Adcentrx gets FDA clearance for phase 1 trial of ADC for tumors

22-Oct-2024 - Last updated on 22-Oct-2024 at 13:29 GMT

The FDA has given clearance to Adcentrx Therapeutics’ IND application for an antibody-drug conjugate (ADC) targeting solid tumors.

The US biotech company Adcentrx Therapeutics announced yesterday that the FDA cleared an IND application for its potential first-in-class ADC, ADRX-0405, for the treatment of advanced solid tumors. The company plans to start a Phase 1a/b trial in the last quarter of 2024.

ADRX-0405 is a next-generation ADC composed of a humanized antibody linked to a topoisomerase inhibitor, a payload that can block the topoisomerase enzyme, which cancer cells need to divide and grow. The antibody used in ADRX-0405 specifically targets a cell surface protein called STEAP1, which is highly expressed in prostate cancer and other cancers, such as colorectal cancer, gastric, and lung cancer.

ADRX-0405 is designed using Adcentrx’s proprietary i-Conjugation technology platform. It is the company’s second drug to receive IND clearance from the FDA, following ADRX-0706, an ADC targeting multiple solid tumor types that is currently in Phase 1a/1b.

Commenting on the most recent FDA green light to start Phase 1 for ADRX-0405, Hui Li, President and CEO of Adcentrx, said in a press statement: "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."

Following preclinical studies that have revealed positive results for pharmacokinetics, safety, and efficacy across different tumor models, this Phase 1a/b clinical trial will study the safety and tolerability of ADRX-0405 and find the optimal dose of the drug for humans. The trial will focus on patients with select advanced solid tumors, such as metastatic castration-resistant prostate cancer. Adcentrx expects to have initial data in the final quarter of 2025.

ADCs are becoming increasingly popular

This latest IND application clearance reflects the rising popularity of ADCs. Recent ADC news included a $1 billion deal between the Danish company Adcendo and Chinese Multitude Therapeutics, as well as a $114 million series A by UK startup Myricx Bio to advance its ADC pipeline.

In fact, a new study by the U.S. company BCC Research has revealed that the global ADCs market is growing at a rapid rate. In 2023, it reached a value of $10.8 billion and is expected to exceed $47 billion by the end of 2029, growing at a CAGR of 28.4%.

Reasons for this rapid ADC market growth are stated in the report as the rising prevalence of cancer and the remaining unmet need in the cancer field; the de-risked development of ADCs because monoclonal antibodies are well-understood; growing investor confidence in ADCs; and strong support from regulatory agencies, such as the FDA and EMA, who are working on increasing ADC approval rates to get therapies to patients faster.