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CureVac Rallies On Interim Phase 1 Data For COVID-19 Vaccine Candidate: What You Need To Know

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CureVac Rallies On Interim Phase 1 Data For COVID-19 Vaccine Candidate: What You Need To Know

German biopharma CureVac BV (NASDAQ: CVAC) — which is developing an  mRNA vaccine against the novel coronavirus — was rallying Tuesday following the release of detailed interim Phase 1 data for the investigational vaccine.

What Happened: Interim analysis of data from the dose-escalation Phase 1 study in healthy volunteers showed that two doses of the vaccine candidate CVnCoV, ranging from 2 μg to 12 μg per dose and administered 28 days apart, were safe, according to a preprint available on medRxiv. 

No vaccine-related serious adverse events were reported.

Immune responses when measured as IgG antibodies against S protein or its receptor-binding domain by ELISA, and SARS-CoV-2-virus neutralizing antibodies measured by micro-neutralization, displayed dose-dependent increases, the manuscript said. 

Median titers measured in these assays two weeks after the second 12 μg dose were comparable to the median titers observed in convalescent sera from COVID-19 patients.

Additionally, seroconversion of virus neutralizing antibodies two weeks after the second vaccination occurred in all participants who received 12 μg doses.

Related Link: The Week Ahead In Biotech: Supernus, Sanofi Await FDA Decisions

In early November, the company reported positive topline data showing that CVnCoV was generally well-tolerated across all tested doses, and induced strong binding and neutralizing antibody responses in addition to first indication of T cell activation.

Why It's Important: The strong interim Phase 3 efficacy data reported by Pfizer Inc. (NYSE: PFE) Monday bodes well for CureVac, given that both developers use the same vaccine technology.

As COVID-19 cases continue to surge globally, CureVac could capitalize on the opportunity if its vaccine candidate is able to replicate the success of the Phase 1 trial in large-scale studies.

What's Next? CureVac said it will also submit the data for publication in a peer-reviewed journal.

At last check, CureVac shares were gaining 6.4% to $58.16. 

Related Link: Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates

 

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