Aprea Therapeutics Secures €50 Million Series C Financing to Advance APR-246 into Phase III Clinical Trials for TP53-Mutant Cancers

VCBeat (WeChat: vcbeat) learned from foreign media that on November 30, 2018, Eastern European Time, Aprea Therapeutics (hereinafter referred to as “Aprea”), a clinical-stage biotechnology company based in Sweden, announced the completion of a €50 million Series C financing round. The round was led by Redmile Group, with participation from new investor Rock Springs Capital and existing investors 5AM Ventures, Versant Ventures, HealthCap, Sectoral Asset Management, and Karolinska Development AB (NASDAQ: KDEV). Following this financing round, a representative from Redmile Group will join Aprea’s Board of Directors.

Aprea, founded in 2003 and headquartered in Stockholm, Sweden, is a clinical-stage biotechnology company led by President and CEO Christian S. Schade. Aprea focuses on developing novel anti-cancer therapies aimed at reactivating the tumor suppressor protein p53 in patients through innovative treatments.

Image source: Aprea official website

The newly raised capital will be used to advance the clinical development of the company’s lead candidate, APR-246. APR-246 is a first-in-class small-molecule anticancer drug that reactivates mutant p53 tumor suppressor protein. Mutations in the TP53 tumor suppressor gene are the most common genetic alterations in human cancers, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anticancer therapies and poor overall survival, representing an unmet medical need in cancer treatment. APR-246 has demonstrated preclinical antitumor activity across a range of solid and hematologic malignancies, including myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and ovarian cancer.

On December 2, at the 2018 American Society of Hematology (ASH) Annual Meeting held in San Diego, Aprea announced the results of the Phase Ib/II clinical study of APR-246 in combination with azacitidine (AZA) in patients with TP53-mutated myelodysplastic syndromes (MDS). The study aimed to evaluate the safety and efficacy of APR-246 when used in combination with azacitidine (AZA) for the treatment of TP53-mutated MDS.

Phase II clinical study results showed that the overall response rate was 95% among the 20 evaluable patients, with 70% (14 patients) achieving complete remission (CR) at the end of the statistical period. Compared with baseline, P53 immunohistochemistry positivity, mutant TP53 variant allele frequency (VAF), and TP53 minimal residual disease (MRD) were all significantly reduced at the time of disease assessment. To date, no dose-limiting toxicities have occurred, and no expected worsening of safety profiles associated with AZA has been observed.

Currently, Aprea is planning to initiate a Phase III clinical study of APR-246 in combination with azacitidine (AZA) for the treatment of TP53-mutated myelodysplastic syndromes (MDS). The company also plans to launch trials evaluating APR-246 for other hematologic malignancies.

According to Crunchbase, Aprea has raised a total of $96 million across two financing rounds, including the current round. Its primary shareholder is KDev Investments AB, an investment firm owned by Karolinska Development AB (NASDAQ: KDEV) and Rosetta Capital Ltd. Other shareholders of Aprea include Östersjöstiftelsen, Praktikerinvest, and KCIF Co-Investment Fund KB. Aprea completed its Series B financing in March 2016, with a total amount of €46 million, marking a significant milestone in its development.

Aprea, founded in 2003 and headquartered in Stockholm, Sweden, is a clinical-stage biotechnology company. Aprea focuses on developing novel anticancer therapies aimed at reactivating the tumor suppressor protein p53 in patients through innovative treatments. Its lead candidate drug, APR-246, is poised to enter Phase 3 clinical trials.

Redmile, founded in 2007 and headquartered in San Francisco, California, is a venture capital firm specializing in debt, early-stage venture capital, late-stage venture capital, and private equity investment.