ADRX-0706 / Adcentrx Therap - LARVOL DELTA

Adcentrx Therapeutics Granted Fast Track Designation for ADRX-0706 Nectin-4 ADC for the Treatment of Advanced Cervical Cancer (PRNewswire) - "Adcentrx Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead program, ADRX-0706, for the treatment of patients with locally advanced or metastatic squamous cell cervical cancer. ADRX-0706 is a Nectin-4 ADC being evaluated in the Phase 1b portion of an ongoing Phase 1a/b clinical trial (NCT06036121) for the treatment of select advanced solid tumors, including cervical cancer. The company will present interim data from the completed Phase 1a dose escalation portion at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting."

Fast track • P1 data • Cervical Cancer

Preliminary results from a first-in-human phase 1 dose escalation trial of ADRX-0706, a next generation Nectin-4 ADC, in subjects with advanced solid tumors. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT06036121 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P1 data • Oncology • Solid Tumor • NECTIN4

Adcentrx Therapeutics to Present First Clinical Data for ADRX-0706 Nectin-4 ADC at ASCO 2025 (PRNewswire) - "Adcentrx will deliver a poster presentation on ADRX-0706, a clinical-stage Nectin-4 ADC. The presentation will include interim clinical data from the Phase 1a portion of the ongoing trial (NCT06036121), demonstrating the best-in-class potential for ADRX-0706. The findings indicate a differentiated safety and pharmacokinetic profile, including a significantly lower incidence of critically meaningful adverse events such as peripheral neuropathy. Additionally, preliminary efficacy signals across different dose levels and tumor types provide strong clinical validation of Adcentrx's ADC platform, including the i-Conjugation technology and novel auristatin payload AP052."

P1 data • Solid Tumor

Adcentrx Therapeutics Doses First Patient in Phase 1b Expansion Cohorts with ADRX-0706 Nectin-4 ADC (PRNewswire) - "Adcentrx Therapeutics...announced the dosing of the first patient in the Phase 1b portion of ADRX-0706-001, the ongoing Phase 1a/b study of ADRX-0706 for the treatment of advanced solid tumors....The first-in-human Phase 1a/b study is an open-label, two-part trial being conducted at sites in the U.S. and China. The Phase 1a part consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in the Phase 1b part....The company expects an initial data readout from the Phase 1b in 4Q 2025."

P1 data • Trial status • Solid Tumor

Adcentrx Therapeutics Announces China NMPA Grants IND Clearance for ADRX-0706, a Novel Nectin-4 ADC for the Treatment of Advanced Solid Tumors (PRNewswire) - "Adcentrx Therapeutics...announced today that China National Medical Products Administration (NMPA) has cleared Adcentrx's Investigational New Drug (IND) application for ADRX-0706 which enables the company to include China-based clinical centers in the ongoing Phase 1a/1b study for the treatment of select advanced solid tumors....The first-in-human Phase 1a/b clinical trial of ADRX-0706 is an open-label, multicenter dose escalation and dose expansion study. The study is enrolling patients with select advanced solid tumors. The primary objectives of the study are to characterize the safety and tolerability and to determine the optimal dose of ADRX-0706. The company expects an initial data readout in mid-2024."

New P1 trial • Solid Tumor

Preclinical characterization of ADRX-0706: A next-generation anti-Nectin-4 antibody-drug conjugate with improved therapeutic window (AACR 2024) - P1 | "A first-generation antibody-drug conjugate targeting Nectin-4, called enfortumab vedotin-ejfv (EV), was granted accelerated FDA approval in 2019 for urothelial cancers, and is currently approved for frontline therapy in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma, providing groundbreaking improvement in patient survival. In summary, the highly selective and potent anti-tumor activity in multiple tumor types and wide preclinical therapeutic index of ADRX-0706 support clinical evaluation of this next generation anti-Nectin-4 ADC. ADRX-0706 is currently in a phase 1a/b study (NCT06036121)."

Preclinical • Bladder Cancer • Cervical Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Urothelial Cancer

ADRX-0706 Nectin-4 antibody-drug conjugate PK/PD characterization elucidates its widened therapeutic window (AACR 2024) - P1 | "A first-generation antibody-drug conjugate targeting Nectin-4, called enfortumab vedotin-ejfv (EV), was granted accelerated FDA approval in 2019 for urothelial cancers, and is currently approved for frontline therapy in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma, providing groundbreaking improvement in patient survival. In summary, the preclinical efficacy and safety properties of ADRX-0706 support clinical evaluation of this next generation anti-Nectin-4 ADC. ADRX-0706 is currently in a phase 1a/b study (NCT06036121)."

IO biomarker • PK/PD data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • PD-L1

Adcentrx Therapeutics to Present Preclinical Data for Nectin-4 ADC Program at the American Association for Cancer Research (AACR) Annual Meeting 2024 (PRNewswire) - "Adcentrx Therapeutics...announced that preclinical data for ADRX-0706 will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2024....The three presentations will include preclinical data for Adcentrx's lead ADC program, ADRX-0706....The preclinical data presentations show improved therapeutic window of ADRX-0706, enhanced bystander effect and improved payload delivery to Nectin-4 expressing tumors while minimizing exposure to normal tissues."

Preclinical • Oncology

Adcentrx Therapeutics Announces First Patient Dosed in the Phase 1a/b Study of ADRX-0706, a Novel ADC Targeting Nectin-4 for the Treatment of Advanced Solid Tumors (PRNewswire) - "Adcentrx Therapeutics...announced the first patient dosed in the Phase 1a/b study of ADRX-0706 for the treatment of advanced solid tumors....The company expects an initial data readout in the middle of 2024."

P1 data • Trial status • Oncology • Solid Tumor

A Study of ADRX-0706 in Select Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Adcentrx Therapeutics

Metastases • New P1 trial • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Adcentrx Therapeutics Announces FDA Clearance of Investigational New Drug Application for ADRX-0706, a Novel ADC Targeting Nectin-4 for the Treatment of Advanced Solid Tumors (PRNewswire) - "Adcentrx Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application of ADRX-0706 for the treatment of select advanced solid tumors....The first-in-human Phase 1a/1b clinical trial of ADRX-0706 will be an open-label, multicenter, non-randomized dose escalation and dose expansion study. The study will enroll patients with select advanced solid tumors. The primary objectives of the study will be to characterize the safety and tolerability and to determine the optimal dose of ADRX-0706. The company expects the first patient to be enrolled in the second half of 2023, with an initial data readout in the middle of 2024."

IND • New P1 trial • P1 data • Oncology • Solid Tumor

Adcentrx Therapeutics Announces Completion of $38 million Series A+ Financing Led by Eight Roads Ventures (PRNewswire) - "Adcentrx Therapeutics...announces the closing of a $38 million Series A+ financing. The round was led by Eight Roads Ventures, with participation from F-Prime Capital, ABio-X, Delta Capital, Trinity Innovation Fund, and other strategic investors. Life Venture Partners and Lighthouse Capital acted as Adcentrx's financial advisors. Adcentrx intends to use the proceeds from the financing to advance its proprietary ADC therapeutic pipeline into the clinic....The company's lead candidate, ADRX-0706, is anticipated to enter a first-in-human Phase 1 clinical trial in the second half of 2023. Adcentrx is developing additional candidates in parallel with the goal of advancing at least one into the clinic each year."

Financing • New P1 trial • Pipeline update • Oncology