Cetuximab

CHICAGO--( BUSINESS WIRE )-- MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has amended the 2021 clinical supply agreement with Regeneron for the expansion portion of THIO-101, its Phase 2 clinical trial evaluating THIO in sequential administration with cemiplimab (Libtayo ® ). The new expansion will further assess the efficacy of MAIA’s lead asset, THIO, sequenced with immune checkpoint inhibitor (CPI) Libtayo ® (cemiplimab) for advanced non-small cell lung cancer (NSCLC) patients receiving third-line therapy who were resistant to previous checkpoint inhibitor treatments and chemotherapy. The original 2021 agreement between MAIA and Regeneron was designed to supply the original THIO-101 trial through the dose selection and safety evaluation process. The THIO-101 trial has been amended and expanded to further evaluate efficacy at the target dose and target third line patient population. "In keeping with our clinical strategy for THIO, we look forward to continuing our collaboration with Regeneron to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. So far, THIO-101 has demonstrated favorable disease control, progression free survival, overall response rates, and we remain on track to achieve our overall survival goals,” said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. Under terms of the amended clinical supply agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo® for the treatment of all patients in the trial including the additional patients in the THIO 101 expansion. MAIA holds an exclusive worldwide patent license to develop and commercialize THIO. MAIA expects to start enrolling new patients in the expansion of THIO-101 in the near future. The company continues to evaluate its regulatory strategy and believes that there could be an opportunity for an accelerated approval in the United States based on the ultimate outcome of the ongoing THIO 101 trial. About THIO THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors. About THIO-101, a Phase 2 Clinical Trial THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab (Libtayo®) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944. About MAIA Biotechnology, Inc. 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. Our 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. For more information, please visit www.maiabiotech.com . Forward Looking Statements MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

DUBLIN--( BUSINESS WIRE )--The "Head and Neck Cancer Therapeutics - A Global Market Overview" report has been added to ResearchAndMarkets.com's offering. The global market for Head and Neck Cancer Therapeutics is estimated at US$1.7 billion in 2024 and is anticipated to post a CAGR of 9.4% during the 2024-2030 analysis period and stand at a projected US$3 billion by 2030. This global report on Head and Neck Cancer Therapeutics analyzes the market based on drug class, treatment type, route of administration, and end-users. In addition to providing profiles of major companies operating in this space, the latest corporate and industrial developments have been covered to offer a clear panorama of how and where the market is progressing. The head and neck cancer market is primarily driven by increased research and development, which leads to the approval of new drugs, particularly for immunotherapy, targeted therapy, and chemotherapy. Healthcare providers are developing effective treatment options for several types of head and neck cancers, as evidenced by FDA approvals for drugs like Cetuximab and Docetaxel. Market growth is also driven by the rising incidence of HPV infections and increased consumption of alcohol and tobacco, which contribute to the prevalence of head and neck cancers. Additionally, advancements in diagnostic techniques allow for earlier detection, thereby improving treatment outcomes and increasing demand. Nevertheless, the market faces challenges such as high treatment costs limiting access for low- and middle-income patients, as well as adverse side effects like neuropathy and fatigue. Treatment resistance, where cancer cells evade therapies, and lengthy regulatory approval processes further impede market growth. Head and Neck Cancer Therapeutics Regional Market Analysis In 2024, North America led the global head and neck cancer therapeutics market, holding an estimated 46.8% market share. Growth in this region is attributed to its advanced healthcare infrastructure, strong awareness of the disease, substantial investments in research and development, and favorable reimbursement policies. The region's dominant position is supported by its robust healthcare system and the high incidence of head and neck cancer associated with tobacco, alcohol, and HPV. Conversely, the Asia Pacific region is expected to witness substantial growth with a CAGR of 10.9% during the forecast period 2024-2030, driven by the increasing number of head and neck cancer cases due to alcohol and tobacco use, growing consumer awareness, and higher healthcare spending. Market expansion in this region is further stimulated by the improving healthcare infrastructure, aging population, and rising disposable incomes. Countries such as China and India are particularly affected by a high prevalence of cancer, influenced by lifestyle factors and government efforts to improve cancer care. Head and Neck Cancer Therapeutics Market Analysis by Drug Class Programmed Cell Death (PD) Inhibitors dominate the head and neck cancer therapeutics market with an estimated share of 42.1% in 2024 and is projected to be the fastest-growing therapeutic class, with a CAGR of 10.5% during the analysis period 2024-2030. These inhibitors have shown promising results in improving survival rates and extending progression-free survival, especially in patients with advanced or recurrent cancer. Due to their effectiveness, there is increasing demand for both monotherapy and combination treatments. Current clinical trials are focused on improving treatment approaches, identifying relevant biomarkers, and exploring new combinations. Head and Neck Cancer Therapeutics Market Analysis by Treatment Type Immunotherapy is the largest market in the head and neck cancer therapeutics market, holding a share of 43.6% in 2024, and is projected to record the fastest CAGR of 10.7% during the analysis period 2024-2030. By utilizing the body's immune system to target cancer cells, immunotherapy presents promising treatment options for advanced or recurring head and neck cancers, with Pembrolizumab established as a primary therapy. Growth in this sector is expected due to increased patient awareness and the active involvement of the FDA and EMA in approving new formulations. Targeted therapy held the second-largest market share at 22% in 2024, concentrating on specific molecular changes in tumors by interrupting critical signaling pathways. The active participation of companies and healthcare organizations further bolsters the expansion of targeted therapies. Head and Neck Cancer Therapeutics Market Analysis by Route of Administration The injectable segment dominated the head and neck cancer therapeutics market in 2024, with a 67.4% share. This dominance is attributed to the effectiveness of various cancer medications, such as chemotherapy and immunotherapy, administered intravenously or through injectables to ensure better absorption and efficacy. Injectable drugs like Cisplatin are notable for their controlled delivery and improved formulations, enhancing treatment efficacy. Conversely, oral administration is anticipated to be the fastest-growing segment, with a CAGR of 10.4% during the forecast period 2024-2030, driven by advancements in oral chemotherapy formulations and patient preferences for convenient at-home treatment options. Oral medications provide flexible treatment schedules, reduce clinic visits, and contribute to personalized head and neck cancer treatment strategies, improving patients' overall quality of life. Head and Neck Cancer Therapeutics Market Analysis by End-User In 2024, hospitals dominate the head and neck cancer therapeutics end-user market, holding an estimated share of 49.1% due to their well-equipped infrastructure and advanced disease diagnosis capabilities. On the other hand, the Ambulatory Surgical Centers (ASCs) segment is anticipated to register the fastest CAGR of 10.9% during the analysis period from 2024 to 2030, propelled by the increasing demand for cost-effective outpatient surgical treatments and technological progress enabling complex procedures in ASCs. Additionally, this growth is further driven by the rising prevalence of the disease and the necessity for faster treatment options. Head and Neck Cancer Therapeutics Market Report Scope Key Attributes: Report Attribute Details No. of Pages 301 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $1.7 billion Forecasted Market Value (USD) by 2030 $3 billion Compound Annual Growth Rate 9.4% Regions Covered Global Key Global Players AbbVie Inc. AstraZeneca plc Bayer AG Bristol-Myers Squibb Company Eli Lilly and Company F. Hoffmann-La Roche AG Merck & Co., Inc. Novartis AG Pfizer Inc. Sanofi S.A. Takeda Pharmaceutical Company Limited Teva Pharmaceutical Industries Ltd. Head and Neck Cancer Therapeutics Market by Geographic Region North America (The United States, Canada, and Mexico) Europe (Germany, France, United Kingdom, Italy, Spain, and Rest of Europe) Asia-Pacific (Japan, China, India, South Korea, and Rest of Asia-Pacific) South America (Brazil, Argentina, and Rest of South America) Rest of World Head and Neck Cancer Therapeutics Market by Drug Class Programmed Cell Death (PD) Inhibitors Microtubule Inhibitors Epidermal Growth Factor Receptor (EGFR) Inhibitors Head and Neck Cancer Therapeutics Market by Treatment Type Immunotherapy Targeted Therapy Chemotherapy Radiation Therapy Surgery Head and Neck Cancer Therapeutics Market by Route of Administration Injectable Oral Head and Neck Cancer Therapeutics Market by End-User Hospitals Specialty Clinics Ambulatory Surgical Centers (ASCs) For more information about this report visit https://www.researchandmarkets.com/r/iwl4td About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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