Apalutamide

LOS ANGELES--(BUSINESS WIRE)--Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today presents on the positive interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) at the annual European Society Medical Oncologists meeting in Berlin, Germany. An interim efficacy analysis from the ongoing trial with ENV-105, a first-in-class CD105 antagonist, is being tested for safety and early efficacy in men with metastatic prostate cancer resistant to standard hormone therapy. Despite progression on prior hormonal therapies, the trial showed clinical benefit when combining ENV-105 with hormone therapy, apalutamide, in 86% of treated patients. All responders remained progression-free for at least four months and half remained progression-free beyond one year. Notably, seven of nine evaluable patients experienced a reduction in PSA levels from baseline. “The positive safety profile and initial clinical benefit we’ve seen through our extensive interim analysis validates the comprehensive mechanism of action studies that preceded this clinical study, demonstrating how ENV-105 restores a patient’s ability to respond to hormone therapy,” said Dr. Neil Bhowmick, CSO of Kairos Pharma. Edwin Posadas, Director of the Experimental Therapeutics Program and the Medical Director of the Center for Uro-Oncology Research Excellence at the Cedars-Sinai Cancer Institute, leads the randomized Phase 2 trial that is currently accruing up to 100 patients at Cedars-Sinai Medical Center, City of Hope Cancer Center, and the Huntsman Cancer Institute. The 13.7 median PFS (progression free survival) achieved by imaging with the ENV-105 and apalutamide combination reported would suggest an improvement over current alternatives of chemotherapy and radioligand therapy, in terms of disease control as well as tolerability. Kairos Pharma seeks to provide a safe and effective therapy with ENV-105 for the over 3 million men with hormone-resistant prostate cancer worldwide. About Kairos Pharma, Ltd. Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) aims to work at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Our lead candidate, ENV105, is an antibody that targets CD105 – a protein identified as a key driver of resistance to various cancer treatments. Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. For more information, visit kairospharma.com. CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements as those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential” or “hopes” or the negative of these or similar terms. The reader is cautioned not to rely on these forward-looking statements. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kairos Pharma. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including: our expectations regarding the success and/or completion of our Phase 2 clinical trial; our success in completing newly initiated clinical trials, commence new trials, and obtain regulatory approval following the conclusion of such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking statements discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us, including those described in Kairos Pharma’s Annual Report on Form 10-K, as amended, and our other filings made with the Securities and Exchange Commission. We are not obligated to publicly update or revise any forward-looking statement, and Kairos Pharma is not required to update any forward-looking statement as a result of new information or future events or developments, except as required by U.S. federal securities laws.

精彩内容 近日，科伦药业公告称，公司申报的4类仿制药罗替高汀贴片获批生产，为国内首仿+首家过评，同时也是公司获批的首款化药贴膏剂。米内网数据显示，2024年中国三大终端六大市场（统计范围详见本文末）化药贴膏剂销售额超过70亿元。 罗替高汀是一种非麦角碱多巴胺激动剂，适用于早期特发性帕金森病症状及体征的单药治疗（不与左旋多巴联用），或与左旋多巴联合用于病程中的各个阶段，直至疾病晚期左旋多巴的疗效减退、不稳定或出现波动时（剂末现象或“开关”现象）。 罗替高汀贴片为全球首个治疗帕金森病的透皮贴剂，是早发型帕金森病程初期的首选药物之一。与其他口服药物相比，透皮贴剂可减少胃肠道不良反应、避免血药浓度波动并减少运动症状起伏，提高患者用药安全性与依从性。 优时比制药的罗替高汀贴片最早于2018年6月获批进入国内市场，2024年、2025年上半年在中国三大终端六大市场的销售额增速分别达48.27%、79.44%。 仿制药申报方面，3家国内药企的罗替高汀贴片以新注册分类报产，其中四川科伦药业的产品于近日顺利获批，拿下国内首仿；北京泰德制药、北京福元医药的产品还在审评审批中。 罗替高汀贴片是科伦药业获批的首款化药贴膏剂。米内网数据显示，近年来中国三大终端六大市场化药贴膏剂的销售额呈逐年上涨态势，2024年超过70亿元，同比增长约10%；2025年上半年超过40亿元，同比增长约15%。 近年来中国三大终端六大市场化药贴膏剂销售情况（单位：万元） 来源：米内网格局数据库 在化药贴膏剂方面，科伦药业还有洛索洛芬钠贴剂、双氯芬酸钠贴片2款产品以新注册分类申报上市/临床。 科伦药业申报的部分化药贴膏剂 来源：米内网中国申报进度（MED）数据库 今年以来，科伦药业（含联营公司）已有47个品种获批生产并视同过评，涵盖12个治疗大类，集中在血液和造血系统药物（13个）、全身用抗感染药物（8个）、消化系统及代谢药（8个）等。 科伦药业今年以来获批上市的仿制药 来源：米内网中国申报进度（MED）数据库 47个品种中，有多个品种为国内首批上市，其中罗替高汀贴片、芦曲泊帕片、注射用亚胺培南西司他丁钠/氯化钠注射液、注射用比阿培南/氯化钠注射液、奈妥匹坦帕洛诺司琼胶囊等为国内首仿+首家过评，布比卡因脂质体注射液、阿帕他胺片、枸橼酸钠血滤置换液、注射用头孢他啶/氯化钠注射液等为国产第2家获批等。 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至10月20日，如有疏漏，欢迎指正！ 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦