Aprea Therapeutics Announces First Patients Enrolled in Phase Ib/II Clinical Study of APR-246 for the Treatment of Esophageal Cancer

BOSTON and STOCKHOLM, Oct. 16, 2017 /PRNewswire/ -- Aprea Therapeutics, a privately held, clinical stage biopharmaceutical company developing novel anticancer therapies targeting the tumor suppressor protein p53, announced today that the first patients were enrolled in a Phase Ib/II clinical study of APR-246 in esophageal cancer. The study is sponsored by the Peter MacCallum Cancer Centre in Australia, and funded by the Victorian Government Department of Health and Human Services through the Victorian Cancer Agency, Australia, and will evaluate APR-246 in combination with cisplatin and 5-fluorouracil for the treatment of platinum-resistant advanced and metastatic esophageal or gastro-esophageal junction cancers.

"Aprea is committed to developing and advancing next-generation therapies that target p53 in both solid tumors and hematological malignancies," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "The initiation of this trial in esophageal cancer expands our pipeline of clinical indications for APR-246 and we are pleased to have the Peter MacCallum Cancer Centre leading this important study."

About p53 and APR-246
The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors.  These mutations are often associated with resistance to anticancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.

APR-246 has been shown to reactivate mutant p53 protein ? by reconverting mutant p53 into wild-type p53 conformation and function ? and thereby induce programmed cell death in human cancer cells.  APR-246 has demonstrated compelling pre-clinical antitumor activity in a wide variety of solid and hematological (blood) tumors, including ovarian cancer, small cell lung cancer, esophageal cancer and acute myeloid leukemia (AML), among others.  Additionally, strong synergy has been seen with both traditional anticancer agents, such as chemotherapy, as well as newer mechanism-based anticancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase I/Ib clinical program with APR-246 has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the p53 gene. The Company is enrolling a randomized Phase II study in platinum-sensitive ovarian cancer, a Phase Ib in platinum-resistant ovarian cancer, a Phase Ib/II study in myelodysplastic syndrome and is expecting to initiate additional clinical studies of APR-246 in 2017.

About Aprea Therapeutics
Aprea Therapeutics is a Boston, Massachusetts- and Stockholm, Sweden-based biopharmaceutical company focused on the discovery and development of novel anticancer compounds reactivating the tumor suppressor protein, p53. The Company's lead program, APR-246, a first-in-class small molecule drug candidate, is in Phase II clinical development in ovarian cancer patients, and additional clinical studies with APR-246 in other cancer indications are planned. In March 2016, Aprea completed a EUR 46 million Series B financing with an international syndicate co-led by Versant Ventures and 5AM Ventures, with additional participation by Sectoral Asset Management, HealthCap, acting as local lead investor, and existing investor, Karolinska Development. For more information, please visit www.apreatherapeutics.com

About Esophageal Cancer
Esophageal cancer is the eighth most common cancer and the sixth most common cause of death from cancer worldwide. The two most common forms of esophageal cancer, squamous cell carcinoma and adenocarcinoma, are often diagnosed at an advanced stage when treatment options are limited. Mutations in p53 are found in up to 70% of esophageal cancer patients and are associated with tumor metastasis, poor prognosis and reduced survival.

Corporate Contacts:

Christian S. Schade
President and Chief Executive Officer
[email protected]

Gregory A. Korbel
Vice President of Business Development
[email protected]

SOURCE Aprea Therapeutics AB