MAIA Biotechnology, Inc. - MAIA STOCK NEWS

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.

MAIA Biotechnology, Inc. (NYSE American: MAIA) will participate in four investor conferences in January and February 2023. Highlighted events include the Biotech Showcase in San Francisco (January 9-11), where they will present on January 9. Additional conferences are the JPM One-on-One Partnering (January 9-12), the Sidoti Micro-Cap Virtual Conference (January 18-19), and the BIO CEO & Investor Conference in New York City (February 6-7). MAIA is currently enrolling patients in the Part A safety lead-arm of the THIO-101 Phase 2 clinical trial for advanced Non-Small Cell Lung Cancer.

MAIA Biotechnology, Inc. announced the completion of a pre-Investigational New Drug (pre-IND) meeting with the FDA regarding the THIO-101 Phase 2 trial for advanced non-small cell lung cancer (NSCLC). The FDA provided positive feedback on MAIA's manufacturing and clinical development plan. MAIA plans to file its U.S. IND in the first half of 2023 and initiate patient enrollment in the second half. The THIO-101 trial aims to evaluate the safety and efficacy of THIO when administered before Regeneron’s anti-PD1 therapy, Libtayo®, targeting patients with advanced NSCLC.

MAIA Biotechnology has received regulatory approval to initiate the THIO-101 Phase 2 clinical trial in Hungary, Poland, and Bulgaria, expanding its patient access for the investigation of THIO in non-small cell lung cancer (NSCLC). The trial aims to evaluate THIO's capacity to enhance immune response when paired with Regeneron's anti-PD1 therapy, Libtayo (cemiplimab). The main focus is on safety, tolerability, and efficacy in patients who have previously relapsed after checkpoint inhibitor treatments. The trial is a significant step for MAIA in advancing cancer therapies.

MAIA Biotechnology, Inc. (NYSE American: MAIA) announced plans for additional insider investments by its CEO, Vlad Vitoc, and Board Member, Stan Smith, Ph.D., under Rule 10b5-1 trading plans. These plans allow purchases of common stock under regulated conditions. Vitoc expressed confidence that MAIA's valuation does not reflect its growth potential, highlighting innovative assets in oncology. Smith reiterated his commitment, noting the company's revolutionary approach to cancer treatment. MAIA focuses on developing first-in-class oncology drugs, particularly a telomere targeting agent for NSCLC.

MAIA Biotechnology announced promising results for its lead drug candidate, THIO, from a pre-clinical study on hepatocellular carcinoma (HCC) presented at the SITC 37th Annual Meeting. The study showed that THIO enhances the efficacy of immune checkpoint inhibitors by directly killing cancer cells and stimulating an anti-tumor immune response. Notably, THIO, which received Orphan Drug Designation from the FDA, exhibited complete responses in several HCC models with no dose-limiting toxicities. MAIA emphasizes THIO's potential to address the growing need for effective HCC treatments.