NRT-YHD_001 / Neornat - LARVOL DELTA

IND enabling study of NRT-YHD_001, a macrophage immune checkpoint inhibitor in liver cancer (AACR 2025) - "We confirmed that weekly intravenous injections of 1mg/kg NRT-YHD_001 showed significantly greater therapeutic efficacy than the sorafenib-treated group. Furthermore, comprehensive evaluations across 4-week repeated dose toxicity and toxicokinetic in mice and monkey, safety pharmacology, and genetic toxicity studies revealed no adverse findings with NRT-YHD_001.For NRT-YHD_001, Drug Substance (DS) and Drug Product (DP) were produced by a global CDMO with experience in U.S. FDA approval of oligonucleotide drugs, and the analysis method was established.These results enabled us to complete the IND-enabling study package for NRT-YHD_001, a liver cancer therapy candidate with FTO analysis completed and intellectual property (IP) fully secured. Regulatory approval submissions to the Korea MFDS and the U.S. FDA are planned for 2025."

Checkpoint inhibition • Liver Cancer • Oncology • Solid Tumor

"RNA Liver Cancer Treatment Domestic Phase 1 Application Next Year… Eyes on Combination Therapy" [Google translation] (HIT News) - "'We will take on the challenge of developing an innovative ribonucleic acid (RNA)-based liver cancer treatment. We plan to apply for a phase 1 clinical trial (IND) from the Ministry of Food and Drug Safety for 'NRT-YHD_001', a lead pipeline (new drug candidate) in the first half of next year. 'We are aiming for global technology transfer (L/O) of liver cancer treatment in 2025.'....Neona's NRT-YHD_001 is an immunotherapy agent based on macrophage activity."

Licensing / partnership • New P1 trial • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

NRT-YHD_001, targeting CD47 for liver cancer immunotherapy (AACR 2024) - "To investigate the in vivo efficacy of NRT-YHD_001, spontaneous (Ras-transgenic) mouse liver cancer model was used and compared with that of sorafenib treatment. In mouse and cynomolgus monkey maximum tolerated dose (MTD) studies, no toxicity of NRT-YHD_001 was found at doses up to 500 mg/kg intravenously. These results showed that NRT-YHD_001 had a robust anticancer effect by converting the macrophage of "don't eat me" into "eat me signal" in the tumor microenvironment of liver cancer, thereby removing or inhibiting liver cancer cells."

IO biomarker • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor • SIRPA • THBS1

In vivo therapeutic validation of NRT-YHD_001, a novel macrophage checkpoint inhibitor, in liver cancer (AACR 2023) - "As a result, the NRT-YHD_001 administration group showed significant therapeutic effect compared to sorafenib. These results showed that NRT-YHD_001 had a strong anticancer effect by converting the macrophage of don't eat me into eat me signal in the tumor microenvironment of liver cancer, thereby removing or inhibiting liver cancer cells.Keywords: let-7i-5p, macrophage, phagocytosis, liver cancer, NRT-YHD_001"

Checkpoint inhibition • Preclinical • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor • SIRPA • THBS1