Adcentrx Therapeutics, Inc.

Initial results expected 4Q 2025 SAN DIEGO, Jan. 6, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, today announced the first patient dosed in the Phase 1a/b study of ADRX-0405 for the treatment of advanced solid tumors. Continue Reading "Advancing our second program into clinical trials marks an important milestone for Adcentrx and further validates the potential of our ADC technology platform," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "STEAP1 is an attractive ADC target, and we are excited about the first-in-class potential for ADRX-0405. We believe this novel ADC offers a unique approach to treating patients with STEAP1-expressing cancers, such as metastatic castration-resistant prostate cancer, where a significant unmet need remains for new targeted therapies." Adcentrx doses first patient in Phase 1a/b study of ADRX-0405, a potential first-in-class STEAP1-targeting ADC. Post this The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label dose escalation and dose expansion study being conducted across sites in the U.S. The trial is enrolling patients with select advanced solid tumors, with the primary objectives of characterizing the safety and tolerability of ADRX-0405 and determining its optimal dose. The company anticipates an initial data readout in 4Q 2025. About ADRX-0405 ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 antibody targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers, yet has limited expression in normal healthy tissue. Adcentrx's proprietary i-Conjugation® technology platform is an important component in the design of ADRX-0405. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with a topoisomerase inhibitor payload conjugated at a drug-to-antibody ratio of eight (DAR 8). ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple tumor models. For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov. About Adcentrx Therapeutics Adcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of i-Conjugation®, an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. In addition to ADRX-0405, Adcentrx is developing a robust pipeline of ADCs with first-in-class and best-in-class potential, including ADRX-0706, a Nectin-4 targeting ADC currently in a Phase 1a/b clinical trial (Study ID NCT06036121 on ClinicalTrials.gov). For more information about Adcentrx and its innovative ADC technologies, please visit . Contact Information: Investor Relations [email protected] SOURCE Adcentrx Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Marks successful completion of Phase 1a dose escalation Phase 1b dose expansion results expected 4Q 2025 SAN DIEGO and SHANGHAI, Dec. 2, 2024 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, today 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. Continue Reading "We are pleased to advance the clinical development of ADRX-0706 into the Phase 1b dose expansion cohorts," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "Encouraging findings from our Phase 1a trial demonstrate the best-in-class potential for ADRX-0706, with differentiated safety and pharmacokinetic properties, including a much lower incidence of critically meaningful AEs for patients, such as peripheral neuropathy. Additionally, the preliminary efficacy responses observed across different dose levels and tumor types provide important clinical validation of Adcentrx's ADC platform, including the i-Conjugation® technology and novel auristatin payload AP-052." First patient dosed in Adcentrx's ADRX-0706 Phase 1b, advancing a new potential treatment option for cancer patients. Post this 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. This second portion of the study will continue to assess the safety and tolerability of ADRX-0706, as well as evaluate preliminary efficacy and determine the optimal dose in urothelial cancer, triple-negative breast cancer, and cervical cancer expansion cohorts. The company expects an initial data readout from the Phase 1b in 4Q 2025. About ADRX-0706 ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs. The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx's innovative i-Conjugation® technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies. ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial. For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov. About Adcentrx Therapeutics Adcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of i-Conjugation®, an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. In addition to ADRX-0706, Adcentrx is developing a robust pipeline of ADCs with first-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit . Contact Information: Investor Relations [email protected] SOURCE Adcentrx Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN DIEGO, CA, USA I October 21, 2024 I Adcentrx Therapeutics (“Adcentrx”), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application of ADRX-0405 for the treatment of select advanced solid tumors. ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 antibody targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers, yet has limited expression in healthy tissue. FDA’s clearance of our second IND marks another major milestone for Adcentrx. Adcentrx’s proprietary i-Conjugation® technology platform is an important component in the design of ADRX-0405. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with a topoisomerase inhibitor payload conjugated at a drug-to-antibody ratio of eight (DAR 8). ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple tumor models. “The FDA’s clearance of our second IND marks another major advancement for Adcentrx,” said Hui Li, Ph.D., President and CEO of Adcentrx. “We are excited about the first-in-class potential for ADRX-0405 and the opportunity to make a meaningful difference for patients battling advanced cancers, including patients with metastatic castration resistant prostate cancer, who have a significant need for new targeted therapies.” The planned first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label, multicenter, non-randomized dose escalation and dose expansion study. The study will enroll patients with select advanced solid tumors, including metastatic castration resistant prostate cancer. The primary objectives of the study will be to characterize the safety and tolerability and to determine the optimal dose of ADRX-0405. The company anticipates the first patient to be enrolled in 4Q 2024, with an estimated initial data readout in 4Q 2025. About Adcentrx Therapeutics Adcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of i-Conjugation®, an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. In addition to ADRX-0405, Adcentrx is developing a robust pipeline of ADCs with first-in-class and best-in-class potential, including ADRX-0706, a Nectin-4 targeting ADC currently in a Phase 1a/b clinical trial (Study ID NCT06036121 on ClinicalTrials.gov). For more information about Adcentrx and its innovative ADC technologies, please visit https://adcentrx.com . SOURCE: Adcentrx Therapeutics