Karolinska Development AB announces that the US Food and Drug Administration (FDA) has accepted the portfolio company Aprea Therapeutics Investigational New Drug (IND) application regarding its new drug candidate APR-548 for the treatment of TP53- mutant myelodysplastic syndrome (MDS). APR-548 is a next generation reactivator of mutated p53 and is being developed for oral administration.

Aprea Therapeutics intends to initiate a Phase 1 clinical trial with APR-548 in MDS to strengthen its leading position in the development of therapeutic options for patients with p53 mutated cancer. In parallel with this, a registration-based phase 3 study is underway with the company's most advanced p53 reactivator, eprenatapopt (APR-246), with expected top line results at the end of 2020.

APR-548 has shown high oral bioavailability, improved potency over eprenetapopt in TP53 mutant cancer cell lines and in vivo tumour growth inhibition after oral dosing in tumour-bearing mice.

Karolinska Development AB is a Nordic investment company in life science. The company focuses on identifying medical innovations and investing to create and develop companies that further develop such innovations into differentiated products that can make a difference to patients' lives and generate an attractive return for shareholders.

Karolinska Development has access to world-class medical research from Karolinska Institutet and other leading universities and research institutions in the Nordic region. The company's goal is to build companies around researchers who are leaders in their respective fields of science, with support from experienced management teams and advisers, and with funding together with international investors who specialize in the sector. To create the best opportunities for success, companies are built with experienced management advisors and they are co-financed by professional life science investors.

Karolinska Development's portfolio consists of ten companies focused on developing innovative treatment methods for diseases that are life-threatening or disabling and other medical conditions.