Adicet Bio (ACET) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Platform and positioning

• Gamma delta 1 T cells are allogeneic, off-the-shelf therapies that home to tissues, supporting development in autoimmune disease and potentially solid tumors.

• Reported advantages over alpha beta CAR T cells include similar potential for efficacy with better tolerability and fewer CRS, ICANS and related events.

• Prula-cel is positioned to induce immunosuppressant-free remission; management cited ~50%–54% remission rates in its dataset and said patients generally stopped immunosuppressants and steroids.

Prula-cel clinical evidence

• The efficacy-evaluable LN/SLE population was 22 patients: 16 with LN and 6 with SLE; all 22 reached 9 months, while 13 had reached 12 months at the reported data cut.

• At 12 months, reported results among the patients evaluated included 50% complete renal response in LN and 54% DORIS remission; both were immunosuppressant-free endpoints.

• Follow-up extended to 21 months, with all but one patient continuing in remission; one LN patient had increased proteinuria, but patients remained immunosuppressant-free.

• CD19 B cells were completely depleted from blood in all 22 patients for ~28 days; recovery was primarily naive B cells, and prior BCR analysis showed refreshed clones after treatment.

• A further update is expected in the next few months, with all 22 patients having at least 12 months of follow-up; management expected the data cut by year-end.

Pivotal study and regulatory plans

• The FDA agreed that the LN pivotal endpoint is immunosuppressant-free complete renal response at 12 months; the study is planned as single-arm, with the LN sample size still under discussion and other studies cited at ~50 patients.

• An FDA meeting this quarter is intended to discuss including SLE alongside LN and agreeing on the SLE endpoint; feedback and pivotal plans are expected to be shared in Q1.

• Pivotal startup activities are underway, with investigator interest reported across the U.S., Europe and Canada; enrollment is expected to proceed in the pivotal study rather than expand the 22-patient dataset.

• Management cited ~100 exposed patients as a general FDA safety expectation based on other therapies and said the existing autoimmune experience plus pivotal enrollment should bring exposure toward that level.