Therorna to Showcase Clinical-Ready Circular RNA in vivo CAR-T and CircRNA Pipeline at the 2026 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting

On May 11, 2026 Therorna Inc., a clinical-stage biotechnology company pioneering circular RNA (circRNA)-based therapies, reported that the company will present three posters at the 2026 American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place May 11–15, 2026, in Boston, Massachusetts. The lead presentation will showcase preclinical data supporting TI-0032, the company’s flagship CD19-targeted, circRNA-based in vivo CAR-T candidate, which recently advanced into a first-in-human investigator-initiated trial (IIT) in patients with recurrent and refractory autoimmune diseases. Two additional posters will feature data from Therorna’s broader pipeline: a circRNA-encoded CD19×CD3 T-cell engager and TI-0093, a circRNA-based HPV16 therapeutic cancer vaccine.

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Therorna’s circRNA platform has been advanced into human studies across multiple programs and therapeutic areas. The company’s SARS-CoV-2 circRNA vaccine was evaluated in 100 healthy subjects. In oncology, Therorna’s TI-0093 HPV16 therapeutic vaccine received the first circRNA IND approval in oncology globally. Building on this clinical foundation, TI-0032 now extends Therorna’s circRNA platform into in vivo CAR-T therapy.

"The launch of the first-in-human study of TI-0032 is a defining milestone for Therorna and for our circRNA-based in vivo CAR-T program," said Lu Gao, Ph.D., Chief Executive Officer of Therorna. "TI-0032 is engineered to deliver re-dosable, off-the-shelf treatment by reprogramming a patient’s T cells in situ. Our preclinical data demonstrates highly potent and durable CAR expression, rapid and durable B-cell depletion at a very low dose in humanized mice, and complete B-cell depletion in non-human primates. With our US/China dual IND filing for TI-0032 on track, we are well positioned to bring a new class of in vivo CAR-T therapy to patients worldwide."

TI-0032: A Differentiated in vivo CAR-T Approach

TI-0032 is Therorna’s lead in vivo CAR-T candidate, designed to enable re-dosable, off-the-shelf treatment by reprogramming a patient’s T cells in situ. The product combines a CD19-directed CAR encoded on Therorna’s proprietary scarless, splint-free circRNA payload with a T cell–targeted lipid nanoparticle (tLNP) delivery system that uses a humanized antibody fragment for site-directed conjugation and an ionizable lipid that avoids hepatic accumulation. Preclinical highlights to be presented at ASGCT (Free ASGCT Whitepaper) include:

In primary human immune cells: durable CAR expression in primary human T cells (≥ 14 days), greater than 90% CD8⁺ selectivity in the CAR⁺ population, and >95% B-cell cytotoxicity at a ≥ 0.01 µg dose, including efficient B-cell depletion in PBMCs from SLE patients.
In humanized mouse models: robust in vivo CAR expression in CD8⁺ T cells across both the blood and tissues after a single dose; complete B-cell depletion within 24 hours; and complete tumor regression in the Nalm6 lymphoma model at 0.02 mg/kg (0.4 μg/mouse).
In non-human primates: complete B-cell depletion across peripheral blood, spleen, bone marrow, and mesenteric lymph nodes (IHC-confirmed).
Additional Pipeline Data to be Presented

Circular RNA-encoded CD19×CD3 T-cell engager (CircMab platform): A novel off-the-shelf approach designed to enable in-body production of a bispecific T-cell engager for deep B-cell depletion in autoimmune diseases, leveraging the durable protein expression of circRNA to extend exposure beyond what is achievable with conventional antibody infusions and with a potentially favorable cytokine release profile.
TI-0093 (CircVac platform): A circRNA-based HPV16 therapeutic vaccine, designed with an antigen architecture that balances T-helper support and CD8⁺ activation, eliciting potent tumor antigen–specific T-cell responses for the clearance of HPV16-positive solid tumors in vivo. TI-0093 has received the first circRNA IND approval in oncology globally.
Poster Presentation Details

Presentation ID: 1254
Title: TI-0032: A Novel Circular RNA-based in vivo CAR-T Therapy
Date/Time: Tuesday, May 12, 2026, 5:00 PM – 6:30 PM ET
Location: Halls B2-C, Exhibit Level

Presentation ID: 2256
Title: A Circular RNA-Encoded CD19×CD3 T-Cell Engager: A Novel Off-the-Shelf Deep B-Cell Depletion Therapy in Autoimmune Diseases
Date/Time: Wednesday, May 13, 2026, 5:00 PM – 6:30 PM ET
Location: Halls B2-C, Exhibit Level

Presentation ID: 3243
Title: A Novel Circular RNA-based HPV16 Therapeutic Vaccine: Eliciting Potent Antitumor Immunity for Tumor Clearance in vivo
Date/Time: Thursday, May 14, 2026, 5:00 PM – 6:30 PM ET
Location: Halls B2-C, Exhibit Level

(Press release, Therorna, MAY 11, 2026, View Source [SID1234665466])