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Expanded implementation of a human-based Malaria-on-a-Chip phenotypic disease model for the evaluation of therapeutic efficacy and off-target toxicity

Award Number: R44AI197758
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Expanded implementation of a human-based Malaria-on-a-Chip phenotypic disease model for the evaluation of therapeutic efficacy and off-target toxicity - ABSTRACT The initial work for this project was funded by the Gates Foundation and enabled us to establish a multi-organ model that reproduces the parasite life cycle and response to three known anti-malarial therapeutics. Due to the significant results achieved with the Gates Foundation support, we believe this justifies this direct to Phase II application. Plasmodium falciparum, the parasite that causes malaria, is the deadliest Plasmodium strain that infects humans. Malaria primarily burdens Asia, Africa, Central and South America; devastating extremely vulnerable populations, particularly impoverished pregnant women and children. The proliferation of drug- resistant strains urgently necessitates developing novel malaria sequestration models and drug delivery methods. We have previously developed a human-based platform, the Malaria-on-a-Chip model, to provide an alternative approach to modeling this disease for pre-clinical drug development in immune suppressed mice. Even with the heightened emphasis on human-based systems using primary and induced-pluripotent stem cells, many in vitro models lack the ability to capture functional impairment and nuanced interactions of multiple cell types or external factors contributing to disease pathology. Consequently, microphysiological systems offer a non-invasive, cost-effective and accelerated method for evaluating function-based disease pathology, especially for malaria. By reducing budget and time constraints, these systems enable higher throughput assessment of clinically and biologically relevant phenotypes, along with complementary biomarker and transcriptomic expression profiles. We demonstrated this model can support all stages of the intraerythrocytic life cycle of multiple human Plasmodium strains, enabling the monitoring of effects of infection on human liver, spleen, and vasculature within a single microfluidic device. In this Direct to Phase II Application, we are proposing the Malaria- on-a-chip phenotypic disease model for use in (1) extension of physiological conditions and for additional strains to better capture pathophysiological parameters of disease as it pertains to infected erythrocyte interactions with endothelium and the immune response to parasitic particles, (2) evaluating parasite clearance and organ toxicity when treated with repeated doses of therapeutics or with combination therapies of known and new therapeutics, and (3) evaluating prophylactic measures on parasite infection and organ toxicity when treated with sequential doses prior to the introduction of infected erythrocytes to the model. These human on a chip models have proven to be acceptable alternatives to animal models in recapitulating human physiology for mechanistic and drug efficacy studies, as demonstrated in our previous IND-enabling studies for Sanofi where efficacy was only from the HoaC platform (NCT04658472) (Rumsey et al. 2022) and Dianthus Therapeutics (NCT06282159). Final deliverables for this proposal include a novel therapeutic delivery method to generate a predictive PK/PD model to translate in vitro results to inform in vivo outcomes as well as new therapeutic candidates for different strains of the parasite.


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 = $1,000,000 )
2026	2026	HESPEROS, INC	12501 RESEARCH PKWY STE 100	ORLANDO	FL	32826	ORANGE	USA	Allergy and Infectious Diseases Research	000	1	8/28/2026	NEW	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $1,000,000

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Expanded implementation of a human-based Malaria-on-a-Chip phenotypic disease model for the evaluation of therapeutic efficacy and off-target toxicity

Award Number: R44AI197758

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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