SOUTH SAN FRANCISCO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc., (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to LYL845, an investigational tumor infiltrating lymphocyte (TIL) product candidate for the treatment of patients with stage IIB-IV melanoma..

南旧金山，加利福尼亚州，2023年11月9日（GLOBE NEWSWIRE）-莱尔免疫制药公司（纳斯达克股票代码：LYEL），一家临床阶段T细胞重编程公司，为实体瘤患者推进多种细胞疗法，今天宣布美国食品和药物管理局（FDA）授予LYL845孤儿药名称，用于治疗IIB-IV期黑素瘤患者的研究性肿瘤浸润淋巴细胞（TIL）产品候选物。。

“There remains a high unmet medical need for patients with advanced melanoma and we believe LYL845 has the potential for differentiated potency and durability needed to deliver better outcomes for patients with melanoma as well as other solid tumors where TIL therapy has not yet been widely effective,” said Lynn Seely, M.D., Lyell’s President and CEO.

莱尔总裁兼首席执行官Lynn Seely说：“对于晚期黑色素瘤患者仍然存在很高的未满足的医疗需求，我们相信LYL845有可能为黑色素瘤患者以及TIL治疗尚未广泛有效的其他实体瘤患者提供更好的疗效和持久性。

“We are pleased to have received Orphan Drug Designation for LYL845 in advanced melanoma and look forward to presenting initial clinical data from this program next year.”.

“我们很高兴在晚期黑色素瘤中获得LYL845的孤儿药名称，并期待明年提供该计划的初步临床数据。”。

LYL845, an autologous TIL product candidate enhanced with Lyell’s Epi-R™ manufacturing protocols, is currently being investigated in a Phase 1 clinical trial in patients with relapsed or refractory metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).

LYL845，一种用Lyell的Epi-R增强的自体TIL产品候选物™ 目前正在复发或难治性转移性或局部晚期黑色素瘤，非小细胞肺癌（NSCLC）和结直肠癌（CRC）患者的1期临床试验中研究制造方案。

In nonclinical studies, LYL845 TIL expanded with Epi-R exhibit characteristics that have previously been associated with improved clinical response rate, including a higher percentage of cytotoxic T cells and stemness phenotypes. LYL845 TIL have also demonstrated enhanced T-cell potency and maintenance of tumor-reactive polyclonality in nonclinical experiments.

在非临床研究中，用Epi-R扩增的LYL845 TIL表现出先前与改善的临床反应率相关的特征，包括更高百分比的细胞毒性T细胞和干性表型。在非临床实验中，LYL845 TIL也显示出增强的T细胞效力和维持肿瘤反应性多克隆性。

Initial data from Lyell’s ongoing Phase 1 clinical trial are expected in 2024..

Lyell正在进行的1期临床试验的初步数据预计在2024年。。

The FDA's Orphan Drug Designation program provides orphan status to drugs or biologics intended for the prevention, diagnosis, or treatment of diseases that affect fewer than 200,000 people in the United States. Sponsors of medicines that are granted Orphan Drug Designation are entitled to certain incentives, including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval..

FDA的孤儿药指定计划为旨在预防，诊断或治疗影响美国不到20万人的疾病的药物或生物制剂提供孤儿身份。获得孤儿药指定的药物赞助商有权获得某些激励措施，包括合格临床试验的税收抵免，处方药用户费用豁免以及FDA批准后可能的七年营销专有权。。

Phase 1 Trial Design (NCT05573035)

第一阶段试验设计（NCT05573035）

The Phase 1 clinical trial is an open-label, dose-escalation trial for patients with relapsed and/or refractory metastatic or locally advanced melanoma with expansion cohorts for patients with melanoma, NSCLC, and CRC. The primary objective of the trial is to determine safety, tolerability and a recommended phase 2 dose range of LYL845.

1期临床试验是针对复发和/或难治性转移性或局部晚期黑色素瘤患者的开放标签剂量递增试验，其具有针对黑素瘤，NSCLC和CRC患者的扩展群组。该试验的主要目的是确定LYL845的安全性，耐受性和推荐的2期剂量范围。

The secondary objective is to determine antitumor activity as evaluated by response rates, duration of response, progression-free survival and overall survival. Exploratory biomarkers of T-cell stemness will also be assessed..

次要目标是通过响应率，响应持续时间，无进展存活和总体存活来评估抗肿瘤活性。还将评估T细胞干性的探索性生物标志物。。

About Melanoma

关于黑色素瘤

Melanoma of the skin is among the most common cancers in the United States. It is one of the most common cancers in young adults and especially in young women. It is estimated there are over 100,000 new cases of melanoma diagnosed in the United States per year. Melanoma arises due to genetic mutations in melanocytes, the pigment producing cells, which can be found in the skin, eye, inner ear and leptomeninges, and represents the most aggressive and the deadliest form of skin cancer.

皮肤黑色素瘤是美国最常见的癌症之一。它是年轻人，特别是年轻女性中最常见的癌症之一。据估计，美国每年诊断出超过100000例新的黑色素瘤病例。黑色素瘤是由于黑色素细胞（可在皮肤，眼睛，内耳和软脑膜中发现的色素生成细胞）中的基因突变而产生的，代表了最具侵略性和最致命的皮肤癌形式。

Although melanoma accounts for only ~1% of all dermatologic cancers, it is responsible for ~80% of deaths from skin cancer, with only ~14% of patients with advanced melanoma surviving for five years..

尽管黑色素瘤仅占所有皮肤病癌症的约1%，但它约占皮肤癌死亡的80%，只有约14%的晚期黑色素瘤患者存活了五年。。

About LYL845

关于LYL845

LYL845 is an investigational autologous TIL product enhanced with Epi-R manufacturing protocols for patients with relapsed and/or refractory metastatic or locally advanced melanoma, NSCLC and CRC. In nonclinical studies, Epi-R creates polyclonal populations of T cells that demonstrate properties of durable stemness and anti-tumor functionality.

LYL845是针对复发和/或难治性转移性或局部晚期黑素瘤，NSCLC和CRC患者的Epi-R制造方案增强的研究性自体TIL产品。在非临床研究中，Epi-R产生多克隆T细胞群，证明持久干细胞和抗肿瘤功能的特性。

Durable stemness is the ability of T cells to persist and self-renew to drive durable tumor cytotoxicity..

持久的干性是T细胞持续和自我更新以驱动持久的肿瘤细胞毒性的能力。。

TIL products are created by expanding T cells taken from the patient’s own tumor. Previous clinical experiences suggest that the efficacy of adoptive transfer of ex vivo expanded TILs is largely driven by specific recognition of mutated tumor neoantigens specific to each patient. To date, broad efficacy of TIL therapies has been limited by variable and often poor product quality, lack of stemness or potential durability of expanded TILs, failure to maintain polyclonality of TILs during production, and failure to enrich the TIL product with tumor-reactive T cells.

TIL产品是通过扩大取自患者自身肿瘤的T细胞而产生的。先前的临床经验表明过继转移离体扩增的TIL的功效主要由对每个患者特异性的突变肿瘤新抗原的特异性识别所驱动。迄今为止，TIL疗法的广泛功效受到可变且通常较差的产品质量，缺乏干性或扩大的TIL的潜在耐久性，在生产过程中未能维持TIL的多克隆性以及未能用肿瘤反应性富集TIL产品的限制。T细胞。

TIL products manufactured using Lyell’s Epi-R manufacturing protocol aim to overcome these challenges. Nonclinical studies supporting the development of LYL845 suggest Epi-R technology improves TIL products by maintaining properties of durable stemness, which leads to superior ex vivo cell expansion and product qualities, maintenance of tumor reactive clones, and enhanced polyclonality..

使用Lyell的Epi-R制造协议制造的TIL产品旨在克服这些挑战。支持LYL845开发的非临床研究表明，Epi-R技术通过保持持久干性的特性来改善TIL产品，从而实现卓越的离体细胞扩增和产品质量，维持肿瘤反应性克隆和增强多克隆性。。

About Lyell

关于莱尔

Lyell is a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors. Lyell is currently enrolling a Phase 1 clinical trial evaluating a ROR1-targeted CAR T-cell therapy in patients with relapsed refractory triple-negative breast cancer and non-small cell lung cancer (NSCLC) and a second Phase 1 clinical trial evaluating reprogrammed tumor infiltrating lymphocytes (TIL) in patients with advanced melanoma, NSCLC and colorectal cancer.

Lyell是一家临床阶段T细胞重编程公司，为实体瘤患者提供多样化的细胞疗法。Lyell目前正在招募一项评估ROR1靶向CAR T细胞治疗复发难治性三阴性乳腺癌和非小细胞肺癌（NSCLC）患者的1期临床试验和第二阶段1临床试验，评估重编程肿瘤晚期黑色素瘤，NSCLC和结直肠癌患者的浸润淋巴细胞（TIL）。

The technologies powering its product candidates are designed to address barriers that limit consistent and long-lasting responses to cell therapy for solid tumors: T-cell exhaustion and lack of durable stemness, which includes the ability to persist and self-renew to drive durable tumor cytotoxicity.

为其候选产品供电的技术旨在解决限制对实体瘤细胞疗法的一致和持久反应的障碍：T细胞衰竭和缺乏持久干性，其中包括持续和自我更新以驱动持久肿瘤的能力细胞毒性。

Lyell is applying its proprietary ex vivo genetic and epigenetic reprogramming technologies to address these barriers in order to develop new medicines with improved durable clinical outcomes. Lyell is based in South San Francisco, California with facilities in Seattle and Bothell, Washington. To learn more, please visit www.lyell.com..

Lyell正在应用其专有的离体遗传和表观遗传重编程技术来解决这些障碍，以开发具有改善的持久临床结果的新药。莱尔总部设在加利福尼亚州南旧金山，在西雅图和华盛顿州博塞尔设有设施。要了解更多信息，请访问www.lyell.com。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell’s anticipated progress, business plans, business strategy and clinical trials; the potential for LYL845 to have differentiated potency and durability needed to deliver better outcomes for patients with melanoma as well as other solid tumors where TIL therapy has not yet been widely effective; the nonclinical data associated with LYL845 and the potential for this data to be replicated in human clinical trials; the benefits associated with the FDA's Orphan Drug Designation, including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval; and other statements that are not historical fact.

本新闻稿包含1995年“私人证券诉讼改革法”含义内的前瞻性声明。本新闻稿中表达或暗示的前瞻性声明包括但不限于以下声明：Lyell的预期进展，业务计划，业务策略和临床试验；LYL845具有分化的效力和耐久性的潜力需要为黑素瘤患者以及TIL治疗尚未广泛有效的其他实体瘤患者提供更好的结果；与LYL845相关的非临床数据以及该数据在人体临床试验中复制的潜力；与FDA的孤儿药指定相关的好处，包括合格临床试验的税收抵免，处方药用户费用豁免以及FDA批准后可能的七年营销专有权；和其他不是历史事实的陈述。

These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the effects of the COVID-19 pandemic; geopolitical instability; macroeconomic conditions; Lyell’s ability to submit planned INDs or initiate or progress clinical trials on the anticipated timelines, if at all; our lack of experience as a company in enrolling, conducting or completing clinical trials; Lyell’s ability to manufacture and supply its product candidates for its clinical trials; the preclin.

这些陈述基于Lyell目前的计划，目标，估计，期望和意图，不能保证未来的表现，并且固有地涉及重大的风险和不确定性。由于这些风险和不确定性，实际结果和事件发生时间可能与此类前瞻性声明中预期的结果有很大差异，其中包括但不限于与以下相关的风险和不确定性：COVID-19的影响大流行；地缘政治不稳定；宏观经济条件；莱尔能够按照预期的时间表提交计划的IND或启动或进行临床试验（如果有的话）；我们缺乏注册，进行或完成临床试验的公司经验；莱尔为其临床试验制造和提供候选产品的能力；preclin。

Contact:

联系方式：

Ellen Rose

艾伦玫瑰

Senior Vice President, Communications and Investor Relations

高级副总裁，通信和投资者关系

erose@lyell.com

erose@lyell.com