TME Pharma Announces 33% of Patients Receiving NOX-A12 in Combination With Bevacizumab and Radiotherapy Achieve Two‑Year Survival in GLORIA Phase 1/2 Trial in Brain Cancer

StreetInsider04-23

Two of six patients receiving NOX-A12 in combination with bevacizumab and radiotherapy exceeded 24-month survival since the start of therapy This survival compares favorably to the 5% survival rate ...

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TigerVision888
04-24
TigerVision888
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}\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nTME Pharma Announces 33% of Patients Receiving NOX-A12 in Combination With Bevacizumab and Radiotherapy Achieve Two‑Year Survival in GLORIA Phase 1/2 Trial in Brain Cancer\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-04-23 14:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.streetinsider.com/dr/news.php?id=23098333><strong>StreetInsider</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Two of six patients receiving NOX-A12 in combination with bevacizumab and radiotherapy exceeded 24-month survival since the start of therapy\n\n\nThis survival compares favorably to the 5% survival rate ...</p>\n\n<a href=\"https://www.streetinsider.com/dr/news.php?id=23098333\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00BSNM7G36.USD","symbol_name":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","start_time":0,"source_url":"https://www.streetinsider.com/dr/news.php?id=23098333","article_id":"2429715807","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2429715807","pubTimestamp":1713852000,"sourceInfo":{"source_id":"highlight_streetinsider","name":"StreetInsider"},"weMediaInfo":null,"summary":"Two of six patients receiving NOX-A12 in combination with bevacizumab and radiotherapy exceeded 24-month survival since the start of therapy. This survival compares favorably to the 5% survival rate at 2 years in the standard of care reference cohort. Final median overall survival rate for this NOX-A12 cohort reached an unprecedented 19.9 months, nearly doubling the 10.5 months mOS rate demonstrated by the standard of care reference cohort. GLORIA survival data supported recently announced FDA clearance of IND application for Phase 2 study in glioblastoma and award of Fast Track designation. \"This positive update from the GLORIA trial underlines the exceptional survival achieved by this cohort of patients with measurable tumors after surgery that are resistant to standard of care chemotherapy and gives more support for the potential of this NOX-A12 treatment regimen to prolong survival while preserving quality of life in patients suffering from this aggressive adult brain cancer,\" said","collect":0,"end_time":0,"defaultTopTitle":"streetinsider.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU0234572021.USD":"高盛美国核心股票组合Acc","SG9999002232.USD":"Allianz Global High Payout USD","BK4571":"数字音乐概念","SG9999002224.SGD":"Allianz Global High Payout SGD","BK4585":"ETF&股票定投概念","LU0965509010.AUD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (AUDHDG) INC","SG9999014559.SGD":"United Income Focus Trust Dis SGD","LU0320765489.SGD":"FTIF - Franklin Mutual US Value A Acc SGD","BK4007":"制药","BK4509":"腾讯概念","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU0070302665.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) ACC","SG9999014567.USD":"UOB UNITED INCOME FOCUS TRUST FUND (USD) ACC","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","LU2023250504.SGD":"Allianz Thematica Cl AMg DIS H2-SGD","BK4559":"巴菲特持仓","LU0861579265.USD":"联博低波幅策略股票基金A","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","BK4550":"红杉资本持仓","BK4526":"热门中概股","LU0985320562.USD":"NORDEA 1 GLOBAL STARS EQUITY \"BP\" (USD) ACC","BK4588":"碎股","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","BK4552":"Archegos爆仓风波概念","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","SG9999014542.SGD":"United Income Focus Trust Acc SGD","LU0965509101.SGD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"A\" (SGDHDG) ACC","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","LU0359202008.SGD":"Blackrock China Fund A2 SGD-H","TME":"腾讯音乐","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","LU1023057109.AUD":"BGF CHINA \"A2\" (AUDHDG) ACC","LU1917777945.USD":"安联专题基金Cl AT Acc","SG9999014575.USD":"UOB UNITED INCOME FOCUS TRUST FUND (USDHDG) INC","LU1974910355.USD":"Allianz Thematica Cl AMg DIS USD","LU0238689110.USD":"贝莱德环球动力股票基金","BK4563":"昨日强势股","BK4565":"NFT概念","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU2106854487.HKD":"ALLIANZ THEMATICA \"AMG\" (HKD) INC","LU2461242641.AUD":"WELLINGTON US QUALITY GROWTH \"A\" (AUDHDG) ACC","LU0266013472.USD":"AXA WF - Framlington Longevity Economy A Cap USD","LU0208291251.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) INC","BK4516":"特朗普概念","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","MRK":"默沙东"},"translate_title":"TME Pharma宣布，在GLORIA脑癌1/2期试验中，接受NOX-A12联合贝伐单抗和放疗的患者中有33%获得两年生存率","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"TME":1,"MRK":0.9},"content_text":"Two of six patients receiving NOX-A12 in combination with bevacizumab and radiotherapy exceeded 24-month survival since the start of therapy\n\n\nThis survival compares favorably to the 5% survival rate at 2 years in the standard of care reference cohort\n\n\nFinal median overall survival rate for this NOX-A12 cohort reached an unprecedented 19.9 months, nearly doubling the 10.5 months mOS rate demonstrated by the standard of care reference cohort\n\n\nGLORIA survival data supported recently announced FDA clearance of IND application for Phase 2 study in glioblastoma and award of Fast Track designation\n\n\n BERLIN--(BUSINESS WIRE)--\nRegulatory News:\n\nTME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announces a positive update on survival at two years for newly diagnosed glioblastoma patients receiving NOX-A12, TME Pharma's CXCL12 inhibitor, with the VEGF inhibitor bevacizumab and radiotherapy.\n\nTwo out of the six glioblastoma patients in this expansion arm of the GLORIA Phase 1/2 trial have survived for more than 24 months since the start of therapy. These two patients had tumors which, at one point during treatment, either disappeared completely or reached near-complete reduction (>99%) in size. The first patient to cross the two-year survival milestone had maintained a physical and cognitive condition within the norm, displaying only minimal disease-specific symptoms at this timepoint. This translates to a preserved quality of life, as evidenced by the patient’s continued ability to engage in hobbies, leisure activities, and social interaction. The second patient’s clinical status at the last assessment at 23 months was stable, although certain neurological functions had been partially affected. This patient’s course is also remarkable in that they received no therapy expected to prolong survival in the last 18 months since they decided to end treatment with the NOX-A12 combination following a near-complete reduction of tumor as assessed by MRI.\n\nIn February, TME Pharma announced the final median overall survival (mOS) for this NOX-A12 cohort had reached an unprecedented 19.9 months. This survival rate compares very favorably to a matched standard of care reference cohort,1 which achieved an mOS of approximately 10 months, and exceeds what TME Pharma believes to be all relevant competitor therapy trials in newly diagnosed glioblastoma patients resistant to standard chemotherapy.2\n\n\"This positive update from the GLORIA trial underlines the exceptional survival achieved by this cohort of patients with measurable tumors after surgery that are resistant to standard of care chemotherapy and gives more support for the potential of this NOX-A12 treatment regimen to prolong survival while preserving quality of life in patients suffering from this aggressive adult brain cancer,\" said Aram Mangasarian, CEO of TME Pharma. \"This latest announcement adds to the significant clinical and regulatory progress we have made in recent months with our lead asset, putting us in an excellent position for our upcoming Phase 2 evaluation and our discussions with potential pharmaceutical and financial partners, as we endeavor to deliver NOX-A12 for the benefit of glioblastoma patients as quickly and efficiently as we can.\"\n\nTME Pharma recently announced two key regulatory milestones with the clearance by the US Food and Drug Administration (FDA) in March of the company's Investigational New Drug (IND) application for NOX-A12 in glioblastoma, allowing TME Pharma to proceed with the continued clinical development of NOX-A12 in a new Phase 2 study. This was followed by the FDA's award of Fast Track designation to NOX-A12 in glioblastoma in April. Fast Track designation aims to facilitate the development of therapies intended to treat serious conditions and address unmet medical needs, and could support an accelerated pathway to US regulatory approval. Preparatory steps for the NOX-A12 Phase 2 in glioblastoma are ongoing, and TME Pharma is aiming to initiate the new study as soon as the necessary resources from financial and industrial partners have been secured.\n\nAbout TME Pharma\n\nTME Pharma is a clinical-stage company focused on developing novel therapies for treatment of the most aggressive cancers. The company’s oncology-focused pipeline is designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. By neutralizing chemokines in the TME, TME Pharma’s approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the GLORIA clinical trial, TME Pharma is studying its lead drug candidate NOX-A12 in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. TME Pharma has delivered top-line data from the NOX-A12 three dose-escalation cohorts combined with radiotherapy of the GLORIA clinical trial, observing consistent tumor reductions and objective tumor responses. Additionally, GLORIA expansion arms evaluate safety and efficacy of NOX-A12 in other combinations where the interim results from the triple combination of NOX-A12, radiotherapy and bevacizumab suggest even deeper and more durable responses, and improved survival. NOX-A12 in combination with radiotherapy has received orphan drug designation for glioblastoma in the United States and glioma in Europe. TME Pharma was also awarded fast track designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. TME Pharma has delivered final top-line data with encouraging overall survival and safety profile from its NOX-A12 combination trial with Keytruda® in metastatic colorectal and pancreatic cancer patients, which was published in the Journal for ImmunoTherapy of Cancer in October 2021. The company has entered in its second collaboration with MSD/Merck for its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. The design of the trial has been approved in France, Spain and the United States. The company’s second clinical-stage drug candidate, NOX-E36, is designed to target the innate immune system. TME Pharma is considering several solid tumors for further clinical development. Further information can be found at: www.tmepharma.com.\n\nTME Pharma® and the TME Pharma logo are registered trademarks.\n\nKeytruda® is a registered trademark of Merck Sharp & Dohme Corp.\n\nVisit TME Pharma on LinkedIn and Twitter.\n\nAbout the GLORIA Study\n\nGLORIA (NCT04121455) is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 three additional arms combining NOX-A12 with: A. radiotherapy in patients with complete tumor resection; B. radiotherapy and bevacizumab; and C. radiotherapy and pembrolizumab.\n\nAbout the OPTIMUS Study\n\nOPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.\n\nDisclaimer\n\nTranslations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain \"forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.\n\n______________________________\n1 Matched reference cohort of 20 patients from Giordano et al (2022 ASCO Poster).\n2 See annex to the TME Pharma press release published on September 13, 2023.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20240422335293/en/\n\nFor more information, please contact:\n\nTME Pharma N.V.\nAram Mangasarian, Ph.D., CEO\nTel. +49 (0) 30 16637082 0\n[email protected]\n\nInvestor and Media Relations:\n\nLifeSci Advisors\nGuillaume van Renterghem\nTel. +41 (0) 76 735 01 31\n[email protected]\n\nNewCap\nArthur Rouillé\nTel. +33 (0) 1 44 71 00 15\n[email protected]\n\nSource: TME Pharma N.V.","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"symbols":[],"gpt_button":1},"commentList":[{"id":298741513621688,"gmtCreate":1713943673804,"gmtModify":1713943677193,"author":{"id":"4146204832639872","authorId":"4146204832639872","name":"TigerVision888","avatar":"https://community-static.tradeup.com/news/default-avatar.jpg","vip":1,"crmLevel":6,"crmLevelSwitch":0},"htmlText":"Why is $TME tagged?","listText":"Why is $TME tagged?","text":"Why is $TME tagged?","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/298741513621688","repostId":2429715807,"repostType":2,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"}],"isCommentEnd":false,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":1,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.22.4","shortVersion":"4.22.4","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2429715807"}