Pipeline

We apply our proprietary AP3 patient selection platform to develop targeted precision oncology medicines that we match to patients whose tumors are predicted to be sensitive to each specific medicine. Our clinical pipeline is initially focused on an advanced asset targeting the DNA Damage Response (DDR) and cell cycle regulation with demonstrated, durable single agent clinical activity in solid tumors but where genetics-based approaches have proven insufficient for response prediction. Likewise, our preclinical  programs target critical nodes in DDR pathways where we believe genetics-based approaches are insufficient for patient responder prediction. Our OncoSignature patient selection method will be used to aim for patient responder enrichment to increase the likelihood of  successful clinical development.

See Pipeline

Acrivon Pipeline

Acrivon’s Lead Program ACR-368 (also known as Prexasertib, in-licensed from Lilly), is a clinically-advanced, potent selective inhibitor of the DNA Damage Response checkpoint kinases, CHK1 and CHK2. ACR-368 has demonstrated deep, durable single-agent anti-tumor clinical  activity, including complete responses, in a proportion of patients with platinum-resistant ovarian cancer* and squamous cell cancer ‡. Using OncoSignature, we have identified endometrial and bladder cancer as two additional high unmet need solid tumor types predicted to be highly sensitive to the drug candidate. The company has received fast track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with platinum-resistant ovarian or endometrial cancer. The FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. Acrivon is also leveraging its proprietary AP3 precision medicine platform for developing its co-crystallography-driven, internally developed pipeline programs, consisting of its clinical candidate, ACR-2316, a selective, dual WEE1/PKMYT1 inhibitor, and a preclinical cell cycle program with an undisclosed target. More information on our clinical trials can be found on clinicaltrials.gov, and information on our Expanded Access Policy can be found here.

*Ref: Lee et al, Lancet Oncology (2018); Konstantinopoulos et al, Gynec Onc (2022); ‡ Ref: Hong et al, CCR (2018)

Preclinical
Phase 1
Phase 2
Phase 3

ACR-368 (CHK1/CHK2)

Single-Arm Trials Based on OncoSignature Prediction
Endometrial Cancer
Fast Track Designation
Phase 2
Phase 2
Platinum-Resistant Ovarian Cancer
Breakthrough Device and Fast Track Designations
Phase 2
Phase 2
Bladder Cancer
Phase 2
Phase 2
Option to Initiate Additional Trials in HPV+ SCC (H&N*, Anal, Cervical) and Sarcomas

ACR-2316 (WEE1/ PKMYT1)

AP3-Identified Tumor Types
Preclinical

Undisclosed cell cycle program

AP3-Identified Tumor Types
Preclinical

AP3-driven co-crystallography programs

Preclinical
ACR-368 Monotherapy Registrational intent Phase 2 single arm trials based on predicted sensitivity to ACR-368 monotherapy in OncoSignature-positive patients
LDG Combination Exploratory Phase 1b/2 single arm trials of ACR-368 in combination with low dose gemcitabine, or LDG, in OncoSignature-negative patients
Phase 1 dose escalation and expansion
*Investigator initiated trial (IIT) activated at Moffitt Cancer Center