OncoPrecision's First-in-Class CD64-Targeting ADC ONC001 Selected for Oral Presentation at ASH 2025
核心洞察
OncoPrecision's ONC001 (搜索), a first-in-class antibody-drug conjugate targeting CD64 (搜索), has been selected for oral presentation at the 67th ASH Annual Meeting in December 2025.
The ADC specifically targets CD64 (搜索), a myeloid-restricted receptor highly expressed in chronic myelomonocytic leukemia (搜索) and M4/M5 acute myeloid leukemia (搜索), including treatment-resistant subsets.
Preclinical data demonstrates selective engagement of patient-derived CMML and AML cells with robust activity against samples resistant to current standard-of-care therapies.
OncoPrecision Corporation (搜索) announced that preclinical data for its lead development candidate ONC001 (搜索) has been selected for an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, scheduled for December 6-9, 2025, in Orlando, Florida. The selection underscores the clinical potential of this novel therapeutic approach for treating aggressive blood cancers.
Novel CD64-Targeting Mechanism
ONC001 (搜索) represents a first-in-class antibody-drug conjugate designed to target CD64 (搜索), a myeloid-restricted receptor that is pervasively expressed in chronic myelomonocytic leukemia (搜索) (CMML) and M4/M5 acute myeloid leukemia (搜索), including highly resistant subsets. According to Dr. Gastón Soria, Co-Founder and Chief Scientific Officer of OncoPrecision, "Although CD64 has long been acknowledged as a biomarker of monocytic leukemia (搜索), no approved or clinical-stage assets have successfully exploited it as a therapeutic target."
The ADC was developed using OncoPrecision's proprietary discovery engine, which integrates large-scale, patient-derived biology and AI-enhanced high-throughput screening to identify actionable cellular vulnerabilities. This platform-driven approach enabled the identification of a lead antibody with high affinity against the previously overlooked target, alongside optimal ADC payload and linker chemistry designed to minimize off-target toxicity and collateral damage to healthy hematopoiesis.
Preclinical Efficacy Data
The preclinical data to be presented by Dr. Soria will highlight three key areas of ONC001 (搜索)'s therapeutic potential. The ADC demonstrates selective engagement of patient-derived CMML and AML cells, showing robust activity in samples that are resistant to current standard-of-care therapies. Additionally, the compound exhibits compelling in vivo efficacy across both heterotopic and orthotopic models.
"ONC001 (搜索) is designed to specifically target resistance mechanisms that drive certain aggressive blood cancers, offering a new way to overcome common treatment failures," said Tarek Zaki, Co-Founder and Chief Executive Officer of OncoPrecision.
Development Progress and Strategic Outlook
ONC001 (搜索) is currently advancing through IND-enabling studies and represents what the company describes as a differentiated approach to overcoming monocyte-driven resistance in hematologic malignancies. The therapeutic candidate emerged from OncoPrecision's platform that integrates translational biology, machine learning, and modular ADC engineering.
The company is actively exploring strategic collaborations and partnerships to accelerate the development and commercialization of its programs. According to Zaki, the team looks forward to "continuing discussions with prospective development and strategic partners" following the ASH presentation.
ASH Presentation Details
Dr. Gastón Soria will present the data during the session titled "Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Novel strategies to overcome therapy resistance in AML" on Saturday, December 6, 2025, from 5:15 PM to 5:30 PM at the OCCC Valencia Room W415D. The presentation is titled "ONC001 (搜索): A first-in-class ADC targeting CD64 (搜索) for the treatment of monocytic leukemia (搜索) developed through patient-guided target and payload selection."