EpicentRx, a privately-operated biopharmaceutical entity, has disclosed that their investigational therapy, AdAPT-001, has been awarded a Fast Track designation by the US Food and Drug Administration. AdAPT-001, combined with immune checkpoint inhibitors like nivolumab or atezolizumab, targets the treatment of advanced or metastatic soft tissue sarcoma (STS) that is resistant to previous treatments, aiming to address disease progression following at least one prior therapeutic attempt.
The Fast Track pathway is designed to expedite the drug development and approval timeline for promising treatments addressing serious conditions or unmet medical needs, such as STS, a rare type of tumor with considerable heterogeneity and inherent resistance to traditional therapies like chemotherapy, radiation, and immunotherapy.
The designation was influenced by AdAPT-001’s potential to make STS tumors more responsive to checkpoint inhibitors such as nivolumab and atezolizumab, even for patients who previously did not benefit or had not yet received these treatments due to low tumor mutation burdens and T-cell gene expression profiles that generally indicate non-responsiveness. Supporting data from Phase 1 and 2 clinical trials, alongside a presentation at ASCO, showcased impressive activity, safety, and long-lasting responses—in particular, a median progression-free survival of around 8.5 months in patients with STS and various other tumor types.
Dr. Tony Reid, CEO and viro-oncologist at EpicentRx, stated, “Immunotherapies that block checkpoints have transformed cancer treatment for numerous patients, extending millions of lives. However, success depends on the immune infiltrate’s presence and suppressive factors like TGFß, which are typically overexpressed. AdAPT-001 is intended to both promote tumor microenvironment inflammation and mitigate immune suppression by trapping and neutralizing TGFß.” He continued, mentioning the Fast Track status as significant recognition of AdAPT-001’s potential to vastly improve treatment options for STS patients in need.
EpicentRx’s innovative 2-in-1 biologic, AdAPT-001, underscored in a 2024 ASCO podium presentation, is engineered to produce a strong TGFß receptor inhibitor, allowing for local TGFß neutralization, reduced regulatory T-cell activity, and maximized therapeutic outcomes when combined with checkpoint inhibitors across various tumor forms, including STS, colorectal, breast, and liver cancer.