CT-0525 is the first CAR-Monocyte to be evaluated in humans in the solid tumor setting

CT-0525是第一个在实体肿瘤环境中在人体中评估的CAR单核细胞

First patient expected to be treated in the first half of 2024

第一个病人预计将在2024年上半年接受治疗

PHILADELPHIA, Nov. 28, 2023 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ('Carisma' or the 'Company'), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the clearance of its Investigational New Drug application (IND) by the U.S.

费城，2023年11月28日/PRNewswire/-Carisma Therapeutics Inc.（纳斯达克股票代码：CARM）（'Carisma'或'公司'），一家专注于发现和开发创新免疫疗法的临床阶段生物制药公司，今天宣布美国批准其研究性新药申请（IND）。

Food and Drug Administration (FDA) for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). Having received a Study May Proceed notification from the FDA, Carisma expects to initiate a Phase 1 study in the coming months and to treat the first patient in the first half of 2024..

食品和药物管理局（FDA）为CT-0525，一种离体基因修饰的自体嵌合抗原受体-单核细胞（CAR-单核细胞）细胞疗法，旨在治疗过表达人表皮生长因子受体2（HER2）的实体瘤。收到研究报告后，可能会收到FDA的通知，Carisma预计将在未来几个月内启动1期研究，并在2024年上半年治疗第一例患者。。

'Clearance of the IND for CT-0525 is a significant milestone in Carisma's mission to develop innovative myeloid cell therapies for metastatic solid tumors,' said Steven Kelly, President and Chief Executive Officer of Carisma. 'Through this Phase 1 study, we aim to advance our understanding of safety, tolerability, manufacturing feasibility and mechanism of action of CT-0525.'.

Carisma总裁兼首席执行官Steven Kelly说：“CT-0525的IND清除是Carisma开发创新性骨髓细胞治疗转移性实体瘤使命的一个重要里程碑。”通过这个第一阶段的研究，我们的目标是提高我们对CT-0525的安全性，耐受性，制造可行性和作用机制的理解。

Monocytes are the precursor cells to macrophages, and there are numerous potential benefits to a CAR-Monocyte approach to help overcome certain challenges of treating solid tumors. The CAR-Monocyte manufacturing platform enables the ability to manufacture up to 10 billion cells from a single apheresis and utilizes a rapid, single-day manufacturing process.

单核细胞是巨噬细胞的前体细胞，CAR单核细胞方法有许多潜在的益处，有助于克服治疗实体瘤的某些挑战。CAR单核细胞制造平台能够通过单次单采血液成分制造多达100亿个细胞，并采用快速，单日的制造工艺。

This manufacturing process holds the potential to significantly reduce the future cost of goods and manufacturing turnaround time associated with this autologous cell therapy. Pre-clinical data presented at The Society for Immunotherapy of Cancer's Annual Meeting in November 2022 demonstrate that CT-0525 therapy reduced tumor growth in multiple pre-clinical solid tumor models..

这种制造过程有可能显着降低与这种自体细胞疗法相关的未来商品成本和制造周转时间。2022年11月在癌症免疫治疗学会年会上发表的临床前数据表明，CT-0525治疗可减少多种临床前实体瘤模型中的肿瘤生长。。

'CT-0525 is the first CAR-Monocyte to be evaluated in the solid tumor setting. With a CAR-Monocyte's in vivo persistence, ability to differentiate into pro-inflammatory CAR macrophages, and multi-modal anti-tumor mechanism of action, along with its high cell yield, CT-0525 has the potential to improve the treatment paradigm for patients with HER2 overexpressing metastatic solid tumors,' said Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma.

'CT-0525是第一个在实体瘤环境中评估的CAR单核细胞。由于CAR单核细胞的体内持久性，分化为促炎性CAR巨噬细胞的能力，以及多模式抗肿瘤作用机制，以及其高细胞产量，CT-0525有可能改善患者的治疗范例HER2过度表达转移性实体瘤，“Michael Klichinsky博士说，Carisma的联合创始人兼首席科学官。

'We look forward to the clinical development of CT-0525.'.

“我们期待CT-0525的临床开发。”。

The Phase 1 study for CT-0525 is designed to assess the safety, tolerability, and the manufacturing feasibility of CT-0525. This study will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies.

CT-0525的第一阶段研究旨在评估CT-0525的安全性，耐受性和制造可行性。本研究将招募患有过表达HER2的局部晚期（不可切除）或转移性实体瘤的参与者，其疾病已在标准批准的疗法中进展。

The study will consist of two cohorts: Cohort 1 will receive IV administration of up to 3 billion CAR-positive cells, while Cohort 2 will receive IV administration of CT-0525 of up to 10 billion CAR-positive cells..

该研究将由两个队列组成：队列1将接受静脉内施用多达30亿个CAR阳性细胞，而队列2将接受静脉内施用多达100亿个CAR阳性细胞的CT-0525。。

About CT-0525

关于CT-0525

CT-0525 is an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2). The CAR-Monocyte approach has the potential to address the challenges of treating solid tumors with cell therapies, including tumor infiltration, immunosuppression within the tumor microenvironment, and antigen heterogeneity..

CT-0525是离体基因修饰的自体嵌合抗原受体单核细胞（CAR-单核细胞）细胞疗法，旨在治疗过表达人表皮生长因子受体2（HER2）的实体瘤。CAR单核细胞方法有可能解决用细胞疗法治疗实体瘤的挑战，包括肿瘤浸润，肿瘤微环境中的免疫抑制和抗原异质性。。

About Carisma

关于Carisma

Carisma Therapeutics Inc. is a clinical stage biopharmaceutical company focused on utilizing our proprietary macrophage and monocyte cell engineering platform to develop transformative immunotherapies to treat cancer and other serious diseases. We have created a comprehensive, differentiated proprietary cell therapy platform focused on engineered macrophages and monocytes, cells that play a crucial role in both the innate and adaptive immune response.

Carisma Therapeutics Inc.是一家临床阶段的生物制药公司，专注于利用我们专有的巨噬细胞和单核细胞工程平台开发转化免疫疗法来治疗癌症和其他严重疾病。我们创建了一个全面，差异化的专有细胞治疗平台，专注于工程巨噬细胞和单核细胞，这些细胞在先天性和适应性免疫反应中起着至关重要的作用。

Carisma is headquartered in Philadelphia, PA. For more information, please visit www.carismatx.com..

Carisma总部设在宾夕法尼亚州费城。欲了解更多信息，请访问www.carismatx.com。。

Cautionary Note on Forward-Looking Statements

关于前瞻性陈述的警示

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements' within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Carisma's business, strategy, future operations, cash runway, the advancement of Carisma's product candidates and product pipeline, and clinical development of Carisma's product candidates, including expectations regarding timing of initiation and results of clinical trials.

本新闻稿中有关未来期望，计划和前景的陈述，以及任何其他有关非历史事实事项的陈述，可能构成1995年“私人证券诉讼改革法”含义内的“前瞻性陈述”。这些陈述包括但不限于与Carisma的业务，战略，未来运营，cash跑道，Carisma产品候选人和产品管道的进步以及Carisma产品候选人的临床开发有关的陈述，包括对启动时间和结果的期望临床试验。

The words 'anticipate,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'goals,' 'intend,' 'may,' 'might,' 'outlook,' 'plan,' 'project,' 'potential,' 'predict,' 'target,' 'possible,' 'will,' 'would,' 'could,' 'should,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words..

“预期”，“相信”，“考虑”，“继续”，“可以”，“估计”，“期望”，“目标”，“打算”，“可能”，“可能”，“展望”，“计划，“项目”，“潜力”，“预测”，“目标”，“可能”，“将会”，“将会”，“可能”，“应该”和类似的表达式旨在标识前瞻性陈述，尽管不是所有的前瞻性陈述都包含这些标识词。。

Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, (i) Carisma's ability to obtain, maintain and protect its intellectual property rights related to its product candidates; (ii) Carisma's ability to advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; (iii) Carisma's ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; (iv) Carisma's ability to realize the anticipated benefits of its research and development programs, strategic partnerships, research and licensing programs and academic and other collaborations; (v) regulatory requirements or developments and Carisma's ability to obtain and maintain necessary approvals from the U.S.

任何前瞻性陈述均基于管理层对未来事件的当前预期，并受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际结果与此类前瞻性陈述中提出或暗示的实际结果产生重大不利影响。这些风险和不确定性包括但不限于：（i）Carisma获得，维护和保护与其候选产品相关的知识产权的能力；（ii）Carisma能够按照计划和未来临床试验的预期时间表推进其候选产品的开发；（iii）Carisma在后期临床试验中复制的能力在其候选产品的临床前研究和早期临床试验中发现阳性结果；（iv）Carisma能够实现其研究和开发计划，战略伙伴关系，研究和许可计划以及学术和其他合作的预期收益；（v） 法规要求或发展以及Carisma获得并保持美国必要批准的能力。

Food and Drug Administration and other regulatory authorities related to its product candidates; (vi) changes to clinical trial designs and regulatory pathways; (vii) risks associated with Carisma's ability to manage expenses; (viii) changes in capital resource requirements; (ix) risks related to the inability of Carisma to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; and (x) legislative, regulatory, political and economic developments..

食品药品监督管理局和其他有关其候选产品的监管机构；（vi）改变临床试验设计和监管途径；（vii）与Carisma管理费用的能力相关的风险；（viii）资本资源需求的变化；（ix）与Carisma无法获得足够额外资金以继续推进其候选产品及其临床前计划有关的风险；（x）立法，监管，政治和经济发展。。

For a discussion of these risks and uncertainties, and other important factors, any of which could cause Carisma's actual results to differ from those contained in the forward-looking statements, see the 'Risk Factors' set forth in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Carisma's other recent filings with the Securities and Exchange Commission.

有关这些风险和不确定性以及其他可能导致Carisma实际结果与前瞻性声明中所包含结果不同的重要因素的讨论，请参阅本公司季度报告中关于表格10-Q于2023年11月9日提交给证券交易委员会的“风险因素”，以及潜在风险的讨论，Carisma最近向证券交易委员会提交的其他重要因素。

Any forward-looking statements that are made in this press release speak as of the date of this press release. Carisma undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws..

本新闻稿中所作的任何前瞻性声明均自本新闻稿发布之日起发言。Carisma不承担修改前瞻性声明或更新前瞻性声明以反映本新闻稿发布之日以后发生的事件或情况的义务，无论是由于新信息，未来发展还是其他原因，除非联邦证券法律要求。。

Media Contact:Julia Stern(763) 350-5223[email protected]

媒体联系：Julia Stern（763）350-5223[电子邮件保护]

Investor Contact:[email protected]

投资者联系人：[电子邮件保护]

SOURCE Carisma Therapeutics Inc.

来源Carisma Therapeutics Inc。