SN BioScience Achieves Milestone with SNB-101’s Phase 2 IND Clearance from FDA
SN BioScience, headquartered in South Korea, has announced a significant advancement in its drug development pipeline. The company's leading asset, SNB-101, has obtained Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA), allowing the commencement of a Phase 1b/2 clinical trial aimed at treating patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). This designation marks a pivotal point as it follows the earlier orphan drug designation granted in 2023 and the Fast Track designation received in 2024 for SNB-101.
The upcoming clinical trial is a hybrid Phase 1b/2 study that emphasizes dose escalation and optimization designed to enhance both safety and efficacy. Approximately 55 patients will partake in this trial, specifically chosen to reflect the racial diversity resonant in the U.S. populace. Not only will the study take place in the U.S. but also in South Korea and Europe, aiming for comprehensive data that supports future regulatory approvals. The primary endpoints will focus on efficacy, safety, and pharmacokinetics.
After the dose optimization phase, SN BioScience plans to evaluate SNB-101’s effectiveness through a single-arm, single-dose, open-label monotherapy study involving about 100 patients. With promising results, the company envisions introducing SNB-101 to the U.S. market as soon as 2028 to transform treatment perspectives for those affected by this aggressive form of lung cancer.
The context of this development aligns with alarming statistics surrounding Small Cell Lung Cancer (SCLC), which accounts for approximately 12-15% of all lung cancer cases. The prognosis for patients diagnosed at an extensive stage is notably bleak, with less than 7% achieving a five-year survival rate due to the advanced nature of their illness. Despite these disheartening figures, projections indicate the SCLC treatment market will experience a compound annual growth rate (CAGR) of 7-10% from 2023 through 2030, suggesting a pressing need for more effective medical interventions.
SN BioScience is strategically positioning SNB-101 as a second or third-line treatment for patients who have become resistant to existing therapies. Ultimately, the company aspires to establish this novel therapy as a foundational first- or second-line option, potentially in conjunction with immuno-oncology treatments, thereby improving recovery rates and quality of life for those battling this formidable disease.
SNB-101 integrates innovative drug delivery systems pioneered by SN BioScience and represents the first nanoparticle formulation of SN-38, the active component of irinotecan. The cutting-edge dual nano-micelle delivery system developed by SN BioScience serves to overcome historical drug resistance and safety issues commonly encountered with traditional therapies. Notably, SNB-101 has been acknowledged for potential applications beyond SCLC, aiming to treat conditions such as pancreatic and stomach cancers following promising preclinical results.
With a foundational history dating back to May 2017, SN BioScience was conceived by leaders in pharmaceutical research, prominent bio-polymer scientists, and knowledgeable clinical practitioners, all committed to innovating cancer therapy methods. Focused on commercializing advanced technologies, the firm champions the development of unique nanoliposome and nanoparticle drug carrier technologies, further strengthened by their expertise in pharmacometrics and pharmacokinetics. The advancement of SNB-101 could herald a new era for patients and practitioners alike, positioning SN BioScience is a pivotal player in the oncology space.
The upcoming clinical trial is a hybrid Phase 1b/2 study that emphasizes dose escalation and optimization designed to enhance both safety and efficacy. Approximately 55 patients will partake in this trial, specifically chosen to reflect the racial diversity resonant in the U.S. populace. Not only will the study take place in the U.S. but also in South Korea and Europe, aiming for comprehensive data that supports future regulatory approvals. The primary endpoints will focus on efficacy, safety, and pharmacokinetics.
After the dose optimization phase, SN BioScience plans to evaluate SNB-101’s effectiveness through a single-arm, single-dose, open-label monotherapy study involving about 100 patients. With promising results, the company envisions introducing SNB-101 to the U.S. market as soon as 2028 to transform treatment perspectives for those affected by this aggressive form of lung cancer.
The context of this development aligns with alarming statistics surrounding Small Cell Lung Cancer (SCLC), which accounts for approximately 12-15% of all lung cancer cases. The prognosis for patients diagnosed at an extensive stage is notably bleak, with less than 7% achieving a five-year survival rate due to the advanced nature of their illness. Despite these disheartening figures, projections indicate the SCLC treatment market will experience a compound annual growth rate (CAGR) of 7-10% from 2023 through 2030, suggesting a pressing need for more effective medical interventions.
SN BioScience is strategically positioning SNB-101 as a second or third-line treatment for patients who have become resistant to existing therapies. Ultimately, the company aspires to establish this novel therapy as a foundational first- or second-line option, potentially in conjunction with immuno-oncology treatments, thereby improving recovery rates and quality of life for those battling this formidable disease.
SNB-101 integrates innovative drug delivery systems pioneered by SN BioScience and represents the first nanoparticle formulation of SN-38, the active component of irinotecan. The cutting-edge dual nano-micelle delivery system developed by SN BioScience serves to overcome historical drug resistance and safety issues commonly encountered with traditional therapies. Notably, SNB-101 has been acknowledged for potential applications beyond SCLC, aiming to treat conditions such as pancreatic and stomach cancers following promising preclinical results.
With a foundational history dating back to May 2017, SN BioScience was conceived by leaders in pharmaceutical research, prominent bio-polymer scientists, and knowledgeable clinical practitioners, all committed to innovating cancer therapy methods. Focused on commercializing advanced technologies, the firm champions the development of unique nanoliposome and nanoparticle drug carrier technologies, further strengthened by their expertise in pharmacometrics and pharmacokinetics. The advancement of SNB-101 could herald a new era for patients and practitioners alike, positioning SN BioScience is a pivotal player in the oncology space.
Topics Health）
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