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Vical Slumps, Cytomegalovirus Vaccine Fails in Phase II Study


Vical Incorporated VICL and partner Astellas Pharma, Inc. ALPMY announced disappointing top-line data from a phase II study on their experimental cytomegalovirus (CMV) vaccine candidate, ASP0113, in kidney transplant patients. Vical’s shares plunged 22.3% on the news.

The randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of ASP0113 in CMV-seronegative kidney transplant recipients, receiving an organ from a CMV-seropositive donor. Data showed that the study failed to meet the primary endpoint, which was the proportion of patients having CMV viremia through one year after first injection of the vaccine.

In addition, the secondary endpoints including CMV-associated disease and CMV-specific antiviral therapy were found to be similar in both treatment groups, as evaluated by an independent, blinded Adjudication Committee.

Although the safety profiles were found to be similar among treatment groups, local injection site reactions were more common in the ASP0113 arm. Additional detailed data from the study is expected to be revealed at an upcoming scientific congress.

Considering that there exists a significant unmet need for treatments addressing CMV, a herpes virus infection, the phase II study results fails to impress.


Vical, however, plans to continue to move with pivotal phase III study on ASP0113 in hematopoietic cell transplant (HCT) recipients, also in collaboration with Astellas. Data from the study is expected in the fourth quarter of 2017. We note that ASP0113 has Orphan Drug status in the both the U.S. and Europe for the prevention of CMV disease in solid organ transplant and HCT recipients.

We remind investors that this is not the first time that Vical has faced a pipeline setback. In 2013, the company had terminated the development of an intratumoral cancer immunotherapy, Allovectin, following negative phase III study results. Further, in 2015, neither its monovalent nor bivalent genital herpes vaccine had met the primary endpoint in a phase I/II study.

Meanwhile, Vical is conducting a phase I study on VL-2397 for the treatment of invasive fungal infections, including invasive aspergillus. We note that Vical had in-licensed the candidate in Mar 2015 from Astellas under an exclusive worldwide license agreement.

Vical carries a Zacks Rank #2 (Buy). A couple of favorably placed stocks in the health care sector are Anika Therapeutics, Inc. ANIK and ANI Pharmaceuticals, Inc. ANIP. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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