NEEDHAM, Mass., Feb. 25, 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 final overall survival data from the completed randomized controlled phase 2 clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection, in patients with borderline resectable PDAC..

马萨诸塞州尼德姆，2025年2月25日（GLOBE NEWSWIRE）——Candel Therapeutics, Inc.（Candel或公司）（纳斯达克股票代码：CADL），一家专注于开发多模式生物免疫疗法以帮助患者对抗癌症的临床阶段生物制药公司，今日宣布了已完成的随机对照二期临床试验的最终总生存期数据，该试验评估了CAN-2409加伐昔洛韦（前药），与标准治疗（SoC）放化疗联合使用，并在手术切除之前，针对边缘可切除的胰腺导管腺癌（PDAC）患者。

Final data of the randomized controlled clinical trial, updated with an additional nine months of follow-up, confirmed a durable improvement in survival for patients treated with CAN-2409 plus SoC therapy (n=7) compared to SoC alone (n=6). Notably, long-term survivors in the CAN-2409 arm, remaining alive at 66.0, 63.6, and 35.8 months post-enrollment experienced disease recurrence but, in contrast to patients in the control arm with disease recurrence, responded to salvage chemotherapy and have experienced extended and ongoing post-progression survival at the time of the data cutoff (February 20, 2025), further highlighting the sustained benefit of CAN-2409 in this aggressive disease setting..

随机对照临床试验的最终数据，经过额外九个月的随访更新后，证实接受CAN-2409联合标准治疗（SoC）（n=7）的患者相比仅接受SoC治疗（n=6）的患者，在生存率上获得了持久改善。值得注意的是，CAN-2409组中的长期幸存者在入组后分别存活了66.0、63.6和35.8个月，尽管他们经历了疾病复发，但与对照组中复发的患者不同，他们对挽救性化疗有反应，并在数据截止时间（2025年2月20日）仍保持延长且持续的进展后生存期，进一步突显了CAN-2409在此侵袭性疾病环境中的持久益处。

“Pancreatic cancer remains one of the most difficult to treat diseases,” said W. Garrett Nichols, MD, MS, Candel’s Chief Medical Officer. “Patients with borderline resectable PDAC often have undetectable metastases that are not cleared with current standard of care neoadjuvant chemoradiation and surgery.

“胰腺癌仍然是最难治疗的疾病之一，”医学博士、理学硕士、Candel公司首席医疗官W. Garrett Nichols表示。“边缘可切除的胰腺导管腺癌（PDAC）患者通常存在无法检测到的转移病灶，这些病灶通过当前的新辅助放化疗和手术标准治疗无法清除。”

CAN-2409 is a first-in-class multimodal immunotherapy candidate designed for in situ vaccination against the patient’s tumor, which offers the potential to control this disease and to prolong survival, thus improving outcomes following this dismal prognosis.”.

CAN-2409是一种首创的多模式免疫治疗候选药物，旨在针对患者的肿瘤进行原位疫苗接种，这有可能控制这种疾病并延长生存期，从而改善这一惨淡预后的结果。

Data highlights:

数据亮点：

Prolonged and sustained survival was observed in this randomized controlled clinical trial after experimental treatment with CAN-2409 compared to the control group in patients with borderline resectable PDAC

在这一随机对照临床试验中，与对照组相比，接受CAN-2409实验治疗的边缘可切除胰腺导管腺癌（PDAC）患者观察到延长且持续的生存期。

Estimated median overall survival after enrollment was 31.4 months in the CAN-2409 group (n=7) versus only 12.5 months in the control group (n=6).

CAN-2409组（n=7）的估计中位总生存期为31.4个月，而对照组（n=6）仅为12.5个月。

Median survival post-progression was 21.2 months in patients who received CAN-2409 compared to 7.2 months in the control arm.

接受CAN-2409治疗的患者进展后的中位生存期为21.2个月，而对照组为7.2个月。

Importantly, three out of seven patients who received CAN-2409 were still alive at the time of data cut-off with a survival of 66.0, 63.6, and 35.8 months, respectively, after enrollment; survival from the time of diagnosis for these patients was 73.5, 68.8, and 41.3 months, respectively. Of these, the first patient had stage IV metastatic disease detected during surgery, the second had residual tumor present at the resection margin, and the third had adenocarcinoma with negative resection margins.

重要的是，在数据截止时，接受CAN-2409治疗的七名患者中有三名仍然存活，其入组后的生存时间分别为66.0个月、63.6个月和35.8个月；这些患者从诊断开始的生存时间分别为73.5个月、68.8个月和41.3个月。其中，第一名患者在手术期间被发现患有IV期转移性疾病，第二名患者在切除边缘存在残留肿瘤，第三名患者患有腺癌且切除边缘为阴性。

In contrast, only one out of six patients randomized to SoC chemotherapy arm remained alive at the data cut-off (61.2 months from enrollment and 65.5 months from diagnosis); histologic analysis at resection showed intraepithelial neoplasia (without evidence of residual invasive adenocarcinoma) in this patient, which is associated with improved prognosis..

相比之下，在随机分配到标准护理化疗组的六名患者中，只有一名在数据截止时仍然存活（从入组起61.2个月，从诊断起65.5个月）；该患者在切除时的组织学分析显示为上皮内瘤变（无残留浸润性腺癌的证据），这与预后改善相关。

Previous analysis at 24 months showed survival rates of 71.4% in patients treated with CAN-2409 compared to 16.7% in the control group.

之前在24个月时的分析显示，接受CAN-2409治疗的患者生存率为71.4%，而对照组为16.7%。

Previous analysis of blood and resected tumors showed consistent and robust activation of the immune response after experimental treatment with CAN-2409

既往对血液和切除肿瘤的分析显示，使用CAN-2409进行实验性治疗后，免疫反应持续且强劲地激活。

In pancreatic tissue of patients treated with CAN-2409 plus prodrug, together with SoC (but not SoC alone), dense aggregates of CD8+ granzyme B+ cytotoxic tumor infiltrating lymphocytes, dendritic cells, and B cells were observed in the tumor microenvironment.

在使用CAN-2409加前药联合标准治疗（而非单独标准治疗）的患者胰腺组织中，观察到肿瘤微环境中存在密集的CD8+颗粒酶B+细胞毒性肿瘤浸润淋巴细胞、树突状细胞和B细胞聚集体。

Increased levels of soluble granzymes B and H, along with pro-inflammatory cytokines, including IFN-γ, were detected in peripheral blood following CAN-2409 treatment, but not in the control arm, supporting CAN-2409’s ability to drive a potent systemic anti-tumoral immune response.

CAN-2409治疗后在外周血中检测到可溶性颗粒酶B和H以及包括IFN-γ在内的促炎性细胞因子水平升高，而对照组中未检测到，这支持了CAN-2409能够引发强烈的全身抗肿瘤免疫反应的能力。

CAN-2409 continued to be associated with a favorable safety/tolerability profile

CAN-2409继续保持良好的安全性/耐受性特征

The addition of CAN-2409 regimen to SoC was generally well-tolerated, with no dose-limiting toxicities, including no cases of pancreatitis.

将CAN-2409方案添加到标准治疗中通常耐受性良好，没有剂量限制性毒性，包括无胰腺炎病例。

“The notable benefits observed with CAN-2409 in this clinical trial, including evidence of a long tail of survival, highlights the transformative potential of this biological multimodal immunotherapy in difficult to treat cancers,” said Paul Peter Tak, MD, PhD, FMedSci, CEO and President of Candel. “Recently, the Company announced positive, statistically significant topline data for CAN-2409 based on a large, randomized, placebo-controlled clinical trial in localized prostate cancer.

“在这一临床试验中观察到的CAN-2409显著益处，包括生存期长尾效应的证据，突显了这种生物多模式免疫疗法在难治性癌症中的变革潜力，”Candel公司首席执行官兼总裁Paul Peter Tak博士表示。“近期，公司宣布了基于一项大型随机、安慰剂对照的局部前列腺癌临床试验的CAN-2409积极且具有统计学意义的初步数据。”

The data presented today support the potential of CAN-2409 across various solid tumors, by showing its potential to alter the balance between the pancreatic tumor and the anti-tumor immune response, even in patients with residual tumor, improving long-term survival in a subset of the patients. Based on these promising findings, the Company has decided to prepare for a larger, late-stage randomized controlled clinical trial of CAN-2409 in PDAC.”.

今天提供的数据支持了CAN-2409在各种实体瘤中的潜力，通过展示其改变胰腺肿瘤与抗肿瘤免疫反应之间平衡的潜力，即使在有残留肿瘤的患者中也能改善部分患者的长期生存率。基于这些令人鼓舞的发现，公司已决定准备进行一项更大规模的晚期随机对照临床试验，以评估CAN-2409在胰腺导管腺癌（PDAC）中的效果。

The FDA previously granted Fast Track Designation and Orphan Drug Designation to the Company for CAN-2409 in combination with valacyclovir for the treatment of patients with PDAC.

FDA之前已授予该公司CAN-2409与伐昔洛韦联合用于治疗PDAC患者的快速通道资格和孤儿药资格。

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 designed 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公司最先进的多模式生物免疫治疗候选药物，它是一种研究性的、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）基因递送到患者的特定肿瘤，并诱导针对该肿瘤的个体化、系统性免疫反应。

HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite 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 vaccination against a variety of 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代谢物，从而杀死附近的癌细胞。这种方案旨在通过针对多种肿瘤抗原的原位疫苗接种，诱发针对注射部位肿瘤和未注射的远处转移瘤的个体化、特异性的CD8+ T细胞介导反应，以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 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，以及与标准护理放疗、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 to date, supporting the potential for combination with other therapeutic strategies..

迄今为止，已有1000多名患者使用了CAN-2409，其耐受性良好，这支持了其与其它治疗策略联合使用的潜力。

Currently, Candel is evaluating CAN-2409 in non-small cell lung cancer (NSCLC), PDAC, and localized, non-metastatic prostate cancer. In December 2024, Candel announced that CAN-2409 achieved its primary endpoint in a pivotal phase 3 clinical trial in men with intermediate-to-high-risk, localized prostate cancer, demonstrating statistically significant improvement in disease-free survival when added to SoC radiation therapy +/- androgen deprivation therapy.

目前，Candel正在评估CAN-2409在非小细胞肺癌（NSCLC）、胰腺导管腺癌（PDAC）以及局部非转移性前列腺癌中的疗效。2024年12月，Candel宣布CAN-2409在其针对中高危局部前列腺癌男性患者的关键3期临床试验中达到了主要终点，结果显示在加入标准治疗（SoC）放疗±雄激素剥夺疗法后，无病生存期取得了统计学上的显著改善。

CAN-2409 plus prodrug has been granted Fast Track Designation by the 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 加前药已被 FDA 授予快速通道资格，用于治疗胰腺导管腺癌（PDAC）、对一线 PD-(L)1 抑制剂治疗耐药且无激活分子驱动突变或已在定向分子治疗中进展的 III/IV 期非小细胞肺癌（NSCLC），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 localized prostate cancer was conducted under a Special Protocol Assessment (SPA) agreed with the FDA..

FDA还授予了CAN-2409治疗胰腺导管腺癌（PDAC）的孤儿药资格。Candel公司在局部前列腺癌的关键性3期临床试验是根据与FDA达成的特殊方案评估（SPA）进行的。

About Candel Therapeutics

关于Candel Therapeutics

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. Candel has established two clinical stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and HSV gene constructs, respectively.

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。Candel已经建立了两个临床阶段的多模式生物免疫治疗平台，分别基于新型的基因改造腺病毒和HSV基因构建体。

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). 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..

CAN-2409是腺病毒平台的主导候选产品。CAN-3110是HSV平台的主导候选产品，目前正在进行一项针对复发性高级别胶质瘤（rHGG）的1b期临床试验。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，利用人类生物学和先进分析技术，为实体瘤创造新的病毒免疫疗法。