Adicet Bio pushes prula-cel Phase 1 update to Q3 2026, cites FDA talks on pivotal trial

Adicet Bio reported second quarter 2026 results on August 5, 2026, and said its Phase 1 clinical update for prulacabtagene leucel (prula-cel) is now expected in the third quarter of 2026, with the additional follow-up time meant to allow a more comprehensive dataset covering 22 LN/SLE patients with a minimum of six months of follow-up, including 13 patients expected to reach at least 12 months.¹ Of those patients, the update is expected to include data from 16 LN and 6 SLE patients.¹

On the regulatory front, the company said recent interactions with the FDA are informing a potential pivotal trial design in LN, with start-up activities for that pivotal program anticipated to begin in the second half of 2026, subject to regulatory clearance.¹ Separately, following FDA alignment reached in November 2025, LN and SLE patients in current and future studies may be dosed with prula-cel in an outpatient setting.¹ Adicet also said it anticipates sharing additional clinical updates for prula-cel in the second half of 2026 in patients with systemic sclerosis.¹

In solid tumors, Adicet expects to submit a regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer in the third quarter of 2026, with Phase 1 enrollment anticipated to begin in the fourth quarter of 2026, subject to regulatory clearance.¹

On the corporate side, following the departure of Dr. Julie Maltzman, Dr. Lloyd Klickstein, who serves on the company's board, was appointed Interim Chief Medical Officer while a search for a permanent CMO continues.¹

Financially, cash, cash equivalents and short-term investments were $118.2 million as of June 30, 2026, which the company said should be sufficient to fund operations into the second half of 2027.¹ Net loss for the quarter was $21.4 million, or $1.99 per basic and diluted share.¹