Perioperative Therapy With Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig for Patients With Resectable Intrahepatic Cholangiocarcinoma (iCCA) - A Phase II Trial

Biliary tract cancer is a highly aggressive and heterogeneous group of gastrointestinal cancers that arise from the intra- or extrahepatic bile ducts (CCA), or the gallbladder (GBC)(1-3). While it accounts for only 0.7% of all malignant tumors and 3% of all gastrointestinal malignancies in adults, both incidence and mortality are increasing. Biliary tract cancers usually present at an advanced stage, with only approximately 20% of patients being diagnosed with an early-stage disease (1, 2, 4). There is a high risk of recurrence post curative radical resection, with 60-70% of patients recurring within 5 years, with 5-year survival of around 25% (1, 2, 5). There is evidence for use of adjuvant chemotherapy with fluoropyrimidine- based regimens as per the BILCAP and ASCOT phase III trials [(5-7).However, despite advances in adjuvant treatment, recurrence rates after resection of BTC remain high even with adjuvant chemotherapy. For example, in the BILCAP study, 5-year RFS was reported as 33.9% (95% CI: 27.6 to 40.2) (1). Therefore, an unmet need exists to optimize peri-operative treatment to reduce recurrence and improve outcomes in patients with resectable BTC.

开始日期2024-12-15

申办/合作机构

University Health Network

[+2]

NCT06692738 / Not yet recruiting临床3期

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

开始日期2024-12-02

申办/合作机构

AstraZeneca PLC

NCT06630130 / Not yet recruiting临床2期IIT

A Phase II Platform Trial of Perioperative Therapies in Locally Advanced Unresectable Gastric Cancer (Neo-VIKTORY)

Gastric cancer (GC) is the fifth most commonly diagnosed cancer, with over one million cases diagnosed annually worldwide. Human epidermal growth factor receptor 2 (HER2) overexpression in GC (seen in 4.4% to 53.4% of patients in different reports) is predictive biomarker of response to HER2-targeting therapies.
Trastuzumab in combination with cisplatin or oxaliplatin, and a fluoropyrimidine (capecitabine or 5-fluorouracil [5-FU]), is approved anti-HER2 therapy for first-line treatment of HER2-positive gastric or gastroesophageal junction (GEJ) cancer.
Rilvegostomig 750 mg Q3W was selected as recommended Phase 2 dose based on all available ARTEMIDE-01 clinical safety, efficacy, PK, RO data as well as modeling analysis. The dose of 750 mg Q3W is predicted to achieve intra-tumoral RO of ≥ 90% in the majority of participants across a broad spectrum of conditions.
This is a phase II study to initially assess the efficacy of perioperative Trastuzumab Deruxtecan (T-DXd) and Capecitabine combination with or without Rilvegostomig in patients with HER2 positive locally advanced unresectable GC and potentially by subsequent protocol amendment in HER2 low locally advanced GC. Other agents may also subsequently be assessed in this protocol, by protocol amendments

开始日期2024-12-01

申办/合作机构

Samsung Medical Center

100 项与 Rilvegostomig 相关的临床结果

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100 项与 Rilvegostomig 相关的转化医学

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100 项与 Rilvegostomig 相关的专利（医药）

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126

项与 Rilvegostomig 相关的新闻（医药）

2024-11-21

·氨基观察

诺华上调未来5年收入预期；来凯医药配股融资2.35亿港币

氨基观察-创新药组原创出品作者 | 黄凯 HER2靶点再迎变局。 11月20日，Jazz Pharmaceuticals宣布Zanidatamab获FDA加速批准上市，用于治疗既往接受过治疗的不可切除或转移性HER2阳性胆道癌成人患者。该药物是第一款获批上市的HER2双抗。诺华制药上调未来5年销售预期 11月21日，诺华制药表示，到2029年，公司营收将以每年6%的速度增长，高于此前5%的预期。诺华上调了对其旗下药物Cosentyx、Kisqali、Kesimpta、Pluvicto和Leqvio的峰值销售预期。又有18A企业配股融资。 11月21日，来凯医药宣布，以13.36港币/股的价格，配股融资2.35亿港币。受该消息影响，来凯医药股价大跌15.39%。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）基石药业PD-L1单抗出海中东和非洲地区 11月21日，基石药业宣布，与Pharmalink Store公司达成商业化战略合作。Pharmalink是一家总部设在阿拉伯联合酋长国的知名医药公司。根据许可及商业化协议，Pharmalink将获得舒格利单抗在中东和北非地区，包括沙特阿拉伯、阿拉伯联合酋长国、科威特、卡塔尔、阿曼、巴林，阿尔及利亚、突尼斯、埃及、摩洛哥、利比亚，以及南非的商业化权利。 2）迈威生物就地舒单抗注射液在秘鲁市场达成战略合作 11月21日，迈威生物宣布，其就两款地舒单抗注射液 9MW0311和 9MW032与秘鲁市场战略合作伙伴签署授权许可及商业化协议。根据协议，该合作伙伴拥有两款产品在秘鲁市场的独家销售权，迈威生物负责产品的开发、生产及商业化供货。 / 02 / 资本信息 1）来凯医药配股融资2.35亿港币 11月21日，来凯医药宣布，以13.36港币/股的价格，配股融资2.35亿港币。受该消息影响，来凯医药股价大跌15.39%。 / 03 / 医药动态 1）民为生物MWN105注射液获临床许可 11月21日，据CDE官网，民为生物MWN105注射液获临床许可，拟开展治疗2型糖尿病、超重或者肥胖的研究。 2）阿斯利康AZD2936获临床许可 11月21日，据CDE官网，阿斯利康AZD2936获临床许可，拟开展治疗一线治疗HER2阳性胃癌的研究。 3）默沙东注射用Zilovertamab vedotin获临床许可 11月21日，据CDE官网，默沙东注射用Zilovertamab vedotin获临床许可，拟开展治疗血液系统恶性肿瘤的研究。 4）默沙东HIF-2α抑制剂获批上市 11月21日，据NMPA官网，默沙东HIF-2α抑制剂Belzutifan片获批上市，适应症为von Hippel-Lindau病相关肾细胞癌、中枢神经系统血管母细胞瘤或胰腺神经内分泌肿瘤。 / 04 / 器械跟踪 1）迪格瑞医疗球囊扩张导管上市申请被拒 11月21日，据NMPA官网，迪格瑞医疗球囊扩张导管上市申请结果为，不予注册。 2）微创骨科髋关节股骨柄上市申请被拒 11月21日，据NMPA官网，微创骨科髋关节股骨柄上市申请结果为，不予注册。 3）欧华美科注射用交联透明质酸钠凝胶上市申请被拒 11月21日，据NMPA官网，欧华美科注射用交联透明质酸钠凝胶上市申请结果为，不予注册。 4）畅德医疗外周血管约束型球囊扩张导管获注册许可 11月21日，据NMPA官网，畅德医疗外周血管约束型球囊扩张导管获注册许可。 5）迪凯尔医疗口腔种植手术导航定位系统获注册许可 11月21日，据NMPA官网，迪凯尔医疗口腔种植手术导航定位系统获注册许可。 6）康迪泰科神经血管支撑导管系统获注册许可 11月21日，据NMPA官网，康迪泰科神经血管支撑导管系统获注册许可。 7）佗道医疗脊柱外科手术导航定位系统获注册许可 11月21日，据NMPA官网，佗道医疗脊柱外科手术导航定位系统获注册许可。 8）圣博玛生物聚乳酸面部填充剂获注册许可 11月21日，据NMPA官网，圣博玛生物聚乳酸面部填充剂获注册许可。 / 05 / 海外药闻 1）诺华制药上调中期销售预期 11月21日，诺华制药表示，到2029年，公司营收将以每年6%的速度增长，高于此前5%的预期。诺华上调了对其旗下药物Cosentyx、Kisqali、Kesimpta、Pluvicto和Leqvio的峰值销售预期。 2）全球首款HER2双抗获FDA批准上市 11月20日，Jazz Pharmaceuticals宣布Zanidatamab获FDA加速批准上市，用于治疗既往接受过治疗的不可切除或转移性HER2阳性胆道癌（BTC）成人患者。该药物是第一款获批上市的HER2双抗。 3）辉瑞长效血友病疗法在欧盟获批 11月20日，辉瑞宣布，欧盟委员会已批准Hympavzi上市，用于常规预防12岁及以上、体重至少35公斤且无FVIII或FIX抑制物的重度血友病A或重度血友病B患者的出血。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

上市批准医药出海临床研究申请上市加速审批

2024-11-14

·ioncology

2024 ESMO ASIA丨一文纵览上消化道肿瘤领域精彩壁报！

编者按 2024年欧洲肿瘤内科学会亚洲年会（ESMO ASIA 2024）将于当地时间12月6~8日在新加坡召开，届时将公布多项全球及亚太地区的最新科研和临床进展，进一步推动领域内的学术交流。目前大会官网已披露了摘要标题，《肿瘤瞭望消化时讯》特此整理了食管癌、胃癌、胰腺癌等上消化道肿瘤领域的摘要标题，带您快速浏览大会的精彩资讯！胃癌 183P-HER2过表达或无过表达时胃腺癌对新辅助化疗的反应：一项前瞻性观察研究作者：Pratap K.Deb（印第安纳州加尔各答） 157P-腹膜转移胃癌分化轨迹和耐药特征的单细胞表征作者：Haoxin Peng（中国北京） 158P-SOX方案联合伊尼妥单抗一线治疗HER2阳性晚期胃癌的最新疗效与安全性作者：Ying Kong（中国济南） 159P-B细胞的空间组织在胃癌预测和预后中的作用作者：Ryan Tay（新加坡） 160P-胃癌腹膜转移的腹膜生态位进化和微环境重塑作者：Joseph J.Zhao（新加坡） 161P-评估口服维生素B12治疗胃癌患者全胃切除术后维生素B12缺乏症的多中心随机对照试验的Ⅱ期研究作者：Three Aoyama（日本横滨） 162P-围手术期FLOT治疗胃癌和胃食管交界处癌实现PCR的疗效：单机构经验的回顾性分析作者：Xue Ru Ting（乔治市，MY） 163P-腹腔镜辅助胃切除术和常规胃切除术胃癌患者术后饮食摄入量的比较作者：Junya Morita（日本横滨） 164P-一项评估安罗替尼联合特瑞普利单抗作为一线方案治疗PS 2晚期胃癌患者的疗效和安全性的开放标签、单臂、Ⅱ期试验作者：刘可（中国上海） 165P-局部晚期胃癌新辅助治疗后病理完全缓解的预后分析：一项全国性、多中心、回顾性研究作者：Jie Chen（中国上海） 166P-幽门螺杆菌感染胃癌样本中CHOP、GRP94和干性状态之间的相互作用作者：Fatemeh Alizadeh（马什哈德，爱尔兰） 167P-与老年Ⅱ/Ⅲ期胃癌患者早期复发相关的因素：一项回顾性队列研究作者：Yu-Hsuan Shih（台中市） 168P-肌肉减少症作为接受手术和辅助化疗的Ⅱ~Ⅲ期胃癌患者的预后指标作者：Jeong Eun Kim（韩国光明） 169P-真实世界研究中PD-1抑制剂、曲妥珠单抗和一线化疗治疗HER-2阳性晚期胃癌的疗效和预后作者：刘宝瑞（中国南京） 170P-通过多模式血浆游离DNA分析鉴别恶性和良性胃病变作者：Ho D.Vo（越南胡志明市） 171P-一项关于80岁及以上Ⅱ/Ⅲ期胃癌患者辅助S-1化疗的多中心调查作者：Ai Harinauchi（日本） 172P-环状RNA谱确定circATXN1失调可作为胃癌的一个增殖因子和预后标志物作者：Jie Chen（中国上海） 173P-胃腺癌位置重要吗？来自单个肿瘤中心的回顾性研究作者：Alaaeldin Shablak（英国南安普敦） 175P-副干酪乳杆菌ZJUZ2-3通过3-IAA抑制NF-κB通路来抑制胃肿瘤发生作者：Rui Yang（中国杭州） 176P-DHX9及其靶基因AURKA通过PI3K/AKT和TNF信号通路在胃癌中的功能和机制作者：Zuhua Chen（中国武汉） 177P-HGF介导的MAP17在胃癌细胞增殖和转移中的重要作用作者：ByeongIl Jang（韩国大邱）食管癌 178P-KEYNOTE-859研究更新：帕博利珠单抗+化疗治疗晚期HER2阴性胃癌或胃食管结合部（G/GEJ）癌作者：Lina Yin（美国凯尼尔沃思） 179P-个性化微小残留病分析可预测接受根治性放疗的食管癌的预后作者：Lin-Rui Gao（中国北京） 180P-微创海绵细胞学检查在食管鳞状细胞癌和胃贲门腺癌筛查中的应用评估作者：Zhiyuan Fang（中国北京） 181P-围手术期亚叶酸、奥沙利铂、多西紫杉醇和S-1（LOTS）治疗局部晚期胃癌或胃食管结合部腺癌的疗效、安全性及游离DNA分析：一项前瞻性Ⅱ期试验作者：Chih Chieh Yen（台南市中环） 182P-东亚地区HER2阳性局部晚期或转移性胃或胃食管结合部腺癌患者的真实世界治疗模式作者：Do-Youn Oh（韩国首尔） 144P-辅助放化疗在食管角化鳞状细胞癌治疗中的作用作者：Mohamed Z.Elkarany（亚历山大市，EG） 186P-每周对比每月新辅助顺铂和氟尿嘧啶放化疗方案在局部区域食管鳞状细胞癌中的疗效和安全性作者：Cheng-Lun Lai（台湾台中市） 187P-卡瑞利珠单抗在晚期食管癌中的有效性、安全性和使用模式：基于来自三项前瞻性观察性队列研究的987例患者的个体病例数据（IPD）汇总分析作者：鲁智豪（中国北京） 188P-原发肿瘤和淋巴结病理消退对新辅助化疗免疫治疗后局部晚期食管鳞状细胞癌患者复发和生存率的影响作者：Yixin Li（中国南京） 189P-NC18（一种新型HER2靶向ADC）对Enhertu耐药CDX模型的优越的抗肿瘤活性作者：Zhi Li（中国北京） 190P-替雷利珠单抗治疗食管癌的系统评价和荟萃分析作者：Hashim Talib Hashim（Karbala） 191P-来自印度南部的资源有限环境中接受多模式治疗的非转移性癌食管患者的真实世界数据作者：Ravi Teja R.Matta（印第安纳州拉贾蒙德里） 192P-探索氯硝柳胺在食管鳞状细胞癌中对EHMT2的调节作用作者：I-Chen Wu（台湾高雄市） 193P-DCLK1的激酶活性驱动其在食管鳞状细胞癌中的促干性作用作者：Yuping Yang（中国福州） 194P-呋喹替尼联合S-1治疗一线免疫治疗失败后ESCC患者的剂量探索结果更新作者：Ningning Li（中国北京） 195P-miR-10a-5p靶向TFAP2C促进食管癌的顺铂耐药作者：Kiran Pasbola（印第安纳州新德里） 196P-可切除胃和胃食管结合部癌的围手术期FLOT+免疫治疗的系统评价和荟萃分析作者：Lorenz Fort E.Revillas（奎松市，菲律宾） 198P-新辅助多西他赛加顺铂、5-FU治疗可切除局部晚期食管鳞状细胞癌后，辅助纳武利尤单抗治疗的疗效和安全性作者：Nozomu Ogura（日本） 244P-基因组分析检测对胃肠道神经内分泌癌治疗结果的影响作者：Toshiki Ozato（日本冈山） 263TiP-TroFuse-015：TROP2定向抗体-药物偶联物sac-TMT对比医生选择的方案治疗经治转移性胃食管腺癌的Ⅲ期研究作者：Kohei Shitara（日本） 264TiP-一项评估德曲妥珠单抗（trastuzumab deruxtecan，T-DXd）联合rilvegostomig和化疗治疗HER2阳性（HER2+）和HER2低表达的胃或胃食管结合部腺癌（GEJA）患者的Ⅰb/Ⅱ期开放标签研究：DESTINY-Gastric03研究第4部分作者：Yelena Y.Janjigian（美国纽约） 265TiP-Ⅰ/Ⅱ期开放标签、伞式平台设计的研究药物联合或不联合pembrolizumab和/或化疗对既往接受过PD-（L）1抑制剂治疗的晚期食管癌患者的研究：KEYMAKER-U06子研究作者：Sean Kato（日本） 266TiP-替雷利珠单抗联合S-1对于新辅助免疫化疗后根治性切除术后残留原发病灶和淋巴结阴性食管鳞状细胞癌患者的疗效：一项Ⅱ期多中心试验（PPIO-008）作者：Yingjian Wang（中国重庆） 267TiP-CHAPTER-GIST-101：pimitespib联合伊马替尼治疗伊马替尼难治性胃肠道间质瘤患者的Ⅰ期研究作者：WeiPeng Yong（新加坡）胰腺癌 250P-评估液体活检衍生的循环肿瘤DNA（ctDNA）作为预测生物标志物对早期胰腺癌治疗反应的影响作者：Hashim Talib Hashim（Karbala） 252P-XELOXIRI方案在不可切除胰腺导管腺癌患者中的安全性和有效性作者：Biyang Cao（中国北京） 253P-预后营养指数是接受新辅助化疗和手术切除的胰腺癌患者继续S-1辅助化疗的独立危险因素作者：Shinnosuke Kawahara（日本横滨） 255P-NALLONG研究的亚洲队列中既往接受过脂质体伊立替康治疗的转移性胰腺导管腺癌长期幸存者的真实世界结果作者：Chang hoon Yoo（韩国首尔） 256P-胰腺导管腺癌中的PIK3CA突变作者：Omali Pitiyarachchi（澳大利亚兰德威克） 257P-“H”至“H”精准新辅助化疗可提高胰腺癌的可切除率作者：Yonggang He（中国重庆） 258P-真实世界背景下晚期胰腺癌患者治疗方案和总生存期的当前趋势作者：Hiroshi Imaoka（日本） 259P-伊立替康脂质体为基础的方案在中国晚期胰腺癌患者中的应用：一项前瞻性、多中心、观察性真实世界研究作者：Jin Xu（中国上海） 260P-NALIRIFOX作为基于吉西他滨的化疗后转移性胰腺癌的后续治疗：单中心真实世界经验作者：Hisn-Chen Lin（台湾嘉义市）（来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期放射疗法

2024-11-12

·PRNewswire

Compugen Reports Third Quarter 2024 Results

Clinical data presented at SITC 2024 demonstrated COM701 (anti-PVRIG) mediated anti-tumor activity with durable responses and good tolerability profile in tumors typically not responding to immunotherapy, aligned with previous data presented by the Company Plans to initiate, in Q2 2025, an adaptive platform trial in patients with relapsed platinum sensitive ovarian cancer in the maintenance setting, to evaluate single agent COM701 and future combinations representing an unmet need and regulatory and commercial opportunity On track to initiate Phase 1 trial evaluating COM503 (anti-IL18BP) in solid tumors in Q4 2024 Partner AstraZeneca reported encouraging rilvegostomig data at WCLC and ESMO 2024 and advanced rilvegostomig into two additional Phase 3 lung cancer trials Solid balance sheet with expected cash runway into 2027 anticipated to reach potential key catalysts, including projected COM701 sub-study 1 interim analysis and support advancement of COM503 in the clinic HOLON, Israel, Nov. 12, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced financial results for the third quarter ended September 30, 2024, and provided a corporate update. "A highlight of the third quarter was the presentation of our validating COM701, COM902, pembrolizumab combination data in heavily pre-treated platinum resistant ovarian cancer (PROC) patients at SITC last week," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "We are highly encouraged that this study confirms previously presented data supporting COM701 mediated durable responses with a good tolerability profile in advanced heavily pre-treated patients. Feedback received from ovarian cancer experts supports advancing development of COM701 in an earlier disease setting. There is a need for durable and well tolerated treatment options in relapsed platinum sensitive ovarian cancer (PSOC) patients who have received prior maintenance treatment and have no options for additional maintenance therapy. These patients are less immune compromised, than more advanced patients, providing the opportunity to harness the unique mechanism of action of COM701 to potentially change the disease trajectory and improve progression free survival. In addition, since there is no established treatment for these women, targeting this patient population to evaluate COM701's single agent activity and as a potential backbone for future combination treatments, presents a regulatory and commercial opportunity. We look forward to initiating an adaptive platform trial, starting with sub-study 1 randomizing patients with relapsed PSOC to single agent COM701 maintenance treatment or placebo in the second quarter of 2025. Since the median progression free survival of these patients is around 6 months, and this is a less competitive space than PROC for enrollment, we project having data from the interim analysis of sub-study 1 in the second half of 2026." Dr. Cohen-Dayag continued, "In the third quarter of 2024, we received a $30 million milestone payment from our partner Gilead following achieving FDA IND clearance for COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics. We are on track to initiate a Phase 1 clinical trial for COM503 in advanced solid tumors, in the fourth quarter of 2024." Dr. Cohen-Dayag added, "Our partner, AstraZeneca, continued to advance development of rilvegostoming, their PD-1/TIGIT bispecific of which the TIGIT component is derived from COM902. In September 2024, AstraZeneca presented clinical data showing promising efficacy and a manageable safety profile in trials evaluating rilvegostomig monotherapy in lung cancer and in combination with chemotherapy in gastric cancer at the WCLC and ESMO, respectively. They also initiated two additional Phase 3 trials bringing the total number of ongoing Phase 3 trials to five. We are eligible for future milestones and mid-single-digit tiered royalty payments, presenting a significant potential revenue source for the Company." Next Planned Milestones Q4 2024- on track to initiate Phase 1 study of COM503 in solid tumors Q2 2025- plan to initiate an adaptive platform trial starting with sub-study 1, randomizing patients with relapsed platinum sensitive ovarian cancer ineligible for PARPi or bevacizumab to single agent COM701 maintenance treatment or placebo H2 2026- data from projected COM701 interim analysis from sub-study 1 Third Quarter 2024 Financial Highlights Cash: As of September 30, 2024, Compugen had approximately $113.2 million in cash, cash equivalents, short-term bank deposits, long term restricted bank deposits, restricted cash and cash investments, compared with approximately $51.1 million as of December 31, 2023. Cash includes a $30 million milestone payment for COM503 IND clearance achieved in July 2024, which was subject to a 15% withholding tax and a $5 million clinical milestone payment from AstraZeneca. Compugen expects that its cash and cash related balances will be sufficient to fund its current operating plans into 2027. The Company has no debt. Revenues: Compugen reported approximately $17.1 million in revenues for the third quarter ended September 30, 2024, compared to no revenues for the comparable period in 2023. The revenues reported reflect the recognition of a portion of the upfront and milestone payments from the license agreement with Gilead. R&D expenses for the third quarter ended September 30, 2024, were approximately $6.3 million, a decrease from $8.3 million for the comparable period in 2023. The decrease is mainly due to the classification of COM503 R&D activities to cost of revenues coupled with lower COM503 expenses, mainly related to CMC. G&A expenses for the third quarter ended September 30, 2024, were approximately $2.6 million, compared to approximately $2.3 million for the comparable period in 2023. Net Profit for the third quarter ended September 30, 2024, was approximately $1.3 million, or $0.01 per basic and diluted share, compared with a net loss of approximately $9.9 million, or $0.11 per basic and diluted share, for the comparable period in 2023. Full financial tables are included below Conference call and webcast information The Company will hold a conference call today, November 12, 2024, at 8:30 am ET to review its third quarter 2024 results and will be joined on the call by Dr. Oladapo Yeku, Assistant Professor of Medicine, Harvard Medical School, and Director of Translational Research, Gynecologic Oncology Program, Massachusetts General Hospital, Boston, MA and an investigator on the Company's PROC study, presented at SITC 2024. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen's website, located at the following link. Following the live webcast, a replay will be available on the Company's website. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery platform (Unigen™) to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development: COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Rilvegostomig, a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, is in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance, of which the most advanced program, COM503, a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which has been granted IND clearance from the FDA, is licensed to Gilead. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Forward-Looking Statement This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statement regarding our plan, and the timing thereof, to initiate clinical trials; statements regarding our expectations as to when we will have clinical data from our clinical trials; and statements regarding our expectation that existing cash and cash related balances will be sufficient to fund our operating plan into 2027 and the catalysts reached with such cash and cash balances. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen may not be able to advance its internal clinical stage programs through clinical development or manufacturing or successfully partner or commercialize them, or obtain marketing approval, either alone or with a collaborator, or may experience significant delays in doing so; clinical development involves a lengthy and expensive process, with an uncertain outcome and Compugen may encounter substantial delays or even an inability to begin clinical trials for any specific product or may not be able to conduct or complete its trials on the timelines it expects; Compugen has limited experience in the development of therapeutic product candidates, and it may be unable to implement its business strategy; the general market, political and economic conditions in the countries in which Compugen operates, including Israel; and the effect of the evolving nature of the recent war in in Israel. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law. Company contact: Yvonne Naughton, Ph.D. VP, Head of Investor Relations, and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071 SOURCE Compugen Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期免疫疗法临床结果引进/卖出临床3期

100 项与 Rilvegostomig 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
鳞状非小细胞肺癌	临床3期	美国	AstraZeneca PLC	2024-12-02
鳞状非小细胞肺癌	临床3期	中国	AstraZeneca PLC	2024-12-02
鳞状非小细胞肺癌	临床3期	日本	AstraZeneca PLC	2024-12-02
鳞状非小细胞肺癌	临床3期	阿根廷	AstraZeneca PLC	2024-12-02
鳞状非小细胞肺癌	临床3期	奥地利	AstraZeneca PLC	2024-12-02
鳞状非小细胞肺癌	临床3期	比利时	AstraZeneca PLC	2024-12-02
鳞状非小细胞肺癌	临床3期	巴西	AstraZeneca PLC	2024-12-02
鳞状非小细胞肺癌	临床3期	加拿大	AstraZeneca PLC	2024-12-02
鳞状非小细胞肺癌	临床3期	法国	AstraZeneca PLC	2024-12-02
鳞状非小细胞肺癌	临床3期	德国	AstraZeneca PLC	2024-12-02

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05702229 (GEMINI-Gastric, ESMO2024) 人工标引	临床2期	HER2阴性胃癌一线 HER2-negative	40	Rilvegostomig + XELOX or FOLFOX	膚憲鬱壓膚壓衊繭淵醖(願廠觸夢築獵淵壓鑰遞) = 廠蓋範築願構築鏇網選願衊選願鑰範獵齋網齋 (衊製繭膚艱鑰衊築鑰淵, 50.9 ~ 81.4) 更多	积极	2024-09-16
NCT04995523 (ARTEMIDE-01, ESMO2023) 人工标引	临床1/2期	非小细胞肺癌二线	83	rilvegostomig	願顧選齋齋構構艱遞觸(壓簾艱繭遞廠衊選製廠) = 鹽膚壓獵願壓鏇網壓窪蓋夢鑰淵製獵鹹簾膚襯 (齋廠淵衊艱壓蓋膚選糧, 1.3 ~ 11.9) 更多	积极	2023-10-23
NCT04995523 (ARTEMIDE-01, ASCO2023) 人工标引	临床1/2期	转移性非小细胞肺癌	80	AZD2936 (overall)	鏇鹽廠選顧壓選製選艱(鹽衊糧觸齋壓範餘範鹹) = 齋積顧選鬱願醖糧構繭糧衊積壓醖製顧衊鹽顧 (餘膚齋憲獵齋築範繭鹽 ) 更多	积极	2023-05-26