Edgewood secures $20m in Series A for clinical development of cancer therapy
2024-03-26
临床1期孤儿药快速通道上市批准疫苗
Preview
来源: Pharmaceutical Technology
Massachusetts-based company Edgewood Oncology has raised $20m in Series A to advance the clinical development of its lead cancer therapy BTX-A51.
The Series A funding round was led by US-based venture fund Alta Partners. Edgewood Oncology expects the funds to finance multiple clinical trials into 2026.
BTX-A51 is a multi-kinase inhibitor of casein kinase 1 alpha (CK1α) and cyclin-dependent kinases 7 and 9 (CDK7 and CDK9). Edgewood acquired the rights to the therapy from the Hebrew University of Jerusalem in 2023.
Edgewood is evaluating BTX-A51 in an open-label Phase I/II trial (NCT04243785) as a monotherapy and in combination with a chemotherapeutic, azacitidine, in patients with relapsed/refractory acute myeloid leukaemia (r/r AML). In Phase Ia, the BTX-A51 monotherapy showed a favourable safety profile along with encouraging antileukemic activity.
The combination cohort started enrolment in December 2023. The cohort is expected to enrol up to 30 participants. The cohort aims to evaluate the response rate, safety, toxicity, and pharmacokinetics of the combination therapy of BTX-A51 and azacytidine in patients with r/r AML.
See Also:
Oncology in 2024: The clinical trial trends reshaping the role of CROs
Preview
来源: Pharmaceutical Technology
Avenzo Therapeutics secures $150m to progress oncology pipeline
Preview
来源: Pharmaceutical Technology
The global market for AMLAML therapies is expected to be worth $6.62bn in 2031, according to a GlobalData report. The AMLAML therapy pipeline consists of more than 200 drugs in early development, with the majority of drugs in development being enzyme inhibitors, according to GlobalData Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
Edgewood is also investigating BTX-A51 as a treatment for solid tumours and non-Hodgkin lymphoma, open-label Phase I trial (NCT04872166). The study expects to enrol up to 116 participants and is estimated to be completed in May 2027. The company also plans to initiate a Phase II trial evaluating BTX-A51 in breast cancer patients with a genetically defined profile in Q2 2024.
Advances in AML therapies include Daiichi Sankyo’s Vanflyta (quizartinib). In November 2023, the European Commission (EC) approved Vanflyta as an add-on therapy for newly diagnosed fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive AML in adults.
In September 2023, Mendus’s cancer vaccine, vividencel, received fast-track designation from the US Food and Drug Administration (FDA). A month later, Sellas Life Sciences Group’s CDK9 inhibitorCDK9 inhibitor, SLS009, received an orphan drug designation from the FDA.
AMLAML therapies in early development include Aptose Biosciences’ tuspetinib. The company started the Phase I/II APTIVATE trial evaluating the drug’s pharmacodynamics, tolerability, safety, and pharmacokinetics in r/r AMLAML patients in January.
In September 2023, Foghorn Therapeutics dosed the first patient in the Phase I trial evaluating the combination therapy of FHD-286 and chemotherapy in patients with r/r AML.
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。
适应症
热门报告
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。