Emergent BioSolutions Inc. EBS announced positive interim results from the mid-stage study on its chikungunya vaccine candidate, CHIKV-VLP. The company is evaluating the safety and immunogenicity of CHIKV-VLP in a phase II program across a series of dosing regimens.
Interim data from the study showed that by day 7, a single dose of the vaccine produced a neutralizing antibody response in almost 98% patients, who are affected by the chikungunya virus. The positive immune responses were sustained through the six-month visit of the patients, even with a single dose of the vaccine. Overall, CHIKV-VLP was well-tolerated with no significant vaccine-related safety concerns reported.
The chikungunya virus has a significant unmet medical need with no vaccines presently available. With the positive interim outcomes, Emergent plans to finalize the development plan and initiate a pivotal study on the candidate next year. Notably, in May 2018, CHIKV-VLP was granted a Fast Track designation by the FDA.
Shares of Emergent have lost 3.9% so far this year, narrower than the industry’s decrease of 12.3%.
We would like to remind investors that Emergent has a strong vaccine portfolio. The company’s key Biodefense product — BioThrax — is the sole vaccine to be marketed for the general use in both pre- and post-exposure prophylaxis of anthrax disease. The United States government is the primary purchaser of the Biodefense products.
Apart from BioThrax vaccine, Emergent markets smallpox vaccine, ACAM2000, and the anthrax monoclonal antibody, raxibacumab, both of which were acquired in the fourth quarter of 2017 from Sanofi SNY and GlaxoSmithKline GSK, respectively.
Last month, Emergent initiated a phase III investigation on the anthrax vaccine, AV7909, for the post-exposure prophylaxis of anthrax disease. The candidate is designed to lead to a faster immune response in patients as compared to the currently available anthrax vaccine.
Notably, last December, Emergent submitted an application to the FDA for the emergency use authorization of its anthrax vaccine candidate, NuThrax, following a public health emergency involving Bacillus anthracis. The regulatory agency will review the application and a decision is awaited in the first half of 2019.
Emergent is also developing Zika vaccine candidate, VLA1601, in partnership with European entity Valneva SE. Last November, both companies announced favorable interim data from the phase I probe on VLA1601.
Zacks Rank & Key Pick
Emergent currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is PDL BioPharma, Inc. PDLI, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
PDL BioPharma’s earnings estimates have been revised 100% upward for 2019 and 30% for 2020 over the past 60 days. The stock has rallied 27.2% year to date.
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