Aprea Therapeutics Secures €5 Million C+ Financing to Advance Clinical Development of APR-246

VCBeat (WeChat Official Account: vcbeat) has learned that Swedish clinical-stage biotechnology company Aprea Therapeutics announced on February 27 the completion of a €5 million Series C+ financing round, with Janus Henderson Investors as the investor. The €5 million investment from Janus Henderson Investors is an extension of the Series C financing round completed by Aprea Therapeutics last year.

On November 30, 2018, Aprea Therapeutics 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. Following this financing round, a representative from Redmile Group will join the Board of Directors of Aprea Therapeutics.

In March 2016, Aprea Therapeutics completed a €46 million Series B financing round.

Through several rounds of financing, Aprea Therapeutics has raised a total of $110 million. The company’s majority shareholder is KDev Investments AB, an investment firm owned by Karolinska Development AB and Rosetta Capital Ltd. Other shareholders of Aprea Therapeutics include Östersjöstiftelsen, Praktikerinvest KCIF Co-Investment Fund KB, and Redmile Group.

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

Tumorigenesis and tumor progression result from dysregulation of normal cellular growth control mechanisms. Approximately 50% of tumors exhibit inhibition of the P53 gene, leading to a deficiency in P53 protein and thereby disrupting critical apoptotic pathways. This promotes tumor cell survival and tumor growth. APR-246 can restore the normal function of the P53 protein, effectively inducing tumor cell death and overcoming resistance to other antineoplastic agents.

Aprea Therapeutics’ APR-246 is a first-in-class small-molecule anticancer agent that reactivates mutant p53 tumor suppressor protein. It has demonstrated preclinical antitumor activity in various solid and hematologic malignancies and is currently under clinical development for the treatment of myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and ovarian cancer.

On December 2, 2018, Aprea presented the results of its Phase Ib/II clinical study of APR-246 in combination with azacitidine (AZA) in patients with TP53-mutated myelodysplastic syndromes (MDS) at the 2018 American Society of Hematology (ASH) Annual Meeting held in San Diego. The study aimed to evaluate the safety and efficacy of APR-246 when combined 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 analysis 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. As of December 2018, no dose-limiting toxicities had been observed with APR-246, nor was there any evidence of the expected worsening of safety profiles associated with AZA.

Currently, Aprea Therapeutics has initiated Phase 3 clinical studies in myelodysplastic syndromes (MDS) and has completed the Phase Ib/II clinical trial of APR-246 in combination with azacitidine (AZA) for the treatment of p53-mutant MDS and acute myeloid leukemia (AML).

The new capital from Janus Henderson Investors will be used to continue advancing the clinical development of APR-246. Additionally, Aprea Therapeutics disclosed plans to develop a second-generation p53 activator with best-in-class potential for restoring tumor suppressor protein function.

Janus Henderson Investors is a global asset management group headquartered in London, UK. Established on May 30, 2017, it currently manages £265.3 billion (approximately $371.9 billion) in assets.

(Compiled by: Tan Xin)