#USA #Orlando #OncoPrecision #ONC001 #CD64

OncoPrecision's Promising Breakthrough: ONC001

During the 67th Annual Meeting of the American Society of Hematology (ASH), OncoPrecision Corporation revealed significant progress regarding its innovative therapeutic candidate, ONC001. This unique antibody-drug conjugate (ADC) specifically targets CD64, a receptor predominantly found in myeloid cells, marking the first solution of its kind for treating monocytic leukemia. Scheduled for presentation from December 6-9, 2025, in Orlando, Florida, this breakthrough has generated considerable anticipation in the medical community.

ONC001 was meticulously developed using OncoPrecision’s proprietary discovery platform, which incorporates large-scale patient-derived biological data coupled with advanced AI-driven high-throughput screening. This novel approach allows the identification of cellular vulnerabilities, which is crucial in formulating targeted therapies. ONC001 was crafted with an antibody that exhibits a strong affinity for the often-overlooked CD64 receptor, along with an optimal ADC payload and linker chemistry that aims to reduce off-target toxicity and protect healthy hematopoietic function.

The presentation will be led by Dr. Gastón Soria, Co-Founder and Chief Scientific Officer at OncoPrecision, and will showcase compelling preclinical data including:

• - Selective engagement of CMML and AML cells derived from patients
• - Robust activity in samples resistant to current standard treatments
• - Convincing in vivo efficacy in heterotopic and orthotopic models

According to Tarek Zaki, Co-Founder and CEO of OncoPrecision, “The selection of ONC001 for an oral presentation at ASH highlights the strength of this fundamentally new therapeutic approach. Designed to specifically target the mechanisms of resistance driving certain aggressive hematological malignancies, ONC001 offers a renewed hope for overcoming common therapeutic failures.” He further expressed eagerness to share their findings with the global hematology community as well as to engage with potential strategic partners.

The foundation for ONC001’s success lies in effectively leveraging patient biology for rational target selection and payload suitability, which Dr. Soria emphasized. Despite the longstanding recognition of CD64 as a biomarker of monocytic leukemia, no approved products have previously managed to utilize it as a therapeutic target successfully. The OncoPrecision platform has unveiled ADC modalities as the optimal route to achieving this goal.

Details of the Oral Presentation

• - Title: ONC001: The First ADC Targeting the CD64 Receptor for Monocytic Leukemia Treatment Developed through Target and Payload Selection Based on Patient-Derived Data
• - Presenter: Dr. Gastón Soria, Co-Founder and Chief Scientific Officer, OncoPrecision
• - Session: 604, Molecular Pharmacology and Drug Resistance, Myeloid Tumors: New Strategies to Overcome AML Treatment Resistance
• - Date: Saturday, December 6, 2025
• - Session Time: 16:00 - 17:30
• - Presentation Duration: 17:15 - 17:30
• - Location: OCCC - Valencia Room W415D

About OncoPrecision

OncoPrecision represents a new generation of oncology therapy, utilizing large-scale patient-derived biology paired with enhanced AI discovery platforms to develop precision medications with a higher likelihood of clinical success. The company integrates translational biology, machine learning, and modular ADC/BsAb engineering to build a robust pipeline of leading interventions focusing on hematological malignancies and solid tumors. Actively seeking collaborations and strategic partnerships, OncoPrecision aims to accelerate the development and commercialization of its groundbreaking 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 significantly from those expressed or implied due to inherent risks and uncertainties associated with drug development. OncoPrecision does not undertake any obligation to update or revise these statements.