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Development of novel neoantigen-based spherical nucleic acid immunotherapeutics

Award Number: R01CA302883
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/07/2026
PERIOD OF PERFORMANCE END DATE: 07/01/2031

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Development of novel neoantigen-based spherical nucleic acid immunotherapeutics - PROJECT SUMMARY Triple negative breast cancer (TNBC) is a highly invasive form of breast cancer with a dismal outcome, accounting for a staggering 25% of all breast cancer associated deaths despite comprising only 10-15% of cases. The standard of care for TNBC includes aggressive surgery, followed by radiation therapy and continued chemoimmunotherapy yet often results in a high rate of recurrence, formation of tumor resistance mechanisms, and metastasis, leading to poor patient outcomes. Current therapies are limited due to the lack of clear molecular targets, genomic instability, and the suppressive tumor microenvironment. Thus, there is an overwhelming need for targeted, effective, and safe therapeutics to combat TNBC. Flashpoint Therapeutics and the Gillanders Laboratory at Washington University School of Medicine (WUSM) proposed solution leverages the combined expertise of both teams to develop a targeted, personalized neoantigen cancer immunotherapeutic for TNBC using a structural nanomedicine platform. Cancer neoantigens represent a potentially optimal target to combat cancer as tumor-specific mutations can be utilized to selectively prime a specific immune response to target and destroy cancer cells while sparing healthy tissue. Additionally, delivery of RNA through lipid nanoparticles (LNPs) decorated with immunostimulatory spherical nucleic acids (SNA) has shown drastic improvement over conventional approaches. Having already demonstrated proof-of-concept feasibility for the safety and efficacy of TNBC personalized neoantigens and proven immunostimulatory RNA LNP SNA properties, we are poised to develop a patient-specific neoantigen-based personalized nanoparticle immunotherapeutic (PNI), termed P-SNA, for TNBC patients. In this Academic-Industrial Partnership R01 application we first aim to evaluate the efficacy and mechanism of action of our lead P-SNA candidate through in vivo preclinical breast cancer mouse models (Aim 1.1), and by use of fluorescently labeled constructs to determine biodistribution, immune activation, and immune priming (Aim 1.2). We will then chemically optimize our lead candidate to improve therapeutic properties using a rigorous Design of Experiments approach (Aim 2.1) and test the efficacy and mechanism of action of optimized candidates in vivo (Aim 2.2). As there is no model which can accurately or completely reproduce the complex immune and non-immune interactions that occur between the host and a tumor, even in the absence of vaccination, the only way to understand the impact of the P-SNA therapeutics are to test in well characterized animal models. Finally, we will develop GMP manufacturing protocols for the production of our optimized P-SNA lead GMP-compliant facilities (Aim 3.1) and complete FDA recommended IND-enabling studies (Aim 3.2). Together, these steps will enable the delivery of a lead P-SNA therapeutic for TNBC, fully characterized and optimized for efficacy and ready for clinical evaluation. Additionally, this work will establish a versatile platform for the development of P-SNAs for other cancer subtypes, increase our knowledge of immune mechanisms to fight cancer, and elucidate important aspects critical for rational PNI design and development.


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 = $562,550 )
2026	2026	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Cancer Treatment Research	000	1	7/7/2026	NEW	$562,550
														Subtotal = $562,550

Grand Total All Awards = $562,550

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Development of novel neoantigen-based spherical nucleic acid immunotherapeutics

Award Number: R01CA302883

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/07/2026

PERIOD OF PERFORMANCE END DATE: 07/01/2031

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