Matt Hewitt

Dewey Steadman

Lenny Dunn

Steve Schwartz

Timothy Stabosz

Bruce Berger

David Wright

Doug O’Bannon

Elliot Wilbur

Lester Petruzzi

Matthew Hewitt

Oliver Butt

Rich Thomson

- Adicet Bio's ADI-001 Phase 1 autoimmune study demonstrated a **well-tolerated safety profile** suitable for outpatient administration, with **no Grade 2 or higher Cytokine Release Syndrome (CRS)** and **no Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)**.  **[1720580_2170220:7]** **[1720580_2170220:11]** 
- The study reported **rapid and sustained reductions in SLEDAI-2K and PGA** across all patients (five LN and two SLE), with **all five LN patients achieving renal responses**, including three complete responses.  **[1720580_2170220:8]** **[1720580_2170220:11]** 
- ADI-001 treatment showed **clear evidence of immune reset**, characterized by deep and broad B cell depletion and reconstitution by naive B cells, leading to all patients discontinuing immunosuppressants and tapering corticosteroids.  **[1720580_2170220:8]** **[1720580_2170220:9]** **[1720580_2170220:11]** 
- Adicet Bio anticipates **key milestones in 2026**, including clinical updates for SLE and LN, alignment with the FDA on pivotal study design, and initiation of a pivotal study in LN or LN/SLE.  **[1720580_2170220:12]**

Adicet Bio Provides Positive ADI-001 Phase 1 Autoimmune Study Update

- Adicet Bio announced promising safety and efficacy results from its ongoing Phase I study of **ADI-one** in patients with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE).  **[1720580_2170449_1]** 
- The study demonstrated **rapid and sustained reductions** in SLEDAI-2K and Physician Global Assessment (PGA) scores across all seven patients (five LN and two SLE).  **[1720580_2170449_1]** **[1720580_2170449_3]** 
- **Kidney function improved in all five LN patients**, with **three achieving complete renal responses (CRR)** and two partial renal responses, representing a **60% CRR rate**.  **[1720580_2170449_1]** **[1720580_2170449_3]** **[1720580_2170449_12]** 
- ADI-one was **very well tolerated**, with **no serious adverse events (SAEs)**, **no ICANS**, and **no CRS events greater than Grade 1**.  **[1720580_2170449_1]** **[1720580_2170449_3]**  All patients discontinued immunosuppressants and tapered steroids to zero or below physiological levels.  **[1720580_2170449_3]** **[1720580_2170449_5]** 
- The company plans to request a meeting with the FDA in **Q1 2026** to inform the Phase II pivotal trial design for LN or LN and SLE, with the study anticipated to commence in **Q2 2026**.  **[1720580_2170449_10]** **[1720580_2170449_12]**

Adicet Bio Reports Positive Phase I Study Results for ADI-one

Adicet Bio (ACET)