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Point Biopharma to Launch Phase I Study of FAP-Targeted Radiopharmaceutical in Canada

NEW YORK – Point Biopharma on Monday announced it will launch a clinical trial evaluating an investigational targeted radiopharmaceutical in solid tumor patients identified by a gallium-68-labeled imaging agent.

According to the Indianapolis-based firm, it has received a "no objection" letter from Health Canada, allowing it to start the Phase I trial in the country this summer. The study, dubbed FRONTIER, is designed to assess Point's fibroblast activation protein-α (FAP-α) directed radiopharmaceutical, 177Lu-PNT6555, in patients with FAP-avid colorectal cancer, pancreatic cancer, esophageal cancer, melanoma, or soft tissue sarcoma. Point will also evaluate the molecular imaging agent version of PNT6555, which uses gallium-68 in the place of lutetium-177 as the radioisotope, as a method of identifying patients eligible for treatment.

The primary aim of the study is to determine PNT6555's maximum tolerated dose and recommended Phase II dose. Point expects the FRONTIER trial to yield initial data next year.

According to the firm, preclinical studies have shown that the gallium-68-labeled version of PNT6555 is an effective imaging agent, and the lutetium-177-labeled therapeutic has demonstrated anti-tumor activity.

"FAP-α is an extremely exciting target for therapeutics," Point CEO Joe McCann said in a statement, adding that the biomarker is expressed in more than 90 percent of epithelial tumors. "Not only would better imaging to detect metastatic disease enable more cancers to be treated earlier, but the capability of delivering radiation directly to a wide variety of cancers could also revolutionize treatment paradigms."

Clovis Oncology is another firm developing a FAP-targeted radionuclide, called FAP-2286, in patients with FAP-positive tumors in the Phase I/II LuMIERE study. FAP-2286 is both a therapeutic and imaging agent based on how it is labeled.

Point, meanwhile, is also evaluating a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, dubbed PNT2002, in metastatic castration-resistant prostate cancer in the Phase III SPLASH trial.