New Hope for Gastric Cancer Patients: Adcentrx's ADRX-0405 Receives Orphan Drug Status from FDA

Adcentrx Therapeutics Receives Orphan Drug Designation for ADRX-0405



In a significant advancement for cancer treatment, the U.S. Food and Drug Administration (FDA) has designated Adcentrx Therapeutics' ADRX-0405 as an orphan drug for gastric cancer. This decision, announced on July 8, 2025, recognizes the potential of ADRX-0405 to address the considerable unmet medical need for patients suffering from gastric malignancies.

Adcentrx Therapeutics is at the forefront of developing innovative antibody-drug conjugate (ADC) therapies designed specifically for tackling cancer and other serious conditions. With its focus on providing targeted therapies that minimize side effects and enhance effectiveness, the company is redefining the treatment landscape for advanced cancers.

The Promise of ADRX-0405



ADRX-0405 is classified as a six-transmembrane epithelial antigen of the prostate 1 (STEAP1) ADC. While primarily associated with prostate cancer, significant expression of this target has also been observed in gastric cancer tissues. This dual potential makes ADRX-0405 an exciting candidate for the ongoing Phase 1a/b clinical trial (NCT06710379), which includes gastric cancer among other advanced solid tumors like metastatic castration-resistant prostate cancer and non-small cell lung cancer.

Hui Li, Ph.D., the Founder and CEO of Adcentrx, commented on the importance of this designation, stating that it serves as a major milestone for the company. "We are encouraged by the progress of our clinical trial and are optimistic about the potential of ADRX-0405 to improve the lives of patients with gastric cancer," he stated.

Gastric cancer, often diagnosed at advanced stages, poses a serious health threat, with the American Cancer Society estimating 30,300 new cases in the U.S. in 2025. By meeting the FDA's criteria for a rare disease, ADRX-0405 qualifies for orphan drug status, which offers several benefits. These include access to grant funding, scientific resources, tax credits for clinical trials, and potential market exclusivity of up to seven years following approval.

Innovative Technology Behind ADRX-0405



The uniqueness of ADRX-0405 lies in its innovative design. The ADC is built using a humanized IgG1 antibody linked to a novel topoisomerase inhibitor. This is accomplished through Adcentrx’s proprietary i-Conjugation® platform, which leverages cutting-edge stabilizing technology to enhance the delivery of therapeutic agents directly to cancer cells.

Preclinical trials have already indicated that ADRX-0405 boasts favorable pharmacokinetics and a robust safety profile, alongside promising efficacy demonstrated in various animal models. As the Phase 1a/b clinical trial progresses, further evaluations will delve deeper into its safety and tolerability, along with its anti-tumor activity across multiple types of cancer.

For more information about ADRX-0405 and its clinical testing, details can be found under Study ID NCT06710379 on ClinicalTrials.gov.

About Adcentrx Therapeutics



Founded to facilitate advancements in the realm of protein conjugate therapeutics, Adcentrx Therapeutics continues to innovate within the ADC landscape. The company is dedicated to addressing key challenges in ADC development, showing promise with its growing pipeline that includes two clinical-stage ADCs and multiple preclinical candidates, all with first-in-class potential.

To stay updated on Adcentrx and their cutting-edge technologies, interested parties can visit their official website at Adcentrx.com.

The recent orphan drug designation for ADRX-0405 marks a hopeful step for patients battling gastric cancer, showing the potential for groundbreaking therapeutic options in the near future.

Topics Health)

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