NanoPass Technologies Supports A CDC-Sponsored Phase 3 Study Of Polio Vaccine In Infants As Part Of its Global Health Initiative

Ness Ziona Israel /PRNewswire/ - NanoPass Technologies Ltd. ("NanoPass"), a pioneer in intradermal (into-the-skin or ID) vaccine delivery solutions, is collaborating with the US Center of Disease Control and prevention (CDC) in conducting a large phase 3 trial of polio vaccine in infants in South East Asia.

This collaboration is a part of NanoPass's long-term commitment to improve Global Health by providing access to its vaccine delivery devices.

The study is a phase 3, open-label, randomized clinical trial comparing immune response after receiving one of five different combinations of polio vaccines delivered as oral drops or as injections into the muscle or the skin. Two of the vaccine regimens include a low (20%) dose vaccine delivered intradermally using the MicronJet device. The study is currently enrolling infants 6 weeks of age and aims to enroll over 1,200 participants.

In the pre-vaccine era, poliomyelitis was the leading cause of permanent disability. Two polio vaccines are used throughout the world to combat poliomyelitis (or polio); injected inactivated poliovirus (IPV) and live attenuated oral vaccine. IPV administration is needed globally to achieve polio eradication, but it is currently unaffordable for most of the developing world. Intradermal delivery may dramatically reduce the dose required for vaccination by several folds, thereby reducing the cost and increasing the affordability, of polio vaccines.

Yotam Levin , CEO of NanoPass, said, "We are delighted to support CDC as part of NanoPass's long term commitment to Global Health. We see an important opportunity for significantly reducing the dose of vaccination and hence its cost, by combining our device approach with polio vaccines. We will continue to provide access to our technology to public and private vaccine developers for Global Health applications, as we have to date with some of our partners including the Infectious Disease Research Institute (IDRI.org). The MicronJet600 device is the shortest microneedle device presently registered with FDA, and since it is about half a millimeter long it is applicable for infants as well as adults.

NanoPass is involved in another Polio study in 231 HIV positive adults. The study is sponsored by the Eastern Virginia Medical School and aims to determine whether a lower dose of inactivated polio vaccine (IPV) injected ID can work equally well or better than the standard dose injected into the muscle. The study is enrolling participants infected with HIV because they are known to respond less well to vaccines than other groups.

NanoPass has also supported a pandemic flu phase I study sponsored by IDRI and Medicago, which investigated multiple strategies including intradermal delivery to improve immune responses and reduce doses for vaccination for the H5 pandemic flu vaccine.

About NanoPass Technologies Ltd.

NanoPass, a company specializing in intradermal delivery, concluded multiple seasonal flu studies as well as the world's first intradermal H1N1 pandemic flu vaccine study, demonstrating equivalent or superior immunogenicity to standard intramuscular delivery using only 20% of the dose [i,ii,iii]. NanoPass has licensed its technology for various indications to Janssen Pharmaceuticals Inc. (pharmaceuticals companies of Johnson & Johnson (J&J) [NYSE: JNJ]), Circassia and IDRI. The Company is backed by prominent investors including IHCV, Ofer Hi-Tech, DPartners, WFD Ventures and ‎Elcam Medical.‎

About MicronJet600

MicronJet is a microneedle-based device for ID delivery of vaccines and drugs, enabling consistent and simple delivery of therapeutics directly into the skin. MicronJet has proven efficacy and safety in multiple applications including flu vaccines and insulin. MicronJet is approved for marketing in various territories including the USA, for use by health care professionals for intradermal delivery (see label).

i Hung IFN et al. Quantitative and ‎qualitative analysis of antibody response after dose sparing intradermal 2009 H1N1 vaccination.‎ Vaccine. 2012;30(17):2707-8.

ii Van Damme P et al. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine. 2009;27(3):454-9.

iii. Hung IFN et al . Dose sparing intradermal trivalent influenza (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain. Vaccine. 2012;30(45):6427-6435.