HP-002 / Helioson Pharmaceutical - LARVOL DELTA

A First-in-Human Study of HP-002 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=114 | Not yet recruiting | Sponsor: Shanghai Helioson Pharmaceutical Co., Ltd.

First-in-human • New P1/2 trial • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

Utilize a soluble T-cell receptor TCR targeting tumor intracellular antigen PRAME to develop therapeutic and radioactive diagnostic agents for PRAME-positive tumors (AACR 2026) - "These data highlight the capability of our discovery and molecular engineering platform to develop the soluble TCRs for therapeutics and radioactive diagnostics in cancer. Our ongoing work focuses on TCR affinity maturation and molecular optimization of HP-002 to improve its affinity and selectivity, aiming to achieve enhanced tumor accumulation for future diagnostic and therapeutic applications."

IO biomarker • Melanoma • Oncology • Solid Tumor • HLA-A • IFNG • PRAME

HP-002: A brain-penetrant PROTAC that demonstrated potent anti-proliferation activities on multiple BTK mutant (AACR 2025) - "In lymphoma cells e.g. REC-1 and TMD8, HP-002 demonstrated 2-digit pM IC50 with up to ~10-fold more potent than NX-5948 and BGB-16673. HP-002 is a potent and highly selective BTK degrader against BTK-WT and multiple BTK inhibitor-resistant mutations. Brain penetration was observed in the TMD8 xenograft tumor model with deeper BTK down-regulation on the HP-002 treatment and robust tumor growth inhibition. With no significant safety risk findings in the preliminary rat and NHP DRF studies, HP-002 is currently under IND-enabling development."

Late-breaking abstract • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • BTK • CRBN • GSPT1 • SALL4