Bitcoin price today: falls to 2-week low below $113k ahead of Fed Jackson Hole
CHICAGO - MAIA Biotechnology, Inc. (NYSE American:MAIA) announced Monday that the U.S. Food and Drug Administration has granted Fast Track designation for its experimental lung cancer drug ateganosine. According to InvestingPro data, MAIA maintains a strong liquidity position with a current ratio of 2.35, holding more cash than debt on its balance sheet.
The designation applies to ateganosine’s development for treating non-small cell lung cancer (NSCLC), which is currently being evaluated in a pivotal Phase 2 clinical trial.
According to the company’s press release statement, ateganosine is a small molecule that targets telomere structure in cancer cells, potentially reversing resistance to immune checkpoint inhibitors.
The Fast Track program is designed to expedite development and review of drugs that address serious conditions with unmet medical needs. If successful in the regulatory pathway, ateganosine could potentially qualify for accelerated FDA approval.
MAIA reported that recent data from its Phase 2 THIO-101 clinical trial showed a median overall survival of 17.8 months in patients as of May 15, 2025. The company noted this compares to overall survival of 5 to 6 months typically seen with standard-of-care chemotherapy treatments for similar NSCLC patients.
The drug is being developed as a second or later line of treatment for NSCLC patients who have progressed beyond standard checkpoint inhibitor regimens.
NSCLC represents a significant oncology market, valued at $34.1 billion in 2024, according to data cited in the company announcement.
The THIO-101 trial is evaluating ateganosine’s anti-tumor activity when administered prior to cemiplimab (Libtayo) in advanced NSCLC patients who previously did not respond or developed resistance to first-line treatment containing another checkpoint inhibitor.
In other recent news, MAIA Biotechnology has announced the publication of preclinical data from its second-generation ateganosine prodrugs platform in the journal Nucleic Acids Research. This study focuses on telomere-targeting compounds for cancer treatment. Additionally, MAIA Biotechnology has dosed the first patient in Taiwan for its THIO-101 Phase 2 trial, which is evaluating ateganosine in patients with advanced non-small cell lung cancer. The trial includes two treatment arms: one with ateganosine sequenced with cemiplimab and another with ateganosine monotherapy.
In another development, MAIA Biotechnology has entered into a stock purchase agreement with Prevail Partners, LLC to issue and sell up to $587,905 of its common stock. This agreement includes an upfront payment and subsequent monthly payments over three years, with shares priced based on the volume-weighted average price of the company’s stock. Furthermore, MAIA Biotechnology has strengthened its Scientific Advisory Board by appointing two experts in hepatocellular carcinoma, who will provide guidance on trials involving the company’s lead candidate, ateganosine. These recent developments highlight MAIA Biotechnology’s ongoing efforts in advancing its cancer treatment research and securing financial agreements to support its initiatives.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.