[SNB-101] Orphan Drug Designation(FDA) of SNB-101 for Small Cell Lung Cancer
Date2023-07-21
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US FDA Grants Orphan Drug Designation of SN Bioscience's Nano Anti-Cancer Drug 'SNB-101' for Small Cell Lung Cancer
2023-07-20
SEONGNAM, South Korea, July 20, 2023 /PRNewswire/ -- SN
Bioscience Co. Ltd. (CEO Park Young-hwan) 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.
SNB-101 showed excellent efficacy in animal small cell lung cancer
models, and based on this, it has been designated as an orphan drug by the US
FDA after application in April and review. Small cell lung cancer accounts for
15-20% of all lung cancers with a very poor prognosis. The current standard
treatment (first-line treatment) is classic drugs, Cisplatin + Etoposide.
However, as there are very limited options for second-line treatment and
others, it is an area with very high medical unmet needs.
Orphan drug designation is a program where the FDA facilitates the
development and approval of treatments for rare/incurable or life-threatening
diseases. SN Bioscience expects the designation as an orphan drug to
accelerate the development of SNB-101, which is being developed as a treatment
for orphan drugs including small cell lung cancer.
Orphan drug designation provides the qualified drug developers with
various benefits such as exclusive rights for 7 years from the date of
marketing approval, tax credits for R&D costs, assistance on clinical trial
design for clinical development, exemption from review application fees, and
priority review support.
About SN BioScience Inc.
SN BioScience is a biotech company established in May 2017. It is
a drug delivery system R&D company specialized in anti-cancer drugs and is
located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. SN
BioScience was founded by pharmaceutical R&D experts, world-class
bio-polymer research professors, and clinical professors. from the beginning of
its establishment, it has focused on "commercialization" and has been
developing nanoliposomes and nanoparticle drug carriers based on pharmacometrics
and pharmacokinetics.
SNB-101
SNB-101 is the world's first product to use the active metabolite
(SN-38) of Irinotecan as an API, and dual nano-micelle technology which is a
core platform technology of SN Bioscience is applied. Compared to existing
irinotecan products, drug resistance and safety have been significantly
improved, and based on the animal studies, it is expected to be effective for
lung cancer, pancreatic cancer, and stomach cancer, which were not previously
included as indications. Scale-up production, the biggest barrier that
prevented existing nano-cancer drugs from entering the clinical stage, was
successful, and clinical trial products were produced at a facility dedicated
to anticancer drugs with EU GMP certification.
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