On March 14, 2024. Karolinska Development AB (Nasdaq Stockholm: KDEV) reported that its portfolio company Aprea Therapeutics has received FDA approval of the company’s IND application for the drug candidate APR-1051 (Press release, Karolinska Development, MAR 14, 2024, View Source [SID1234641189]). Aprea has also secured funding up to USD 34 million through a financing round led by Sphera Healthcare. With the approval and financing in place, the company will be able to start the first clinical study with APR-1051.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The American Food and Drug Administration (FDA) has approved Aprea Therapeutics Investigational New Drug (IND) application for the drug candidate APR-1051. APR-1051 is a next-generation inhibitor of Wee1 kinase and the company plans to initiate the clinical phase I study ACESOT-1051. The aim is to evaluate therapeutic activity of APR-1051 in patients, focusing on cancer forms that overexpress Cyclin E, including ovarian and breast cancers.
Aprea Therapeutics has recently conducted a private placement financing of up to USD 34 million that will be used to finance the clinical study. The financing was led by Sphera Healthcare with participation from new and existing healthcare-focused institutional investors including Nantahala Capital, DAFNA Capital Management, Exome Asset Management and Stonepine Capital Management, among others. The financing brings Aprea Therapeutics USD 16 million in up front gross proceeds, with the potential to receive up to an additional USD 18 million.
"The FDA approval and the financial support our portfolio company now receives are clear statements of strength that drive the development of our portfolio company´s innovative drug project forward. We look forward to following the continued development and progress of the company and the project," says Viktor Drvota, CEO Karolinska Development.
Via KDev Investments, Karolinska Development owns 2 percent of the shares in Aprea Therapeutics (before the transaction).
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: [email protected]
Johan Dighed, General Counsel and Deputy CEO, Karolinska Development AB
Phone: +46 70 207 48 26, e-mail: [email protected]