EpicentRx's AdAPT-001 TGFß Inhibitor Gains FDA Fast Track for Sarcoma

EpicentRx, a privately held biopharmaceutical company, has announced that the US Food and Drug Administration granted fast track designation for the oncolytic adenovirus-delivered transforming growth factor beta (TGFß) inhibitor, AdAPT-001, plus the anti-PD-1, nivolumab, or anti-PD-L1, atezolizumab, to treat recurrent or refractory advanced or metastatic soft tissue sarcoma (STS) with disease progression after at least one prior line of therapy.

The purpose of Fast Track designation is to facilitate the development and approval process of drugs like AdAPT-001 that treat a serious condition or meet an unmet need such as STS, a rare tumor type with high heterogeneity, low chemo-, radio- and immunosensitivity, and a poor prognosis.

The fast track designation was based on the promising potential of AdAPT-001 to sensitize STS tumors to checkpoint inhibitors like nivolumab or atezolizumab that they previously received and failed or never previously received because of low levels of both tumor mutation burden and T-cell inflamed gene expression profiles (GEP) that predicted for non-response. Supporting evidence for fast track designation came from phase 1 and 2 clinical trials and an ASCO podium presentation where the activity, safety, and durability of response (progression free survival of ~8.5 months) in patients with STS and other tumor types either alone or in combination with checkpoint inhibition were on full display.

According to EpicentRx CEO and viro-oncologist, Dr. Tony Reid, “Checkpoint blockade immunotherapies have revolutionized cancer therapy for many patients and prolonged the lives of millions. But efficacy depends on - the presence of an immune infiltrate, which is often absent or immunosuppressive, and low levels of immunosuppressive factors like TGFß, which are frequently overexpressed. AdAPT-001 is designed both to inflame the tumor microenvironment and to combat immunosuppression by neutralization of TGFß through the expression of a TGFß trap. Fast Track designation is a terrific acknowledgement of the potential of AdAPT-001 to make a meaningful difference for STS patients who desperately require new treatment options.”

AdAPT-001, EpicentRx’s proprietary 2-in-1 biologic, whose activity was highlighted in a 2024 ASCO podium presentation, is designed to express a potent TGFßR inhibitor for local TGFß neutralization, decreased Treg cell function, and superior therapeutic responses in combination with checkpoint inhibitors for several tumor types including STS, colorectal cancer, breast cancer and hepatocellular carcinoma.

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