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Product Development

EC looks to CureVac for first mRNA COVID-19 vaccine deal

Plus details on J&J’s pivotal vaccine trial and data from CalciMedica

Aug 21, 2020 | 2:26 AM GMT

The European Commission is nearing a procurement deal for CureVac’s COVID-19 mRNA-based vaccine, which would add mechanistic diversity of the portfolio of vaccines it is pursuing. The EU has secured doses of an adenovirus vector vaccine and is in talks for a second vaccine in the class, as well as a recombinant protein-based vaccine.

Separately, J&J’s Phase III vaccine trial could enroll twice as many volunteers as pivotal studies of three other candidates, and a therapy from CalciMedica shows promise in severe COVID-19 patients.

CureVac N.V. (NASDAQ:CVAC) said Thursday it has concluded exploratory talks with the European Commission to purchase 225 million doses of its COVID-19 vaccine, with an option to purchase an additional 180 million.

Shares of CureVac added $9.10 (16%) to $66 on Thursday, pushing its market cap to about $11.7 billion. The German biotech’s stock has more than quadrupled since the company raised $213.3 million at a $2.8 billion valuation in its NASDAQ debut on Aug. 14 (see “Big Post-IPO Gain for CureVac”).

The mRNA-based vaccine is in Phase I testing in Germany and Belgium, with data expected 4Q20. If the results are positive, a Phase IIb/III trial could start that quarter.

The EC has also completed exploratory talks with Johnson & Johnson (NYSE:JNJ) for 200 million doses of adenovirus vector vaccine Ad26.COV2.S, and with Sanofi (Euronext:SAN; NASDAQ:SNY) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for 300 million doses of their recombinant protein vaccine.

On Aug. 14, the EC closed its first advance purchase agreement for a COVID-19 vaccine, agreeing to purchase 300 million doses of adenovirus vector vaccine AZD1222 from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see “EU Picks AZ-Oxford Team for First COVID-19 Vaccine Contract”).

J&J vaccine trial could go above and beyond

A ClinicalTrials.gov entry for a Phase III trial of J&J’s COVID-19 vaccine suggests the pharma plans to enroll about 60,000 volunteers in the study, twice the population that three other vaccine groups are targeting for their studies. J&J’s trial is expected to start on Sept. 5 and enroll volunteers at 178 sites across the U.S., South America, South Africa, Mexico, the Philippines and Ukraine.

Operation Warp Speed has committed $1.5 billion to develop and procure 100 million doses of J&J’s vaccine (see “Warp Speed makes J&J Vaccine Fifth Above $1B”).

Pivotal trials from Moderna Inc. (NASDAQ:MRNA), Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), and AstraZeneca are each expected to enroll about 30,000 volunteers.

CalciMedica strengthens trial design

CalciMedica Inc. said it will convert an open-label Phase II trial of Auxora (CM4620-IE) into a double-blind, placebo-controlled study after the CRAC channel inhibitor increased recovery speed and reduced the use of invasive ventilation and death in patients with severe COVID-19 pneumonia. 

The study results, which were published in Critical Care, showed that 17 patients with severe disease treated with Auxora recovered in an average 5 days, compared with a 12-day recovery time for nine patients treated with standard of care (SOC) (recovery rate ratio = 1.87; 95% CI: 0.72, 4.89).

The therapy also led to a statistically significant difference on a composite measure defined as invasive mechanical ventilation or death. Three (18%) severe patients treated with Auxora reached the endpoint vs. five (56%) patients on SOC (HR=0.23; 95%CI: 0.05, 0.96; p<0.05).

Auxora also appeared to be safe. Of the 20 total severe and critical COVID-19 patients given the CRAC channel inhibitor, six (30%) experienced one or more serious adverse event, compared with five (50%) of the 10 total patients treated with SOC. 

The placebo-controlled portion of the trial will enroll 400 patients.

CalciMedica is evaluating Auxora in the clinic for several diseases including viral pneumonia, acute pancreatitis and rheumatoid arthritis. The company began exploring its potential to treat COVID-19 due to the role CRAC channel activation plays in driving the production and release of pro-inflammatory cytokines, which can lead to acute respiratory distress syndrome.

CRAC – Calcium release-activated calcium channel 

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