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

TI-0032 first-in-human study initiated; US/China dual IND filing on track

BEIJING & SHANGHAI--(BUSINESS WIRE)--Therorna Inc., a clinical-stage biotechnology company pioneering circular RNA (circRNA)-based therapies, today announced that the company will present three posters at the 2026 American Society of Gene & Cell Therapy (ASGCT) 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.

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 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

About Therorna

Therorna Inc. is a clinical-stage biotechnology company dedicated to designing and delivering circular RNA (circRNA)-based therapies and vaccines to address high unmet medical needs. Founded in Beijing in April 2021 by a team of leading scientists and seasoned biopharma operators, the company maintains operations in Beijing and Shanghai, China. Therorna is built on a proprietary, splint-free enzymatic circularization technology and a targeted LNP delivery platform, and has advanced three differentiated platforms — CircCAR™ (in vivo CAR-T), CircMab™ (in-body antibodies and T-cell engagers), and CircVac™ (therapeutic and prophylactic vaccines) — supported by a 16,000 sq ft in-house GMP facility with end-to-end manufacturing capability and six clinical batches completed to date. The company is backed by leading investors including Quan Capital, Sherpa Healthcare Partners, Cenova Capital, and Tencent Investment. To learn more, please visit www.therorna.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding Therorna’s research and development plans, clinical development timelines, regulatory filings, and the therapeutic potential of its circRNA-based product candidates. These statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Therorna undertakes no obligation to update these statements, except as required by law.