TARGETED ONCÓLOGY , 13 ENERO 2025 .
The FDA has cleared the investigational new drug application of SNB-101 as a potential treatment for patients with SCLC, allowing for the commencement of a phase 1b/2 trial .
In the phase 1b/2 trial, SNB-101 will be evaluated in patients with extensive-stage SCLC. The study will focus on dose escalation and dose optimization to enhance both efficacy and safety .
The trial aims to support PHASE 2 clearance in Europe, and will take place in South Korea, the US, and Europe. Approximately 55 patients will be enrolled and the primary end points of the study will include efficacy, safety, and pharmacokinetics .
Following the dose optimization phase, SN BioScience, the developer of SNB-101, plans to assess the agent’s safety and efficacy in a single-arm, single-dose, open-label monotherapy study involving around 100 patients .
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If Successful, The Company Aims For Early US Commercialization, With a Potential Market Entry As Soon As 2028 .
Preclinical findings suggest that SNB-101 may also be effective in treating Lung, Pancreatic, and Stomach Cancers . Further, SN BioScience aims to position SNB-101 as a second - or third-line treatment option for patients who are resistant to current therapies . Their ultimate goal is to establish SNB-101 as a first- or second-line standard treatment for patients with cancer that can potentially be given in combination with immuno-oncology agents .
SNB-101 previously was granted orphan drug designation from the FDA in SCLC in 2023, as well as Fast Track Designation in 2024 .
SEOUL, South Korea , May 9, 2024 /PRNewswire/ -- SN Bioscience Co. Ltd. (CEO Park Young -hwan) announced on May 7 that the FDA has Granted FAST TRACK Designation for small cell lung cancer (SCLC) for SNB-101 (API: SN-38), a New Drug For Polymer Nanoparticle Anticancer under Clinical Trial .
SNB-101 was designated as an ORPHAN DRUG for SMALL CELL LUNG CÁNCER and Pancreatic Cancer in July of last Year and February of This Year, Respectively . 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 II CLINICAL TRIALS .
Despite a long period of Research and Development, SCLC still remains a field with high medical Unmet Needs . Currently, the FIRST-LINE STANDARD Treatment is a Combination Therapy of CISPLATIN And ETOPÓSIDE, a classic cytotoxic Anticancer Drug, and ' CLINICAL TRIALS ' are included as SECOND-LINE Treatments in the NCCN GUIDELINES .
FAST TRACK is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need . The FAST TRACK Designation facilitates the interactions with the FDA and allows a Rolling REVIEW For the Submission Package so it can be Reviewed in each section, rather than waiting until every section of the NDA is Completed . Additionally, it May Be Possible To Apply For ACCELERATED APPROVAL After The Completion of PHASE II CLINICAL TRIALS and PRIORITY REVIEW Immediately After The Completion of PHASE III CLINICAL TRIALS When Qualified . ...
