SNB-101 / SN BioSci, Boryung Group - LARVOL DELTA

Model-based prediction of nanoparticle and dissolved form ratios using total concentration data: a case study of SNB-101. (PubMed, Front Pharmacol) - P1 | "Irinotecan (CPT-11), a topoisomerase I inhibitor, serves as a prodrug for SN-38, its active metabolite with significantly higher cytotoxic potency. This model-based approach underscores the utility of nanoparticle formulations in improving drug delivery and highlights the importance of distinguishing between NP and S forms for accurate efficacy and toxicity predictions. The framework may provide a useful tool for optimizing dose selection and accelerating the clinical development of nanoparticle-based therapeutics."

Journal • Hematological Disorders • Neutropenia • Oncology

SNB-101 Earns Government Backing as Promising Therapy for Small Cell Lung Cancer (PRNewswire) - "In a strong endorsement of its cutting-edge drug delivery technology, SN BioScience announced that its anticancer candidate SNB-101 has been selected as a clinical-stage project under the 2025 Korea Drug Development Project, a government-initiated program led by the Korea Drug Development Fund (KDDF). The program includes two years of research support, aiding the company's advancement of SNB-101 into global Phase 1b/2 trials...The Korea Drug Development Fund (KDDF) is a government agency funded by three ministries. It aims to actively fund and provide necessary support for drug development in academia and the pharmaceutical industry....SN BioScience is set to launch a multinational Phase 1b/2 clinical trial for patients with extensive-stage small cell lung cancer (ES-SCLC), spanning key sites across South Korea, the United States, and Europe."

Financing • New P1/2 trial • Small Cell Lung Cancer

SN BioScience Propels SNB-101 to Phase 2 with IND Clearance from FDA (PRNewswire) - "SN BioScience today announced that its lead asset SNB-101 has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial....SN BioScience expects to initiate the clinical trials in Q2, 2025."

IND • New P1/2 trial • Small Cell Lung Cancer

SN Biosciences Receives FDA Phase 2 Approval for Nano-Cancer Drug for Small Cell Lung Cancer [Google translation] (BioTimes) - "SN Bioscience...announced on the 24th that it had received approval for a single-therapy clinical phase 1b/2 trial plan (IND) for the nano-oncology drug 'SNB-101' (main ingredient: SN-38) from the U.S. Food and Drug Administration (FDA)....In particular, in order to enter the US market, it plans to enroll approximately 55 patients considering the racial ratio in the US, and in the future, it will proceed with multinational clinical trials in Korea, the US, and Europe by adding European Phase 2 approval....After the dose optimization trial is completed, efficacy and safety will be evaluated in about 100 small cell lung cancer patients in a single-group, single-dose, open-label, monotherapy manner, and if positive results are obtained, it is expected to be commercialized in the United States as early as 2028."

IND • Launch US • New P1/2 trial • Small Cell Lung Cancer

SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer (PRNewswire) - "SN Bioscience Co. Ltd...announced on May 7 that the FDA has granted Fast Track Designation for small cell lung cancer (SCLC) for SNB-101...a new drug for polymer nanoparticle anticancer under clinical trial...By receiving fast-track designation this time, it is evaluated that it has laid the groundwork that can be commercialized immediately after completion of phase 2 clinical trials."

Fast track • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Generation of anti-SN38 antibody for loading efficacy and therapeutic monitoring of SN38-containing therapeutics. (PubMed, Heliyon) - "However, it has garnered significant scientific interest as a payload in conjugated nanomedicine platforms (e.g., SN-38lip, NK012, SNB-101, and ADCs) to enhance their effectiveness and safety...The immunization efficiency, reactivity, binding affinity, specificity, and cross-reactivity of purified pAb and mAb against Irinotecan, a model for the emergence of an SN38 derivative in clinical settings, were evaluated using ELISA and western blotting (WB) techniques...The affinity of both pAb and mAb also meets the acceptance criteria for quantifying SN38 in fluidic material, as well as in Therapeutic drug monitoring (TDM) studies, a crucial aspect of personalized medicine. The potential applications of the anti-SN38 antibodies extend to reducing SN38-induced systemic toxicity through an inverse targeting strategy, a novel approach that piques further interest in our findings."

Journal • Oncology

Following the FDA, EMA also Grants an Orphan Drug Designation of SN Bioscience's Nano Anti-Cancer Drug 'SNB-101' for Small Cell Lung Cancer. (PRNewswire) - "SN Bioscience...announced on May 24 that European Medicines Agency(EMA) had granted an orphan drug designation for small cell lung cancer(SCLC), a rare disease, for SNB-101 (API: SN-38) which is a new polymer nanoparticle drug under development....By receiving an orphan drug designation from EMA following FDA, it is expected that the expansion of indications and clinical development for SNB-101 will gain momentum."

Orphan drug • Small Cell Lung Cancer

SN BioScience received US FDA Orphan Drug Designation for its Nano Anti-Cancer Drug ’SNB-101’ on Pancreatic Cancer (PRNewswire) - "SN Bioscience...announced on Feb 27 that the US FDA had granted an orphan drug designation for pancreatic cancer for SNB-101...based on the pre-clinical data of SNB-101 on pancreatic cancer animal model. SNB-101 is the world's first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. It has been approved for phase 1 clinical trials in the US (NCT04640480) and Korea, and the INDs for phase 2 clinical trials are planned in the US and Europe in the second half of this year."

IND • New P2 trial • Orphan drug • Pancreatic Cancer

Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: SN BioScience | Trial completion date: Dec 2023 ➔ Jun 2025

Trial completion date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

Preliminary findings from a phase I, open-label, dose-finding study of SNB-101 in patients with advanced solid tumors (ESMO 2023) - P1 | "Background SNB-101 is a nanoparticle lyophilized injection of SN-38 (active metabolite of irinotecan), using polymer micelle technology, that is being developed to treat advanced solid tumors. SNB-101 demonstrated antitumor efficacy, which appeared to be dose dependent. A phase 1b/2a trial combining SNB-101 with immunotherapy is planned."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

SN Bioscience Announces Phase 1 Study Results of SNB-101 (SN-38 Nanoparticle Anti-cancer Drug) at ESMO (PRNewswire) - P1 | N=36 | NCT04640480 | Sponsor: SN BioScience | "SN Bioscience Co., Ltd...announced the results of the phase 1 clinical study of SNB-101, a nanoparticle anti-cancer new drug pipeline, at ESMO Congress 2023 held in Madrid, Spain from October 20 to 24....In terms of the efficacy evaluation results, out of a total of 21 patients, partial response (PR) was 14.3% (3 patients, small cell lung cancer, non-small cell lung cancer, rectal cancer), and stable disease (SD) was 28.6% (6 patients, small cell lung cancer, non-small cell lung cancer, rectal cancer, head and neck cancer, gastric cancer), and progressive disease (PD) was 57.1% (12 patients). The disease control rate (DCR) of all patients was 42.9%, well demonstrating the characteristics of general cytotoxic anti-cancer drugs. In particular, in the high dose group (40~50mg/m2), the DCR was 83.3%, well indicating dose dependency."

P1 data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Rectal Cancer • Small Cell Lung Cancer • Solid Tumor

Orphan Designation: Treatment of Small-Cell Lung Carcinoma (FDA) - Date Designated: 07/18/2023

Orphan drug • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

US FDA Grants Orphan Drug Designation of SN Bioscience's Nano Anti-Cancer Drug 'SNB-101' for Small Cell Lung Cancer (PRNewswire) - "SN Bioscience...announced on July 19 that the US FDA had granted an orphan drug designation for small cell lung cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development. SNB-101 is the world's first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. It has been approved for phase 1 clinical trials in the US (NCT04640480) and Korea, and the IND for phase 2 has been filed after phase 1 clinical trial in Korea."

New P2 trial • Orphan drug • Trial status • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer

Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: SN BioScience | Trial completion date: Mar 2022 ➔ Dec 2023 | Trial primary completion date: Jan 2022 ➔ May 2023

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Neuroendocrine Tumor • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

[VIRTUAL] Enhanced anti-tumor effect and tolerance of novel irinotecan (sn-38) nanoparticle with double core-shell micelle technology (AACR 2021) - "First, we have examined synergistic antitumor activity of SNB-101 in combined therapy with Docetaxel in various mouse xenograft models of gastric cancer (Hs746T), breast cancer (MDA-MB-231), and lung cancer (A549). As the addition of Bevacizumab to SNB-101 monotherapy is associated with profound inhibition of HT-29 tumor growth progression, the consistent reduction in tumor weights was also observed. Although tolerability of the substance in clinical studies is well known, there are some limitations in correlating the results of pre-clinical models to in-depth comprehension of human model; thus, we hope to further investigate the pharmacological action of SNB-101 in new regimens and indications in the next step - First in Human trial."

Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor

Boryung to market SN BioScience’s nanoparticle anticancer therapy (Korea Biomedical Review) - "Boryung Pharmaceutical said that it has signed an exclusive marketing agreement with SN BioScience to market the latter's SNB-101, the world's first nanoparticle anticancer therapy...Under the accord, Boryung will hold exclusive local sales rights for SNB-101 for 10 years after its launch."

Licensing / partnership • Oncology

Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: SN BioScience

Clinical • New P1 trial • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Neutropenia • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

S&Bio, “first patient administration” of nano cancer drug in Korea (Biospectator) - “On the 18th, S&Bioscience announced that it has begun administering the first phase 1 clinical trial in Korea of 'SNB-101 (nanoized SN-38)', a nanoparticle anticancer drug. According to the announcement, S&Bio is a phase 1 clinical trial to study the safety, tolerability, efficacy, and pharmacokinetic properties of SNB-101, targeting 36 patients with solid cancer such as lung cancer, stomach cancer, colon cancer, pancreatic cancer, breast cancer, and ovarian cancer….In addition, S&Bio is planning a phase 1 clinical trial of the second pipeline,'SNA-001', in the second half of next year.”

New P1 trial • Trial status • Oncology • Solid Tumor

S&B Bio approves first phase of nano-cancer drug in the US (Biospectator) - "S&B Science has been approved for the first phase of the US for SNB-101, a double-nanoparticle anticancer drug, and will begin full-scale clinical trials in the second half of this year…Accordingly, S&B Bio is entering Phase I to confirm the tolerability, safety, and efficacy of SNB-101 for 12 to 36 patients with solid cancer in the US and Korea in the second half of this year."

FDA event • New P1 trial • Oncology • Solid Tumor

Novel SN-38 double core-shell micelle formulation, SNB-101, enhanced anti-tumor effect and tolerance. (PubMed, Ann Oncol) - No abstract available

Journal

Novel SN-38 double core-shell micelle formulation, SNB-101, enhanced anti-tumor effect and tolerance (ESMO-GI 2019) - "Introduction SN-38 (7-Ethyl-10-hydroxycamptothecin) is a potent active metabolite of irinotecan (Camptosar®, Pfizer) with a wide range of anti-tumor effects for pancreatic, ovarian, lung, and breast cancer models as well as for colorectal cancer. At least 2.67 fold the maximum tolerable dose (MTD) increase was achieved through nanoparticle formulation. Conclusion In conclusion, we developed a camptothecin version of Abraxane® with increased MTD and superior efficacy, as well as new possible indications for gastric, pancreatic, breast, lung and ovarian cancers."