AwesomeStocks Donât want emails from us anymore? Click [here]( to unsubscribe. Hello! New Alert: MAIA Biotechnology, Inc. (NYSE American: MAIA) MAIA is our brand new NYSE alert that is presenting a breakout opportunity. MAIA has a history of experiencing significant upside and a chart setup suggesting the potential for increased gains. In addition, MAIA announced multiple developments recently... Including the companyâs big breaking news this morning. MAIA is a NYSE listed âtargeted therapy, immuno-oncology companyâ. MAIA is âfocused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancerâ. The companyâs âlead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cellsâ. âTHIO is currently in Phase 2 human clinical trials for non-small cell lung cancer treatment.â As the company recently explained: âThe main objectives of the THIO-101 trial are to evaluate the safety, tolerability, and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy.â âThe trial dosed its first patient in Australia in July 2022 and expanded to include European patients in March 2023.â Non-small cell lung cancer (NSCLC) âis the most common type of lung cancer in the United States, accounting for 81% of all lung cancer diagnosesâ. Sadly, âeach year, more people die of lung cancer than of colon, breast, and prostate cancers combinedâ. According to the American Cancer Society, âLung cancer is by far the leading cause of cancer death in the US, accounting for about 1 in 5 of all cancer deathsâ. âWorldwide, lung cancer is the second most commonly diagnosed cancer.â MAIA has announced multiple accomplishments recently that could be significant growth catalysts for the company. At the end of September, the company announced: âMAIA Biotechnology Announces Share Repurchase Programâ Here are some of the companyâs comments from this press release: "This share repurchase program demonstrates the confidence we have in our market opportunity and our strategy to invest for long-term growth, which we believe is not reflected in the current market valuation," said Vlad Vitoc, MAIAâs Chief Executive Officer. "By establishing a repurchase plan, we add another tool to our arsenal that can assist with our future financing efforts, enable us to unlock more of the long-term opportunity we see ahead, and drive sustainable value for all stakeholders." Earlier this month the company announced a big accomplishment: âMAIA Biotechnology Announces FDA Clearance of IND Application for THIO, a First-in-Class Telomere Targeting Agent for the Treatment of Non-Small Cell Lung Cancerâ Here are some of the companyâs comments from this press release: - â"We are extremely pleased to obtain clearance to extend our go-to-market THIO-101 trial to the U.S. and further develop THIOâs global reach," said Vlad Vitoc, MAIAâs Chief Executive Officer.â
- â"The FDA IND clearance represents an essential milestone in the clinical development of THIO, as a first-in-class telomere targeting agent in clinical development for patients with advanced NSCLC," said Mihail Obrocea, M.D., MAIAâs Chief Medical Officer.â
- â"We worked diligently with the FDA throughout the pre-IND/IND process to successfully align with their regulatory guidance and recommendations and we remain committed to developing novel, safe and effective treatments for patients with cancer," added K. Robinson Lewis, MAIAâs Head of Regulatory and Quality.â In addition, the company also announced: âMAIA Biotechnology Announces Potent Anticancer Activity of THIO in Gliomasâ MAIA âannounced that its lead asset THIO showed highly potent anticancer activity in gliomas, an aggressive type of brain tumor that originates from glial cells. THIOâs novel dual mechanism of action - direct telomere targeting and immune system activation, has previously demonstrated similar efficacy in multiple types of telomerase-active tumors.â Importantly: âTHIO was evaluated in various in vitro and in vivo models of gliomas. The results demonstrate the promising therapeutic role of THIO for the treatment of primary and temozolomide-resistant recurrent gliomas through specific telomerase-mediated induction of telomeric DNA damage in glioma cellsâ Here are some of the companyâs comments from this press release: "High grade adult gliomas are among the most difficult-to-treat cancers, with less-than-desirable clinical outcomes. These encouraging results further highlight THIOâs excellent anti-cancer activity across several cancer indications," said Vlad Vitoc, M.D., MAIAâs Chief Executive Officer. "We look forward to evaluate THIO as a treatment for brain cancer in clinical setting." In addition: "THIO was effective in the majority of human and mouse glioma cell lines with no apparent toxicity against normal astrocytes. As a monotherapy, THIO demonstrated efficacy in multiple glioma cell lines that had acquired resistance to the current state-of-the art care temozolomide (TMZ). THIO induced apoptosis in several human glioma cell lines that grow as three-dimensional tumor mass-mimicking neurospheres," said MAIAâs Chief Scientific Officer Sergei Gryaznov, Ph.D. "Additionally, THIO produced telomeric DNA damage responses not only in glioma cell lines, but also in diverse human-derived tumor specimens (PDXs). In vivo, THIO significantly decreased tumor proliferation in glioblastoma xenografts and a PDX model of glioblastoma." The company also announced: âMAIA Biotechnology Accelerates Enrollment in THIO-101 Phase II Clinical Trial as Efficacy Is Observed in Dosed Patientsâ Here are the highlights from this press release: - â49 patients dosed to date; 37 have completed at least 1 post baseline assessmentâ
- âTHIO-101 enrollment pace currently exceeds average for similar NSCLC trialsâ As the company further explained: "In feedback received from the clinical trial investigators, the encouraging efficacy observed in dosed patients is prompting physicians to speed up trial enrollment even further. Following U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application, we expect to more than double the number of sites in the near future," said Vlad Vitoc, M.D., MAIAâs Chairman and Chief Executive Officer. "We are pleased with the pace of enrollment for THIO-101, our go-to-market trial, which is currently exceeding the average enrollment pace in similar NSCLC trials. We look forward to sharing preliminary safety and efficacy data in the coming weeks." But thatâs not all⦠âMAIA Biotechnology Reveals New Data Showing THIOâs Potent Anticancer Activity in Aggressive Pediatric Brain Cancerâ - âTreatment demonstrates decreased cancer cell proliferation and increased tumor sensitivity to ionizing radiationâ Here are some of the companyâs comments from this press release: "We have shown that THIO treatment sensitized DIPG cells to ionizing radiation (IR), leading to a significant decrease in DIPG cell proliferation in vitro and in vivo models," said MAIAâs Chief Scientific Officer Sergei Gryaznov, Ph.D. "These encouraging preclinical studies may support further potential preclinical and clinical development of THIO to be used in combination with IR to treat children with high-risk pediatric brain tumors." In addition, just this morning, the company announced big breaking news: - âMAIA Biotechnology Announces 100% Disease Control in Second-Line Non-Small Cell Lung Cancer Demonstrating Impressive Positive Preliminary Efficacy Data for Ongoing THIO-101 Phase 2 Trialâ MAIA could be in a position to experience increased growth. Make sure to do your own due diligence. Sources: [Society]( [Cancer]( [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [PR6]( [PR7]( [PR8]( [PR9]( [PR10]( [Website]( [Chart]( Happy Trading! AwesomeStocks Note: We encourage all traders and investors to develop personal trading rules that you can follow and that work for you. Always protect your downside and note that we alert extremely volatile short-term opportunities. Before investing in securities, you should always consult with your financial, tax and legal advisor and never invest money you cannot afford to lose. 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