Aprea Therapeutics, Inc. (Nasdaq: APRE) is making strides in its clinical-stage oncology programs, particularly with its WEE1 inhibitor, APR-1051, and ATR inhibitor, ATRN-119. The company's latest financial results for Q3 2024 highlight these advancements, alongside the strategic addition of Dr. Philippe Pultar as a senior medical advisor.
APR-1051: Targeting Cyclin E Over-expression
The ACESOT-1051 Phase 1 trial, evaluating APR-1051, is progressing rapidly. This study focuses on cancers with Cyclin E over-expression, a patient population with limited effective treatment options. Preliminary data indicates that APR-1051 is well-tolerated, with no unexpected toxicities observed at sub-therapeutic doses. This supports the belief that APR-1051 could be a best-in-class WEE1 inhibitor.
Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea, stated, "We are ahead of schedule with the enrollment of the Phase 1 ACESOT-1051 trial evaluating our next generation WEE1 inhibitor, APR-1051. Preliminary results at subtherapeutic doses demonstrate the product to be well-tolerated with no unexpected toxicities."
The trial's primary objectives include assessing safety, dose-limiting toxicities (DLTs), and determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Secondary objectives involve evaluating pharmacokinetics and preliminary efficacy based on RECIST or PCWG3 criteria. Enrollment is ongoing, with cohort 4 (50 mg) currently enrolling. Preliminary efficacy data is expected in the first half of 2025 (NCT06260514).
ATRN-119: Addressing DDR-Related Gene Mutations
The ABOYA-119 Phase 1/2a study is evaluating ATRN-119 in patients with advanced solid tumors harboring mutations in DDR-related genes. These mutations are associated with poor prognosis and a lack of effective therapies. The trial is designed to assess the tolerability and pharmacokinetics of ATRN-119 when administered orally on a continuous schedule (NCT04905914).
As of October 2, 2024, 14 out of 20 patients experienced adverse events (AEs) potentially related to ATRN-119, with no related serious adverse events (SAEs) or grade 4-5 AEs observed. Preliminary signs of clinical benefit were noted in two patients at lower dose levels (50 mg and 200 mg). To optimize dosing, a protocol amendment has been submitted to include twice-daily dosing regimens, supported by the drug's pharmacodynamic properties. Phase 1 readout is anticipated in the second half of 2025.
Financial Position and Corporate Updates
Aprea Therapeutics reported cash and cash equivalents of $26.2 million as of September 30, 2024, which is projected to fund operations for at least the next twelve months. The company's net loss for the quarter was $3.8 million, compared to $3.2 million in the same period last year, reflecting increased investment in clinical development. Research and development expenses increased to $2.8 million, driven by ongoing trials and personnel investments.
The engagement of Dr. Philippe Pultar as a senior medical advisor is expected to bolster the development and advancement of APR-1051. Dr. Pultar's extensive experience in oncology, particularly with WEE1 inhibitors, will be invaluable in guiding Aprea's clinical objectives.
