Cemiplimab-RWLC

Hundreds of women with aggressive cervical cancer are to be offered a new immunotherapy on the NHS, which could help more women survive and stay cancer-free in the long-term. Pembrolizumab – which experts describe as being able to ‘take the handbrake off the body’s immune system’ to target cancer – will now offer a new option for women in England with locally-advanced cervical cancer. This means the cancer has grown beyond the cervix to regions such as the pelvic wall, but not yet spread further around the body. Trials found that adding pembrolizumab to standard chemoradiotherapy helped keep cancer at bay for longer and improved survival rates. 2 years after starting the treatment, nearly 7 in 10 patients (68%) were still living without their cancer progressing, compared with 57% for those receiving chemoradiotherapy alone. The trial also found that 82.6% of patients were still alive three years after treatment with pembrolizumab and chemoradiotherapy, compared with 74.8% with chemoradiotherapy alone. The drug is given every 3 or 6 weeks via an infusion or as a ‘one-minute’ injection, following the NHS’s recent rollout of a faster, injectable version of pembrolizumab – alongside chemoradiotherapy. Professor Peter Johnson, NHS National Clinical Director for Cancer, said: “This is great news for women facing a diagnosis of aggressive cervical cancer – and represents one of the biggest improvements in treatment for this disease in recent years. “Combining this immunotherapy with existing treatment has had very positive effect for patients in trials, helping the body’s immune system to target cancer more effectively. “We’re delighted it will be available for patients on the NHS as it could help hundreds more women survive and stay cancer-free in the long-term.” The NHS estimates around 550 patients in England will be eligible for the treatment over the next 2 years, around 270 per year. The treatment has today been approved by the National Institute for Health and Care Excellence (NICE) for treating patients with stages 3 or 4 locally advanced cervical cancer, following a commercial deal struck by NHS England with manufacturer MSD. Patients will receive fast-tracked access from today, funded by NHS England’s Cancer Drugs Fund. Louise Broadbelt, 55, from Surrey, was diagnosed with stage 3 locally advanced cervical cancer aged 50 and accessed the treatment via a clinical trial at The Royal Marsden. She said: “Nothing can prepare you for being diagnosed with cancer. All you want to hear is you will get the best possible treatment and have hope. “I’m very grateful that I was offered the chance to go on the pembrolizumab clinical trial in 2021. I feel incredibly blessed and lucky that I was offered to participate in the trial and that I am still here today.” The global clinical trial KEYNOTE-A18 involved 2 NHS hospitals the Royal Devon and Exeter Foundation Trust Hospital and The Royal Marsden NHS Foundation Trust. Cervical cancer is the 14th most common cancer among women in the UK , with 3,300 people diagnosed every year, according to Cancer Research UK. Pembrolizumab, manufactured by MSD, is a type of immunotherapy which works by blocking a protein called PD-1, which acts as a brake on immune responses enabling patients’ immune cells to kill cancer cells. This follows other recent developments in cervical cancer, including cemiplimab for recurrent or metastatic cervical cancer after chemotherapy and new research showing children vaccinated at age 12-13 against HPV have close to zero risk of dying from cervical cancer before the age of 30. Public Health Minister Sharon Hodgson said: “This is a significant step forward for women facing one of the most aggressive forms of cervical cancer. Making pembrolizumab available on the NHS will give more patients access to a treatment that could help them live longer and, for some, achieve cancer-free lives. “Thanks to the NHS, NICE and our partnership with industry, women in England will be among the first to benefit, ensuring the latest advances in cancer care reach those who need them most, as quickly as possible.” Lyndsy Ambler, Cancer Research UK’s senior strategic evidence manager, said: “Adding immunotherapy to standard cancer treatment could improve people’s chances of survival, so it’s encouraging that pembrolizumab is being made available for some people with locally advanced cervical cancer through the Cancer Drugs Fund. This decision may also allow some patients to access the drug earlier in their treatment than previously.” John McNeill, Oncology Business Unit Director at MSD in the UK, said: “We welcome today’s recommendation from NICE, which is an important step forward for women living with locally advanced cervical cancer. “This is a cancer which disproportionately impacts women from underserved backgrounds and where there has long been an unmet need. Today’s decision represents a meaningful development for these patients, who may benefit from additional treatment options.” Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Part C domestic enrollment is underway at three clinical sites in the U.S. CHICAGO, June 25, 2026 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that it has completed international enrollment in Part C of its Phase 2 THIO-101 expansion trial evaluating its lead candidate, ateganosine, in advanced non-small cell lung cancer (NSCLC) patients receiving third line (3L) therapy. Ateganosine is an investigational dual-mechanism therapy targeting telomeres and immune activation in difficult-to-treat cancers. THIO-101 Part C patients, who are resistant to prior checkpoint inhibitor (CPI) therapy and chemotherapy, are randomized between MAIA’s proposed combination regimen of ateganosine followed by cemiplimab (Libtayo ® ) and treatment with ateganosine alone for two cycles. International screening was conducted in Taiwan, Turkey, Poland, Hungary, Romania and Georgia, with 41 patients enrolled and receiving treatment. The Part C study is currently screening patients at multiple clinical sites in the United States. “We greatly appreciate the dedication and contributions of the investigators supporting our THIO-101 trial,” said Vlad Vitoc, Founder and Chief Executive Officer of MAIA Biotechnology. “With enrollment now complete at the international Part C clinical sites, we are closely monitoring patient outcomes as the data continues to mature, including key efficacy measures such as disease control rate and overall survival, which have remained central endpoints throughout the Phase 2 THIO-101 trial. Meanwhile, patient screening is ongoing at three activated clinical sites in the United States.” In Parts A and B of THIO-101, MAIA reported data showing median survival of 17.8 months. Overall survival (OS) beyond two years was observed for eight patients in Parts A and B of THIO-101; the patients did not receive subsequent lines of therapy. One patient in this cohort receiving 3L therapy has survived for over 33 months. Expected survival in this heavily pre-treated population is 5.8 months. 1 The FDA has granted Fast Track designation for ateganosine in NSCLC treatment, potentially expediting the regulatory process to a potential Accelerated Approval and Priority Review. About Ateganosine Ateganosine (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 induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine 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. Ateganosine 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 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 ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine 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 ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo ® ) has shown an acceptable safety pro 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 ateganosine (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 . 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. Investor Relations Contact +1 (872) 270-3518 ir@maiabiotech.com 1 Girard N, et al. J Thorac Onc 2009;12:1544-1549