Durcabtagene autoleucel

Just five months after closing its $2.9 billion deal for MorphoSys, Novartis has recorded an $800 million impairment on the acquisition after a review of “certain clinical trial data,” the company said in its third-quarter earnings report . A company spokesperson confirmed that the review was triggered by pelabresib, an oncology candidate at the center of the MorphoSys buyout. Novartis shared Tuesday that it’s expecting a delayed regulatory submission for pelabresib, as it needs to follow patients longer to assess concerns about emergent malignancies. The company had initially hoped to file for approval in myelofibrosis this year. Emergent malignancies in patients treated with pelabresib were first reported by STAT earlier this year. Novartis will “look at the data over the course of next year,” and assess the potential need for additional studies, CEO Vas Narasimhan said during its Q3 earnings call with the media. Novartis also disclosed three Phase 2 pipeline cuts Tuesday: a BCMA cell therapy called durcabtagene autoleucel or PHE885 in multiple myeloma; XXB750 in hypertension and heart failure; and an IL-17 inhibitor subbed CMK389 in pulmonary sarcoidosis. Overall, Barclays analysts said Novartis had a “strong” quarter. The company raised its end-of-year guidance, with Narasimhan saying its “pure-play” strategy is starting to pay off. While executives previously expected net sales growth in the high single digits to low double digits, Novartis now says the low end of that range will be in the double digits. “The changes we’ve made to become a focused, pure-play company focused on key therapeutic areas, focused on key geographies, is really working,” Narasimhan told reporters. Elsewhere, Narasimhan also fielded a variety of questions about Novartis’ new structure, legal strategy and manufacturing capacity: On the company’s reorganization: It’s been roughly two years since Novartis announced a global restructuring that impacted thousands of positions and involved the spinout of generics unit Sandoz. The company said it completed its transformation in November 2023, though “additional streamlining” this year brought some cuts on the development side. Narasimhan said Novartis is “always going to be fine-tuning at a low level, but we don’t foresee any other large changes at this time.” On radioligand supply: Novartis applied for a label expansion last quarter to bring Pluvicto into the pre-taxane setting for patients with metastatic castration-resistant prostate cancer. But despite recent shortage concerns across the radiopharma space, Narasimhan said Novartis’ manufacturing plans will enable not only the supply of Pluvicto, but also “a very large pipeline of radioligand therapies moving forward.” He added that Novartis’ supply has been “unconstrained for most of this year,” with the ability to produce volumes that support $7 billion to $8 billion-plus in sales. The company has plans to expand its Indianapolis site, and is putting up new sites in California, China and Japan. On the Inflation Reduction Act and a recent court loss: A New Jersey federal court recently rejected Novartis’ legal challenge to the IRA. The company has appealed, though Narasimhan said it’s “difficult to say” whether Novartis’ case or cases brought by other drugmakers will conclude before negotiated prices take effect in 2026. For now, the CEO said Novartis is pushing for legislative changes, including around a provision that calls for negotiations to occur sooner for small molecule drugs than for biologics. “We are operating under the assumption that we need to work under the rules of the law and rather focus on trying to educate policymakers,” he said. On generic entry: Novartis said it expects generic rivals to Tasigna, Promacta and Entresto to hit the US market in mid-2025. “That will certainly be a headwind we’ll face in the second half of 2025,” Narasimhan said. “We still expect good growth next year, both on the top and bottom line.” Editor’s note: This story has been updated to include comment from Novartis on the MorphoSys impairment.

传奇生物近日宣布，与诺华就传奇生物的特定靶向DLL3的嵌合抗原受体T细胞（CAR-T）疗法签订了独家全球许可协议，包括其自体CAR-T细胞疗法候选药物LB2102。协议授予诺华开发、制造和商业化这些细胞疗法的全球独家权利，诺华可以用自身T-Charge平台进行这些细胞疗法的生产。根据许可协议的条款，传奇生物将获得1亿美元的预付款，并有资格获得高达10.1亿美元的临床、监管和商业里程碑付款以及分级特许权使用费。诺华T-Charge平台诺华T-Charge平台是下一代CAR-T细胞疗法生产平台，可减少在体外长时间培养的需求。与传统的CAR-T相比，T-Charge平台只需要不到2天就能完成CAR-T细胞的生产，输注至患者体内后可进行大幅增殖。此外，诺华公司表示，与标准的自体CAR-T相比，在实验室培养细胞的时间越短，“T细胞干性”（自我更新和成熟的能力）就会提高，从而使T细胞具有更大的增殖潜力，并减少耗竭的T细胞，这意味着对患者的疗效更好。不同于其他企业对通用型CAR-T的青睐，诺华对T-Charge平台的能力充满信心。继2022年美国FDA批准其新药临床试验（IND）申请后，传奇生物正在启动LB2102的临床开发，用于治疗广泛期小细胞肺癌和大细胞神经内分泌癌。2023 年，美国FDA授予候选产品“孤儿药”称号。诺华有两种自主研发基于“T-Charge”平台的候选药物已进入临床试验阶段，一种是靶向CD19的rapcabtagene autoleucel（YTB323），正在进行用于一系列血液肿瘤的I/II期临床试验。另一种是正在进行治疗多发性骨髓瘤的II期试验的BCMA靶向CAR-T疗法PHE885。这两种靶点都更适合血液系统恶性肿瘤，而传奇生物的DLL3靶向候选药物通过靶向实体瘤来区分，因此如果成功，可能会更有商业潜力。诺华和传奇生物都是领先的CAR-T公司。2017年，诺华与宾夕法尼亚大学共同开发的靶向CD19的Kymriah（tisagenlecleucel）在美国获批上市，成为全球首款CAR-T疗法。该公司在细胞和基因治疗领域积累了大量的专业知识。传奇生物旗下CAR-T产品CARVYKTI（西达基奥仑赛）是全球第二款靶向BCMA的CAR-T药物。2017年12月，传奇生物和强生达成许可协议，在全球范围内共同开发与商业化该药物。\ | /★联 系 我 们投稿 | 发稿 | 媒体合作▶ sylvia.hua@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击 阅读原文 订阅全球行业新闻