This Just In... (MAIA) Makes Huge Phase 2 Trial Update Announcement (Breakout Potential Grows?)

Moments ago, MAIA dropped a major news announcement. With it, this NYSE American profile could draw some serious breakout buzz. This Just In... (MAIA) Makes Huge Phase 2 Trial Update Announcement (Breakout Potential Grows?) February 22nd Dear Reader, Moments ago, MAIA dropped a major news announcement. With it, this NYSE American profile could draw some serious breakout buzz. Take a look at the news here: [MAIA Biotechnology Completes Enrollment in THIO-101 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer]( From the article: “Enrollment in our Phase 2 THIO-101 trial has been strong from the start. With excellent results across all doses and our selection of the optimal dose in December 2023, we enrolled the necessary number of patients in the Simon 2-stage design to achieve our trial endpoints earlier than expected,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “THIO-101 preliminary data has demonstrated unprecedented rates of disease control and response to date, and we look forward to the long-term efficacy results as we continue to monitor the enrolled patients in the upcoming months. As the only direct telomere targeting agent currently undergoing clinical development in the field of cancer, we believe THIO holds a time-to-market advantage and strong potential to become a new standard of care for NSCLC.” Being a low float idea, with fewer than 11Mn shares according to [Yahoo Finance]( MAIA could witness significant volatility after this explosive news. Read my initial report below on MAIA and get this NYSE American past champ on your radar quickly. ----- Back on watch right now is MAIA Biotechnology, Inc. (NYSE American: MAIA). This former breakout runner has clipped 2 separate short term, double-digit (approx.) moves after my alerts including a 25+% (approx.) blast. And with [two different]( [analyst targets]( suggesting as much as 600+% potential upside from its closing valuation Wednesday, this past champ needs immediate attention once again. But those are not the only reasons... Lest I forget. Having a [low float]( of fewer than 11Mn shares, volatility could take hold of this profile in an instant. So, when the company drops huge news like "[Positive Phase 2 Clinical Updates]( it's time to start focusing in closely on everything they're up to. See, MAIA is a targeted therapy, immuno-oncology company focused 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 cancer. Their lead 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 cells. And based on multiple potential breakout catalysts, MAIA needs to be on your watch-list right now. Check them out: #1. Analyst's Target Suggests Over 800% Potential Upside From MAIA's Current Chart Levels. #2. Another Analyst Weighs In (Diamond Equity Research Report Suggests $11.25 Target). #3. Volatility Could Be In Full Force Based On MAIA's Low Float. #4. MAIA Biotechnology Provides Positive Phase 2 Clinical Updates For Lead Anticancer Agent And Outlines Targeted Milestones For 2024. But more on those in a second... MAIA's First-In-Class Cancer Telomere Targeting Agent: THIO THIO (aka 6-thio-dG, 6-thio-2’-deoxyguanosine) is a potentially first-in-class small molecule that is the only direct telomere targeting agent currently in clinical development. Telomerase is present in >85% of human cancers and contributes significantly to the proliferation and reproductive immortality of cancer cells. THIO’s in vitro activity has been studied in models of several tumor types with active telomerase. A New Therapeutic Strategy THIO is recognized by telomerase and incorporated into telomeres in cancer cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends and thus resulting in rapid tumor cell death. Low doses of THIO, followed by anti-PD-L1 or anti-PD1 therapy, completely eliminated advanced tumors in preclinical models in vivo, and produced cancer cell specific immune memory, where the immune system continued to be active against the cancer cells after extended periods of time, with no additional treatment. These results demonstrate how the THIO-produced telomere stress increases innate sensing and adaptive anti-tumor immunity, which provides a strong rationale for sequentially combining their telomere-targeted therapy with immunotherapy ([Mender et al., 2020](. Clinical Development MAIA is currently advancing THIO in a Phase 2 clinical study in Non-Small Cell Lung Cancer (NSCLC). This is the first study to test THIO’s immune system activation followed by administration of the checkpoint inhibitor cemiplimab, allowing for the immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that lower doses of THIO administered prior to Libtayo treatment would enhance and prolong responses in subjects with advanced NSCLC who did not respond or progressed after first-line treatment with a checkpoint inhibitor. THIO followed by Libtayo for the treatment of advanced non-small cell lung cancer is in clinical development, and the safety and efficacy of THIO or its administration with Libtayo have not been reviewed yet by any regulatory authorities. Second-Generation Telomere Targeting Agents MAIA has initiated an early-stage research and discovery program aimed at identifying new compounds capable of acting through similar mechanisms of activity as THIO, such as the targeting and modifying telomeric structures of cancer cells through cancer-cell intrinsic telomerase activity. The main objective for this program is to discover new compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity. This program may also allow us to strengthen their patent portfolio. Although the program is in early stages and they may not be able to identify suitable compounds, they believe they will be able to create a second generation of THIO-like compounds. Their current second-generation pipeline of potential telomere-targeting agents includes five compounds that have successfully undergone in vitro inhibitory testing in five cancer models. The data from those studies showed a significantly lower 50% inhibitory concentration (IC50) for those compounds compared to THIO. Based on those data, the company has progressed those five compounds to in vivo testing and with proceeds from the IPO, they plan to initiate pre-IND testing for two of them in mid-2022, with the goal of advancing them to clinical trials by the end of 2024. MAIA's Pipeline The company's pipeline includes several targeted immuno-oncology therapies for difficult-to-treat cancers: Grab Sources And More Here: [Company Website.]( ----- As mentioned above, MAIA has several explosive potential catalysts to pay close attention to right now. Here they are: #1. Analyst's Target Suggests Over 800% Potential Upside From MAIA's Current Chart Levels. Back in October of 2023, Robert LeBoyer, Senior Vice President and equity research analyst with [Noble Life Science Partners]( reiterated a $14.00 target on MAIA. From Wednesday's opening valuation, that provides MAIA with upside potential well over 800%! Check out some key report highlights: ESMO Data Shows Unusually High Survival Rates. MAIA Biotechnology presented preliminary data from the THIO-101 trial in non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology conference. The disease control rate (DCR) reached 100% in second line patients compared with about 53% to 64% for standard of care therapies. DCR for third line patients reached 88%, compared with about 30% expected. We see these results as extremely strong, and believe DCR could correlate with overall survival (OS), a primary endpoint of the trial. Preliminary Data Shows Strong Response. The results showed a disease control rate (DCR, consisting of complete responses, partial responses, or stable disease) of 100% or 19 out of 19 patients in second line therapy and 88% or 14 out of 16 patients in third line. Published data from 74 clinical trials with standard of care therapies show 53% to 64% DCR in second line and about 30% in third line. We see this as a substantial improvement over results from standard of care therapies. Patients In The Trial Are Still In The Follow-Up Stage. The first 2 subjects that entered the trial both received THIO as a 3rd line of treatment. These patients had reported survival of 14.6 and 12.5 months, compared with expected survival of about 3 to 6 months. At the time of assessment, 37 subjects completed at least 1 post-baseline evaluation with 26 of 37 (70%) patients still on treatment. Many have been treated recently but showed a median duration of treatment of 12.4 weeks (range 3.4 – 28.4 weeks). Out of these patients, partial responses (PRs) were reported for 6 subjects, with 2 PRs confirmed by a 2nd scan. Conclusion. We see the updated data as a strong initial sign of efficacy for the THIO-101 trial. Additional response data is expected in the coming months as more recently treated patients reach longer follow-up points. MAIA recently announced clearance of the IND to start clinical trials in the US and increase enrollment in THIO-101. Top-line overall response data this stage of the trial is expected toward year-end to early 1Q, with the THIO-102 Phase 2 trial in in colorectal cancer, liver cancer, and solid tumors expected to begin around year-end. We are reiterating our Outperform rating and $14 price target. ----- #2. Another Analyst Weighs In (Diamond Equity Research Report Suggests $11.25 Target). Back in November, an analyst at [Diamond Equity Research]( announced a target of $11.25. From Wednesday's open, that target provides a potential upside of way over 600%! Here's a quick summary from the report: Valuation - MAIA Biotechnology has showcased marked progress, particularly pertaining to the clinical development of THIO-101 and has even announced highly promising preliminary efficacy and safety data, coupled with its recent IND clearance. Following a review of the latest fi-nan-cial results, we have revised our valuation approach and updated our fi-nan-cial projections accordingly. In addition, after updating our analysis of peer comparable companies, we have arrived at a valuation of $11.25 per share, contingent on successful execution by the company. ----- #3. Volatility Could Be In Full Force Based On MAIA's Low Float. According to the [Yahoo Finance]( website, MAIA has a low float. The website reports this profile to have roughly 10.03Mn shares in its float. Why is that important? It's important on one crucial level. Volatility. Could even more positive company news early in 2024 provide a breakout spark? ----- #4. MAIA Biotechnology Provides Positive Phase 2 Clinical Updates For Lead Anticancer Agent And Outlines Targeted Milestones For 2024. - Lead candidate THIO maintains unprecedented disease control rates in Phase 2 non-small cell lung cancer (NSCLC) clinical trial - Multiple clinical milestones ahead for THIO-101 Phase 2 trial - Company enters 2024 with robust clinical pipeline in multiple hard-to-treat cancer indications CHICAGO, January 17, 2024--(BUSINESS WIRE)--MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, announced new interim data for its ongoing THIO-101 Phase 2 trial in non-small cell lung cancer (NSCLC) and outlined key clinical milestones for 2024. In the latest available data from THIO-101 (November 13, 2023), 60 patients had been dosed with THIO in sequential combination with Libtayo®. The patients received either 60mg, 180mg, or 360mg of THIO per dose, and 42 had at least one post baseline assessment completed. The observed disease control was well sustained compared to previous scans. "We are entering 2024 with strong momentum and great excitement about our programs and pipeline," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "To date, preliminary Phase 2 data on THIO in NSCLC has demonstrated unprecedented rates of disease control and response — measures that vastly outperform the standard of care." "In addition to NSCLC, our pipeline of immuno-oncology therapies includes THIO orphan drug designations for multiple hard-to-treat cancers, and our research includes THIO-like second-generation telomere-targeting agents. The main objective for the second-generation program is to discover new compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity," Dr. Vitoc continued. "Multiple milestones are on target for 2024 as enrollment continues in THIO-101, including long-term efficacy as a major clinical inflection point." ... [Read the full article here.]( ----- MAIA Recap - NYSE American Breakout Idea Has 4 Explosive Potential Catalysts #1. Analyst's Target Suggests Over 800% Potential Upside From MAIA's Current Chart Levels. #2. Another Analyst Weighs In (Diamond Equity Research Report Suggests $11.25 Target). #3. Volatility Could Be In Full Force Based On MAIA's Low Float. #4. MAIA Biotechnology Provides Positive Phase 2 Clinical Updates For Lead Anticancer Agent And Outlines Targeted Milestones For 2024. ----- Coverage is officially reinitiated on MAIA. When updates are available, we'll get them out quickly. Talk soon. Sincerely, FierceAnalyst | Jaks Swift Editorial Writer (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Ownership of FI has now moved to a single individual. Disclosure: I am not a lic-ensed fina-ncial adviser. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. Fierce full disclosure is to be read and fully understood before using Fierce's website, or joining Fierce's email or text list. By viewing Fierce's website and/or reading Fierce's email or text newsletter you are agreeing to -> [( An owner of SWN Media LLC owns and operates smallcapfirm . com (“SCF”), owns and operates stockwirenews . com (“SWN”), and owns and operates stockstreetwire . com ("SSW"). 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