ONC001 / OncoPrecision - LARVOL DELTA

ONC001: A first-in-class ADC targeting CD64 for the treatment of monocytic leukemia developed through patient-guided target and payload selection (ASH 2025) - "Notably, strong single agent ex vivo activity is observed in CMML and M4/M5 AML patients,substantially outperforming SoC drugs such as Azacitidine (Aza) and Venetoclax (Ven). By leveraging high-throughput patient-derived biology we exposed a bona fide vulnerability of malignantmonocytic cells that can be therapeutically exploited by our first-in-class ADC targeting CD64. Given theunique expression profile of CD64 across the monocytic differentiation lineage, with low/null expressionin the lymphoid compartment and other non-hematologic tissues, ONC001 emerges as a promising newtreatment with monotherapy potential in areas of high unmet need such as CMML and M4/M5 AML."

Clinical • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • CD14 • CD34

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

Preclinical • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia

Results from the First Phase 1 Clinical Study of DR-01, a Non-Fucosylated Anti-CD94 Targeting Antibody in Patients with Relapsed/Refractory Cytotoxic Lymphomas: Dose Escalation and Optimization (ASH 2024) - P1/2 | "An encouraging response rate including 3 durable CRs points to the potential for DR-01 as a viable treatment option for CTL. Study DR-01-ONC-001 is currently enrolling an international cohort of patients with CTL into phase 2, part B2 of the trial."

Clinical • P1 data • Bone Marrow Transplantation • Constipation • Extranodal Natural Killer/T-cell Lymphoma • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • Oncology • CD8 • KLRD1