Wednesday, GSK plc (NYSE:GSK) and CureVac N.V. (NASDAQ:CVAC) announced they have restructured their existing collaboration into a new licensing agreement, allowing the companies to prioritize investment and focus on its respective mRNA development activities.
Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases.
Through this collaboration, GSK and CureVac have vaccine candidates for seasonal influenza and COVID-19 in Phase 2 and avian influenza in Phase 1 clinical development.
All candidates are based on CureVac's proprietary second-generation mRNA backbone.
Also Read: CureVac, GSK Partner Release Data On Influenza Vaccine Study.
GSK will assume full control of developing and manufacturing these candidate vaccines.
GSK will have worldwide rights to commercialize the candidate vaccines.
CureVac will receive an upfront payment of around $430.4 million (400 million euros) and up to $1.13 billion (1.05 billion euros) in development, regulatory, and sales milestones and tiered royalties in the high single to low teens range.
The new agreement replaces all previous financial considerations from the prior collaboration agreement between GSK and CureVac.
CureVac retains exclusive rights to the additional undisclosed and preclinically validated infectious disease targets from the prior collaboration and the freedom to independently develop and partner mRNA vaccines for any other infectious disease or indication.
The new agreement does not affect CureVac's ongoing patent litigation against Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX).
CureVac also announced a significant strategic restructuring to focus its resources on mRNA projects in oncology.
The restructuring includes a workforce reduction of approximately 30%.
The restructuring initiative follows the recent new licensing agreement with GSK, valued at up to 1.45 billion euros plus royalties.
The company expects to report data from the Phase 1 study of its cancer vaccine candidate CVGBM in glioblastoma in the second half of 2024.
CureVac expects two clinical candidates for shared-antigen cancer vaccines in solid tumors and hematological cancers by the end of 2025 and plans to initiate two additional Phase 1 studies by the end of 2026.
As a result of the restructuring, CureVac expects operational expenses to decrease by more than 30% from 2025 onward, including a decrease in personnel costs of approximately 25 million euros.
The company estimates it will incur one-time restructuring charges of approximately 15 million euros in the fourth quarter of 2024.
The cost savings, with an upfront payment of 400 million euros and up to 1.05 billion euros in milestones plus tiered royalties from the GSK agreement, will extend CureVac's cash runway into 2028.
Price Action: CVAC shares are up 23.4% at $4.12, and GSK shares are down 0.34% at $38.08 during the premarket session at last check Wednesday.
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Photo via Wikimedia Commons
格拉克斯史密斯(NYSE:GSK)和CureVac N.V.(NASDAQ:CVAC)于星期三宣布,他们已将现有的合作关系重组为新的许可协议,使企业能够优先投资并专注于各自的mRNA开发活动。
自2020年以来,格拉克斯史密斯和CureVac一直在共同开发用于传染病的mRNA疫苗。
通过此项合作,格拉克斯史密斯和CureVac拥有季节性流感和COVID-19的疫苗候选者,正在二期临床开发中,以及禽流感正在一期临床开发中。
所有的候选者都是基于CureVac的专有第二代mRNA骨架。
另请参阅:CureVac,GSK合作发布流感疫苗研究数据。
GSK将全面控制疫苗候选者的开发和制造。
GSK将在全球范围内拥有商业化候选疫苗的权利。
CureVac将获得约4.304亿美元(4亿欧元)的前期支付以及高单位数至低十年代阶梯式的发展,监管和销售里程碑以及版税。
新协议取代了GSK和CureVac之间旧合作协议中的所有先前财务考虑因素。
CureVac保留了来自先前合作的其他未公开和临床验证的传染病靶点的独家权利,并自由地开发并合作开发其他传染病或适应症的mRNA疫苗。
新协议不影响CureVac对辉瑞股份有限公司(NYSE:PFE)和BioNTech SE(NASDAQ:BNTX)进行的专利诉讼。
CureVac还宣布了重大的战略重组,将其资源集中于mRNA肿瘤项目上。
重组包括约30%的员工裁员。
重组举措是在最近与GSK的新许可协议中,该协议的价值为高达14.5亿欧元加上版税。
该公司预计将在2024年下半年报告其癌症疫苗候选者CVGBM在胶质母细胞瘤的一期研究数据。
CureVac预计将在2025年底之前拥有两种用于固体肿瘤和血液系统肿瘤的共同抗原癌症疫苗临床候选者,并计划在2026年底之前启动另外两项一期研究。
由于重组的结果,CureVac预计从2025年起的运营费用将减少超过30%,其中人员成本减少约2500万欧元。
该公司估计将在2024年第四季度承担约1,500万欧元的一次性重组费用。
与GSK协议的前期支付为4亿欧元,开发里程碑和销售版税高达10.5亿欧元,这将延长CureVac的现金流至2028。
报价:CVAC股票在周三的盘前交易中上涨23.4%,为4.12美元,GSK股票在最后一次检查时下跌0.34%,为38.08美元。
- COVID-19专利纠纷解决了: Acuitas Therapeutics和curevac解决了专利之争。
照片通过Wikimedia Commons