PDS Biotechnology has successfully completed subject recruitment for stage one of its open-label Phase II clinical trial. This trial evaluates the systemic administration of the fused antibody drug conjugate (ADC) known as PDS01ADC, combined with floxuridine delivered via a hepatic artery infusion pump, specifically targeting patients with metastatic colorectal cancer.
The trial, led by Dr. Jonathan Hernandez, the surgical oncology section chief at the National Cancer Institute (NCI), is being conducted at a single site and follows a non-randomised design. It encompasses three distinct cohorts, including those with metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. Each cohort is structured using a Simon two-stage trial design, which allows for a systematic evaluation of treatment responses.
For the colorectal cancer cohort, advancing to the next stage requires that at least six out of nine participants demonstrate an objective response based on the response evaluation criteria in solid tumours (RECIST) v1.1. The trial has successfully met this criterion, paving the way for expansion into stage two. Meanwhile, recruitment for the other two cohorts continues.
PDS Biotechnology highlighted that the ADC used in the trial consists of two interleukin-12 (IL-12) heterodimers, each fused to the NHS76 antibody. This design specifically targets areas of tumour necrosis where DNA is exposed, aiming to enhance the therapeutic effect while minimizing systemic exposure to IL-12.
Frank Bedu-Addo, CEO and president of PDS Biotechnology, expressed enthusiasm about reaching this recruitment milestone. He stated, “This novel investigational approach to the targeting and use of IL-12 results in little or no systemic exposure to IL-12, and may allow patients to reap the benefits of cytokine therapy without the typical treatment-limiting toxicities. We anticipate completion of patient recruitment for the metastatic colorectal cancer cohort of the study by the fourth quarter of 2025.”
In addition to this trial, PDS Biotechnology is set to launch a pivotal study to further advance its lead programme focused on advanced human papillomavirus (HPV) 16-positive head and neck squamous cell cancers. The company’s investigational immunotherapy, Versamune HPV, is being developed alongside a standard immune checkpoint inhibitor and in a triple combination that includes PDS01ADC.
This research initiative underscores the ongoing collaboration between PDS Biotechnology and the NCI, reflecting a commitment to addressing challenging cancer types with innovative therapeutic strategies. As the trial progresses, it holds the potential to bring forward new treatment options for patients facing these aggressive cancers.
