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Late-stage development and de-risking of a novel monoclonal antibody immunotherapy for EGFR-positive solid cancers

Award Number: R44CA291266
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/06/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Late-stage development and de-risking of a novel monoclonal antibody immunotherapy for EGFR-positive solid cancers - Abstract The primary objective of this project is to develop therapeutic IgA to uniquely harness the tumor cytolytic potential of neutrophils to target EGFR-mutant non-small cell lung cancer (NSCLC), thereby enabling these patients to live better, longer lives. Toward this goal, TigaTx is developing TIGA-001, a first-in-class, IgA-based monoclonal antibody treatment for advanced/metastatic EGFR-positive NSCLC, with plans to initiate a first-in-human clinical trial. TigaTx has generated a robust data package around the TIGA-001 molecule, leading to its selection as our first development candidate. TIGA-001 has demonstrated excellent in vitro potency and in vivo efficacy, and is well tolerated in non-human primates with favorable safety and pharmacokinetic profiles. TIGA-001 utilizes our patented, structure-driven protein engineering to overcome the known manufacturing liabilities of natural IgA, enabling us to be the first to transform IgA into a clinically-relevant platform technology. In this project, we will progress our TIGA-001 candidate into CMC activities, in vitro pharmacology, and biomarker identification and assay development to support filing of an Investigational New Drug application with the FDA. Supported CMC activities will consist of vector generation through master cell bank establishment. Supported pharmacology studies will focus on in vitro safety assessment and studies to support GLP toxicology species selection. Biomarker assays developed from these studies will be incorporated into our first-in-human clinical trial to evaluate dose-PD response relationships, enable patient selection/enrichment, and otherwise inform clinical strategy. Because therapeutic IgA is a platform technology with potential to target a wide variety of tumor- associated antigens, demonstrating clinical proof of concept with our TIGA-001 program would not only benefit patients with EGFR-expressing tumors, but would also open the door to using this approach against other targets in a wide range of additional clinical settings.


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 = -$334,483 )
2026	2024	TIGATX INC	75 KNEELAND ST FL 14	BOSTON	MA	02111	SUFFOLK	USA	Cancer Treatment Research	000	1	12/16/2025	NEW	-$334,483
														Subtotal = -$334,483

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	TIGATX INC	75 KNEELAND ST FL 14	BOSTON	MA	02111	SUFFOLK	USA	Cancer Treatment Research	000	1	8/28/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,418,424 )
2024	2024	TIGATX INC	75 KNEELAND ST FL 14	BOSTON	MA	02111	SUFFOLK	USA	Cancer Treatment Research	000	1	9/6/2024	NEW	$1,418,424
														Subtotal = $1,418,424

Grand Total All Awards = $1,083,941

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Late-stage development and de-risking of a novel monoclonal antibody immunotherapy for EGFR-positive solid cancers

Award Number: R44CA291266

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/06/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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