at the Sanofi Pasteur site in Marcy-l’Etoile.

Sanofi is partnered with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to develop a recombinant protein vaccine; and with Translate Bio Inc. (NASDAQ:TBIO) to develop an RNA vaccine.

WHO let the HCQ out

The World Health Organization has once against halted the hydroxychloroquine arm of the SOLIDARITY trial. The organization said Wednesday the malaria drug does not result in the reduction of mortality in hospitalized COVID-19 patients, based on data from its own trial and the U.K.’s RECOVERY trial.

WHO had paused hydroxychloroquine testing on May 25 after a study published in Lancet found an association between the antimalarial and increased mortality. When the journal later retracted the paper, the WHO restarted the trial’s arm on June 3 (see “WHO Restarts Trial”).

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