BioNTech SE

当地时间3月5日，美国疫苗厂商Moderna在投资者会议上表示，该公司有望于2027年推出首个肿瘤疫苗。当天收盘，Moderna股价大涨近16%。 Moderna正在与默沙东共同开发一款个性化的肿瘤疫苗，并已对严重的皮肤癌（黑色素瘤）患者进行后期临床试验。Moderna公司总裁Stephen Hoge在周三的投资者会议上表示，首款肿瘤疫苗可能有机会为公司带来“相当大的收入”。 Moderna早在2023年底就已发布一项关于该疫苗的中期研究数据，数据显示，接受这种疫苗和默沙东癌症疗法Keytruda联合治疗黑色素瘤患者的死亡或癌症复发的可能性减少了一半。 这种肿瘤疫苗基于Moderna的mRNA技术。此前，mRNA新冠疫苗已经证明了通过遗传基因编码输送至人体，能够让细胞产生抗体，从而激活人体的免疫反应。基于新冠疫苗的成功，研究人员认为，同样的原理也应该能够在对抗肿瘤方面被验证，通过接种肿瘤疫苗，人体将能够启动免疫系统，从而攻击肿瘤细胞。 不过，与普通疫苗接种后防止疾病发生不同，Moderna等公司正在研发的肿瘤疫苗是一种治疗性的疫苗，作为一种癌症治疗手段，促使免疫系统破坏癌细胞，从而预防肿瘤的复发。 如果Moderna的肿瘤疫苗能在2027年推出，那么也将令该公司处于竞争的领跑地位。Moderna的直接竞争对手BioNTech也在开发针对直肠癌、黑色素瘤和其他癌症的疫苗，但该公司此前预计，mRNA肿瘤疫苗的上市可能要等到2030年左右。 Moderna和BioNTech都在面临新冠疫苗下滑的严峻挑战。投资者寄希望于最新的肿瘤疫苗能够为该公司的销售增长带来转机。Moderna股价过去一年累计跌幅超过三分之二。 去年9月，Moderna宣布削减超过10亿美元研发开支，导致股价暴跌。由于新冠疫苗业务迅速下滑，Moderna计划在2027年前削减11亿美元的研发开支，至36亿美元至38亿美元，低于此前预计的48亿美元。 但Moderna仍然预计，到2027年前，将有10种新产品获批，其中也包括与默沙东联合开发的这款肿瘤疫苗。公司表示，随着更多新产品的推出，2026年至2028年的复合年增长率将超过25%。 识别微信二维码，可添加药时空小编 请注明：姓名+研究方向！

In the ongoing global patent disputes surrounding COVID-19 vaccines, Pfizer and BioNTech scored a significant victory this week against rival Moderna as two crucial decisions were rendered in the United States and Germany. On Wednesday, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) declared that all challenged claims in two of Moderna's vaccine patents are "unpatentable." This unexpected ruling follows Moderna's 2022 lawsuit against Pfizer and BioNTech for alleged infringement of three patents, including the two invalidated by the PTAB. Moderna had contended that it was the pioneer in discovering the effectiveness of "using mRNA encoding for a full-length coronavirus spike protein in a lipid nanoparticle formulation" for generating neutralizing antibodies. The disputed patents, referred to as the "’600 and ’127 patents," were central to this claim. While Pfizer and BioNTech successfully defended their stance on the invalidity of Moderna's patents, they also sought validation from the PTAB regarding the two patents. A spokesperson for BioNTech expressed satisfaction with the ruling, stating, "We believe in the value and strength of our innovative science and our intellectual property." Moderna, however, expressed its intention to appeal the PTAB's decision to the U.S. Court of Appeals for the Federal Circuit, asserting that it "respectfully disagrees" with the outcome. Notably, this ruling does not impact Moderna's '574 patent, which remains part of the Massachusetts lawsuit. In contrast, the week also brought setbacks for Pfizer and BioNTech. The Düsseldorf Regional Court in Germany ruled in favor of Moderna, determining that the companies infringed upon one of Moderna's European patents and should provide "appropriate compensation." A representative for BioNTech stated that they believe the ruling on EP949 is invalid and will appeal the decision. The financial stakes are high in this patent landscape, with Pfizer, BioNTech, and Moderna having generated tens of billions in revenue from their COVID-19 vaccines. With numerous ongoing lawsuits across the globe, including the U.S., U.K., Europe, Canada, and Japan, the implications of these legal battles could be substantial for all parties involved.

Moderna says its long-running patent dispute with Pfizer and BioNTech isn’t over, even after a decision by an administrative tribunal that invalidated two of its Covid-19 vaccine-related patents. The Wednesday decision by the US Patent and Trademark Office’s Patent Trial and Appeal Board marked a win for Pfizer and BioNTech and could complicate Moderna’s arguments in an ongoing infringement lawsuit in federal district court. Moderna told Endpoints News on Thursday that it “respectfully disagrees” with PTAB’s decision, and “is evaluating its options to appeal.” Moderna sued Pfizer and BioNTech for patent infringement in 2022. Moderna asserted three patents, which it said cover a chemical modification that helps mRNA evade the immune system and a design that uses the full-length spike protein in the vaccine. In response, Pfizer and BioNTech petitioned PTAB, challenging the validity of two patents: the ‘600 patent and the ‘127 patent. The PTAB decision does not impact Moderna’s third patent, dubbed ‘574, which the company said it will continue to assert against Pfizer and BioNTech in court. “We continue to believe in the strength and validity of our intellectual property and look forward to presenting our case at trial at the appropriate time,” a Moderna spokesperson told Endpoints. Pfizer and BioNTech said in a joint statement to Endpoints that they “believe in the value and strength of our innovative science and our own intellectual property and are pleased with the decision.” Moderna’s court case in the US District Court for the District of Massachusetts was put on hold last year while PTAB reviewed the company’s patents. The parties involved are scheduled to submit a joint status report by April 29.