LA JOLLA, Calif., Dec. 5, 2024 /PRNewswire/ — EpicentRx announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the oncolytic adenovirus-delivered transforming growth factor beta (TGFβ) 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 (TMB) 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, MD, PhD, “Checkpoint blockade immunotherapies have revolutionized cancer therapy for many patients and prolonged the lives of millions. But efficacy depends on 1) the presence of an immune infiltrate, which is often absent or immunosuppressive, and 2) low levels of immunosuppressive factors like TGFβ, which are frequently overexpressed. AdAPT-001 is designed both to inflame the tumor microenvironment and to combat immunosuppression by neutralization of TGFβ through the expression of a TGFβ 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.”
About AdAPT-001
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 TGFβR inhibitor for local TGFβ 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.
About EpicentRx
EpicentRx is a privately held biopharmaceutical company with two Fast Tracked lead therapies, the large molecule TGFβ inhibitor, AdAPT-001, and the small molecule radiochemoprotector, RRx-001 (nibrozetone). Both AdAPT-001 and RRx-001 are in late-stage clinical trials for STS and severe oral mucositis, and endometriosis, respectively. RRx-001 has also received several lucrative grants to study its antioxidant and anti-inflammatory effects in neurodegenerative diseases like Parkinson’s and ALS/MND and in the setting of neurotoxic exposures. For more information about EpicentRx and lead therapies AdAPT-001 and RRx-001 visit www.epicentrx.com
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SOURCE EpicentRx, Inc.
