Shares of PDS Biotechnology Corp (NASDAQ:PDSB) increased 3.8% after the company revealed its clinical trial for metastatic colorectal cancer has met key benchmarks, allowing progression to Stage 2.
The late-stage immunotherapy developer confirmed that Stage 1 patient enrollment is complete for the trial testing the PDS01ADC therapy administered alongside floxuridine. Conducted by the National Cancer Institute (NCI), the study met the target objective response rate, with at least 6 of 9 patients showing a response per RECIST v1.1 criteria.
This open-label, single-center, non-randomized Phase 2 trial includes three patient groups: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. While the colorectal cancer cohort will expand to enroll up to 22 participants, recruitment continues in Stage 1 for the other two groups.
“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,” stated Frank Bedu-Addo, PhD, President and CEO of PDS Biotech.
The company expects to complete recruitment for the metastatic colorectal cancer group by the fourth quarter of 2025. The American Cancer Society reports colorectal cancer as the second leading cause of cancer deaths in the U.S., with over 150,000 new diagnoses each year.
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