STOCKHOLM, SWEDEN – April 9, 2021. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Aprea Therapeutics’ drug candidate eprenetapopt for the treatment of acute myeloid leukemia (AML). KDev Investments, a company jointly owned by Karolinska Development and Rosetta Capital, holds 8 percent of the shares in Aprea Therapeutics, which is listed on Nasdaq Global Select Market in the USA.
Eprenetapopt is a small molecule targeting the tumor suppressor protein p53. Mutations of the p53 gene occur in around 50% of all human tumors and are associated with poor overall survival.
The drug candidate is currently being investigated in clinical trials as a potential treatment of hematologic malignancies and solid tumors. In November 2020, the FDA granted fast track designation for eprenetapopt in AML.
“We are pleased by the FDA:s decision to grant orphan drug designation for eprenetapopt in acute myeloid leukemia, a potentially fatal medical condition where better treatments are urgently needed,” comments Karolinska Development's CEO, Viktor Drvota.
Orphan Drug designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. The designation can provide development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, tax credits related to clinical trial expenses, and an exemption from FDA user fees.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: email@example.com
Johan Dighed, General Counsel and Deputy CEO, Karolinska Development AB
Phone: +46 70 207 48 26, e-mail: firstname.lastname@example.org
TO THE EDITORS
About Karolinska Development AB
Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders.
Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success.
Karolinska Development has a portfolio of ten companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases.
The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network.
For more information, please visit www.karolinskadevelopment.com