Aprea AB has presented preliminary data from its ongoing Phase Ib/II clinical study in ovarian cancer at the American Association for Cancer Research (AACR) Annual Meeting in Philadelphia. The data presented indicate that APR-246 can be combined with standard chemotherapy, that preliminary efficacy data indicate that the combination regimen has activity in patients with recurrent ovarian cancer, and that no new safety concerns have emerged in the first treatment cohort.
Aprea’s first-in-class lead candidate drug APR-246 reactivates the tumor suppressor protein p53 which is deficient in around 50% of all human tumors, mainly due to mutations of its DNA-binding domain.
The mutations result in loss of p53-dependent cell cycle arrest and apoptosis which is an important growth control mechanism that protects against tumor growth. In addition, mutations in p53 or its regulators are associated with increased resistance to standard chemotherapy and hence poor prognosis.
Aprea’s Phase Ib/II PiSARRO trial investigates the safety and efficacy of APR-246 in combination with carboplatin and doxorubicin in second-line treatment of patients with high grade serous ovarian cancer. The poster presented at the AACR Annual Meeting shows preliminary results for the first dosing cohort with three patients in the Phase Ib part of the study.
“The data on the first three patients in the PiSARRO study indicates that APR-246 can be used in this combination regimen for the intended patient group and we have not seen any new safety concerns. Also, early indications of activity have been observed with partial RECIST responses from all three patients. However, while these data are encouraging, we are also careful not to draw any conclusions from these first patients in the dose escalation part of the study that does not have a control arm. We are now awaiting the full Phase Ib results,” comments Ulf Björklund, CEO of Aprea.
In addition, Aprea will also present two posters at the AACR Annual Meeting with preclinical data of APR-246, showing strong synergistic response with APR-246 and chemotherapy in ex vivo cancer cells from ovarian cancer and lung cancer cells respectively.