Prothena nets more cash from Novo Nordisk; Khondrion fails to hit endpoint

2022-11-22

临床2期引进/卖出临床结果免疫疗法优先审批

A year after Novo Nordisk paid $100 million upfront to grab Prothena’s antibody and wider program in ATTR amyloidosis, the deal has hit a milestone, earning more cash for the biotech. Prothena announced on Tuesday that it has earned a $40 million milestone payment from the Danish pharma. The payment is related to its candidate NNC6019, formerly known as PRX004, a Prothena spokesperson told Endpoints News in an email. The company hit the clinical milestone due to the “initiation of the phase II study,” the spokesperson said. The candidate is meant to treat patients with ATTR cardiomyopathy. The agreement with Novo Nordisk could net Prothena Prothena up to $1.2 billion upon the achievement of several development and sales milestones. Novo Nordisk, for its part, will gain full worldwide rights to the intellectual property and other rights of the ATTR amyloidosis business. Dutch biotech Khondrion has dropped the results for its Phase IIb study in 27 patients for its asset sonlicromanol, which is being investigated for use in adults with MELAS spectrum disorders. The drug missed its primary mark. Patients who received both the 50mg and 100mg doses for 28 days did not achieve a statistically significant improvement in the “attention domain score” of cognitive functioning, compared to those who received a placebo. Yet Khondrion is touting the post hoc analyses of the study showing “positive trends” in other data points related to cognition and mood-related secondary endpoints. The data showed a p-value for Beck Depression Inventory at p=0.01 and the Cognitive Failure Questionnaire having a value of p=0.007. The biotech stated that the 100mg dose is more effective as well. Khondrion CEO Jan Smeitink said in a statement : Smeitink added in his statement that he will be discussing plans with US and European regulators as the company will push forward with a Phase III trial, which is predicted to start later next year. Genmab is making headway for its lymphoma asset with the FDA. According to the company, the FDA has accepted the priority review for a BLA for subcutaneous epcoritamab, a bispecific antibody meant to treat patients with relapsed or refractory large B-cell lymphoma after two or more lines of “systemic therapy.” The FDA has set a PDUFA date for May 21, 2023. The move has also triggered an $80 million milestone payment from AbbVie, with whom Genmab is collaborating on the work on epcoritamab as part of a wider oncology pact. Both companies share commercial responsibilities in Japan and the US. The asset is being investigated as a monotherapy and in combination with several different therapies. Nona Biosciences and Dragonfly Therapeutics are teaming up. The deal is based on Nona’s “fully human heavy chain only” antibody (HCAb) transgenic mice platform, which aims to discover and develop those antibodies. Nona will provide Dragonfly with access to its HCAb tech and antibody generation services for targets that are designated by Dragonfly. The financial terms of the deal were not disclosed. This comes after Nona roped in a license and collaboration agreement with Moderna for “nucleic acid-based immunotherapies” for certain oncology targets.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构