Adcentrx Therapeutics Receives FDA Orphan Drug Designation for Promising Gastric Cancer Treatment
Adcentrx Therapeutics, Inc., a clinical-stage biotechnology company, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for its novel investigational drug, ADRX-0405. This Antibody-Drug Conjugate (ADC) is being developed as a targeted therapy for gastric cancer, a disease that significantly impacts patient populations globally.
The Orphan Drug Designation is a significant milestone, recognizing that ADRX-0405 has the potential to address a rare disease or condition, or in cases where the drug is intended for a patient population that is not expected to exceed 200,000 people in the United States. While gastric cancer is a common malignancy worldwide, this designation suggests that the specific patient subset that ADRX-0405 is designed to treat, likely those with tumors expressing the STEAP1 target, may meet the criteria for orphan drug consideration.
ADRX-0405 is an ADC that precisely targets the STEAP1 (Six-transmembrane epithelial antigen of the prostate 1) protein. STEAP1 has emerged as a promising target in oncology due to its overexpression in various solid tumors, including a significant proportion of gastric cancers. ADCs are a sophisticated class of drugs designed to deliver potent cytotoxic agents directly to cancer cells while minimizing damage to healthy tissues, thereby potentially improving efficacy and reducing side effects compared to traditional chemotherapy.
The FDA’s Orphan Drug Designation provides several benefits to drug developers, including market exclusivity for seven years following approval, potential tax credits for clinical research, assistance in the drug development process through FDA guidance, and the possibility of user fee waivers for certain regulatory submissions. These incentives are crucial for fostering the development of therapies for conditions that may otherwise be less commercially viable but are of significant unmet medical need.
This designation underscores the potential of ADRX-0405 to offer a new therapeutic option for patients with gastric cancer who may have limited or ineffective treatment alternatives. Adcentrx Therapeutics’ commitment to advancing this innovative therapy aligns with the ongoing global efforts to improve outcomes for individuals battling this challenging disease.
The company is expected to continue its clinical development program for ADRX-0405, with the hope that this targeted approach will demonstrate significant clinical benefit for patients with STEAP1-positive gastric cancer. This development marks a hopeful step forward in the fight against gastric cancer.
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PR Newswire Policy Public Interest published ‘U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics’ ADRX-0405 STEAP1 ADC for Gastric Cancer’ at 2025-07-08 23:00. Please write a detailed article about this news in a polite tone with relevant information. Please reply in English with the article only.