Adcentrx Receives FDA Approval to Initiate Phase 1 Study of ADC Targeting Tumors

Adcentrx Receives FDA Approval to Initiate Phase 1 Study of ADC Targeting Tumors

Adcentrx Receives FDA Approval to Initiate Phase 1 Study of ADC Targeting Tumors

Adcentrx Therapeutics, a biotechnology firm based in the United States, revealed yesterday that the FDA has cleared its IND application for ADRX-0405, a promising first-in-class antibody-drug conjugate (ADC) aimed at treating advanced solid tumors. The company is set to initiate a Phase 1a/b clinical trial in the last quarter of 2024.

ADRX-0405 is a cutting-edge ADC that features a humanized antibody linked to a topoisomerase inhibitor. This payload targets the topoisomerase enzyme, essential for the growth and division of cancer cells. The specific antibody in ADRX-0405 is designed to hit a cell surface protein named STEAP1, which is overexpressed in various cancers, including prostate cancer, as well as colorectal, gastric, and lung cancers.

Utilizing Adcentrx’s proprietary i-Conjugation technology platform, ADRX-0405 marks the second FDA IND clearance for the company, following its previous ADC, ADRX-0706, which targets various solid tumor types and is currently undergoing Phase 1a/1b trials.

Hui Li, President and CEO of Adcentrx, expressed enthusiasm regarding the FDA’s recent approval, stating, “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 Phase 1a/b clinical trial will evaluate the safety and tolerability of ADRX-0405, aiming to identify the optimal dosage for patients with specific advanced solid tumors, including metastatic castration-resistant prostate cancer. With positive preclinical results relating to pharmacokinetics, safety, and efficacy across diverse tumor models, initial data from this trial is anticipated by the end of 2025.

The Growing Appeal of ADCs

This recent IND application approval underscores the increasing prominence of ADCs in the therapeutic landscape. Notable ADC developments include a billion partnership between Denmark’s Adcendo and China’s Multitude Therapeutics, along with a 4 million Series A fundraising round by UK-based Myricx Bio, aimed at enhancing its ADC portfolio.

According to a recent analysis by BCC Research, the ADC market is experiencing explosive growth, valued at .8 billion in 2023, with projections to surpass billion by 2029, growing at a CAGR of 28.4%.

This surge in the ADC market is attributed to factors such as the increasing occurrence of cancer cases, the continuing need for innovative treatments, the established nature of monoclonal antibodies that mitigate development risks, heightened investor interest, and enhanced regulatory support from agencies like the FDA and EMA, which are working to expedite ADC approvals for patient access.