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ErythroMer Nanoscale Bio Synthetic Red Cell Substitute

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R42HL135965-01A1
Agency Tracking Number: R42HL135965
Amount: $397,622.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-05-11
Award End Date (Contract End Date): 2018-04-30
Small Business Information
Saint Louis, MO 63108-2979
United States
DUNS: 080177219
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (314) 454-0021
Business Contact
Phone: (636) 346-3140
Research Institution
Campus Box 1054 1 Brookings Drive
SAINT LOUIS, MO 63130-4862
United States

 Nonprofit College or University

There is need for an artificial oxygen O carrier to substitute for banked blood in settings where stored
blood is unavailable pre hospital care transport austere environments undeveloped countries or
undesirable transfusion risk exceeds benefit To address this need we developed ErythroMer EM a first in
class nano cyte blood substitute EM is a deformable cross linked polymeric nanoparticle that incorporates high
per particle payloads of hemoglobin Hb Our artificial cell design has yielded a prototype that emulates RBC
physiology in all key respects and represents a potentially disruptive introduction into Transfusion Medicine To
date efforts to develop Hb based oxygen carriers HBOCs have failed because of design flaws which do not
preserve physiologic interactions of Hb with O they capture O in lungs but do not release O effectively to
tissue and nitric oxide NO they trap NO causing vasoconstriction The EM design surmounts these
weaknesses by encapsulating Hb controlling O capture release with a novel DPG shuttle DPG
is the major heterotropic effector for Hb and diminishes O affinity attenuating NO uptake through shell
properties and retarding metHb formation by co packaging a reduction system Moreover EM is designed for
sterile lyophilization and so is amenable to facile reconstitution after extended dry storage under ambient
conditions EM offers a pragmatic approach to a complex need and is designed for cost effective production at
scale Our prototype has passed rigorous initial ex vivo and in vivo proof of concept testing We founded
KaloCyte so that we may translate ErythroMer innovations into a pragmatic therapeutic and as well as realize
the commercial potential of a disruptive introduction into transfusion medicine Our project goals are to scale up
reliable EM production perform pharmacokinetic studies initiate toxicity screening and affirm efficacy in a robust
animal model of hemorrhagic shock resuscitation ErythroMer intellectual property is robust and secured by
KaloCyte which has been supported by robust entrepreneur incubator programs that have afforded business
and regulatory expertise initial space and administrative support STTR funding will enable KaloCyte to transition
EM production from research to pilot scale Phase I and initiate groundwork required for IND authorization
Phase II Of note our initial studies and the approach herein meet published FDA expectations for blood
substitutes Given the significant potential for Department of Defense DoD collaboration and support we have
chosen to pursue hemorrhagic shock as the first indication for FDA approval Our strategy to accelerate EM to
human study involves collaborating with the DoD on a highly prioritized project to develop a Multifunctional
Resuscitation Fluid MRF We have established firm collaborations with the US Army and the MRF program
which currently lacks an O carrier Following a successful trial for hemorrhagic shock we would expand EM into
other settings pre hospital use blood banking in the developing world and exploit the design to extend efficacies
beyond that of stored blood PROJECT NARRATIVE
There is need for an artificial oxygen carrier to care for anemic and bleeding patients in settings in
settings where donated human blood is unavailable or undesirable To address this need we
developed ErythroMer EM a first in class nano cyte blood substitute and founded KaloCyte to we
may translate these innovations into a pragmatic therapeutic This proposal will support that effort

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

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