[2023. 11. 17.][NYSE:MAIA]MAIA Biotechnology （NYSE： MAIA） Has Received FDA Orphan Drug Designation For THIO As A Treatment For Most Aggressive Brain Cancer

 [2023. 11. 17.][NYSE:MAIA]MAIA Biotechnology （NYSE： MAIA） Has Received FDA Orphan Drug Designation For THIO As A Treatment For Most Aggressive Brain Cancer

CHICAGO, IL / ACCESSWIRE / November 17, 2023 / In a groundbreaking development, MAIA Biotechnology Inc. (NYSE: MAIA) has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for their pioneering cancer telomere-targeting agent, THIO, aimed at transforming the treatment landscape for glioblastoma, one of the most aggressive and prevalent forms of brain cancer.

Glioblastoma, a devastating disease that affects over 15,000 individuals annually in the United States alone, has limited treatment options and a grim prognosis, with only 7% of patients surviving beyond five years after diagnosis.

What sets THIO apart is its unique ability to breach the formidable blood-brain barrier (BBB) in both syngeneic and humanized mouse models of telomerase-expressing brain cancers. This breakthrough enables THIO to directly target brain tumors in vivo, offering hope to glioblastoma patients.

Sergei Gryaznov, Ph.D., MAIA's Chief Scientific Officer, expressed enthusiasm about the data presented to the FDA, which showcased THIO's remarkable mechanism of action and BBB-penetrating property. In preclinical studies, treatment with THIO demonstrated potent anticancer activity and significantly extended the lifespan of animal models, particularly in cases that are traditionally challenging to treat.

The FDA's Orphan Drug Act of 1983 aims to incentivize the development of therapies for rare diseases, affecting fewer than 200,000 people in the U.S. annually. With glioblastoma falling into this category, MAIA's orphan drug designation for THIO brings substantial financial incentives, including up to seven years of market exclusivity if approved.

The glioblastoma market is expected to grow from $2.2 billion to $3.2 billion globally in the next three years, and MAIA Biotechnology is poised to make a significant impact with its groundbreaking therapy.

THIO is not limited to glioblastoma; it has previously received orphan drug designations for hepatocellular carcinoma (HCC) and small-cell lung cancer (SCLC) in 2022, highlighting its potential to treat various cancer types, including rare ones.

Furthermore, MAIA Biotechnology is actively conducting a phase 2 clinical trial of THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). Recent data from the THIO-101 trial revealed an unprecedented Disease Control Rate (DCR) of 100% in second-line treatment for NSCLC, surpassing the standard-of-care DCR by a significant margin.

This news positions MAIA Biotechnology as a frontrunner in the race to combat challenging cancers, offering new hope to patients and investors alike.

Investor Relations ir@maiabiotech.com

SOURCE: MAIA Biotechnology