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CHICAGO - MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company with a market capitalization of $45.51 million, has announced the expansion of its THIO-101 Phase 2 trial to include more patients with advanced non-small cell lung cancer (NSCLC). The study focuses on those who have not responded to checkpoint inhibitor treatments and chemotherapy. According to InvestingPro analysis, MAIA’s stock appears undervalued at its current price of $1.74, with analysts setting price targets between $11.25 and $14.
The trial will now consist of two arms, with the first continuing to evaluate THIO in sequence with Libtayo® (cemiplimab) and the second to assess THIO as a standalone treatment. The treatment regimen involves administering THIO for three consecutive days, followed by immune activation on the fourth day. In the first arm, patients will receive Libtayo on the fifth day. MAIA plans to enroll an additional 100 patients in the U.S. and selected countries in Europe and Asia for the registration phase of the trial. InvestingPro data shows the company maintains strong liquidity with a current ratio of 2.56 and holds more cash than debt on its balance sheet, supporting its clinical development plans.
Dr. Vlad Vitoc, CEO of MAIA, expressed optimism about the expansion, stating that the trial aims to determine overall response rates in third-line NSCLC treatment. He highlighted that the THIO-101 study has shown promising disease control, response, and survival results thus far. The company anticipates new patient enrollment in the coming weeks and is eyeing multiple milestones for 2025.
The amended clinical supply agreement with Regeneron (NASDAQ:REGN) includes providing Libtayo for the treatment of all patients in the expanded trial. Data as of January 15, 2025, indicated a median overall survival of 16.9 months in third-line treatment, with the treatment being generally well-tolerated.
THIO, or 6-thio-2’-deoxyguanosine, is an investigational telomere-targeting agent designed to induce selective cancer cell death and activate immune responses. The THIO-101 trial is the first to evaluate the anti-tumor activity of THIO followed by PD-(L)1 inhibition.
MAIA Biotechnology focuses on developing targeted immunotherapies for cancer, with THIO as their lead program for treating NSCLC patients with telomerase-positive cancer cells. While the company is not yet profitable, with earnings per share at -$1.31 over the last twelve months, analysts expect improved performance ahead. For deeper insights into MAIA’s financial health and growth prospects, InvestingPro subscribers have access to over 30 additional financial metrics and expert analysis.
In other recent news, MAIA Biotechnology, Inc. announced promising results from its Phase 2 clinical trial, THIO-101, which evaluates THIO in combination with Regeneron’s cemiplimab for advanced non-small cell lung cancer (NSCLC). The trial showed a median overall survival of 16.9 months in patients, a notable improvement over the typical 5 to 6 months with standard chemotherapy. Additionally, MAIA Biotechnology has expanded its financial strategy by increasing the maximum aggregate offering price of its shares to $30 million under its At The Market Offering Agreement with H.C. Wainwright & Co. This move aims to bolster the company’s research and development efforts.
In another development, MAIA Biotechnology has secured $2.7 million through a private placement to fund Part C of the Phase II THIO-101 trial and other working capital needs. The company also announced a collaboration with BeiGene (NASDAQ:ONC) to conduct Phase 2 trials for THIO in combination with tislelizumab, targeting several cancer types, including hepatocellular carcinoma and colorectal cancer. Furthermore, MAIA Biotechnology updated employment agreements for key executives, including salary increases and revised terms for Dr. Vlad Vitoc and Dr. Sergei Gryaznov. These developments reflect MAIA Biotechnology’s ongoing efforts to advance its clinical programs and strategic partnerships in the oncology field.
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