OncoPrecision Announces Oral Presentation of ONC001, a First-in-Class CD64-Targeting ADC for Monocytic Leukemia, at the 67th ASH Annual Meeting

NEW YORK, Dec. 1, 2025 /PRNewswire/ -- OncoPrecision Corporation ("OncoPrecision"), a translational therapeutics company developing novel antibody-based cancer therapies informed by large-scale patient-derived biology, announced that data from its development candidate, ONC001, has been selected for an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 6–9, 2025, in Orlando, Florida.

ONC001 is a first-in-class antibody-drug conjugate (ADC) designed to uniquely target CD64, a myeloid-restricted receptor pervasively expressed in CMML and M4/M5 acute myeloid leukemia, including highly resistant subsets. The ADC was developed using OncoPrecision's proprietary discovery engine, which integrates large-scale, patient-derived biology and AI-enhanced high-throughput screening to reveal the most actionable cellular vulnerabilities. This process enabled the identification of a lead antibody with high affinity against an overlooked target, alongside the optimal ADC payload and linker chemistry to minimize off-target toxicity and collateral damage to healthy hematopoiesis. ONC001 is advancing through IND-enabling studies and represents a differentiated approach to overcoming monocyte-driven resistance.

Preclinical data to be presented by Dr. Gastón Soria, Co-Founder and Chief Scientific Officer, will highlight:

• Selective engagement of patient-derived CMML and AML cells
• Robust activity in samples resistant to current standard-of-care therapies
• Compelling in vivo efficacy across heterotopic and orthotopic models

"The selection of ONC001 for an oral presentation at ASH underscores the strength of this fundamentally new therapeutic approach," said Tarek Zaki, Co-Founder & Chief Executive Officer of OncoPrecision. "ONC001 is designed to specifically target resistance mechanisms that drive certain aggressive blood cancers, offering a new way to overcome common treatment failures. We look forward to sharing this data with the global hematology community and to continuing discussions with prospective development and strategic partners."

"ONC001 is the direct result of our platform's ability to integrate insights from patient-derived biology with rational target selection and payload matching," said Dr. Gastón Soria. "Although CD64 has long been acknowledged as a biomarker of monocytic leukemia, no approved or clinical-stage assets have successfully exploited it as a therapeutic target. Our platform unveiled that an ADC modality is the optimal path to achieve this."

Oral Presentation Details

• Title: ONC001: A first-in-class ADC targeting CD64 for the treatment of monocytic leukemia developed through patient-guided target and payload selection
• Presenter: Gastón Soria, PhD, Co-Founder & Chief Scientific Officer, OncoPrecision
• Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Novel strategies to overcome therapy resistance in AML
• Date: Saturday, December 6, 2025
• Session Time: 4:00 PM – 5:30 PM
• Presentation Time: 5:15 PM – 5:30 PM
• Location: OCCC – Valencia Room W415D

About OncoPrecision

OncoPrecision is a next-generation oncology therapeutics company leveraging large-scale, patient-derived biology and AI-enhanced discovery platforms to develop precision medicines with a higher probability of clinical success. The company integrates translational biology, machine learning, and modular ADC/BsAb engineering to build a pipeline of first-in-class interventions across hematologic malignancies and solid tumors. The company is actively exploring strategic collaborations and partnerships to accelerate the development and commercialization of its programs.

Forward-Looking Statements

This press release contains forward-looking statements regarding the development, safety, and therapeutic potential of ONC001 and other product candidates. Actual results may differ materially from those expressed or implied due to risks and uncertainties inherent in drug development. OncoPrecision undertakes no obligation to update or revise these statements.

Contact Information

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SOURCE OncoPrecision Corporation