PDS Biotechnology has completed subject recruitment for stage one of its open-label Phase II trial, evaluating the systemic administration of fused antibody drug conjugate (ADC) PDS01ADC in conjunction with floxuridine given via hepatic artery infusion pump for metastatic colorectal cancer patients.
Spearheaded by the National Cancer Institute (NCI)’s surgical oncology section chief Dr Jonathan Hernandez, the single-centre, non-randomised trial includes three cohorts of metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer.
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By GlobalDataEach cohort leverages a Simon two-stage trial design.
For the colorectal cancer cohort, the continuation to enrol up to a total of 22 subjects was contingent on at least six out of nine participants showing an objective response by response evaluation criteria in solid tumours (RECIST) v1.1 criteria.
The trial has met the pre-set RECIST v1.1 criteria for expansion into stage two.
The other two cohorts are still recruiting in stage one. The trial is part of a collaborative research and development agreement with the NCI.
PDS Biotechnology noted that the ADC is composed of two interleukin-12 (IL-12) heterodimers.
Each of these is fused to the NHS76 antibody, which attaches to single-stranded and double-stranded DNA and targets areas of tumour necrosis, where there is DNA exposure.
PDS Biotechnology CEO and president Frank Bedu-Addo said: “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 are delighted that the NCI has achieved this milestone and anticipate completion of patient recruitment for the metastatic colorectal cancer cohort of the study by the fourth quarter of 2025.”
The company is also commencing a pivotal trial to progress its lead programme in advanced human papillomavirus (HPV)16-positive head and neck squamous cell cancers.
Versamune HPV, the company’s lead investigational targeted immunotherapy, is under development in conjunction with a standard-of-care immune checkpoint inhibitor and in a triple combo that includes PDS01ADC.
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