Boston-based Aprea Therapeutics, Inc. (NASDAQ: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today presented data at the European Society of Medical Oncology (ESMO) Congress 2021 from its Phase I/II clinical trial in advanced solid tumors. The trial is evaluating the safety and efficacy of eprenetapopt in combination with pembrolizumab.
As of the data cutoff in July, 33 patients were enrolled on study and 31 had initiated treatment. The Phase I safety lead-in part was a dose de-escalation design and no dose-limiting toxicities were reported in the six enrolled patients.
A Phase II expansion part was initiated and, as of the data cutoff, has enrolled three patients in the gastric/GEJ cancer, three in the bladder/urothelial cancer and 19 in the non-small cell lung cancer (NSCLC) cohorts. Patients in the NSCLC Phase II cohort were required to have prior exposure to a PD-1 or PD-L1 inhibitor. Across all patients, 25 (76%) had a mutation in the TP53 gene. The trial continues to enroll and treat patients and exploratory studies involving analyses of patient-derived immune cell populations are ongoing.
The Company’s lead product candidate is eprenetapopt (APR-246), a small molecule in clinical development for hematologic malignancies and solid tumors. A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS has been completed and failed to meet the primary statistical endpoint of complete remission.
APRE shares dwindled 22 cents, or 4.5%, to $4.63.
