AdAPT-001

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 Media Contact Ashley Thomaz MCS Healthcare Public Relations Investor Contact Scott Caroen Senior Director of Operations & Corporate Development [email protected] SOURCE EpicentRx, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The combination AdAPT-001 + a checkpoint inhibitor achieved high durable overall response rates and an 8 month+ PFS in patients who progressed on checkpoint inhibitors and chemotherapy TORREY PINES, Calif., Oct. 28, 2024 – EpicentRx, a clinical-stage biopharmaceutical company, announced a poster presentation on the combination of AdAPT-001 plus a checkpoint inhibitor in checkpoint inhibitor-resistant tumors at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC) in Houston, Texas from November 6-10, 2024. Primary resistance to immune checkpoint blockade therapy (ICBT) is widespread, and so are cases where tumors initially respond but subsequently acquire resistance and relapse. A central mechanism of ICBT resistance is overexpression of the immunosuppressive cytokine, transforming growth factor-beta (TGFβ). AdAPT-001 expresses a TGFβ trap that selectively neutralizes TGFβ isoforms 1 and 3. “Checkpoint blockade immunotherapies are effective in a minority of patients with tumors that are infiltrated by T cells,” said EpicentRx CEO and oncologist, Dr. Tony Reid. “Results from the Phase 2 clinical trial with AdAPT-001 in multiple metastatic tumor types, including melanoma, sarcoma, triple negative breast cancer and squamous cell cancer of the head and neck strongly suggest that the TGFβ trap, which AdAPT-001 expresses, durably sensitizes previously checkpoint inhibitor-resistant tumors in many cases for six months or more to those same checkpoint inhibitors. These are potentially practice-changing results.” MD Anderson Sarcoma Specialist and Lead Investigator, Dr. Anthony Conley, concurred that, “Most of the tumors on this Phase 2 clinical trial are not only without driver mutations, but are also non-inflamed and non-immunogenic, which makes them broadly resistant to tyrosine kinase inhibitors, checkpoint inhibitors, and chemotherapy. My colleagues and I are very encouraged by the impressively durable overall response rates and long PFS with AdAPT-001 to date, which highlight its potential to redefine the standard of care for late-stage, therapy resistant patients.” Abstract Number 663: AdAPT-001, a first-in-class 2-in-1 TGF-beta inhibitor plus a checkpoint inhibitor: updated results from a Phase 2 study in solid tumors Presenter: Anthony P. Conley, MD, Lead Investigator, MD Anderson Cancer Center. Date: Friday, November 8, 2024 About EpicentRx EpicentRx is at the epicenter of innovative drug development with therapies like AdAPT-001 and RRx-001 that target diseases and toxicities of hugely unmet medical need. For more information about the trial and EpicentRx’s pipeline, please visit www.epicentrx.com. Business Development Contact: Scott Caroen EpicentRx scaroen@epicentrx.com Media Contact: Ashley Thomaz MCS Healthcare Public Relations ashleyt@mcspr.com