Inovio hurled an early stage clinical study in July of the GLS-5700 Zika serum that it's evolving with partner GeneOne Life Sciences and academic collaborators in the U.S. and Canada. This clinical study tracked successful pre-clinical testing of GLS-5700 in mice and monkeys in the first half of this year 2016.
The study focus and includes 40 patients who had no previous contact to the Zika virus. Patients were separated into two groups, with one group receiving a low dose of GLS-5700 and the other group receiving a high dose. After one or two immunizations, patients in both groups established Zika antigen-specific antibody comebacks.
Inovio also informed more good news from the study. The Zika vaccine give the impression to be well tolerated by patients. No substantial safety concerns have been acknowledged in any of the patients so far.
Early Results And What It Means
So, what exactly does signifying "Zika antigen-specific antibody responses" mean? When the body's immune system distinguishes a virus like Zika, B cells and T cells are activated. B cells are white blood cells that produce antibodies. T cells are also white blood cells that play an important role in immune responses.
The antibodies produced by B cells attack the virus. However, they also stay in the blood after that first response. The next time the body is infected by the same virus, the antibodies go on the attack before the virus can cause sickness.
Inovio's finding of Zika antigen-specific antibody answers in its clinical study means that the GLS-5700 vaccine is doing what it should do. The vaccine is aggravating the creation of B cells, which in turn create antibodies that specifically target the Zika virus. In theory, those antibodies will remain in the patients' blood and prevent future contamination by the Zika virus.
Dr. J. Joseph Kim, president and CEO of Inovio, commented:
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.
He added:
We also look forward to completing our second phase I study of 160 subjects in Puerto Rico, where the CDC estimates 25% of the population could be infected with Zika virus by year end. We expect results next year which may provide exploratory signals of vaccine efficacy. 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.
Inovio's DNA vaccine is vaccinated along with a brief low voltage microelectronic pulse that makes cell membranes to open, making them more amenable, in theory, to accepting the vaccine's genetic material.
The view of an epic vaccine has also attracted the interest of big drug producers, including Sanofi SA, GlaxoSmithKline Plc and Takeda Pharmaceuticals.
