Adicet Bio Eyes Key Lupus Data This Quarter for Off-the-Shelf Cell Therapy

Key Points

• Adicet Bio expects to report lupus data this quarter for its off-the-shelf CAR-T candidate ADI-001, covering 22 patients with at least six months of follow-up and 13 with at least 12 months. The company aims to show 12-month complete-response rates comparable to autologous CAR-T therapies.
• The company is focusing initially on a potential registrational path in lupus nephritis after recent FDA discussions, while preserving the option to expand into systemic lupus erythematosus. Potential studies could use single-arm designs and assess steroid reduction, quality of life, and other measures beyond standard lupus endpoints.
• Adicet also plans additional pipeline updates, including systemic-sclerosis data later this year, a prostate-cancer gamma delta cell therapy, and details on an in vivo CAR-T program.

Adicet Bio NASDAQ: ACET expects to report clinical data this quarter for its lead autoimmune program, ADI-001, also known as prula-cel, including results in lupus nephritis (LN) and systemic lupus erythematosus (SLE), Chief Executive Officer Chen Schor said at the 46th Annual Canaccord Genuity Growth Conference.

ADI-001 is an off-the-shelf gamma delta 1 cell therapy targeting CD20. Schor said the company expects its upcoming LN and SLE update to include 22 enrolled patients, all with at least six months of follow-up. Thirteen of those patients are expected to have at least 12 months of follow-up, primarily in lupus nephritis.

“One year seems to be the benchmark that people are looking at,” Schor said, adding that Adicet’s goal is to demonstrate a complete-response rate at 12 months comparable with rates reported for autologous CAR-T therapies.

Focus on B-Cell Depletion and Durability

Schor said CD20 targeting has shown B-cell depletion results that appear comparable to CD19-directed approaches based on the company’s data. He said Adicet has observed complete depletion of CD19-positive B cells in blood and lymph-node biopsy samples, along with what he characterized as an immune-system reset as patients recover.

He emphasized that tissue penetration, particularly B-cell depletion in lymph nodes, is important for evaluating activity in autoimmune disease. The company has not yet completed the data cut for its upcoming disclosure, he said, but expects to announce the results during the current quarter.

Adicet enrolled patients across five countries and was able to recruit at centers that do not necessarily conduct cell-therapy studies, according to Schor. He attributed that enrollment flexibility to the product’s off-the-shelf availability and the lack of a need for leukapheresis, the process used to collect a patient’s cells for autologous therapies.

Potential Registrational Path in Lupus Nephritis

Following a recent meeting with the U.S. Food and Drug Administration, Adicet plans to provide regulatory feedback alongside its data update, Schor said. He indicated that the company’s initial registrational focus is expected to be lupus nephritis, reflecting the composition of its existing clinical data set, while retaining the option to later expand into SLE.

According to Schor, registrational studies in LN, SLE, or a combined LN and SLE population could potentially use single-arm designs. He said study sizes in the field have ranged from approximately 35 patients in more heavily pretreated populations to roughly 90 patients in populations that have failed fewer prior therapies.

Schor also discussed endpoints beyond conventional lupus measures. He said the company may evaluate factors such as physician global assessment, patient quality of life, reduced use of immunosuppressive drugs, and low or reduced steroid use. He characterized the ability to measure responses without chronic immunosuppression as a potential distinction for cell therapy relative to treatments that require ongoing therapy.

Other Clinical and Pipeline Updates

Adicet also expects to report data in systemic sclerosis during the second half of the year. Schor said the company enrolled a “reasonable number” of patients in that study but did not provide additional guidance on the expected data set.

In rheumatoid arthritis, Adicet is conducting a small study comparing lymphodepletion regimens using cyclophosphamide and fludarabine versus cyclophosphamide alone. Schor said the study is intended to determine whether fludarabine is needed with gamma delta CAR-T cells and could inform conditioning approaches in other indications. The company currently plans to use standard cyclophosphamide/fludarabine conditioning in its pivotal study.

Beyond ADI-001, Schor said Adicet has an off-the-shelf gamma delta 1 cell therapy for prostate cancer planned for clinical development. The candidate targets prostate-specific membrane antigen, or PSMA, and incorporates two additional technologies intended to improve potency and address challenges associated with cell therapy in solid tumors.

The company also plans to disclose details of an in vivo CAR-T pipeline in the near future. “There’s going to be a lot coming from us in the next few months,” Schor said.

About Adicet Bio (NASDAQ:ACET)

Adicet Bio, Inc NASDAQ: ACET is a clinical‐stage biotechnology company specializing in the development of off‐the‐shelf, allogeneic gamma delta (γδ) T cell therapies for oncology and autoimmune disorders. The company's proprietary platform enables the genetic engineering of γδ T cells with chimeric antigen receptors (CARs) and other molecular modifications to enhance tumor targeting, expansion, and persistence. By leveraging the innate tumor-recognition properties of γδ T cells, Adicet seeks to overcome the manufacturing and safety challenges associated with autologous cell therapies.

Adicet's lead product candidate, ADI-001, is a CAR‐engineered allogeneic γδ T cell therapy directed against CD20 for the treatment of relapsed or refractory B-cell malignancies.

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