Aprea Therapeutics, Inc. Presents Data From Phase 1/2 Trial of Eprenetapopt (APR-246) in Advanced Solid Tumors at ESMO Congress 2021
September 21, 2021 at 01:45 am IST
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Aprea Therapeutics, Inc. 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 July 31, 2021 data cutoff, 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 6 enrolled patients. A Phase II expansion part was initiated and, as of the data cutoff, has enrolled 3 patients in the gastric/GEJ cancer, 3 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. In the bladder/urothelial cohort, 1 patient with locally advanced TP53 mutant high-grade transitional cell bladder cancer had achieved complete remission (CR) by RECIST criteria at the first response assessment at 9 weeks. In the NSCLC cohort, 2 patients with TP53 mutant squamous NSCLC had reductions in target lesions of 26.7% and 8.2%, respectively, from baseline by RECIST criteria at the first response assessment at 9 weeks. Adverse events, regardless of causality, were mostly grade 1/2. Grade =3 events occurring in more than 1 patient included anemia (3), dyspnea (3), dizziness (2), pain (2) and malnutrition (2). Dizziness (2 patients) was the only grade =3 adverse event assessed by an investigator as eprenetapopt-related and occurring in more than 1 patient. One patient experienced a fatal adverse event of disease progression which was assessed by an investigator as not related to study treatment, and one patient experienced adverse events of fatigue, dyspnea and maculo-papular rash leading to discontinuation of eprenetapopt.
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality. The Company's advanced synthetic lethality product candidate is ATRN-119, a clinical-stage small molecule inhibitor of ataxia telangiectasia and Rad3-related (ATR) a kinase that plays a critical role in DNA damage response (DDR). ATR and Checkpoint Kinase 1 are critical DDR kinases that prevent the collapse of replication forks into DNA double-strand breaks. It has completed all IND enabling studies for its oral, small molecule WEE1 inhibitor, APR-1051, and received United States Food and Drug Administration (FDA) clearance of its IND. It has an early-stage program that is in the lead optimization stage, for an undisclosed DDR target. The Company is evaluating potential combination opportunities within its pipeline, including research on the combination of ATRN-119 and APR-1051 that is supported by a Phase II SBIR grant from the National Cancer Institute.