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MAIA Biotechnology (MAIA) – Pediatric Designation Qualifies THIO For A Priority Review Voucher

Health
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Wednesday, December 18, 2024

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Successful Development Could Qualify For A Valuable Asset. Maia announced that THIO has received FDA designation as a drug for a rare pediatric disease (RPD) when used to treat pediatric-type diffuse high-grade gliomas (PDHGG). This designation makes MAIA eligible to receive a Priority Review Voucher (PRV) upon approval. The PRV can be redeemed for priority review for a different new drug application or sold to another company. During 2024, PRVs have been sold for between $100 million and $158 million.

Data In Pediatric Brain Cancer Was Presented In April 2024. MAIA presented clinical data testing THIO in the PDHGG indication at the American Association for Cancer Research (AACR) Annual Meeting in April 2024. Patients with a highly aggressive subtype of PDHGG known as diffuse intrinsic pontine glioma (DIPG) were treated with ionizing radiation and THIO. The results showed significant decreases in cell proliferation and anti-cancer effects.


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