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NanoPass Technologies Supports a CDC-Sponsored Phase 3 Study of Polio Vaccine in Infants as Part of its Global Health Initiative

May 13, 2013

NES ZIONA, Israel, May 13, 2013 /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 [http://en.wikipedia.org/wiki/Vaccine ] are used throughout the world
to combat poliomyelitis [http://en.wikipedia.org/wiki/Poliomyelitis ] (or polio); injected
inactivated poliovirus [http://en.wikipedia.org/wiki/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.

        Contact:
        Yotam Levin, CEO:
        +972-523-392727
        yotam@nanopass.com

SOURCE NanoPass Technologies LTD.


Source: PR Newswire