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Aug 12, 2013

Vical Scraps Melanoma Candidate After Phase III Failure

  • Vical said today it would end development of its lead drug Allovectin® (velimogene aliplasmid) for metastatic melanoma after the investigational intratumoral cancer immunotherapy failed to meet efficacy endpoints in a Phase III clinical trial. Vical said that it would refocus its development efforts on vaccines for infectious diseases.

    The company said Allovectin failed to demonstrate statistically significant improvement vs. first-line chemotherapy for either the primary endpoint of objective response rate at 24 weeks or more after randomization, or the secondary endpoint of overall survival, in the 390-patient trial. Data from the trial will be further analyzed, with detailed results to be submitted for publication at an unspecified time.

    "We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed," Vijay B. Samant, Vical’s president and CEO, said in a statement.

    Samant also warned that Allovectin’s failure would lead to cutbacks at Vical: "In the coming weeks, we will make the necessary changes to focus resources on our infectious disease vaccine programs and reduce expenses to conserve cash.”

    Vical reported cash and investments as of June 30 of $70 million—a sum the company said it believes “is adequate for its anticipated needs at least through the end of 2014.”

    Vical cited numerous infectious disease vaccine programs it had in development, some of which are being carried out independently and the rest with partners. Furthest along of these is a 500-patient Phase III trial by Astellas Pharma of Vical’s ASP0113, an investigational therapeutic vaccine designed to control cytomegalovirus (CMV) in hematopoietic cell transplant (HCT) recipients in June. Vical said it expected to launch a Phase II trial of ASP0113 for solid organ transplant recipients later this year.

    Astellas agreed in 2011 to license ASP0113 from Vical for up to $130 million.

    Other Vical development programs are as follows:

    • The company plans to initiate a Phase I/II trial of its Vaxfectin®-formulated therapeutic vaccine against herpes simplex virus type 2 before year’s end.
    • Vical is seeking a partner for further development of its Vaxfectin-formulated CyMVectin™ prophylactic vaccine, designed to prevent CMV infection before and during pregnancy. CyMVectin has completed preclinical development and has an allowed investigational new drug application (IND) pending with FDA.
    • Vaxfectin adjuvant has been licensed by Vical to Bristol-Myers Squibb for production of antibodies, and to vaccine developer Cyvax for malaria vaccines—two licensing deals in addition to other deals Vical said it hopes to finalize.

    Two of Vical’s products have been licensed for animal indications by other companies: In 2009 before its acquisition by Sanofi, Merial won approval from the U.S. Department of Agriculture to sell the therapeutic DNA vaccine, ONCEPT®, designed to aid in extending the survival time of dogs with oral melanoma. And four years earlier, Aqua Health, a subsidiary of Novartis Animal Health, received Canadian approval to market the DNA vaccine Apex®-IHN, against infectious hematopoietic necrosis virus in farm-raised salmon. 


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