KN510713 / NCC-Bio, National Cancer Center - LARVOL DELTA

Inhibiting fatty acid oxidation can overcome acquired drug resistance in pancreatic cancer: A Phase 2 trial has begun (AACR 2026) - "FAO is essential for ADR via autophagy in cancer cells. Preclinical studies have shown that combining anticancer drugs with FAO inhibitors, such as KN510713, can overcome ADR. A Phase 1 trial has been completed, demonstrating safety."

P2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Acquired drug resistance with autophagy is suppressed by fatty acid oxidation inhibition in pancreatic ductal adenocarcinoma (AACR 2026) - "These findings highlight that the FAO pathway is a key mechanism of cancer-specific autophagy, supporting its role in the development of acquired drug resistance during chemotherapy.Funding source: Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science and ICT to SK (NRF-2019M3A9G1104345) and was supported by a grant from the National Cancer Center of Korea to WC (NCC 2410891-2)."

Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Inhibiting Fatty Acid Oxidation Reverses Autophagy-Mediated Acquired Chemotherapy Resistance in Pancreatic Ductal Adenocarcinoma. (PubMed, Cancer Res) - "In xenograft models, combining irinotecan with KN510713 significantly prevented tumor regrowth compared with irinotecan alone. These findings suggest that targeting FAO induced by autophagy activation may overcome acquired drug resistance in PDAC while minimizing the toxic side effects associated with systemic inhibition of autophagy in healthy cells."

Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • BECN1 • MAPK8

The KN510713 Study in Combination With mFOLFIRINOX (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: New Cancer Cure-Bio Co.,Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Solid Tumor

Chemotherapy combined with fatty acid oxidation inhibition completely regressed tumor growth in a pancreatic cancer model (AACR 2025) - "Furthermore, xenograft pancreatic cancer showed completely suppressed effect of KN510713 treated with chemotherapeutics such as irinotecan only or FOLFIRINOX regimen. FAO inhibition stopped tumor growth by ATP depletion in pancreatic cancer... FAO inhibition stopped tumor growth by ATP depletion in pancreatic cancer. The changes in molecular signaling upon FAO inhibition revealed that ATP levels are a key regulator of all signaling. This suggests that whatever the signaling induced by the growth receptor, ATP down-regulation through FAO inhibition may provide a novel therapeutic effect."

Preclinical • Oncology • Pancreatic Cancer • Solid Tumor

Fatty acid oxidation inhibition with anti-cancer agents abrogated tumor growth in a melanoma cancer model (AACR 2025) - "Using allograft and xenograft models with mouse and human melanoma cancer cells, we investigated the anti-cancer effects of KN510713 in combination with standard chemotherapy. Anti-cancer drug treatment such as dabrafenib and dacarbazine induced fatty acid catabolism as well as mitochondrial oxidative phosphorylation for ATP production which is the core metabolic pathway for FAO. FAO inhibition abrogated tumor growth by ATP depletion in melanoma. The changes in molecular signaling upon FAO inhibition revealed that ATP levels are a key regulator of all signaling. Thus, combinations of systemic anti-cancer agents with FAO inhibitors have shown excellent anti-cancer activity in mice."

Preclinical • Melanoma • Oncology • Solid Tumor

A phase I study of the first-in-class anti-fatty acid oxidation agent, KN510713, in patients with advanced solid cancers (AACR 2025) - P1 | "Our findings indicate that KN510713 was well-tolerated up to the highest dose tested, with no DLTs observed.(ClinicalTrials.gov identifier: NCT06012708)"

Clinical • Metastases • P1 data • Oncology • Pancreatic Cancer • Solid Tumor

Inhibiting Fatty Acid Oxidation Suppresses Acquired Resistance to Standard Chemotherapy in Melanoma. (PubMed, Int J Mol Sci) - "When resistance to initial treatment develops, the older chemotherapy drug Dacarbazine is used. A375 melanoma (BRAFV600E) developed resistance after four weeks of Dabrafenib treatment, yet the combination of Dabrafenib and KN510713 resulted in near-complete remission with no signs of regrowth. Based on these findings, combining FAO inhibitors with first-line therapies may be a promising approach for managing melanoma, regardless of RAF mutation status."

IO biomarker • Journal • Preclinical • Melanoma • Oncology • Solid Tumor

The KN510713 Study in Combination With mFOLFIRINOX (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: New Cancer Cure-Bio Co.,Ltd.

New P1/2 trial • Oncology • Pancreatic Cancer • Solid Tumor

Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713 (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: New Cancer Cure-Bio Co.,Ltd. | Recruiting ➔ Completed | N=24 ➔ 12

Enrollment change • Trial completion • Oncology • Solid Tumor

Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713 (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: New Cancer Cure-Bio Co.,Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: New Cancer Cure-Bio Co.,Ltd.

Combination therapy • Metastases • New P1 trial • Gastrointestinal Cancer • Oncology • Solid Tumor

NCC’s novel anti-cancer fatty acid oxidation inhibitor OKed to begin clinical trials (Korea Biomedical Review) - "The National Cancer Center (NCC) said on Tuesday that its anti-cancer drug targeting fatty acid oxidation inhibition, KN510713, was approved to enter clinical trials by the Ministry of Food and Drug Safety (MFDS) on Wednesday. The small molecule fatty acid oxidation inhibitor, KN510713, is an innovative new anticancer drug developed after 12 years of research....After the NCC applied for a patent and transferring the technology to NCC-Bio in 2023, NCC-Bio completed clinical trial preparation and received approval to begin clinical trials from the MFDS. Accordingly, the clinical team of the NCC will initiate phase 1 clinical trials for the drug to treat pancreatic cancer."

New P1 trial • Patent • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor