Pipeline

Building a broad pipeline in autoimmune
diseases & cancer

Adicet Bio Pipeline graphic

AAV= anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis; ccRCC= Clear cell renal cell carcinoma; IIM= idiopathic inflammatory myopathy; IND= Investigational new drug; LN= lupus nephritis; mCRPC= Metastatic castration-resistant prostate cancer; PSMA= Prostate specific membrane antigen; SLE= systemic lupus erythematosus; SPS= stiff person syndrome; SSC= systemic sclerosis; ST= Solid tumor

Adicet Bio is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer.

Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients.

ADI-001

Our lead product candidate, ADI-001, is a first-in-class investigational allogeneic gamma delta CAR T cell therapy currently being developed in autoimmune indications. It’s being studied in a Phase 1 study in lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).

In Autoimmune Diseases

ADI-001 is ideally suited for the treatment of autoimmune diseases given its robust B-cell depletion consistent with other autologous CAR T therapies tested in autoimmune diseases, its tissue homing, and the safety data observed in our oncology Phase 1 study.

In June 2024, the FDA granted ADI-001 Fast Track Designation for the potential treatment of relapsed/refractory class III or class IV LN.

ADI-270

ADI-270, an armored CD70 CAR γδ T cell targeting CD70 via the CD27-ligand, has shown superiority to scFv (single-chain variable fragment) CARs¹
Innate and adaptive targeting mechanisms associated with activity in solid tumors such as renal cell carcinoma (RCC) and other indications
Armoring via dominant negative receptor; addresses TGFβ in Tumor Microenvironment²
Lead CAR demonstrated potency and improved serial killing, and resilience against suppressive factors and graft vs host rejection
Homing and activity of gamma delta 1 T cells demonstrated in RCC
Received IND clearance and FDA Fast Track Designation

¹ Sauer et al. Blood (2021)
² Junker et al. Cytokine (2000)

Armored PSMA CAR Gamma Delta T Cell Program

Potent CAR construct active against heterogeneous PSMA
Three mechanisms of action designed to address tumor heterogeneity
Homing of gamma delta 1 T cells documented in mCRPC
Inclusion of armoring to address suppressive TME
No significant CRS and ICANS demonstrated with Adicet CAR gamma delta 1 T cells in clinical trials reported to-date

Liu et al. Cancer Res. (1997)

Expanded Access Policy

Expanded Access refers to the use of an investigational therapy outside of a clinical trial for potential treatment of a serious or life-threatening condition. Adicet is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Consistent with our commitment to bring innovative, safe, and effective therapies to patients, we are focused on conducting the clinical trials necessary to gain regulatory approvals to make our therapies available to patients as quickly as possible. Participation in one of our clinical trials is the best way to access Adicet gamma delta T cell investigational therapies. As such, Adicet does not provide access to our investigational therapies on an Expanded Access basis at this time.

We encourage patients interested in our investigational therapies to learn more about our ongoing studies by visiting clinicaltrials.gov. Treating physicians may request additional information about Adicet’s Expanded Access policy by contacting inquiries@adicetbio.com