Acrivon Therapeutics (ACRV) Study Update summary

Clinical trial updates and results

• Interim Phase II data in high-grade, advanced endometrial cancer show a confirmed ORR of 62.5% (95% CI: 30.4–86.5%) in OncoSignature-positive patients, all of whom had progressed on prior anti-PD-1 therapy.

• Statistically significant segregation between OncoSignature-positive and negative patients validates the predictive biomarker approach (p = 0.009).

• Median duration of response not yet reached (~6 months at data cut-off), with all responders still on therapy.

• Safety profile is favorable, with mainly transient, reversible hematological adverse events and absence of severe non-hematological toxicities.

• Exploratory data in biomarker-negative subjects treated with ACR-368 plus low/ultra-low dose gemcitabine show initial disease control in a subset, including 1 confirmed complete response.

Platform and biomarker development

• The AP3 platform enables high-resolution, functional proteomics and machine learning to directly measure disease-driving pathways, supporting drug discovery and patient selection.

• OncoSignature tests are low-complexity, function-based biomarker panels that guide patient selection and predict drug sensitivity.

• The AP3 interactome, now in version two, integrates proprietary datasets for real-time computational analysis and drug profiling.

• The platform has been used for indication finding, resistance mechanism discovery, and drug optimization, leading to the identification of endometrial cancer as a sensitive tumor type.

• AP3 platform supports rational drug design, resistance mechanism identification, and companion diagnostic development.

Pipeline and future directions

• Enrollment and dosing are ongoing in platinum-resistant ovarian and bladder cancers under a master protocol, with updates planned.

• ACR-2316, a dual WEE1/PKMYT1 inhibitor designed using AP3, has IND clearance and initial clinical sites activated ahead of schedule; Phase I dosing expected Q4 2024.

• Preclinical studies of ACR-2316 show superior single-agent activity, high selectivity, and a favorable safety profile.

• Investigator-initiated trials are underway in squamous cell cancers, including head and neck, and sarcomas, with promising early activity.

• The AP3 platform is being applied to additional drug discovery programs and target validation, with potential expansion into autoimmune and inflammatory diseases.