(RTTNews) - MAIA Biotechnology (MAIA), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, on Monday, announced that the FDA has granted Rare Pediatric Disease Designation to its investigational drug, THIO for the treatment of pediatric-type diffuse high-grade gliomas.
The FDA's Rare Pediatric Disease Designation provides several incentives, including the potential for a priority review voucher upon approval of THIO for PDHGG, which can be sold or used for priority review of another product.
A phase II trial evaluating THIO sequenced with Regeneron's immune checkpoint inhibitor (CPI) Libtayo in patients with advanced non-small cell lung cancer who failed two or more standard-of-care therapy regimens is ongoing.
The company has planned phase II trials of THIO in colorectal cancer, liver cancer, small cell lung cancer, and solid tumors.
THIO already carries the FDA's orphan drug designations for hepatocellular carcinoma, small-cell lung cancer, and glioblastoma.
The company's collaboration with Nationwide Children's Hospital has demonstrated THIO's effectiveness when combined with ionizing radiation in the treatment of diffuse intrinsic pontine glioma (DIPG), a subtype of PDHGG.
These findings were recently presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2024.
Vlad Vitoc, MAIA's Chairman and CEO, noted that it enhances the company's plans for continued research in pediatric glioma.
Additionally, THIO's ongoing development is supported by its promising mechanism of action that activates both innate and adaptive immune responses to fight cancer cells, offering a new approach to treating pediatric cancers.
Currently, MAIA is trading at $2.08, up by 4.25%
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