STOCKHOLM, December 2, 2018. Karolinska Development's portfolio company Aprea Therapeutics today presented positive clinical results for its drug candidate APR 246 at the 2018 American Society of Hematology (ASH) Annual Meeting in San Diego, US. An Overall Response Rate of 95% and a Complete Remission (CR) rate of 70% were achieved in an ongoing Phase I/II combination study of APR 246 and azacitidine (AZA) for the treatment of TP53 mutated Myelodysplastic Syndrome (MDS). No dose-limiting toxicities have been observed. Based on these encouraging data, Aprea intends to progress APR 246 into a Phase III study in the near future.
The results presented at the ASH meeting is based on 20 patients with TP53 mutated MDS. The overall response rate was 95%, and 14 (70%) patients achieved a complete remission at data cutoff. These findings were accompanied by a deep molecular remission in the majority of patients as assessed by serial TP53 analysis. No dose-limiting toxicities have been experienced to date and no exacerbation of the expected azacitidine-related safety profile has been observed.
Aprea recently secured EUR 50m (approx. SEK 512m) in a financing round directed to international, leading life science investors including its current shareholders. The proceeds will be used for the continued clinical development of APR-246, where an imminent step forward is the initiation of a Phase III study in MDS patients.
"Virtually all MDS patients in the study have benefitted from treatment with the APR-246/AZA combination, and no safety or tolerability issues have so far been recorded. A comparison to historical clinical experience suggests that this may constitute a substantially better treatment option for these patients than AZA alone," said Viktor Drvota, Chief Executive Officer of Karolinska Development.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com
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 established 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
