Three-year follow-up data of an investigator-initiated Phase 1 trial of the individualized mRNA cancer vaccine candidate autogene cevumeran (BNT122, RO7198457) continue to show polyspecific T cell responses up to three years and delayed tumor recurrence in patients with resected pancreatic ductal adenocarcinoma (“PDAC”)A randomized Phase 2 clinical trial with autogene cevumeran in patients with resected PDAC is currently enrolling patients at clinical trial sites in the United States, with additional sites planned to open globallyThe medical need in PDAC is high with a 5-year overall survival rate of only 8-10%1,2, high recurrence rates after surgery at nearly 80%3 and limited treatment optionsAutogene cevumeran, jointly developed by BioNTech and Genentech Inc.

个体化mRNA癌症疫苗候选物自体基因cevumeran（BNT122，RO7198457）的研究者启动的1期临床试验的三年随访数据继续显示，切除的胰腺导管腺癌患者的多特异性T细胞反应长达三年，并延迟了肿瘤复发。一项针对切除的PDAC患者的自体基因cevumeran随机2期临床试验目前正在美国的临床试验地点招募患者，计划在全球开放其他地点。PDAC的医疗需求很高，5年总生存率仅为8-10%1,2，手术后复发率高达近80%3有限的治疗选择autogene cevumeran，由BioNTech和Genentech Inc.联合开发。

(“Genentech”), a member of the Roche Group, is the lead candidate of BioNTech’s mRNA-based individualized cancer vaccine platform iNeST and currently being evaluated in three ongoing randomized Phase 2 clinical trials in adjuvant PDAC, first-line melanoma, and adjuvant colorectal cancer MAINZ, Germany, April 7, 2024 - BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced three-year follow-up data from a Phase 1 trial with the mRNA-based individualized neoantigen-specific immunotherapy (“iNeST”) candidate autogene cevumeran (also known as BNT122, RO7198457) in patients with resected pancreatic ductal adenocarcinoma (“PDAC”).

（“Genentech”）是罗氏集团的成员，是BioNTech基于mRNA的个体化癌症疫苗平台iNeST的主要候选人，目前正在进行三项正在进行的辅助PDAC，一线黑色素瘤和辅助性结直肠癌的随机2期临床试验中进行评估。德国美因茨，2024年4月7日-BioNTech SE（纳斯达克：BNTX，“BioNTech”或“该公司”）今天宣布了一项基于mRNA的个体化新抗原特异性免疫疗法（“iNeST”）候选自体基因cevumeran（也称为BNT122，RO7198457）在切除的胰腺导管腺癌（“iNeST”）患者中进行的一期临床试验的三年随访数据PDAC”）。

The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells. The persistence of T cels was associated with a longer median recurrence-free survival in cancer vaccine responders. “These new data are an early signal for the potential of our individualized mRNA cancer vaccine appro.

数据显示，在16名患者中，有8名患者的自体cevumeran在给药后三年内通过活化的T细胞引发了免疫反应。T细胞的持续存在与癌症疫苗应答者的中位无复发生存期较长有关。“这些新数据是我们个体化mRNA癌症疫苗批准潜力的早期信号。