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ErythroMer: Nanoscale BioSynthetic Red Cell Substitute

Award Number: R44HL135965
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/11/2017
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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ErythroMer: Nanoscale BioSynthetic Red Cell Substitute - Research Summary/Abstract ErythroMer (EM) is a novel biosynthetic blood substitute developed to address the critically unmet need for emergency transfusion in situations where the use of banked red blood cells (RBCs) are either not available or undesirable. EM is a self-assembled lipid-oligomeric hybrid nanoparticle with a high per particle payload of hemoglobin (Hb) and the allosteric modifier, RSR13. EM is specifically designed to rectify failures of previous hemoglobin-based oxygen carriers, which do not preserve RBC physiology. The bio-inspired EM design surmounts previous obstacles by emulating RBC features: long term stability, precise dynamically-responsive allosteric effector control of Hb oxygen affinity, control of Hb interaction with nitric oxide (NO), preventing vasospasm, and mitigation of hemoglobin oxidation by containment in the vascular compartment. EM is designed for sterile lyophilization enabling extended shelf life at ambient conditions and offers cost-effective production at scale. KaloCyte has developed a pragmatic yet robust step-wise goal oriented development plan for commercialization including meticulous evaluation of preclinical safety to support FIH dosing. A systematic and rigorous in vitro, ex vivo and animal model based pre-clinical proof-of-concept strategy provides strong evidence supporting the premise for and feasibility of this proposal. Further, our commitment to characterize a comprehensive non-GLP pharmacokinetic and exploratory toxicology as well as an FDA vetted GLP toxicology plan for EM is elucidated. To meet these milestones in a timely fashion, non-GLP dose dependent pharmacokinetic studies of EM that probe tissue distribution, metabolism, and elimination and exploratory toxicology studies will be conducted. Successful completion of these experimental studies will inform on pharmacokinetic behavior, potential dose dependent safety signals and product quantity needs, moving forward into GLP toxicology studies and eventually FIH dosing. The described, comprehensive dose dependent toxicology studies are tailored to meet FDA expectations that allows for dosing of EM in a Phase 1 clinical trial. This process requires, escalating single dose toxicology study in rabbits expanded to 14 days for post dose recovery. Parallel studies investigating cardiac electrophysiology, pulmonary hemodynamics, and systemic hemodynamics in a dog safety pharmacology study with an added toxicokinetic arm. Completion of these IND- enabling studies provides necessary pre-clinical animal data qualifying KaloCyte to submit an IND package for EM. EM has the capability to dramatically transform care in situations where the adverse effects of stored RBCs exceed benefit and may enable novel efficacies. However, the most compelling use will be in settings where stored RBCs are unavailable or undesirable. 1


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	KALOCYTE INC	4 N MARTIN LUTHER KING JR BLVD FL 3	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Blood Diseases and Resources Research	000	6	4/16/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $995,470 )
2025	2025	KALOCYTE INC	670 W BALTIMORE ST	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Blood Diseases and Resources Research	001	6	5/22/2025	NON-COMPETING CONTINUATION	$995,470
2025	2024	KALOCYTE INC	670 W BALTIMORE ST	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Blood Diseases and Resources Research	000	5	10/30/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $995,470

Issue Date FY: 2024 ( Subtotal = $997,590 )
2024	2024	KALOCYTE INC	670 W BALTIMORE ST	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Blood Diseases and Resources Research	000	5	8/1/2024	NON-COMPETING CONTINUATION	$997,590
														Subtotal = $997,590

Issue Date FY: 2023 ( Subtotal = $1,050,000 )
2023	2023	KALOCYTE INC	670 W BALTIMORE ST	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Blood Diseases and Resources Research	001	4	6/21/2023	COMPETING CONTINUATION	$0
2023	2023	KALOCYTE INC	670 W BALTIMORE ST	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Blood Diseases and Resources Research	000	4	5/19/2023	COMPETING CONTINUATION	$1,050,000
														Subtotal = $1,050,000

Grand Total All Awards = $3,043,060

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ErythroMer: Nanoscale BioSynthetic Red Cell Substitute

Award Number: R44HL135965

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/11/2017

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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