The US Food and Drug Administration (FDA) has granted breakthrough device designation for Acrivon Therapeutics’ ACR-368 OncoSignature assay designed to detect endometrial cancer patients who can benefit from the treatment of ACR-368.
Developed using the Acrivon Predictive Precision Proteomics (AP3) platform, the multiplex immunofluorescence assay is currently being used in an ongoing, multicentre Phase IIb trial to detect subjects who are responsive to ACR-368.
This registrational intent trial includes subjects with endometrial cancer and other types of tumours.
Acrivon Therapeutics' CEO, president, and founder Peter Blume-Jensen said: “This is the second such designation for our ACR-368 OncoSignature assay and represents yet another powerful validation of our generative AI-driven AP3 platform. The enrolment and dosing continue for both ACR-368 in our ongoing Phase IIb trials, as well as for ACR-2316, our internally-developed Phase I asset, which is a novel, differentiated WEE1/PKMYT1 inhibitor uniquely enabled by AP3.
“We have now completed enrolment in the first two dose-escalation cohorts of the ACR-2316 Phase I trial and initiated dosing in the third cohort.”
Also referred to as prexasertib, Acrivon’s lead candidate ACR-368 is a selective small molecule inhibitor that targets checkpoint kinase 1(CHK1) and CHK2.
The company is currently progressing ACR-368 in a registrational Phase II trial across various types of tumours. Fast track status was granted by the FDA for evaluating ACR-368 as a monotherapy.
This designation was based on OncoSignature-predicted sensitivity in subjects with platinum-resistant ovarian or endometrial cancer.
Clinical-stage biopharmaceutical company Acrivon is focused on developing precision oncology medicines. Its AP3 platform uses generative AI for measuring compound-specific effects on the complete tumour cell protein signalling network, as well as drug-induced resistance mechanisms.
This approach claims to generate vast amounts of high-resolution, quantitative data, measuring terabytes of information that are crucial for pathway-based drug design, identifying potential indications, and predicting responses.
Acrivon's pipeline also includes ACR-2316, another clinical-stage asset that is tailored to activate cyclin-dependent kinase 1 (CDK1), CDK2, and polo-like kinase 1 (PLK1), driving pro-apoptotic cell death.
The FDA's breakthrough device designation is given to devices that have the potential to provide effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions.
