Lyophilised haemostat platelet derivatives (Cellphire)

在接受了手术和多轮药物治疗后，R先生的肿瘤仍在不断进展，医生说临床上已经没有其他可用的治疗方案了...幸运的是，他抓住了最后一根救命稻草，一种实验性免疫疗法拯救了他，治疗后仅2个月，肿瘤就出现了大幅缩小，他重新回到了正常的生活。 美国知名的纪念斯隆凯特琳癌症中心使用一种“革命性”的免疫疗法，将晚期癌症患者体内的特殊的T细胞采集出来，培养出一支T细胞免疫大军回输到体内，这支精锐的作战部队能将肿瘤迅速围剿并清除体内“逃窜”的残存癌细胞，众多接受该疗法的患者用自己的免疫细胞打败了癌症，实现了长期缓解，重新回到了正常的生活！ 治疗2个月重返正常生活！“革命性”免疫疗法拯救晚期患者 2015年，R先生突然注意到自己脚趾甲下的一颗黑痣比之前明显增大了，他去医院进行检查后，医生告诉他这颗痣已经恶变为黑色素瘤了，他需要尽快接受治疗。 R先生马上进行了根治手术，但这种恶性的肿瘤没过多久就卷土重来了，就这样，手术，复发，再切除，再复发，R先生反复进行了多次手术和各类方案的药物治疗，肿瘤仍然在猖狂的生长，并开始侵袭他体内的其他器官。2022年秋天，R先生的身体每况愈下，医生遗憾的告诉他， 临床上已经没有其他的治疗方案了... 51岁的R先生不相信自己的人生就这样结束了，他开始四处寻求新的治疗方案，终于，他看到美国知名的纪念斯隆凯特琳癌症中心 (MSK) 正在进行一项免疫疗法的临床试验，他抓住了最后一线生机。 这种方法是称为 TIL（发音为“till”），Alexander Shoushtari 博士是 纪念斯隆癌症中心TIL 疗法的专家。他告诉R先生，TIL代表肿瘤浸润淋巴细胞，是免疫系统中一种特殊类型的白细胞，这些细胞已经知道如何发现癌症。 这个概念很简单，但却是革命性的：医生首先需要从肿瘤内部取出这些珍贵的免疫细胞——它们是深入肿瘤内部对抗癌症的一群最有效的免疫细胞——在体外将它们培养成数 10亿~1500亿 ，然后将这支庞大的具有精准杀伤能力的免疫细胞放回患者体内。 就像一小群士兵被扩充为一支更强大的精英军队一样，他们成为寻找和消灭癌症的更强大力量 。 2022年圣诞前夕，R先生顺利入组了这项临床实验。 医生切除了R先生已经转移到结肠附近腹部内壁的肿瘤组织送到实验室进行分离筛选培养。随后，他接受了高剂量的化疗清淋，为TIL治疗做准备。10天后，他的 TIL细胞制备好了，最终得到 三到四袋半透明的白色液体 ，其中包含着一支数量达到数十亿的免疫细胞大军，通过胸部的一个输液港注入，在他的整个身体内循环并寻找肿瘤细胞。 最初的几周很糟糕。他发高烧，由于免疫系统较弱，无法见任何人。但当他慢慢康复后，他在大厅里走了几个小时，并在房间里骑固定自行车。2023年1月底，他顺利康复回家；2月，他已经重返工作岗位。令R先生他惊讶又欣慰的是，扫描显示他的肿瘤正在缩小。R先生激动的说“ 这真是太神奇了，因为在治疗过程中，有些时候我觉得自己出不了院了。 ” Alexander Shoushtari 博士正在给R先生看最新的影像检查结果，肿瘤正在显著缩小 2023年3月，R先生再次开始慢跑，他计划要参加纽约市马拉松比赛。 近80%患者肿瘤缩小或稳定！“革命性”免疫疗法2024即将上市！ 令所有癌症病友振奋的是，上文中提到的全球首款TIL疗法终于要来了！这款让病友们苦苦等待多年的免疫疗法“新宠”有望成为攻克实体瘤的一把利剑，给无数晚期癌症患者带来新的曙光。 2023年5月30日，美国Iovance生物公司重磅官宣，美国食品和药物管理局(FDA) 接受了大名鼎鼎的TIL疗法-- lifileucel（LN-144） 的生物制品许可申请（BLA），并授予 lifileucel 优先审评权，用于免疫检查点抑制剂和靶向治疗期间或之后进展的晚期黑色素瘤患者，将2023 年 11 月 25 日作为最终决定的目标行动日期（近期因FDA的资源原因推迟至明年2月）。这意味着，一旦2024年初顺利获批，这将是全球首款上市的TIL疗法，将为实体瘤治疗开启新纪元，具有里程碑式意义！ 在目前最大的黑色素瘤2 期研究结果显示，晚期黑色素瘤接受TIL疗法后：客观缓解率（ORR）达到31.4%，疾病控制率（DCR）高达77.8％！这意味着近80%的极晚期患者肿瘤出现不同程度缩小或控制稳定！特别值得一提的是，在接受lifileucel 治疗2年后， 7 名 部分缓解（PR）的患者肿瘤持续缩小，最终全部消失， 达到完全缓解（ CR） ！ 好消息！实体瘤“克星”TIL疗法已登陆中国，国内患者可申请！ TIL疗法除了在黑色素瘤治疗中取得了卓越的数据，这款新型的免疫疗法在国际各大肿瘤学会议上公布的 肺癌、乳腺癌、结直肠癌、宫颈癌、胆管癌、头颈部肿瘤 等多种实体肿瘤临床试验数据也璀璨夺目，振奋人心！ 宫颈癌 最新的数据显示，客观缓解率（ORR） 44% ，完全缓解率（CR） 11% ，疾病控制率（DCR）高达 85% 。 肺癌 最新的临床数据（2020AACR）显示，TIL疗法对于晚期肺癌可达到25%的总缓解率。 肉瘤 首次公布的截止到2020年6月1日的数据显示，客观缓解率（ORR）达到33.3%。 卵巢癌 的初步数据显示，结果显示，疾病控制率100%。一名患者获得了部分缓解，其他五名患者经历了长达12个月的疾病稳定期。 头颈癌： 客观缓解率44.4%，87.5的患者肿瘤缩小。 乳腺癌： 一半患者的肿瘤缩小达到客观缓解，包括1名完全缓解（现在持续 超过 5.5 年！ 原文链接：五年无癌里程碑！首位接受新型免疫疗法的乳腺癌患者宣布“临床治愈”）需要告诉国内病友的好消息是，近两年，中国的研究人员也研发出多种新型TIL疗法，救命新疗法不再遥不可及！ 据全球肿瘤医生网医学部了解，国内的TILs疗法是在美国的肿瘤浸润淋巴细胞（TIL）疗法基础上经过改良，提升其克服肿瘤微环境和增加自我扩增的能力，在前期的概念验证临床研究中已取得了非常积极的疗效和安全性验证， 目前已获得批准正式开展人体临床试验 ，包括以下实体肿瘤类型 ：肺癌、宫颈癌、头颈部肿瘤、黑色素瘤、胆道肿瘤等实体肿瘤 。想寻求TILs及其他国内外新抗癌治疗帮助，且经济条件允许的情况下，患者可以先将病历提交至全球肿瘤医生网医学部进行初步评估。 随着更多治疗方案的发展，晚期肿瘤患者将迎来更多治疗选择和希望，我们期待人类攻克癌症的那一天早日到来。 参考资料：https://www.mskcc.org/news/how-msk-used-til-therapy-to-treat-melanoma-in-roberto

SAN CARLOS, Calif., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that on November 16, 2023 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 59,950 shares of Iovance’s common stock to nine new non-executive employees. The awards were granted under Iovance’s 2021 Inducement Plan, which was adopted on September 22, 2021 and amended on January 12, 2022 and May 10, 2023, and provides for the granting of equity awards to new employees of Iovance by the Company’s compensation committee in accordance with Nasdaq Listing Rule 5635(c)(4). Each of the stock options granted as referenced in this press release has an exercise price of $4.40, the closing price of Iovance’s common stock on the Date of Grant. Each stock option vests over a three-year period, with one-third of the shares vesting on the first anniversary of the employee’s start date (referred to as the “First Vesting Date”), and the remaining shares vesting in eight quarterly installments over the next two years, commencing with the first quarter following the First Vesting Date, subject to continued employment with the Company through the applicable vesting dates. About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com. Forward-Looking Statements Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”) within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). All such written or oral statements made in this press release, other than statements of historical fact, are forward-looking statements and are intended to be covered by the safe harbor for forward-looking statements provided by the PSLRA. Without limiting the foregoing, we may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “forecast,” “guidance,” “outlook,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the effects of the COVID-19 pandemic; risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain U.S. Food and Drug Administration (“FDA”), European Medicines Agency (“EMA”), or other regulatory authority approval of, or other action with respect to, our product candidates, and our ability to successfully commercialize any product candidates for which we obtain FDA, EMA, or other regulatory authority approval; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from the prior pre-BLA meeting with the FDA and/or regarding our prior meetings with the FDA regarding our NSCLC clinical trials); the risk that the FDA, EMA, or other regulatory authorities may not approve or may delay approval for our BLA submission for lifileucel in metastatic melanoma; the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved, in the U.S. and other international markets; our ability or inability to manufacture our therapies using third party manufacturers or our own facility may adversely affect our potential commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; and other factors, including general economic conditions and regulatory developments, not within our control. CONTACTS Iovance Biotherapeutics, Inc:Sara Pellegrino, IRCSenior Vice President, Investor Relations & Corporate Communications650-260-7120 ext. 264Sara.Pellegrino@iovance.com Jen SaundersDirector, Investor Relations & Public Relations267-485-3119Jen.Saunders@iovance.com