MAIA Biotechnology, Inc. - MAIA STOCK NEWS

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.

MAIA Biotechnology, Inc. (NYSE American: MAIA) has confirmed that it has no financial exposure to Silicon Valley Bank (SVB), which is under control of the Federal Deposit Insurance Corp. due to liquidity concerns. The company does not hold any deposits or investments at SVB, Silvergate Bank, or Signature Bank. MAIA's cash is managed across top-tier financial institutions. This assurance reflects MAIA's cautious financial management amid industry uncertainties, allowing it to focus on its lead program, THIO, aimed at treating telomerase-positive cancers.

MAIA Biotechnology, Inc. (NYSE American: MAIA) announced the dosing of the first two patients in its Phase 2 trial, THIO-101, in Europe for advanced Non-Small Cell Lung Cancer (NSCLC). The trial aims to assess the safety, tolerability, and preliminary efficacy of THIO, a novel telomere-targeting agent. Following clearances in Hungary, Poland, and Bulgaria, five clinical sites have been activated. The trial commenced in Australia in July 2022 and in Europe in March 2023. The primary endpoint is Overall Response Rate (ORR), with data expected later this year, providing a potential treatment avenue for patients with high unmet needs.

MAIA Biotechnology announced plans to initiate its second Phase 2 trial, THIO-102, for evaluating its telomere-targeting agent THIO in combination with checkpoint inhibitors such as pembrolizumab and atezolizumab. This trial will target multiple cancer types, including small cell lung cancer and liver cancer. THIO has already received two Orphan Drug Designations from the FDA, reflecting its significant potential. Positive preclinical results indicate that THIO enhances the efficacy of pembrolizumab and can convert 'cold' tumors into responsive ones. The trial aims for accelerated approvals across several indications, potentially numbering over ten.

MAIA Biotechnology, Inc. (NYSE American: MAIA) announced advancements in its Telomere-Targeting Molecule Program, known as Project T3, aimed at developing novel anti-cancer agents. The company has identified two lead candidates, MAIA-2021-20 and MAIA-2022-12, for further preclinical evaluation, with potential progression to human clinical trials. The research showed promising anti-cancer activity in various models and demonstrated the compounds' ability to induce tumor cell death. Additionally, a provisional patent for these new molecules was filed in Q4 2022, marking a significant milestone for MAIA in its oncology-focused initiatives.