Lifileucel

SAN CARLOS, Calif., Jan. 17, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (“TIL”) therapies for patients with cancer, today announced that on January 16, 2025 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 224,550 shares of Iovance’s common stock to forty-one new, non-executive employees. The awards were granted under Iovance’s Amended and Restated 2021 Inducement Plan, which was adopted on September 22, 2021 and amended and restated on January 12, 2022, March 13, 2023, February 26, 2024, and November 22, 2024 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 $5.76, 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 (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, Inc. 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. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. 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. Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. 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”). 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,” “can,” “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 U.S. 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 risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration (“FDA”) approval, and Proleukin, for which we have obtained FDA and European Medicines Agency (“EMA”) approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our 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, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; 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 our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues may not continue to serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates.

2024年，FDA药品评审与研究中心‌（‌CDER）该年度共批准50款新药，尽管该数据并不能挤进‌CDER年度批准新药数量前三，但已是‌CDER年度批准新药数量达到50款的5个年度之一（2018年59款、2023年55款、2020年53款、2020年50款）。 小分子依然强劲 ‌CDER批准小分子化药31款，占比超过60%。其中，8款新药是获得FDA突破性疗法认定的“first-in-class”药物。 其中更是多款获批具有里程碑意义的小分子新药，备受关注。 百时美施贵宝的精神分裂症新药Cobenfy（xanomeline/trospium chloride）是半个多世纪来精神分裂症领域获得FDA批准首个新型作用机制的药物（M1/M4毒蕈碱激动剂）。 VeronaPharma公司开发的选择性PDE3/PDE4双重抑制剂Ohtuvayre（ensifentrine）获FDA批准用于治疗慢性阻塞性肺病（COPD），也成为20多年来首款用于COPD维持治疗的具有新型作用机制吸入药物。 Madrigal公司的甲状腺激素受体（THR）-β选择性激动剂Rezdiffra（resmetirom）获批联合饮食和运动，治疗患有中重度肝纤维化（F2至F3期）的非肝硬化非酒精性脂肪性肝炎（NASH）/代谢功能障碍相关脂肪性肝炎（MASH）成人患者，这是获得FDA批准的首款NASH疗法，也被认为是该领域的一项重要里程碑。 抗体药多点开花 在热门的抗体药物领域，有13款产品获得批准。 肿瘤仍旧是抗体药物开发的主导领域，获批产品占据半壁江山。其中，百济神州的Tevimbra（tislelizumab-jsgr）被批准用于不可切除或转移性食管鳞状细胞癌，成为获得FDA批准的第二款国产PD-1单抗。Merus公司获批用于治疗携带NRG1基因融合（NRG1+）晚期不可切除或转移性胰腺导管腺癌或非小细胞肺癌（NSCLC）成年患者的Bizengri（zenocutuzumab-zbco）是首款HER2×HER3双特异性抗体。 自身免疫疾病领域也不甘示弱。Galderma公司靶向IL-31单抗Nemluvio（nemolizumab）获批用于治疗成人结节性痒疹。礼来靶向IL-13单抗Ebglyss(lebrikizumab-lbkz)获批用于治疗患有中度至重度特应性皮炎(AD)。Incyte/Syndax开发的CSF-1R单抗Niktimvo(axatilimab-csfr)用于慢性移植物抗宿主病(cGVHD)。 此外，神经疾病（Kisunla用于治疗阿尔茨海默病）、免疫缺陷（Piasky用于治疗阵发性夜间血红蛋白尿）和遗传性出血性疾病（Hympavzi和Alhemo 用于预防或减少A型和B型血友病出血发作）领域各有斩获。 核酸类药物继续发力 近年来，小核酸药物研发取得了多项新突破，已成为生物制药关注的新焦点之一。 两款核酸疗法首次获批上市：首款端粒酶抑制剂Rytelo（imetelstat）获批准用于治疗骨髓增生异常综合征（MDS）成年患者；反义寡核苷酸（ASO）疗法Tryngolza (olezarsen)获批作为辅助饮食疗法用于降低成年家族性乳糜微粒血症综合症（FCS）患者的甘油三酯水平。 此外，‌CDER还批准1款多肽药物、1款融合蛋白药物和3款诊断产品。 细胞基因疗法迎来爆发期 FDA生物制品评价与研究中心(CBER)也批准多款疗法，包括12款细胞基因/免疫球蛋白/疫苗疗法。 首款基于CRISPR技术的开创性基因编辑疗法Casgevy获批开启了基因编辑药物的新纪元。首款获批上市的TCR-T细胞疗法Tecelra也是十多年来滑膜肉瘤患者的新治疗选择。浸润淋巴细胞疗法（TIL）Amtagvi是首款获批治疗实体瘤-黑色瘤的细胞治疗产品。 细胞基因疗法的批准数量突飞猛进，但定价同样屡创新高。Orchard Therapeutics公司获批用于治疗异染性脑白质营养不良（MLD）的基因疗法Lenmeldy在美国一次性治疗的批发采购成本（WAC）为425万美元，跃升为有史以来最昂贵的药物。 备注：同步刊载《医药经济报》 本文由「新药前沿」微信公众号根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构转载授权请在「新药前沿」微信公众号留言公众号名称，审核通过后开通白名单获取转载授权，转载请标识来源。 免责声明：本文仅作信息交流之目的，非投资建议或者治疗方案推荐，「新药前沿」微信公众号不对任何主体因使用本文内容而导致的任何损失承担责任。 限于作者水平和专业知识所限，如有谬误，欢迎指正！