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MAIA Biotechnology, Inc. develops targeted immunotherapies for cancer, with news centered on its lead investigational therapy, ateganosine, also known as THIO, for non-small cell lung cancer. Company updates frequently address the THIO-101 clinical program, ateganosine’s telomere-targeting and immune-activating mechanism, use with the checkpoint inhibitor cemiplimab, and FDA Fast Track designation in third-line NSCLC.
Recurring MAIA news also includes oncology data presentations, shareholder letters on the development pipeline, clinical-site and trial-expansion updates, and financing activity tied to its clinical programs. Capital-market announcements have included common stock offerings, shelf registration use, and stated uses of proceeds for clinical trials, working capital, and general corporate purposes.
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.
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.