Inovio Pharmaceuticals Inc. (INO:NASDAQ) has reported that its first-in-man Phase 1 trial for its DNA-based Zika vaccine (GLS-5700) generated robust antigen-specific antibody responses in the subjects. Forty volunteers at three sites, Miami, Philadelphia and Quebec, were divided into low-dose and high-dose groups; both groups demonstrated antibody responses out 14 weeks from the initiation of dosing. The company stated that the "vaccine was well tolerated and no significant safety concerns were noted in any of the test subjects."
Analyst Raghuram Selvaraju of H.C. Wainwright & Co., wrote, "In our view, the initial clinical data are encouraging and are consistent with the preclinical results, which showed that GLS-5700 protected animals from infection, brain damage and death."
Inovio's CEO, Dr. J. Joseph Kim, noted, "These early clinical results show that Inovio is on track to rapidly develop Zika countermeasures for this disease that has no currently existing vaccine or treatment. Our synthetic vaccine technology allows rapid development of new products, leading Inovio to be the first to create a Zika vaccine, the first to generate preclinical data, the first to initiate human testing, and now first to report positive clinical data."
The company is also conducting a second Phase 1 trial in Puerto Rico, where an estimated 25% of the population is infected with Zika; 160 subjects are enrolled in that study. Inovio plans to release data early this year.
Dr. Kim stated, "Based on these two studies, we plan to meet with regulators to map out the most efficient path forward to bring our Zika vaccine to patients and help mitigate this widespread Zika outbreak that has expanded into the continental United States."
Selvaraju also noted that Inovio and The Wistar Institute "have received an $8.8M grant from the Bill & Melinda Gates Foundation to develop a DNA-based monoclonal antibody that can provide fast-acting protection against Zika infection and can be co-administered with the Zika vaccine."
According to Inovio, "monoclonal antibody-based therapies could provide more immediate protection but do not develop long-term immune memory. An ideal approach would therefore include the co-administration of a dMAb product for immediate protection and a DNA vaccine to train the immune system for longer-term, persistent protection against Zika infection."
Selvaraju also stated that Inovio's "Phase 1/2a study of INO-3112 cancer immunotherapy in HPV-positive head and neck cancer patients showed that INO-3112 generated HPV16/18 antigen-specific CD8+ killer T cell responses measured both in tumor tissue and in peripheral blood in four of five subjects. The four subjects remained disease free in continuing follow-up that ranged from 9 to 24 months at the time of analysis. We note that these data are consistent with those of VGX-3100 in HPV-associated cervical dysplasia. We expect additional data readouts from this 22-subject trial in 2017."
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1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She owns, or members of her immediate household or family own, shares of the following companies mentioned in this article: None. She is, or members of her immediate household or family are, paid by the following companies mentioned in this article: None.
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