Bevacizumab

NXP800 demonstrated single agent activity New dosing schedule successfully minimized thrombocytopenia Fort Lee, NJ, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today reported encouraging data from the Phase 1b study evaluating NXP800 in patients with platinum resistant ARID1a-mutated ovarian cancer. Platinum-resistant, ARID1a-mutated ovarian cancer is a serious condition that carries a poor prognosis with an estimated life expectancy of approximately one year from diagnosis. The NXP800 development program in this disease was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”), and NXP800 was granted Orphan Drug Designation by the FDA for the treatment of ARID1a deficient ovarian, fallopian tube and primary peritoneal cancers. Phase 1B Update Three dosing regimens have been evaluated to date in twelve patients (four patients were treated on a once per day dosing schedule, two with 75 mg/day and two with 50 mg/day. Subsequently, eight additional patients were treated with 50 mg/day on an intermittent dosing schedule of five days on / two days off, a dosing schedule implemented to mitigate thrombocytopenia). All patients enrolled into the study failed at least two prior lines of systemic chemotherapy, including at least one prior platinum-based chemotherapy regimen, and most had also failed treatment with bevacizumab. In eleven efficacy-evaluable patients, antitumor activity was observed with best responses including one patient with an unconfirmed partial response and six patients with stable disease, including tumor shrinkage. The Phase 1b interim data reported earlier this year included four patients evaluable for safety, of which three experienced Grade 4 thrombocytopenia. Subsequently, in the eight patients treated with NXP800 using the intermittent dosing schedule (50 mg/day, 5 days on / 2 days off), the highest grade of thrombocytopenia observed was Grade 2 (one patient). Other than thrombocytopenia, the most common treatment emergent adverse events included nausea, fatigue, vomiting, diarrhea and constipation, the majority of which being Grade 1-2. Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented: “We continue to be encouraged by the early results from our Phase 1b study with NXP800. The antitumor activity observed despite patients’ advanced disease and extensive pre-treatment, while controlling for thrombocytopenia, is promising. However, it is clear that we need to increase the dose intensity to drive more efficacy in the next set of patients. We are already enrolling patients into a cohort of up to 10-12 additional patients utilizing a regimen of 75 mg/day on an intermittent dosing schedule, which is expected to be the last cohort in this Phase 1b study. We believe that NXP800 is an active agent and that this higher dose intensity should provide for increased exposure that could enable us to reach our goal of demonstrating enhanced activity with acceptable overall tolerability. We expect to provide additional clinical data from the Phase 1b study in the second quarter of 2025.” Mr. Bentsur concluded, “With the Phase 1b study advancing as described, we also expect to regain momentum in the ongoing Investigator-Initiated Study in cholangiocarcinoma, being conducted in collaboration with the Mayo Clinic. We believe that together with NXP900’s continued advancement and significant development options of blockbuster potential, our pipeline positions us to deliver on our mission of developing novel treatments for serious conditions of unmet medical needs in oncology.” About the Phase 1b Study The Phase 1b study is a multicenter, single arm, open-label clinical trial of NXP800 in patients with platinum-resistant, ARID1a-mutated ovarian cancer. The study is designed to examine the safety and preliminary efficacy of NXP800 in this target patient population. The study is being conducted in the US and UK in collaboration with the GOG Foundation, Inc. and the European Network of Gynecological Oncological Trial Groups, recognized as the world's leading gynecology oncology clinical trials consortia. About NXP800 NXP800 is an oral, small molecule, potentially first-in-class GCN2 kinase activator. The NXP800 development program in platinum-resistant, ARID1a-mutated ovarian cancer was granted Fast Track Designation by the FDA, and Orphan Drug Designation for the treatment of ARID1a-deficient ovarian, fallopian tube and primary peritoneal cancers. NXP800 is also being evaluated in an investigator-initiated study conducted in collaboration with the Mayo Clinic for the treatment of cholangiocarcinoma. The FDA has also granted NXP800 Orphan Drug Designation in this indication. Nuvectis licensed exclusive world-wide rights to NXP800 from the Institute of Cancer Research in London, UK. About Platinum-Resistant, ARID1a-Mutated Ovarian Carcinoma ARID1a-mutated ovarian carcinoma is comprised almost exclusively of two histologies, ovarian clear cell carcinoma (“OCCC”) and ovarian endometrioid carcinoma (“OEC”), each representing about 10% of the overall ovarian cancer cases in the U.S. with an annual incidence of approximately 2,200 patients per histology. Platinum resistant ovarian carcinoma is recognized as a serious condition of unmet medical need, given the lack of effective treatments and the poor patient prognosis in this setting, with median life expectancy estimated to be approximately one year upon diagnosis. It is estimated that approximately 66% of patients with OCCC and 40% of patients with OEC have the ARID1a-mutation. About Nuvectis Pharma, Inc. Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900 has a unique mechanism of action in that it inhibits both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” "project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, including safety and efficacy data generated to date for NXP800 and NXP900, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include statements and data regarding the preclinical studies for NXP800 and NXP900, and the Phase 1a data for NXP800 and the NXP900 Phase 1a study to date, as well as the clinical expectations for the ongoing NXP800 Phase 1b study in platinum-resistant, ARID1a-mutated ovarian carcinoma, including the potential ability of a higher dose intensity going forward in the NXP800 Phase 1b study to generate satisfactory safety and efficacy results, statements regarding NXP800's potential ability to become a therapeutic option for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma, cholangiocarcinoma, and potentially other cancer indications, and the timing for completion of the clinical trials, including the ongoing NXP800 investigator-initiated study in cholangiocarcinoma and statements regarding NXP900's therapeutic potential. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled “Risk Factors” in our 3Q 2024 Form 10-Q and our other public filings with the Securities and Exchange Commission (“SEC”). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company ContactRon BentsurChairman, Chief Executive Officer and President201-614-3151rbentsur@nuvectis.com Media Relations ContactChristopher M. CalabreseLifeSci AdvisorsTel: 917-680-5608ccalabrese@lifesciadvisors.com

“ 点击蓝字 关注我们 基石药业在2024年癌症免疫治疗学会（SITC）年会上公布CS2009临床前研究数据PPS  中国苏州，2024年11月11日——基石药业（股票代码：2616.HK），一家专注于抗肿瘤药物研发的创新驱动型生物医药企业，今日宣布公司在第39届癌症免疫治疗学会（SITC年会）年会上公布管线2.0重磅产品CS2009的临床前数据。CS2009是一款靶向PD-1、CTLA-4及VEGFA的三特异性抗体。 关键亮点 CS2009是一款靶向PD-1、CTLA-4及VEGFA的三特异性抗体。 临床前数据显示，CS2009具有明显优于潜在竞品的抗肿瘤活性。 CS2009有望覆盖广泛瘤种、成为同类首创/同类最优的下一代肿瘤免疫骨架产品。 基石药业计划于2024年底或2025年初提交CS2009的临床研究用新药(IND)申请，并在2025年初开展首次人体研究。 基石药业首席执行官、研发总裁、执行董事杨建新博士表示：“我们很高兴能够在SITC年会上公布CS2009的最新临床前数据，这也是CS2009首次登上国际学术舞台。作为基石药业管线2.0重磅产品，CS2009是一款潜在同类首创/同类最优的下一代肿瘤免疫骨架产品，有望替代现有PD-(L)1疗法。CS2009优异的临床前数据进一步增强了我们对后续临床开发的信心。我们期待看到CS2009能让包括非小细胞肺癌、卵巢癌、肾细胞癌、宫颈癌、肝细胞癌、胃癌在内的患者、尤其对于PD-(L)1疗法响应不佳的PD-L1低表达或PD-L1阴性的群体进一步获益。” 数据亮点 创新的分子设计：CS2009的创新结构设计使其拥有平衡的抗PD-1和抗CTLA-4亲和力，并且分别在蛋白和细胞水平上被证明可以同时结合PD-1、CTLA-4及VEGFA三个靶点。 倾向性的靶向结合：CS2009能够倾向性地结合PD-1和CTLA-4双阳性的肿瘤浸润T细胞，而不会阻碍CTLA-4在外周T细胞的作用，从而在保证药效的前提下提高了安全性。CS2009还可以诱导双阳性T细胞膜表面快速内化PD-1和CTLA-4，从而减少了这两种免疫抑制型分子在细胞表面的数量。 优异的抗肿瘤活性：在免疫功能完全的小鼠体内抑瘤实验中，CS2009展示出优于潜在竞品（包括PD-1/CTLA双抗、PD-1/VEGFA双抗以及抗PD-1/抗CTLA-4联合疗法）的抗肿瘤活性。 抗VEGFA功能：CS2009保留了完整的抗VEGFA功能。在小鼠体内实验中，CS2009表现出与潜在竞品及贝伐珠单抗相似的疗效。 药代动力学特征：CS2009的药代动力学（PK）数据表明，其在小鼠和食蟹猴中的PK特征与大多数单抗类药物相似。 CS2009目前正处于IND申请准备流程中，预计于2024年底或2025年初提交IND申请、2025年初正式进入首次人体研究。 关于CS2009（PD-1/CTLA-4/VEGFA三特异性抗体） CS2009是一款靶向PD-1、CTLA-4及VEGFA的三特异性分子，作为靶向大瘤种的三特异性抗体，具备同类首创/同类最优潜力。CS2009具备差异化的分子设计，结合了3个经临床验证的靶点，能够重新启动接近耗竭状态的肿瘤浸润T细胞，并具备与原抗VEGFA抗体相当的VEGFA中和能力。其疾病覆盖范围广泛，包括非小细胞肺癌、卵巢癌、肾细胞癌、宫颈癌、肝细胞癌、胃癌等。 文章来源：基石药业 美编排版：史鑫宇 文章审核：周碧远 史鑫宇 罗琪 【免责声明】以上内容来源于互联网，不代表本平台立场或观点；如有侵犯作者著作权，请及时与我们联系（Tel：025-83271227，或直接在微信平台留言），我们将及时更正或删除。 《药学进展》杂志由中国药科大学和中国药学会共同主办、国家教育部主管，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。 《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.216，具有较高的影响力。 《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。 联系《药学进展》↓↓↓ 编辑部官网：pps.cpu.edu.cn； 邮箱：yxjz@163.com； 电话：025-83271227。 欢迎投稿、订阅！ 往期推荐 聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航 我知道你在看哟