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Expanding the Market and Success Rates for Myeloablative Cancer Treatments Using PUL an Innate Immune Stimulant

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 9R44HL127677-04
Agency Tracking Number: R44HL127677
Amount: $2,980,030.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: HL13-016
Solicitation Year: 2013
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-05-01
Award End Date (Contract End Date): 2019-04-30
Small Business Information
3900 ESSEX LN STE 575
Houston, TX 77027-5175
United States
DUNS: 786704143
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (713) 579-9226
Business Contact
Phone: (713) 579-9226
Research Institution

Pulmotect Inc was founded in to translate discoveries that induce innate immune resistance in the lung
into therapeutics that will provide protection from inhaled pathogens Our technology platform is a direct result
of basic research by our founders on the mechanisms of microbial resistance in the lung epithelium We have
developed an inhaled therapeutic PUL that provides immediate protection against a broad spectrum of
respiratory pathogens PUL is a clinical stage specific combination of two well characterized synthetic
molecules a lipopeptide Pam CSK and an oligodeoxynucleotide ODN M that act as agonists of the
Toll like Receptors TLR and TLR respectively This unique proprietary combination of molecules
synergizes to rapidly and powerfully stimulate the body s natural defenses The response is localized and
specific to the site of administration In mice treatment before and after exposure with aerosolized PUL
results in increased survival rates to pathogens including multiple Gram and Gram bacteria three of which
are Class A bioterror agents the fungus Aspergillus fumigatus and the Sendai and influenza viruses In each
case increased survival is associated with a reduction of lung pathogen burden not simply increased
tolerance to the pathogen by the host which indicates a resistance mechanism of action
Pulmotectandapos s long term strategy is to leverage its technology across a wide array of important threats from
inhaled pathogens by limiting the pathogen burden and transmission of disease The range of applications for
PUL currently in development includes use in immunosuppressed patients pandemic influenza asthma
exacerbations associated with viral infections and manmade bioterror threats as well as naturally emerging
viruses While this broad spectrum technology is not envisioned to replace traditional vaccine approaches its
value and differentiation reside in the ability to confer immediate host based protection that is not limited by the
identity of the pathogen The potential indications that lie outside the scope of this proposal are synergistic
building on experimental methods that we established since our earliest research in this field The scientific
basis of boosting the innate immune system in the lungs is rapidly expanding as we better understand the
underlying mechanism of action
The primary goal of this proposal is to complete a Phase II clinical trial in immunosuppressed cancer patients
This will be a multi center randomized double blind trial that will compare PUL against placebo on the
overall incidence and severity of pneumonia specifically on those who have been screened to have a
parainfluenza infection prior to enrollment The three objectives of the trial are described below
Primary objective to determine the safety and tolerability of PUL inhalation solution in patients with
documented parainfluenza infection
Secondary objective to determine the efficacy of PUL inhalation solution to prevent the progression of
documented parainfluenza infection to clinically documented lower respiratory tract infection
Exploratory objectives evaluate the effect of PUL on parainfluenza viral titers and neutralizing
antibodies evaluate the effect of PUL over time on the microbiome and virome in nasal washes in
the study population and determine whether PUL induces neutralizing antibodies against PUL
The successful achievement of these objectives will demonstrate proof of concept in man and further validate
the technology for market use With secured matching funds already in place this NIH proposal is designed to
help move the project to the end goal rather than provide the initial seed funds to start the process The
Company would be well positioned to advance existing collaborations partnerships and discussions with
leading large pharma and biotechnology organizations accelerating the path to the market to address the
serious unmet needs that many patients are currently facing Pulmotect Inc is developing novel therapeutics that stimulate the innate immune system to protect against
infectious diseases even in cases of severely compromised immunity Proof of concept data has shown that
this technology effectively protects against a broad range of inhaled pathogens including viral challenges that
often cause asthma exacerbations Early clinical studies have shown the drug to safe in humans up to the
expected therapeutic dose This project aims to further advance the clinical development of this technology by
completing a proof of concept Phase II clinical trial in immunosuppressed cancer patients

* Information listed above is at the time of submission. *

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