NEW YORK – BriaCell Therapeutics said this week that it has partnered with contract manufacturing organization Waisman Biomanufacturing at the University of Wisconsin-Madison to manufacture BriaCell's prostate cancer therapy, Bria-Pros, for an anticipated clinical trial. The investigational treatment is a patient-specific off-the-shelf immunotherapy that involves human leukocyte antigen-specific immunotherapy cell lines. Under the terms of the manufacturing agreement, Waisman will work with BriaCell's scientific and product development teams to manufacture Bria-Pros for a Phase I/II trial, which the firm expects to begin as soon as it completes manufacturing and testing regulatory filings.
The US Food and Drug Administration this week granted orphan drug designation to Pyramid Biosciences' PBI-200, a therapy the firm is developing for NTRK fusion-positive solid tumors. The company is conducting a Phase I/II trial of PBI-200 in patients with NTRK fusion-positive advanced or metastatic tumors, including primary and metastatic CNS tumors.
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