Adcentrx Therapeutics, Inc.

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

Company appoints Mike Varney, Ph.D. and Kerry Blanchard, M.D., Ph.D. as founding SAB members SAN DIEGO and SHANGHAI, Sept. 10, 2024 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company focused on accelerating breakthroughs in developing protein conjugate therapeutics for cancer and other life-threatening diseases, today announces the formation of its Scientific Advisory Board (SAB) to support the advancement of its innovative Antibody-Drug Conjugate (ADC) technology platform and pipeline, including ADRX-0706, a Nectin-4 targeting ADC therapeutic currently being evaluated in a Phase 1a/b clinical trial. Continue Reading The inaugural SAB will work closely with Adcentrx's executive team to provide strategic guidance and expert insights to advance its mission of creating the best therapies to treat serious and life-threatening diseases. Formation of SAB with founding members Dr. Varney and Dr. Blanchard represents significant advancement for Adcentrx. Post this "The establishment of our SAB represents a significant advancement for Adcentrx as we progress our ADC portfolio," said Hui Li, Ph.D., President and CEO of Adcentrx. "We are privileged to welcome these exceptional scientific leaders to the Adcentrx team, and their combined expertise and guidance will be instrumental in shaping our future research and clinical development." The Founding Members of the Adcentrx SAB are: Mike Varney, Ph.D. Dr. Varney brings extensive experience in drug discovery and development, having served as Executive Vice President, Head of Genentech Research and Early Development, where he was responsible for all research activities. During his tenure at Genentech, he oversaw the discovery and development of multiple innovative therapies, including the approved cancer treatments Erivedge® and Cotellic®. Earlier in his career, Dr. Varney pioneered the use of protein-structure based drug design at Agouron Pharmaceuticals. This innovative approach led to the discovery and market approval of HIV protease inhibitor, Viracept®. After Agouron's acquisition by Warner Lambert and subsequently by Pfizer, he served as Vice President of Drug Discovery at Pfizer Global Research & Development, leading research initiatives across oncology, virology, diabetes, and ophthalmology at the La Jolla site. Dr. Varney holds a Ph.D. in Organic Synthesis from the California Institute of Technology and a B.S. in Chemistry from the University of California, Los Angeles, and was an American Cancer Society Postdoctoral Research Fellow at Columbia University. Kerry Blanchard, M.D., Ph.D. Dr. Blanchard has been a drug hunter and entrepreneur for more than four decades in the US and Asia. He is currently cofounder, Chairman, and CEO of Perpetual Medicines, a peptide therapeutics/computational AI platform company. Previously, he was the CEO of Everest Medicines, Chief Science Officer at Innovent Biologics, Senior Vice President of Lilly China Drug Development and External Innovation, and a senior executive at Eli Lilly and Company. He was a member of the board for Lilly China and Zymeworks Inc., and was the co-chairman of the Lilly Asia Ventures Investment Committee. Prior to joining Lilly in 2000, he was a tenured Professor of Medicine and Biochemistry & Molecular Biology at Louisiana State University Health Sciences Center in Shreveport, LA. Dr. Blanchard has brought four medicines to the market from his own research including Verzenio®, a CDK 4/6 inhibitor, and, his development teams in China have had more than 30 approved medicines in Asia including Trodelvy®, Trulicity®, Byetta®, Forteo®, and Tyvyt®. At Innovent and Everest, Dr. Blanchard successfully raised over $2 billion to support and expand their pipelines. His track record in accelerating clinical development and navigating regulatory landscapes will significantly enhance Adcentrx's strategic initiatives and global expansion. Dr. Blanchard received his M.D. and Ph.D. in Biochemistry from Indiana University and completed his residency and fellowships at Brigham and Women's Hospital, Dana Farber Cancer Institute, and Harvard Medical School. 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

Follows initiation of Phase 1a/1b study in the U.S. Company plans to include clinical centers in China to broaden geographic representation and accelerate patient enrollment into the Phase 1a/1b study SAN DIEGO and SHANGHAI, May 6, 2024 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a biotechnology company revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, 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. ADRX-0706 is an ADC comprised of a novel fully human IgG1 antibody targeting human Nectin-4 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. Nectin-4 is a validated target for ADCs with high expression in multiple solid tumors and limited expression in normal tissues. It plays a crucial role in tumor progression and has been associated with poor prognosis and resistance to conventional therapies. "NMPA's clearance of the ADRX-0706 IND is an important milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "We now have the ability to recruit patients in both the U.S. and China to generate valuable data in different patient populations, and the data will enable us to further explore ADRX-0706 in treating patients with high unmet needs across multiple tumor types." 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. About ADRX-0706 ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. 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