On November 6, 2026 Azalea Therapeutics, Inc., a biotechnology company redefining precision genomic medicines in vivo, reported new preclinical data demonstrating durable anti-tumor activity and the versatility of its proprietary in vivo TRAC-CAR T cell platform. The findings, to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting (SITC 2026), taking place November 4 – 8, 2026, in Phoenix, Arizona, highlight the platform’s ability to generate functional CAR T cells through precise genomic integration, achieve durable tumor control across hematologic and solid tumor models and enable advanced engineering strategies designed to address key limitations of conventional CAR T cell therapies.

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Azalea’s proprietary dual-vector platform combines T cell-targeted enveloped delivery vehicles (EDVs) delivering transient CRISPR-Cas9 complexes with T cell-tropic adeno-associated viruses (AAVs) carrying a promoterless CAR gene. This approach enables precise insertion of the CAR gene at the TRAC locus, placing CAR expression under control of the endogenous T cell promoter. The platform is designed to generate potent, durable and physiologically regulated CAR T cells directly inside the body, without the need for individualized ex vivo manufacturing.

"These data reinforce both the potency and versatility of our precision in vivo CAR T platform," said Jenny Hamilton, Ph.D., co-founder, president and chief executive officer of Azalea Therapeutics. "Beyond generating functional CAR T cells directly in the body, we are demonstrating the ability to engineer increasingly sophisticated CAR designs that address important challenges in cell therapy, including antigen escape, solid tumor activity and long-term disease control. Combined with our previously reported non-human primate findings, these results strengthen our confidence in the platform’s potential to deliver a new generation of more accessible and durable cell therapies."

Key Findings from the SITC (Free SITC Whitepaper) Presentation

The presentation highlights new preclinical data demonstrating:

Durable leukemia tumor clearance, including following rechallenge
A single intravenous administration of EDV and AAV generated TRAC-CAR T cells in humanized mouse models, resulting in dose-dependent CAR T cell generation and complete clearance of CD19-positive NALM6 leukemia at active dose levels. In select treatment groups, tumor control was maintained following a secondary tumor challenge approximately 60 days after initial treatment, without additional dosing, supporting the potential for durable anti-tumor activity.
Dual-antigen targeting to address tumor escape
The modular platform enabled in vivo generation of dual CD19/CD20-targeted TRAC-CAR T cells, demonstrating activity against antigen-heterogeneous leukemia cells and supporting the potential to limit antigen escape, an important mechanism of resistance to CAR T cell therapy.
Enhanced solid tumor activity through CAR armoring
In a humanized mouse model of mesothelin-expressing solid tumors, in vivo-engineered TRAC-CAR T cells demonstrated strong anti-tumor activity, with co-delivery of performance-enhancing peptides (PEPs) further improving tumor control. These findings support the platform’s ability to incorporate additional functional elements to enhance CAR T cell activity in challenging tumor settings.
Precise genomic integration
Genome-wide integration-site analysis in human splenocytes from humanized mice showed that 99% of sequencing reads passing filtering mapped to the intended TRAC locus, supporting the genomic locus-specific integration capabilities of the platform.
Robust pharmacodynamic activity in non-human primates
Consistent with previously reported results, a single intravenous administration generated TRAC-CAR T cells in immunocompetent non-human primates, with CAR T cells reaching up to 41% of peripheral T cells and deep B cell depletion observed across peripheral blood, lymph nodes and bone marrow without prior lymphodepletion.
"One of the key advantages of our approach is the ability to combine cell-selective delivery with precise, programmable genomic integration," said Connor Tsuchida, Ph.D., scientific co-founder and vice president of research and development at Azalea Therapeutics. "The durable tumor control following rechallenge, along with our ability to engineer dual-targeting and armored CAR T cells, demonstrates the flexibility of this platform to address diverse therapeutic challenges even beyond hematologic malignancies. Importantly, the activity observed across mouse and non-human primate models provides further support for advancing this technology toward clinical translation."

Azalea will present these data at the SITC (Free SITC Whitepaper) 2026 Annual Meeting.

Abstract Number: 950
Title: In vivo TRAC-CAR T cell engineering via cell-selective delivery and genomic locus-specific integration results in potent tumor clearance in mice and B cell depletion in non-human primates
Presenting Author: Connor Tsuchida, Ph.D., Azalea Therapeutics
Presentation Date: Saturday, November 7, 2026
Poster Presentation Times: 12:15 – 1:45 pm and 6:45 – 8:10 pm MST
Location: Phoenix Convention Center

The ePoster will be available on the SITC (Free SITC Whitepaper) virtual meeting platform beginning Friday, November 6, 2026, at 9:00 am ET.

(Press release, Azalea Therapeutics, NOV 6, 2026, View Source [SID1234674427])