Initiation of Phase 2 builds on data from a Phase 1 clinical trial evaluating the safety and tolerability of autogene cevumeran (BNT122, RO7198457) in combination with the anti-PD-L1 immune checkpoint inhibitor atezolizumab and standard of care chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC)The Phase 2 trial is expected to enroll approximately 260 patients with PDAC at clinical trial sites initially in the United States, followed by Europe and Asia Pacific region This is the third later-stage trial with a product candidate based on BioNTech’s individualized cancer vaccine platform iNeST aimed at treating patients with solid tumors in a high unmet need indication MAINZ, Germany, October 19, 2023 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that the first patient has been treated in a Phase 2 clinical trial evaluating the mRNA-based individualized neoantigen-specific immunotherapy (iNeST) candidate autogene cevumeran (also known as BNT122, RO7198457) in resected pancreatic ductal adenocarcinoma (PDAC).

第二阶段的启动建立在第一阶段临床试验的数据基础上，该试验评估了自体基因cevumeran（BNT122，RO7198457）联合抗PD-L1免疫检查点抑制剂atezolizumab和标准化疗对切除胰腺导管腺癌（PDAC）患者的安全性和耐受性。第二阶段试验预计将招募约260名PDAC患者在最初在美国进行的临床试验场所，随后是欧洲和亚太地区，这是基于BioNTech个性化癌症疫苗平台iNeST的产品候选产品的第三个后期试验，旨在治疗未满足需求高的实体瘤患者指示德国美因茨，10月19日，2023年（GLOBE NEWSWIRE）-BioNTech SE（纳斯达克股票代码：BNTX，“BioNTech”或“the Company”）今天宣布，第一名患者已接受2期临床试验，评估基于mRNA的个体化新抗原特异性免疫治疗（iNeST）候选自体基因cevumeran（也称为BNT122，RO7198457）切除胰腺导管腺癌（PDAC）。

PDACs are solid tumors with a poor prognosis reflected in a 5-year overall survival rate of only 8-10%1,2, high recurrence rates3 and limited treatment options. Autogene cevumeran, which is being jointly developed by BioNTech and Genentech, a member of the Roche Group, is a therapeutic, individualized cancer vaccine candidate encoding up to 20 patient-specific cancer mutations selected for their proficiency to serve as neoantigens.

PDAC是预后不良的实体瘤，反映在5年总生存率仅为8-10%1,2，高复发率3和有限的治疗选择。Autogene cevumeran由BioNTech和罗氏集团成员Genentech共同开发，是一种治疗性个体化癌症疫苗候选物，编码多达20种患者特异性癌症突变，因其熟练程度而被选为新抗原。

Neoantigens are proteins that are produced by cancer cells that differ from the proteins produced by healthy cells. The investigational treatment aims to induce a neoantigen-directed immune response against the patient’s individual tumor. The open-label, multicenter, ra.

新抗原是由与健康细胞产生的蛋白质不同的癌细胞产生的蛋白质。研究性治疗旨在诱导针对患者个体肿瘤的新抗原定向免疫应答。开放标签，多中心，ra。