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NEEDHAM, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that an abstract was accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 to June 3, 2025, in Chicago, IL.

马萨诸塞州尼德汉，2025年4月23日（环球新闻社）——Candel Therapeutics公司（Candel或本公司）（纳斯达克：CADL），一家专注于开发多模式生物免疫疗法以帮助患者抗击癌症的临床阶段生物制药公司，今日宣布，一份摘要已被接受，将在2025年5月30日至6月3日于伊利诺伊州芝加哥举行的美国临床肿瘤学会（ASCO）年会上进行口头报告。

The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer..

口头报告将介绍公司关于CAN-2409在中高风险局部前列腺癌患者中的三期临床试验数据。

Details are as follows:

详情如下：

CAN-2409 – Localized Prostate Cancer

CAN-2409 – 局部前列腺癌

Abstract Title:

摘要标题：

Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard-of-care external beam radiation therapy (EBRT) for newly diagnosed localized prostate cancer

第三阶段，随机，安慰剂对照的临床试验，评估CAN-2409+前药联合标准治疗外照射放疗（EBRT）用于新诊断的局部前列腺癌。

Presenter:

主持人：

Theodore DeWeese, M.D. *, the Francis Watt Baker, M.D., and Lenox D. Baker Jr., M.D., Dean of the Medical Faculty and CEO, Johns Hopkins Medicine

西奥多·德威斯，医学博士*，弗朗西斯·瓦特·贝克，医学博士，小莱诺克斯·D·贝克，医学博士，霍普金斯大学医学院院长兼首席执行官

Session Title:

会议标题：

Oral Abstract Session – Genitourinary Cancer – Prostate, Testicular, and Penile

口腔报告会——泌尿生殖系统癌症——前列腺、睾丸和阴茎

Session Date/Time:

会话日期/时间：

Tuesday, June 3, 2025; 9:45 AM - 12:45 PM CT

2025年6月3日，星期二；上午9:45 - 下午12:45（中部时间）

Location:

位置：

Hall A, McCormick Place Convention Center, Chicago, IL

芝加哥麦考密克会展中心A厅，伊利诺伊州芝加哥

Full abstracts will be released by ASCO on Thursday, May 22, 2025, at 5:00 PM ET. Details from the presentations will be available following the event on the Candel website at

完整摘要将于2025年5月22日星期四东部时间下午5:00由ASCO发布。演讲的详细信息将在活动结束后在Candel网站上提供。

Candel Media

蜡烛媒体

.

。

* Dr. DeWeese has no relationship with Candel, other than serving as the national principal investigator for Candel’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high risk localized prostate cancer. He has never received reimbursements, consulting fees, or EAB fees from Candel, and he has no shares of common stock, options to purchase common stock or other stake in Candel..

* 德威斯博士与Candel没有任何关系，除了担任Candel针对中高风险局部前列腺癌患者的CAN-2409第三阶段临床试验的全国首席研究员。他从未从Candel获得过报销、咨询费或EAB费用，并且他不持有Candel的普通股、购买普通股的期权或其他任何权益。

About CAN-2409

关于CAN-2409

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor.

CAN-2409是Candel最先进的多模式生物免疫治疗候选药物，是一种研究性、现成的、复制缺陷型腺病毒，旨在将单纯疱疹病毒胸苷激酶（HSV-tk）基因递送到患者特定的肿瘤中，并诱导针对该肿瘤的个体化、全身性免疫反应。

HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic nucleotide analogue that kills nearby cancer cells. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of the patient’s own tumor antigens.

HSV-tk是一种酶，它将口服的伐昔洛韦在局部转化为一种有毒的核苷酸类似物，从而杀死附近的癌细胞。该方案旨在通过针对患者自身多种肿瘤抗原的原位免疫，诱导个体化和特异性的CD8+ T细胞介导的反应，攻击注射部位的肿瘤以及未注射的远处转移灶，从而实现广泛的抗肿瘤活性。

Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity, as well as combination activity with standard of care (SoC) radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors, have previously been shown in several preclinical and clinical settings.

由于其多功能性，CAN-2409有潜力治疗广泛的实体肿瘤。在多个临床前和临床环境中，之前已展示出令人鼓舞的单药活性，以及与标准治疗（SoC）放疗、手术、化疗和免疫检查点抑制剂联合使用的活性。

More than 1,000 patients have been dosed with CAN-2409 with a favorable tolerability profile reported to date, supporting the potential for combination with other therapeutic strategies..

已有1000多名患者接受过CAN-2409的治疗，迄今为止报告显示其耐受性良好，这为其与其他治疗策略的联合应用提供了支持。

Candel's clinical development program for CAN-2409 includes completed positive phase 2a clinical trials in both non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), as well as a positive pivotal randomized, placebo-controlled phase 3 clinical trial of CAN-2409 in localized, non-metastatic prostate cancer.

Candel公司针对CAN-2409的临床开发计划包括已完成的非小细胞肺癌（NSCLC）和胰腺导管腺癌（PDAC）的阳性2a期临床试验，以及在局部非转移性前列腺癌中进行的阳性关键随机、安慰剂对照的3期临床试验。

In December 2024, Candel announced that CAN-2409 achieved its primary endpoint in this phase 3 clinical trial in men with intermediate-to-high-risk, localized prostate cancer, demonstrating statistically significant and clinically meaningful improvement in disease-free survival when added to SoC radiation therapy +/- androgen deprivation therapy..

2024年12月，Candel宣布CAN-2409在这项针对中高危局部前列腺癌男性的III期临床试验中达到了主要终点，证明在标准治疗放疗±雄激素剥夺疗法的基础上加入CAN-2409后，无病生存期取得了统计学上显著且具有临床意义的改善。

In the Company’s randomized controlled phase 2a clinical trial of CAN-2409 in borderline resectable PDAC, positive survival data showed notable improvement with an estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 plus SoC versus 12.5 months in the control group in patients with PDAC who only received SoC.

在公司进行的CAN-2409针对边缘可切除PDAC的随机对照2a期临床试验中，积极的生存数据显示出显著改善，接受CAN-2409联合标准治疗（SoC）的实验组患者估计中位总生存期为31.4个月，而仅接受标准治疗（SoC）的PDAC患者对照组中位总生存期仅为12.5个月。

Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 6.4 months in the control arm. The final survival data from the phase 2a clinical trial of CAN-2409, in patients with stage III/IV NSCLC, showed an mOS of 24.5 months in 46 evaluable patients receiving 2 courses of CAN-2409 (per protocol population; cohort 1 and 2) and 21.5 months in evaluable patients from cohort 2 (n=41) that had progressive disease at baseline, despite Immune Checkpoint Inhibitor treatment.

进展后的中位生存期在接受CAN-2409治疗的患者中为21.2个月，而对照组为6.4个月。来自CAN-2409二期临床试验（针对III/IV期非小细胞肺癌患者）的最终生存数据显示，在接受两疗程CAN-2409治疗的46名可评估患者中（按方案人群；队列1和2），中位总生存期（mOS）为24.5个月，而在基线时尽管接受免疫检查点抑制剂治疗仍有疾病进展的队列2可评估患者（n=41）中，中位总生存期为21.5个月。

CAN-2409 plus prodrug has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of PDAC, stage III/IV NSCLC in patients who are resistant to first line PD-(L)1 inhibitor therapy and who do not have activating molecular driver mutations or have progressed on directed molecular therapy and localized prostate cancer.

CAN-2409 加前药已获得美国食品药品监督管理局（FDA）的快速通道资格，用于治疗胰腺导管腺癌（PDAC）、III/IV期非小细胞肺癌（NSCLC），这些患者对一线PD-(L)1抑制剂治疗耐药，且无激活的分子驱动突变或在定向分子治疗后进展，以及局部前列腺癌。

The FDA has also granted Orphan Drug Designation to CAN-2409 for the treatment of PDAC. Candel’s pivotal phase 3 clinical trial in newly diagnosed, localized prostate cancer was conducted under a Special Protocol Assessment agreed with the FDA..

FDA还授予了CAN-2409孤儿药资格，用于治疗PDAC。Candel公司在新诊断的局部前列腺癌中的关键性3期临床试验是根据与FDA达成的特殊方案评估进行的。

About Candel Therapeutics

关于Candel治疗学

Candel is a clinical stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. CAN-2409 is the lead product candidate from the adenovirus platform. CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma (rHGG).

Candel是一家临床阶段的生物制药公司，专注于开发现成的多模式生物免疫疗法，以激发个体化的全身抗肿瘤免疫反应，帮助患者对抗癌症。CAN-2409是腺病毒平台的主要候选产品。CAN-3110是HSV平台的主要候选产品，目前正在进行针对复发性高级别胶质瘤（rHGG）的1b期临床试验。

In October 2023, the Company announced that .

2023年10月，公司宣布了。

Nature

自然

published initial results from this ongoing clinical trial: CAN-3110 was well tolerated and the investigators observed nearly two-fold increase in median overall survival compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.

发表了这项正在进行的临床试验的初步结果：CAN-3110 耐受性良好，研究人员观察到，在这种对治疗有抵抗力的情况下，单次注射 CAN-3110 后，中位总生存期比历史对照组增加了近两倍。

1

1

Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.

最后，Candel的enLIGHTEN™发现平台是一个系统化的、迭代的基于HSV的发现平台，利用人体生物学和先进分析技术，为实体瘤创造新的病毒免疫疗法。

For more information about Candel, visit:

有关 Candel 的更多信息，请访问：

www.candeltx.com

www.candeltx.com

Forward-Looking Statements

前瞻性声明

This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; including the timing and availability of additional data and key data readout milestones and presentations; expectations regarding early biological readouts as predictor of clinical response; and expectations regarding the therapeutic benefit of the Company’s programs, including the ability of CAN-2409 to treat localized prostate cancer and improve disease-free survival, overall survival, and post-progression survival.

本新闻稿包含某些“前瞻性声明”，这些声明符合1995年《私人证券诉讼改革法案》及其修订案的定义，包括但不限于关于当前和未来开发计划的时间安排与进展的明确或隐含声明；包括额外数据的时间安排、关键数据读出里程碑及展示；关于早期生物学读数作为临床反应预测指标的预期；以及对公司项目治疗益处的预期，包括CAN-2409治疗局部前列腺癌以及改善无病生存期、总生存期和进展后生存期的能力。

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

“可能”、“将”、“可以”、“会”、“应该”、“预期”、“计划”、“预期”、“打算”、“相信”、“估计”、“预测”、“项目”、“潜力”、“继续”、“目标”等类似表述旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词语。

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ab.

本新闻稿中的任何前瞻性陈述均基于管理层的当前预期和信念，并受多种风险、不确定性和重要因素的影响，这些因素可能导致实际事件或结果与本新闻稿中包含的任何前瞻性陈述所表达或暗示的内容存在重大差异，包括但不限于与开发计划的时间安排和进展相关的风险和不确定性；对公司计划的治疗益处的预期；公司临床前研究和已完成的临床试验的最终数据可能与正在进行的研究和试验中报告的中期数据存在重大差异；公司的能力。

Investor Contact:

投资者联系方式：

Theodore Jenkins

西奥多·詹金斯

VP, Investor Relations and Business Development

副总裁，投资者关系与业务发展

Candel Therapeutics, Inc.

Candel Therapeutics公司

tjenkins@candeltx.com

tjenkins@candeltx.com

Media Contact:

媒体联系人：

Ben Shannon

本·香农

ICR Healthcare

ICR医疗保健

CandelPR@icrhealthcare.com

CandelPR@icrhealthcare.com

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1. Ling AL, et al. Nature. 2023;623(7985):157-166.

1. 林AL，等。《自然》。2023年；623（7985）：157-166。