SKL35501 / Full-Life Technologies Limited, SK Bio - LARVOL DELTA

SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: SK Life Science, Inc.

New P1 trial • Biliary Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Optimization of Specific Activity Enhances the Therapeutic Window of the NTSR1-Targeted Alpha Radiotherapeutic 225Ac-labeled SKL35501 for NTSR1-Expressing Solid Tumors (SNMMI 2026) - "Optimization of specific activity significantly enhances the therapeutic window of SKL35501, resulting in pronounced tumor regression, durable survival benefit, and manageable, reversible toxicity across multiple NTSR1-expressing tumor models. These data support SKL35501 as a promising NTSR1-targeted alpha radiotherapeutic and provide a strong rationale for continued clinical development."

Colorectal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Optimization of Specific Activity Enhances the Therapeutic Window of the NTSR1-Targeted Alpha Radiotherapeutic 225Ac-labeled SKL35501 for NTSR1-Expressing Solid Tumors (SNMMI 2026) - "Optimization of specific activity significantly enhances the therapeutic window of SKL35501, resulting in pronounced tumor regression, durable survival benefit, and manageable, reversible toxicity across multiple NTSR1-expressing tumor models. These data support SKL35501 as a promising NTSR1-targeted alpha radiotherapeutic and provide a strong rationale for continued clinical development."

Colorectal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

A novel NTSR1-targeting alpha radiotherapeutic SKL35501 demonstrating potent anti-tumor efficacy in HCT116 colorectal tumor model (AACR 2026) - "SKL35501 is a highly effective, first-in-class, 225Ac-labeled NTSR1-targeting alpha radiotherapeutic demonstrating excellent tumor selectivity, durable tumor retention, potent antitumor activity, and a favorable safety profile. These preclinical findings strongly support advancement to the FIH trial for patients with NTSR1-positive advanced solid tumors using the SKL35501."

Preclinical • Biliary Cancer • Biliary Tract Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

[AACR 2026] SK biopharmaceuticals highlights ‘theranostic’ strategy in RPT at AACR 2026 (Korea Biomedical Review) - "At the AACR Annual Meeting 2026 in San Diego on Tuesday (local time), the company presented preclinical data in a poster session, highlighting a precision medicine approach that spans patient selection to treatment...According to preclinical data, this compound showed rapid, high tumor accumulation (about 30 percent ID/g) in animal models and maintained it for a long time. These characteristics may be reproduced in clinical settings. In particular, considering mouse-to-human cross-reactivity, we expect similar distribution patterns in humans...We plan to conduct combination studies in the preclinical stage alongside clinical trials. In phase 1, we will first confirm the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) with monotherapy, and then review combination strategies in earnest."

New P1 trial • Preclinical • Colorectal Cancer • Solid Tumor

SK biopharmaceuticals said Monday it would present research findings on its radiopharmaceutical (RPT) therapy, SKL35501, and diagnostic agent, SKL35502, at the 2026 American Association for Cancer Research (AACR) Annual Meeting. (Korea Biomedical Review) - "The NTSR1-targeted therapy SKL35501, which utilizes the alpha-emitting radionuclide actinium-225 (225Ac), demonstrated high tumor specificity and prolonged retention in the HCT116 human colorectal cancer cell model....In the HCT116 model, SKL35502 showed high sensitivity, with tumor exposure about 22 times higher than in the blood. After 96 hours, 84 percent of the administered radioactivity was excreted."

Preclinical • Colorectal Cancer

SK Biopharm said on the 12th that it received U.S. Food and Drug Administration (FDA) approval for an investigational new drug (IND) application for a phase 1 clinical trial of the radiopharmaceutical (RPT) therapy "SKL35501" (Chosun Biz) - "Based on this approval, SK Biopharm is pursuing global clinical development centered on the United States while also submitting the same clinical trial protocol to the Ministery of Food and Drug Safety for review. The company plans to conduct trials in the United States and Korea in parallel to speed up development."

IND • Oncology

Preclinical development of FL-091, a novel NTSR1 targeting radionuclide drug conjugate for the treatment of NTSR1-positive cancers (EANM 2024) - "NTSR1 was highly expressed across multiple types of cancers, especially in head and neck and colorectal cancer. These data, along with the encouraging anti-tumor activity observed across in vivo models, suggest that 177Lu-FL-091 is a promising RDC candidate for the treatment of NTSR1-positive cancers. Studies to investigate FL-091 conjugated to the radionuclide Actinium-225 are in progress."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • FOLH1

Full-Life Technologies, SK Biopharmaceuticals Enter Licensing Agreement for Novel Therapeutic Targeting Multiple Solid Tumors (PRNewswire) - "Full-Life Technologies...announced today that it has entered into a license agreement with SK Biopharmaceuticals, a global biotech company, for exclusive worldwide clinical research, development, manufacturing, and commercialization rights to Full-Life's 'FL-091' radiopharmaceutical compound targeting neurotensin receptor 1 (NTSR1) positive cancers. This licensing deal worth $571.5 million includes an upfront payment, and development and commercial milestones, separate from royalties. Under the terms of the agreement, SK Biopharmaceuticals will in-license the NTSR1-targeting Radionuclide Drug Conjugate (RDC) program FL-091 - as well as its back-up compounds - aimed at developing and commercializing it as an innovative anti-cancer drug....SK Biopharmaceuticals also has a right of first negotiation to license other pre-selected RDC programs of Full-Life."

Licensing / partnership • Solid Tumor

Development of 177Lu-FL-091 for the treatment of NTSR1-positive cancers (SNMMI 2024) - "In PC-3 xenograft model that was negative for AR or PSMA expression, single dose of 177Lu-FL-091 at 37 MBq induced >30% tumor shrinkage in all treated mice (Figure E). NTSR1 was found to be highly expressed across multiple types of cancers, especially in head and neck and colorectal cancer. FL-091 displayed enhanced binding affinity to NTST1 and antagonist activity compared to 3BP-227. In addition, 177Lu-FL-091 demonstrated improved in vivo biodistribution profile vs."

Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • FOLH1

Full-Life Technologies Acquires Focus-X Therapeutics (WCG’s FDAnews) - "Full-Life Technologies...has entered into an agreement to acquire Focus-X Therapeutics and its cancer-targeting radiopharmaceuticals....Under the terms of the acquisition, Full-Life will gain Focus-X’s two investigational lead compounds. The first is a prostate specific membrane antigen-targeted peptide for the treatment of metastatic castration resistant prostate cancer. The second is a neurotensin receptor type 1 (NTSR1)-targeted peptide for the treatment of pancreatic cancer....Full-Life will also be acquiring Focus-X’s six other programs that are in earlier stages of development...Under the terms of the acquisition, Focus-X shareholders are eligible to receive an upfront payment along with potential development, regulatory and sales-based milestone payments of up to $245 million. The acquisition is expected to close in the first quarter of 2023."

M&A • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor