Unprecedented disease control rate (DCR) of 100% in second-line of treatment far surpasses standard of care (SoC) DCR of 53-64% DCR is far stronger than overall response rate (ORR) in predicting overall survival benefit, as shown in recent meta-analysis of 74 clinical trials worldwide1 CHICAGO--(BUSINESS WIRE)-- MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today reported positive preliminary efficacy data from its ongoing Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo®). Key findings: 100% Preliminary DCR observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment. DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the trial. “In NSCLC patients who received at least one line of therapy, DCRs have shown to be excellent predictors of overall survival.1 Observing 100% DCR to date in second-line treatment is unprecedented compared to DCRs for the SoC ranging from 53-64%,2” said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer. “We have also observed unprecedented high DCRs in third-line, with an 88% control rate, with treatment of THIO followed by cemiplimab. The results are even more remarkable given patients in this population have previously failed treatment with a checkpoint inhibitor. Currently, there is no SoC for third-line, but previous studies have reported an approximate 30% DCR.3 These exceptional preliminary results underscore our confidence in advancing the trial to bring our novel treatment to advanced stage NSCLC patients.” 1 Matsumoto H et al. Transl Lung Cancer Res. 2021 May; 10(5): 2278–2289 2 REVEL 3 Journal of Thoracic Oncology (VOLUME 16, ISSUE 10, OCTOBER 2021), T. Beninato et al. Study Disease Control Rates by Line of Treatment Treatment Line Standard of Care Treatment DCR Treatment Line THIO + Libtayo® (cemiplimab) DCR NSCLC-1 pembrolizumab (KEYNOTE-024) 71% NSCLC-1 TBD NSCLC-2 ramucirumab + docetaxel (REVEL) 64% NSCLC-2 100% docetaxel monotherapy (REVEL) 53% NSCLC-3 chemotherapy (RWD) 25-35% NSCLC-3 88% The Company presented the data at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 23, 2023. Full preliminary data is detailed in the poster available here. 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, 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 Regeneron’s anti-PD-1 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 a 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 cemiplimab followed by THIO 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 . 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.

临床结果临床2期免疫疗法

2023-10-22

·FiercePharma

ESMO: AstraZeneca proposes adding Lynparza to Imfinzi as endometrial cancer race heats up

GSK and Merck have reported positive first-line endometrial cancer data for their PD-1 inhibitors, and AstraZeneca is now proposing adding the PARP inhibitor Lynparza to its PD-L1 med Imfinzi. After two immunotherapies demonstrated their power against endometrial cancer, AstraZeneca now suggests that adding Merck-partnered Lynparza to its Imfinzi may offer another option. The addition of Imfinzi and Lynparza on top of chemotherapy reduced the risk of disease progression or death by 45% in patients with newly diagnosed advanced or recurrent endometrial cancer. Adding just Imfinzi to chemo cut that same risk by 29%. The results, from the phase 3 DUO-E trial, were presented at the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid. They followed positive readouts from two PD-1 inhibitors—GSK’s Jemperli and Merck’s Keytruda—also in first-line endometrial cancer. The DUO-E study is positive in the overall trial population, meeting its primary endpoint for both the doublet and triplet regimens, Cristian Massacesi, M.D., chief medical officer and oncology chief development officer at AstraZeneca, said in an interview with Fierce Pharma. But some patients appeared to have benefited more than others. First, PD-1/L1 inhibitors are known to work very well against tumors with genetic abnormalities known as mismatch repair deficiency (dMMR). In these patients, just putting Imfinzi on top of chemo pared down the risk of progression or death by 58%. But the further addition of Lynparza didn’t appear to offer any extra benefit as the triplet reduced the same risk by 59% over chemo alone. What’s more, the Imfinzi-chemo combo’s 58% progression-free survival (PFS) benefit in the dMMR population was notably smaller than the 70%-plus showing Jemperli and Keytruda have put up with chemo in their separate first-line endometrial cancer trials. Massacesi acknowledged that the benefit from the addition of Lynparza on the doublet is numerically less in dMMR and that the approach’s real potential was in the MMR-proficient population, where immunotherapies have less power. In the pMMR subgroup, the Imfinzi-chemo combo reduced the risk of progression or death by 23% compared with chemo alone, whereas the Lynparza-containing triplet improved that to 43%. The AZ doublet’s risk reduction in the pMMR group was similar to what GSK’s Jemperli showed in the RUBY trial. But the Imfinzi-chemo regimen merely improved the median PFS over chemo alone by 0.2 months. Massacesi argued that the median doesn’t accurately reflect Imfinzi’s benefit, which often happens later in treatment. Massacesi would not comment on AZ’s regulatory plan nor on whether the British pharma will seek FDA approval for both the doublet and triplet for all patients, dMMR and pMMR alike. Based on the RUBY data, GSK in July won a fast FDA nod for Jemperli in first-line dMMR endometrial cancer while waiting for more mature data to decide on the pMMR population. By comparison, Keytruda has shown a 46% PFS improvement in the pMMR population in the NRG-GY018 trial, although the number was drawn from a very short follow-up time. Merck has yet to disclose its plan with the FDA regarding a first-line endometrial cancer indication. The FDA has recently increased its scrutiny around PARP inhibitors like Lynparza. Some clinical data in the late-stage treatment settings have suggested that these drugs might cause long-term harm to patient survival, especially in tumors without homologous recombination repair mutations, despite an initial disease progression benefit. While the data remained immature, the Imfinzi-chemo arm showed a 23% reduction in the risk of death over chemo, and the Imfinzi-Lynparza-chemo regimen a 41% reduction. When presenting the DUO-E data at ESMO 2023, investigator Shannon Westin, M.D., from the MD Anderson Cancer Center noted that Asian patients, who make up about a third of the DUO-E population, didn’t seem to have benefited at all from the Imfinzi-chemo doublet. Researchers are still trying to understand the reason, she said. Then there’s the question of whether Imfinzi is the best immunotherapy partner for Lynparza in an endometrial cancer population. At least for now, Massacesi said, Imfinzi is the only one that has such data.

临床结果临床3期免疫疗法上市批准生物类似药

2023-10-19

·BioSpace

MAIA Biotechnology to Present Preliminary Safety and Efficacy Data from THIO-101 Phase 2 Clinical Trial at European Society for Medical Oncology Congress 2023

CHICAGO--(BUSINESS WIRE)-- MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that preliminary safety and efficacy data from its ongoing Phase 2 clinical trial, THIO-101, was accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2023, being held in Madrid, Spain, October 20-24, 2023. THIO-101 is evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo®). “We look forward to presenting THIO data at the esteemed ESMO Congress, where we will have the opportunity to update global leaders in cancer research from around the world on the only direct telomere targeting agent currently in clinical development,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA Biotechnology. The abstract is available online at the ESMO Congress website, and MAIA is scheduled for poster presentation on Monday, October 23. Details of the presentation are as follows: Abstract title: A Phase 2, Multi-Center, Open-Label, Dose-Optimization Study Evaluating Telomere Targeting Agent THIO Sequenced with Cemiplimab in Patients with Advanced NSCLC - Preliminary Results Presenter: Tomasz Jankowski, M.D. Presentation Number: 1493P Session title: NSCLC, metastatic About ESMO and the ESPO Congress The European Society for Medical Oncology is the leading professional organization for medical oncology. With more than 30,000 members representing oncology professionals from 168 countries worldwide, ESMO is the society of reference for oncology education and information. The ESMO Congress is one of the most influential oncology platforms for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. Only the highest quality studies are approved to be presented, supporting dissemination of the latest cutting-edge data, high quality education and unparalleled networking opportunities for oncologists and other stakeholders from all around the world. 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 vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for patients with advanced NSCLC who progressed after first line treatment regimens containing an immune check point inhibitor. 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 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 Regeneron’s anti-PD-1 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 a 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. 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 . 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.

临床2期免疫疗法

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