Latest news with #Adcentrx
Malaysian Reserve
5 days ago
- Business
- Malaysian Reserve
U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for Gastric Cancer
Orphan drug designation highlights the potential for ADRX-0405 to address the high unmet need in gastric cancer SAN DIEGO, July 8, 2025 /PRNewswire/ — Adcentrx Therapeutics ('Adcentrx'), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ADRX-0405, for the treatment of patients with gastric cancer. ADRX-0405 is a STEAP1 ADC being evaluated in the Phase 1a portion of an ongoing Phase 1a/b clinical trial (NCT06710379) for the treatment of select advanced solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer. While STEAP1 is primarily associated with prostate cancer, there is a meaningful amount of target expression in gastric cancer, making this a potential indication of interest for future clinical development. 'Receiving orphan drug designation from FDA is a notable milestone for Adcentrx and reinforces the potential for ADRX-0405 to improve the lives of patients with gastric cancer,' said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. 'We are encouraged by the progress of our Phase 1a trial and look forward to further evaluating the safety, tolerability and anti-tumor activity of ADRX-0405 in gastric and other cancers.' Gastric cancer, or stomach cancer, is a serious malignancy that develops in the stomach lining and is often diagnosed at advanced stages. The American Cancer Society estimates there will be 30,300 new cases of gastric cancer in the U.S. in 2025, meeting FDA's criteria for a rare disease. The orphan drug designation is a program designed to stimulate the development of treatments for rare diseases, defined as conditions affecting fewer than 200,000 people in the U.S. Benefits of this designation include access to grant funding and scientific assistance, tax credits for qualified clinical trials, waiver of Prescription Drug User Fee Act (PDUFA) application fees, and the potential for seven years of market exclusivity following regulatory approval. About ADRX-0405ADRX-0405 is a clinical-stage next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers with limited expression in normal healthy tissue. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx's innovative i-Conjugation® technology platform – a core component in the design of the company's ADCs. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial. For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on About Adcentrx TherapeuticsAdcentrx 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 an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. Adcentrx is developing a robust pipeline including two clinical-stage ADCs and multiple preclinical ADCs, all with first-in-class and best-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit Contact Information:Investor Relationsir@
Yahoo
5 days ago
- Business
- Yahoo
U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics' ADRX-0405 STEAP1 ADC for Gastric Cancer
Orphan drug designation highlights the potential for ADRX-0405 to address the high unmet need in gastric cancer SAN DIEGO, July 8, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ADRX-0405, for the treatment of patients with gastric cancer. ADRX-0405 is a STEAP1 ADC being evaluated in the Phase 1a portion of an ongoing Phase 1a/b clinical trial (NCT06710379) for the treatment of select advanced solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer. While STEAP1 is primarily associated with prostate cancer, there is a meaningful amount of target expression in gastric cancer, making this a potential indication of interest for future clinical development. "Receiving orphan drug designation from FDA is a notable milestone for Adcentrx and reinforces the potential for ADRX-0405 to improve the lives of patients with gastric cancer," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "We are encouraged by the progress of our Phase 1a trial and look forward to further evaluating the safety, tolerability and anti-tumor activity of ADRX-0405 in gastric and other cancers." Gastric cancer, or stomach cancer, is a serious malignancy that develops in the stomach lining and is often diagnosed at advanced stages. The American Cancer Society estimates there will be 30,300 new cases of gastric cancer in the U.S. in 2025, meeting FDA's criteria for a rare disease. The orphan drug designation is a program designed to stimulate the development of treatments for rare diseases, defined as conditions affecting fewer than 200,000 people in the U.S. Benefits of this designation include access to grant funding and scientific assistance, tax credits for qualified clinical trials, waiver of Prescription Drug User Fee Act (PDUFA) application fees, and the potential for seven years of market exclusivity following regulatory approval. About ADRX-0405ADRX-0405 is a clinical-stage next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers with limited expression in normal healthy tissue. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx's innovative i-Conjugation® technology platform – a core component in the design of the company's ADCs. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial. For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on About Adcentrx TherapeuticsAdcentrx 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 an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. Adcentrx is developing a robust pipeline including two clinical-stage ADCs and multiple preclinical ADCs, all with first-in-class and best-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit Contact Information:Investor Relationsir@ View original content to download multimedia: SOURCE Adcentrx Therapeutics
Yahoo
06-05-2025
- Business
- Yahoo
Adcentrx Therapeutics Granted Fast Track Designation for ADRX-0706 Nectin-4 ADC for the Treatment of Advanced Cervical Cancer
Fast Track designation underscores the potential for ADRX-0706 to address the high unmet need in advanced cervical cancer SAN DIEGO, May 6, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, today 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. Adcentrx Logo (PRNewsfoto/Adcentrx Therapeutics) 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. Early findings demonstrated a differentiated safety and pharmacokinetic profile, including a notably lower incidence of adverse events such as peripheral neuropathy, along with preliminary efficacy signals across multiple tumor types. Cervical cancer represents a significant unmet need, particularly for patients whose disease progresses following initial treatment. Nectin-4 is highly expressed in cervical cancer, making it a compelling tumor type for treatment with a Nectin-4 ADC. "The Fast Track designation granted by the FDA underscores the significant unmet need in advanced cervical cancer and marks another meaningful milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "This recognition, together with the early clinical signals observed for ADRX-0706, reinforces the best-in-class potential of our Nectin-4 ADC and provides the opportunity for enhanced regulatory dialogue as we continue advancing this important program through clinical development." The FDA's Fast Track program is designed to accelerate the development and review of therapies for serious conditions with unmet medical needs, with the goal of getting important new treatments to patients sooner. The designation enables earlier and more frequent communication with the FDA throughout development and may offer regulatory advantages such as eligibility for Accelerated Approval, Priority Review, and Rolling Review, which allows completed sections of a New Drug Application (NDA) or Biologic License Application (BLA) to be reviewed, rather than waiting for the entire completed application.
Malaysian Reserve
24-04-2025
- Business
- Malaysian Reserve
Adcentrx Therapeutics to Present First Clinical Data for ADRX-0706 Nectin-4 ADC at ASCO 2025
Interim results from Phase 1a dose escalation to be presented Data provide clinical proof of concept for Adcentrx's novel technology platform; highlight unique opportunity for ADRX-0706 to address significant unmet needs for patients with limited therapeutic options SAN DIEGO, April 23, 2025 /PRNewswire/ — Adcentrx Therapeutics ('Adcentrx'), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, will present the first clinical data for ADRX-0706 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 – June 3, 2025) in Chicago, IL. 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. 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 completed Phase 1a portion 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 Phase 1b. This ongoing second portion of the study aims to further evaluate ADRX-0706's safety and tolerability, preliminary efficacy, and optimal dose in urothelial, triple-negative breast and cervical cancers. Details of the poster presentation at the ASCO Meeting are as follows: Title: 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 tumorsAbstract Number: 3018Session Date & Time: Monday, June 2, 1:30 p.m. – 4:30 p.m. CSTSession Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology The full abstract will be published by ASCO in conjunction with the Meeting. About i-Conjugation® TechnologyAdcentrx's proprietary i-Conjugation® technology platform is a core component in the design of the company's ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload. About ADRX-0706ADRX-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 About Adcentrx TherapeuticsAdcentrx 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 an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. Adcentrx is developing a robust pipeline including two clinical-stage ADCs and multiple preclinical ADCs, all with first-in-class and best-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit Contact Information:Investor Relationsir@
Yahoo
23-04-2025
- Business
- Yahoo
Adcentrx Therapeutics to Present First Clinical Data for ADRX-0706 Nectin-4 ADC at ASCO 2025
Interim results from Phase 1a dose escalation to be presented Data provide clinical proof of concept for Adcentrx's novel technology platform; highlight unique opportunity for ADRX-0706 to address significant unmet needs for patients with limited therapeutic options SAN DIEGO, April 23, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, will present the first clinical data for ADRX-0706 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025) in Chicago, IL. 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. 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 completed Phase 1a portion 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 Phase 1b. This ongoing second portion of the study aims to further evaluate ADRX-0706's safety and tolerability, preliminary efficacy, and optimal dose in urothelial, triple-negative breast and cervical cancers. Details of the poster presentation at the ASCO Meeting are as follows: Title: 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 tumorsAbstract Number: 3018Session Date & Time: Monday, June 2, 1:30 p.m. – 4:30 p.m. CSTSession Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology The full abstract will be published by ASCO in conjunction with the Meeting. About i-Conjugation® TechnologyAdcentrx's proprietary i-Conjugation® technology platform is a core component in the design of the company's ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload. About ADRX-0706ADRX-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 About Adcentrx TherapeuticsAdcentrx 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 an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. Adcentrx is developing a robust pipeline including two clinical-stage ADCs and multiple preclinical ADCs, all with first-in-class and best-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit Contact Information:Investor Relationsir@ View original content to download multimedia: SOURCE Adcentrx Therapeutics Sign in to access your portfolio
