Candel Therapeutics, Inc. 宣布获得 FDA 对胰腺导管腺癌的孤儿药物认定 - Candel Therapeutics, Inc. 宣布其首席调查腺病毒免疫疗法候选药物 CAN-2409 获得 FDA 对胰腺导管腺癌（PDAC）的孤儿药物认定[1] - 孤儿药物认定将为 Candel 在 PDAC 治疗中的 CAN-2409 提供市场排他性，免除 FDA 申请费用和对符合条件的临床研究提供税收抵免[2] - CAN-2409 获得孤儿认定再次证实了其治疗罕见和难治癌症的潜力，去年 FDA 还为相同适应症的 CAN-2409 授予了快速通道认定[3]

NEEDHAM, Mass., April 11, 2024 (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 the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-2409, Candel's most advanced multimodal biological immunotherapy candidate, for the treatment of pancreatic cancer. "We recently reported data from the ph ...

First-in-class multimodal immunotherapy candidate, for induction of tertiary lymphoid structures, being developed as a novel therapeutic strategy for solid tumors from the enLIGHTEN™ Discovery PlatformDelivery of two unique payload combinations, predicted in silico using the enLIGHTEN™ Advanced Analytics suite, was shown to induce tertiary lymphoid structure formation, inhibit tumor growth, and improve response to immune checkpoint inhibitor therapy in preclinical models of cancerThis presentation accelerat ...

CADL股价飙升 - Candel Therapeutics, Inc.（CADL）股价在4月5日飙升了280.9%[1] CAN-2409治疗效果 - CAN-2409联合瓦拉西克洛韦和标准治疗方案化疗放疗，治疗边缘可切除PDAC的II期研究显示出积极的中期数据[1] - CAN-2409实验治疗导致边缘可切除PDAC患者的估计中位总生存期显著提高至28.8个月[2] - 在治疗24个月后，接受CAN-2409治疗的患者的生存率为71.4%，而对照组仅为16.7%；在治疗36个月后，接受CAN-2409治疗的患者的生存率为47.6%，而对照组仅为16.7%[3] CAN-2409未来展望 - FDA于2023年12月授予CAN-2409加前药治疗PDAC的快速通道认定[6] - CADL预计在2024年第二季度晚些时候在非小细胞肺癌中获得CAN-2409的关键数据结果，而在2024年第四季度预计在前列腺癌中获得首要数据[8] 商业机会展望 - Candel表示，如果CAN-2409成功开发并获得批准，将为公司带来重大商业机会，因为对于非转移性PDAC，SoC化疗的复发频率高且生存期短，对于PDAC的有效新治疗仍存在高度未满足的医疗需求[7] 公司发展焦点 - 在没有上市产品的情况下，该临床阶段生物制药公司的成功开发其产品线候选品仍是重点关注的焦点[9]

Candel Therapeutics Inc is up roughly 30% in premarket on Friday after reporting positive interim data for its experimental treatment of non-metastatic pancreatic cancer.CAN-2409 data sends Candel Therapeutics stock up Copy link to section Patients on CAN-2409 showed a meaningful increase in survival in a Phase II study, as per the biotechnology company. No new safety concerns were discovered in the clinical trial either. Garrett Nichols – the chief medical officer of $CADL said in a press release today:“CA ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40629 t CANDEL THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 52-2214851 (State or other jurisdic ...

Exhibit 99.1 Candel Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Highlights • On track for topline data from CAN-2409 phase 3 in localized intermediate/high risk prostate cancer, expected in Q4 2024 • Results from ongoing, first-in-human, phase 1b clinical trial of CAN-3110, in recurrent high- grade glioma, published in Nature • Catalyst-rich 2024 paves way for transformational year NEEDHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. ( ...

NEEDHAM, Mass., March 05, 2024 (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 the Company will present a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting taking place April 5-10, 2024, in San Diego, CA. The presentation will describe the second candidate from the enLIGHTEN™ Discover ...

CAN-3110疗效 - CAN-3110在治疗复发性高级别胶质瘤患者中表现出潜在的疗效，可提高患者整体生存率[2] CAN-3110特点 - CAN-3110是一种首创的HSV-1病毒免疫疗法候选药物，设计用于在癌细胞中表达Nestin的条件下进行活性，正在进行临床试验[3] FDA认定 - Candel Therapeutics宣布其HSV-1病毒免疫疗法候选药物CAN-3110获得FDA快速通道认定[1]

公司概况 - Candel Therapeutics, Inc.是一家专注于开发多模式生物免疫疗法的临床阶段生物制药公司[1] - Candel公司的战略重点是实现运营卓越和效率，以延长公司的运营时间，并为CAN-3110在新适应症中的扩展提供支持[1] 产品信息 - CAN-2409是Candel的最先进的多模式生物免疫疗法候选药物，目前正在进行多项临床试验，包括非小细胞肺癌、边缘可切除胰腺癌和局部、非转移性前列腺癌[1] - CAN-3110是Candel的HSV平台的主要产品候选药物，目前正在进行针对复发性高级别胶质母细胞瘤(HGG)的调查者发起的1期临床试验[1] 数据结果 - 公司计划在2024年的3个平台上发布6个数据结果，包括非小细胞肺癌(NSCLC)的生存数据和前列腺癌的潜在注册性3期临床试验[1] FDA认证 - CAN-2409获得了FDA的快速通道认定，用于治疗非小细胞肺癌患者[4] 临床试验结果 - CAN-2409在边缘可切除胰腺癌患者中表现出积极的初步临床活性和生物标志数据[5] - CAN-3110在高级别胶质母细胞瘤患者中表现出良好的耐受性，且与改善生存相关[7] 技术平台 - enLIGHTEN™ Discovery Platform是一种系统性的、迭代的基于HSV的发现平台，利用人类生物学和先进的分析技术为固体肿瘤创造新的多模式生物免疫疗法[1] - enLIGHTEN™ Discovery Platform展示了潜在的抗肿瘤效果，为开发新的治疗方法提供了可能性[9] 公司愿景 - Candel公司致力于推动下一代病毒免疫疗法的发展，利用数据驱动方法设计新的资产，创造新的价值转折点[10]