Welcome to our dedicated page for MAIA Biotechnology news (Ticker: MAIA), a resource for investors and traders seeking the latest updates and insights on MAIA Biotechnology stock.
MAIA Biotechnology, Inc. (NYSE American: MAIA) is a clinical-stage biopharmaceutical company whose news flow is closely tied to the development of ateganosine (THIO), a first-in-class telomere-targeting therapy for advanced non-small cell lung cancer (NSCLC). News about MAIA often centers on clinical milestones, regulatory designations, and financing activities that support its oncology programs.
Investors and observers following MAIA’s news can expect regular updates on its Phase 2 THIO-101 and Phase 3 THIO-104 trials. These items include announcements of first patient dosing, expansion into new countries, enrollment progress, and presentations of trial-in-progress posters at major conferences such as the Society for Immunotherapy of Cancer (SITC), the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, and the European Society for Medical Oncology (ESMO) Congress.
MAIA’s press releases, many of which are furnished via Form 8-K filings, also highlight regulatory developments such as the U.S. FDA Fast Track designation for ateganosine in NSCLC and Orphan Drug Designations in additional tumor types. Another recurring theme in the company’s news is insider activity: open-market share purchases by the CEO and directors, and participation by board members in private placement financings, which the company frames as signals of confidence in the ateganosine platform.
On this news page, readers can review MAIA’s announcements related to clinical data signals, trial design details, international site activations, and capital raises that fund key study steps. For those tracking the progress of telomere-targeting approaches in oncology and the later-line NSCLC treatment landscape, MAIA’s news provides an ongoing record of how its investigational therapy is advancing through mid- to late-stage clinical development.
MAIA Biotechnology, Inc. (NYSE: MAIA) has priced an underwritten public offering of 2,222,200 shares of its common stock at $2.25 per share, aiming to raise approximately $5 million. The offering includes a 45-day option for underwriters to purchase an additional 333,300 shares at the public offering price. The net proceeds will be allocated to fund ongoing clinical trials of THIO, development of second-generation telomere targeting compounds, and general corporate purposes. The offering is expected to close on
MAIA Biotechnology, Inc. (NYSE American: MAIA) revealed preliminary survival data from the ongoing Phase 2 trial THIO-101, assessing THIO for advanced Non-Small Cell Lung Cancer (NSCLC). The initial two patients remain alive approximately 10 and 9 months post-treatment. Notably, these individuals are Stage IV metastatic cases, previously treated with multiple therapies. The trial has shown that the first six evaluable patients tolerated the THIO high dose without dose-limiting toxicities. Currently, these patients exhibit no disease progression, with reports of 7 and 6 months progression-free survival. These preliminary outcomes suggest potential advancements in treatment options for heavily pretreated lung cancer patients, offering a significant improvement over standard survival rates of 3-4 months.
MAIA Biotechnology has announced the peer-reviewed publication of a study in Molecular Cancer Therapeutics detailing the anticancer effects of THIO in treating Hepatocellular Carcinoma (HCC). The research shows that THIO induces immune responses and can significantly enhance tumor regression, particularly when combined with checkpoint inhibitors.
The results indicate a strong rationale for a clinical trial of THIO in HCC, supported by the US FDA's Orphan Drug Designation. MAIA’s leadership expressed confidence in THIO’s potential as a treatment, emphasizing the findings' relevance to their ongoing clinical development plans.
MAIA Biotechnology, Inc. (NYSE American: MAIA) announced its participation in the AACR Annual Meeting 2023 where it will present a poster detailing its ongoing Phase 2 clinical trial, THIO-101, for patients with advanced Non-Small Cell Lung Cancer (NSCLC).
The presentation will occur on April 17, 2023, during the session titled "Phase II and Phase III Clinical Trials in Progress". The primary goals of the THIO-101 trial are to assess the safety and tolerability of THIO, as well as its efficacy using Overall Response Rate as the primary endpoint. This trial represents a significant advancement in evaluating THIO's effectiveness in NSCLC patients who have previously shown resistance to treatments.
MAIA Biotechnology, Inc. (NYSE American: MAIA) has announced positive topline data from Part A of its THIO-101 Phase 2 trial for advanced Non-Small Cell Lung Cancer (NSCLC). The safety lead-in demonstrated that MAIA’s telomere-targeting agent, THIO, combined with Regeneron’s Libtayo (cemiplimab), was well tolerated with no dose-limiting toxicities or significant adverse events. Part A involved six patients and indicated mild toxicities like grade 1 fatigue and muscle pain. The company is now recruiting for Part B, aimed at randomized efficacy and dose selection, with a plan to report preliminary efficacy data later this year. This progression marks a significant achievement for MAIA, emphasizing the potential for THIO as a treatment in NSCLC patients who have not responded to previous therapies.
MAIA Biotechnology (NYSE: MAIA) has reported progress with its clinical trials and financial results for 2022. Patient enrollment is underway for the Phase 2 trial, THIO-101, targeting advanced non-small cell lung cancer (NSCLC) in Europe. Plans are also in place for a second Phase 2 Go-To-Market trial, THIO-102. The company presented promising preclinical data at the SITC Annual Meeting regarding THIO's efficacy in hepatocellular carcinoma. As of December 31, 2022, MAIA held approximately $10.9 million in cash, with R&D expenses increasing to $8.9 million, leading to a net loss of $15.7 million for the year.
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