CHICAGO - MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company valued at $54.7 million, has announced an expansion to its ongoing Phase 2 clinical trial, THIO-101, to further evaluate the efficacy of its lead drug candidate THIO in combination with Regeneron (NASDAQ:REGN)'s Libtayo® for the treatment of third-line non-small cell lung cancer (NSCLC) patients. According to InvestingPro data, MAIA maintains a strong liquidity position with more cash than debt on its balance sheet. This trial targets patients who have shown resistance to prior checkpoint inhibitor therapies and chemotherapy.
The amended clinical supply agreement with Regeneron, initially established in 2021, is set to provide an additional supply of Libtayo® for the expanded trial. MAIA sponsors the THIO-101 trial and maintains an exclusive worldwide patent license to develop and commercialize THIO.
THIO-101 is a multicenter, open-label trial designed to assess the safety, tolerability, and clinical efficacy of THIO, a telomere-targeting agent, followed by PD-(L)1 inhibition with Libtayo®. The trial aims to enhance and prolong immune response in advanced NSCLC patients who have not responded or have developed resistance to first-line checkpoint inhibitors.
MAIA's Chairman and CEO, Vlad Vitoc, M.D., expressed optimism about the trial's progress, citing favorable disease control and overall response rates. The company expects to begin enrolling new patients soon and is considering an accelerated approval pathway in the United States based on the trial's outcomes. While the stock has seen an impressive 84.6% gain year-to-date, InvestingPro analysis suggests the company remains undervalued relative to its Fair Value, with analyst price targets ranging from $11.25 to $14.00 per share.
THIO functions by inducing selective cancer cell death and activating immune responses, potentially serving as a second or later line of treatment for NSCLC.
This announcement is based on a press release statement from MAIA Biotechnology, Inc. The company continues to explore its regulatory strategy and the potential impact of THIO-101's results on future approvals. With a current ratio of 2.56, MAIA maintains sufficient liquidity to fund its ongoing clinical trials. Unlock more insights about MAIA's financial health and growth potential with InvestingPro, which offers additional exclusive tips and detailed financial metrics for informed investment decisions.
In other recent news, MAIA Biotechnology, Inc. revealed promising interim results from its Phase 2 trial of THIO, its lead clinical candidate for treating advanced non-small cell lung cancer (NSCLC). The trial, THIO-101, is evaluating the efficacy of THIO in combination with Regeneron’s immune checkpoint inhibitor cemiplimab for patients who have not responded to two or more standard-of-care therapy regimens. As of recent updates, 16 patients surpassed a 12-month survival follow-up, with 9 of these being third-line treatment patients. The interim median survival follow-up for these third-line patients was reported at 10.6 months, which compares favorably to the standard-of-care overall survival of 5.8 months. Earlier, MAIA announced that THIO in combination with cemiplimab showed an overall response rate of 38%, a disease control rate of 88%, and a median progression-free survival of 5.5 months for third-line treatment. The THIO-101 trial continues to assess the safety and clinical efficacy of THIO, with the overall response rate as the primary endpoint. MAIA anticipates releasing full efficacy results from the trial within the current year.
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