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Investing.com -- PDS Biotechnology Corp (NASDAQ:PDSB) stock rose 3.8% after the company announced that its clinical trial for metastatic colorectal cancer treatment has met pre-set criteria for expansion into Stage 2.
The late-stage immunotherapy company reported that patient recruitment has been completed in Stage 1 of the trial testing PDS01ADC therapeutic administered systemically in combination with floxuridine. The study, led by the National Cancer Institute (NCI), achieved the required objective response rate, with at least 6 of 9 participants experiencing a response according to RECIST v1.1 criteria.
The trial is an open-label, single-center, non-randomized Phase 2 study with three cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. While the colorectal cancer cohort will now enroll up to a total of 22 participants, the other two cohorts continue to enroll in Stage 1.
"Colorectal cancer is among the most deadly and difficult to treat cancers. In 2020, it was estimated that more than 930,000 deaths were due to colorectal cancer worldwide according to the World Health Organization, and more effective treatments are desperately needed," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech.
The company anticipates completing patient recruitment for the metastatic colorectal cancer cohort by the fourth quarter of 2025. According to the American Cancer Society, colorectal cancer is the second leading cause of cancer-related deaths in the U.S., with over 150,000 new cases diagnosed annually.
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