Grab Sources And More Here: Company Website.
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As mentioned above, MAIA has several explosive potential catalysts to pay close attention to right now. Here they are:
No. 1 MAIA Potential Catalyst - FDA Clearance Is An "Essential Milestone" That Can't Be Taken Lightly
MAIA Biotechnology Announces FDA Clearance of IND Application for THIO, a First-in-Class Telomere Targeting Agent for the Treatment of Non-Small Cell Lung Cancer
- THIO to be Evaluated in the U.S. as Part of Current THIO-101 Global Phase 2 Clinical Trial
CHICAGO, October 03, 2023--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for THIO to be evaluated in the U.S. as part of THIO-101, the Company’s ongoing global phase 2 clinical study in patients with advanced Non-Small Cell Lung Cancer (NSCLC). THIO is being tested in sequential combination with Regeneron’s anti PD-1 monoclonal antibody cemiplimab (Libtayo®) to evaluate anti-tumor activity and immune response in NSCLC patients.
"We are extremely pleased to obtain clearance to extend our go-to-market THIO-101 trial to the U.S. and further develop THIO’s global reach," said Vlad Vitoc, MAIA’s Chief Executive Officer.
"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., MAIA’s Chief Medical Officer.
"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, MAIA’s Head of Regulatory and Quality.
About Investigational New Drug Application
An Investigational New Drug (IND) application is a request for authorization from the U.S. Food and Drug Administration to administer an investigational drug or biological product to humans in the United States. Organizations can initiate a clinical trial in the U.S. with IND clearance from the FDA.
Read the full article here.
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No. 2 MAIA Potential Catalyst - Analyst's Target Suggests Over 450% Potential Upside From MAIA's Current Chart Levels
Back in July, Robert LeBoyer, Senior Vice President and equity research analyst with Noble Life Science Partners, reiterated a $14.00 target on MAIA.
From Wednesday's closing valuation, that provides MAIA with upside potential well over 450%!
Check out some key report highlights:
Survival Data From The First Two Patients Announced. MAIA Biotechnology announced updated survival data from the first two patients treated in its Phase 2 THIO-101 trial. The patients remain alive without disease progression for 12.2 and 11.5 months from treatment initiation and 10.2 months and 8.5 months after completing THIO treatment. These results compare with expected survival of about 3 months to 4 months after disease progression or about 6 months if a third line of therapy is given. We see these positive results as consistent with the preclinical data.
Patients Were From The Safety Lead-In Stage. The THIO-101 trial enrolls patients with recurrent or metastatic Stage 4 non-small cell lung cancer that have failed 2 lines of therapy. These prior therapies include an immune checkpoint inhibitor and a platinum-based (standard) chemotherapy regimen. The two patients were from the Part A safety verification stage. The patients were treated with 360 mg of THIO followed by a standard regimen of Libtayo (cemiplimab, an immune checkpoint inhibitor from Regeneron). The patients have not received any new cancer therapies.
The Part A Data Showed Safety and Tolerability. The safety data from Part A was announced in April 2023, followed by the start of the Part B dose-finding stage. This stage tests three doses (90 mg, 180 mg, and 360 mg) in combination with Libtayo. The 90 mg low dose is the human equivalent of the curative dose in animal models, while the 360 mg high dose was shown to be safe in Part A. One of the doses will be selected for the Part C registration stage.
Conclusion. Although survival was only reported from two patients, it has exceeded expectations for advanced NSCLC. Additional data from Part B is expected in late 3Q/4Q, to be followed by the start of the Part C registration stage. This fundamental progress has not been reflected in MAIA's stock price. We attribute its depressed valuation to the current environment for small-cap biotechnology, which has been down to flat for the past several months. ... We are reiterating our Outperform rating and $14 price target.
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No. 3 MAIA Potential Catalyst - 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 8.66Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility.
Could even more positive company news towards the end of 2023 provide a breakout spark?
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No. 4 MAIA Potential Catalyst - Huge Announcement: Repurchase Program Indicates Company's Own Confidence
MAIA Biotechnology Announces Share Repurchase Program
CHICAGO, September 28, 2023--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its Board of Directors has approved a share repurchase program with authorization to purchase up to $800k of its Class A common st-ock through September 2024.
"This share repurchase program demonstrates the confidence we have in our market opp. and our strategy to in-vest for long-term growth, which we believe is not reflected in the current market valuation," said Vlad Vitoc, MAIA’s 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 opp. we see ahead, and drive sustainable value for all stakeholders."
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Read the full article here.
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No. 5 MAIA Potential Catalyst - Patent Filing Builds Key Protection For IP Portfolio
MAIA Biotechnology Files Second Patent For New Telomere-Targeting Molecules Program
Filed provisional new composition of matter patent application for MAIA’s third entirely home-grown telomere-targeting molecule
CHICAGO, June 07, 2023--(BUSINESS WIRE)--MAIA Biotechnology, Inc. (NYSE American: MAIA) today announced its second broad provisional patent application covering the composition of matter for a new telomere-targeting molecule. MAIA is creating and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell - intrinsic telomerase activity - and thus cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules.
MAIA has nominated a new molecular entity candidate (designated as MAIA-2021- 029) for further advancement into preclinical GLP-toxicity and other studies, and may advance this candidate into human clinical trials upon completion of the required preclinical evaluations. The patent titled "TUMOR REDOX-ACTIVATED 6-THIOPURINE CONTAINING DIMER COMPOUNDS" further adds to MAIA’s Telomere-Targeting Molecule Program, which includes THIO, the lead therapeutic candidate currently being evaluated in a Phase 2 clinical trial, and follow-on compounds MAIA-2021-020 and MAIA-2022-012, patented in the fourth quarter of 2022.
"The discovery and preclinical advancements of these new telomere-targeting compounds represent another significant chapter for MAIA. We have observed impressive single-agent activity in several different tumor types for the new candidates, as well as in combination with immune checkpoint inhibitors," said Sergei Gryaznov, Ph.D., MAIA Chief Scientific Officer. "The observed anti-cancer activity in vitro and in vivo is quite remarkable, often leading to complete tumor eliminations. We are working diligently to advance these candidates toward clinical development."
"The development of proprietary new molecular entity candidates is a key component to MAIA’s strategy and greatly increases the chances to bring a highly efficacious telomere-targeting therapy to market. Our molecules can be used in the treatment of multiple cancer indications, and with the excellent preliminary results observed in our ongoing Phase II trial evaluating THIO in patients with Non-Small Cell Lung Cancer, we look forward to announcing further developments of MAIA’s proprietary new molecular entity candidates," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D.
Read the full article here.
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MAIA Recap - NYSE American Breakout Idea Has 5 Explosive Potential Catalysts
No. 1 - FDA Clearance Is An "Essential Milestone" That Can't Be Taken Lightly
No. 2 - Analyst's Target Suggests Over 450% Potential Upside From MAIA's Current Chart Levels
No. 3 - Volatility Could Be In Full Force Based On MAIA's Low Float
No. 4 - Huge Announcement: Repurchase Program Indicates Company's Own Confidence
No. 5 - Patent Filing Builds Key Protection For IP Portfolio
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Coverage is officially initiated on MAIA. When time allows, do this:
