Acrivon Therapeutics (NASDAQ:ACRV) Chief Executive Officer Peter outlined the company’s lead oncology program and pipeline during a presentation at the TD Cowen Oncology Innovation Summit, with a primary focus on ACR-368 in endometrial cancer and upcoming development steps for other assets.
Peter said Acrivon’s development strategy is based on its Acrivon Predictive Precision Proteomics, or AP3, platform, which is designed to evaluate the activity states of drug-regulated signaling pathways rather than relying solely on genetic alterations. The company uses its OncoSignature assay to prospectively identify patients it believes are more likely to respond to therapy.
ACR-368 Data Highlight Serous Endometrial Cancer
The company said the strongest efficacy signal came from patients with serous endometrial cancer, an aggressive subtype. Across serous patients, including both biomarker-positive and biomarker-negative patients, Peter said Acrivon observed a confirmed overall response rate of 52%, with a lower bound of the confidence interval of 33%. He also cited a disease control rate of nearly 75% and a clinical benefit rate at or above 16 weeks of 65%.
Peter said serous endometrial cancer accounts for about 8% to 10% of new endometrial cancer cases annually but contributes an increasing share of mortality. He said the subtype has overall survival of about 12 to 24 months, compared with 12.7 years for all endometrial cancer, and noted that Europe and the U.S. have about 20,000 endometrial cancer deaths per year.
Asked by TD Cowen’s Marc to place the response rate in context, Peter cited a subgroup analysis from KEYNOTE-775 in serous patients, where the control arm showed a 13% response rate, median progression-free survival of 3.6 months and overall survival of 10 months. He said Acrivon sees “a clear second-line opportunity,” while also noting that patients may move into third-line treatment as antibody-drug conjugates evolve in the treatment landscape.
Registration-Intent Arms and Interim Readout
Peter described three key arms in Acrivon’s registration-intent program. Arm 1 uses the OncoSignature assay to prospectively identify biomarker-positive patients for ACR-368 monotherapy, while biomarker-negative patients receive ACR-368 with ultra-low-dose gemcitabine. He said enrollment in this arm has been slower than desired because it requires a pretreatment tumor biopsy and is currently running only in the U.S.
Arms 3 and 4 focus on all-comer serous endometrial cancer, treating serous histology as a lineage biomarker. Arm 3 evaluates ACR-368 plus ultra-low-dose gemcitabine, while arm 4 evaluates single-agent ACR-368. Peter said enrollment in these arms is moving quickly, supported by expansion into Europe and strong investigator interest.
Acrivon expects a pre-specified interim analysis for arms 3 and 4 in the first part of the fourth quarter. Peter said the arms will be analyzed independently, not pooled, and the results will guide which arm the company pursues toward registration. If efficacy is comparable, he said Acrivon would prefer the single-agent arm because it could provide a cleaner path for single-arm accelerated approval intent.
The company also plans to use the interim data to help determine next steps for a confirmatory phase 3 trial, which Peter said is currently designed as a switch-maintenance study involving immune checkpoint inhibitor therapy.
Safety Profile and Combination Potential
Peter said ACR-368 has shown a favorable adverse event profile that is consistent with prior trials. He said the company primarily sees hematological adverse events and noted the absence of gastrointestinal toxicities, interstitial lung disease and other potentially severe non-hematological events.
He also said Acrivon has observed strong synergy between ACR-368 and both immune checkpoint inhibitors and topoisomerase 1 inhibitors, the latter being a common payload class for antibody-drug conjugates. The company believes those findings may support future combination or maintenance approaches.
Pipeline Includes WEE1/PKMYT1 and CDK11 Programs
Acrivon also discussed ACR-2316, which Peter described as a potential first-in-class dual WEE1/PKMYT1 inhibitor. The program is in an ongoing phase 1 trial and is expected to enter an expansion phase soon. Peter said the AP3 platform predicted lung cancer sensitivity, which he described as atypical for this drug class, and that the company has seen clinical benefit in treated lung cancer patients, including tumor shrinkage or partial responses.
Peter identified three differentiators for ACR-2316: single-agent activity, potential activity in lung cancer and a safety profile primarily characterized by transient neutropenia rather than gastrointestinal toxicity or broad hematologic adverse events. He said a second-half update is expected, though patient numbers in the expansion phase may remain limited.
Acrivon’s earlier-stage pipeline includes a CDK11 inhibitor program, including development candidate ACR-6840. Peter said the company has seen complete regression across aggressive AML models in preclinical studies and expects an IND filing in the first half of 2027.
About Acrivon Therapeutics (NASDAQ:ACRV)
Acrivon Therapeutics (NASDAQ:ACRV) is a clinical-stage biotechnology company focused on the discovery and development of stapled peptide therapeutics for the treatment of RAS-driven cancers. Its proprietary platform is designed to enhance the stability, cell permeability and target specificity of peptide molecules, enabling the disruption of protein–protein interactions that are traditionally challenging to inhibit with small-molecule drugs or biologics.
The company’s lead development candidate is a hydrocarbon-stapled peptide selectively targeting the KRAS G12C mutation, currently in early clinical trials.
