Aprea Therapeutics (APRE) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Strategic focus and clinical program overview

• Precision oncology approach targets DNA damage response pathway, aiming for safer, biomarker-driven therapies distinct from traditional chemotherapy.

• Lead program APR-1051, a next-generation WEE1 inhibitor, is the primary focus, with dose escalation ongoing and early signs of efficacy and tolerability.

• Patient enrollment is biomarker-driven, focusing on mutations such as PPP2R1A, FBXW7, and HPV, with enrichment planned for these groups.

• Financing was recently secured to support expanded enrollment and de-risk dose optimization for the next development phase.

Clinical data and safety profile

• Early clinical data show partial responses at 150 mg and 220 mg doses, with 50% tumor reduction and 90% biomarker reduction in key patients.

• Drug is well tolerated, with minimal adverse effects; no significant hematologic or gastrointestinal toxicity observed.

• Stable disease and durable responses seen in heavily pre-treated patients, including those with PPP2R1A mutations and HPV-positive cancers.

• Dose escalation continues, with plans to enroll at 300 mg and expand cohorts for endometrial, CRC, and HPV-positive patients.

Competitive landscape and differentiation

• Previous WEE1 inhibitors from Merck, AstraZeneca, and others faced narrow therapeutic windows and toxicity issues; APR-1051 aims to overcome these limitations.

• Daily dosing differentiates the program from competitors using intermittent schedules, potentially improving efficacy.

• Chemistry optimization avoids off-target PLK inhibition, reducing toxicity and maintaining WEE1 activity.