STOCHOLM, SWEDEN – December 28, 2020. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that its portfolio company, Aprea Therapeutics, has reported results from a pivotal Phase 3 study evaluating the efficacy of eprenetapopt in combination with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS). The trial failed to meet its primary endpoint of complete remission (CR) rate. Analysis of the primary endpoint at this data cut demonstrated a higher CR rate in the experimental arm receiving eprenetapopt with AZA versus the control arm receiving AZA alone, but did not reach statistical significance.
In the intention-to-treat population of 154 patients, the CR rate in the eprenetapopt with AZA arm was 33.3% (95% CI: 23.1% - 44.9%) compared to 22.4% (95% CI: 13.6% - 33.4%) in the AZA alone arm (P = 0.13). CR rate was 53% higher in eprenetapopt with AZA arm compared to AZA alone, but did not reach statistical significance.
“Following the top-line results from Aprea Therapeutics’ Phase 3 study of eprenetapopt we are now looking forward to the forthcoming in-depth data analysis, to get a better understanding of the consequences for the further development of eprenetapopt in myelodysplastic syndromes and other potential indications”, said Karolinska Development’s CEO, Viktor Drvota.
Eprenetapopt (APR-246) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein by restoring wild-type p53 conformation and function – thereby inducing programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with eprenetapopt in a wide variety of solid and hematological cancers, including myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and ovarian cancer. For further information on the additional ongoing clinical trials of eprenetapopt in hematologic malignancies and solid tumors and Aprea Therapeutics additional candidate drug, APR-548, please visit www.aprea.com
Karolinska Development’s holding in Aprea Therapeutics, through KDev Investments AB, amounts to 8,4 %.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: email@example.com
Fredrik Järrsten, CFO and deputy CEO, Karolinska Development AB
Phone: +46 70 496 46 28, 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
This information is information that Karolinska Development AB (publ) (Nasdaq Stockholm: KDEV) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of Viktor Drvota, at 16:20 CET on 28 December, 2020