Karolinska Development’s portfolio company Aprea Therapeutics lead candidate drug eprenetapopt reaches primary efficacy endpoint in combination therapy of acute myeloid leukemia

STOCKHOLM, SWEDEN – June 17, 2021. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that its portfolio company Aprea Therapeutics has reported positive outcomes in an ongoing Phase 1/2 study evaluating the efficacy of the company’s candidate drug eprenetapopt in combination with venteoclax and azacitidine in patients treated for TP53 mutated acute myeloid leukemia, AML. The results show that the primary efficacy endpoint of complete remission was reached in 37% of patients.

The results are underpinned by an analysis performed on 30 evaluable patients, demonstrating complete remission in 37% of the cases. the composite response rate, i.e. CR combined with CR with incomplete hematologic recovery (CRi), CR/CRi, was 53%. The pre-defined primary efficacy endpoint concerning complete remission was thus reached in accordance with the applied study design (Simon’s 2-stage). Eleven patients remain on the study treatment and is continuously monitored on safety and efficacy parameters. Aprea Therapeutics will discuss the dataset with the U.S Food and Drug Agency (FDA) in the second half of 2021 and expects to present the study results at future scientific and medical conferences

Eprenetapopt is a small-molecular drug candidate that targets the tumor inhibitory protein p53 and reactivates its activity. Mutations in the p53 gene occur in approximately 50% of all human tumors and are associated with poor overall disease survival. The drug candidate is currently undergoing clinical studies as a potential treatment for hematological malignancies and solid tumors.

“We are positive to the recent data presented in Aprea Therapeutics’ Phase 1/2 study showing clinical efficacy of eprenetapopt in a difficult-to-treat group of the patient population. As the study finishes and the final results are presented, we look forward to evaluating the data and the continued efforts toward more efficient treatments of severe forms of cancer,” comments Karolinska Development's CEO, Viktor Drvota.

Karolinska Development has an interest in Aprea Therapeutics through KDev Investment amounting to a total holding of 8.4% of the outstanding shares in Aprea Therapeutics.

For further information, please contact:

Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com

Johan Dighed, General Counsel and Deputy CEO, Karolinska Development AB
Phone: +46 70 207 48 26, e-mail: johan.dighed@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 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.

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• PM KD Aprea Tx fas12-data eng 17-06-2021

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