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 cancer 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 2 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 etoposide, 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 2 clinical trials and priority review
immediately after the completion of phase 3 clinical trials when
qualified.
SNB-101 is the world's first nanoparticle anticancer drug that
has been developed extremely insoluble SN-38 into polymer
nanoparticles. The nano micelle technology, a core platform
technology of SN Bioscience, has been applied. Preclinical and
phase 1 clinical results showed that it significantly reduced
digestive system adverse events (nausea, vomiting, diarrhea, etc.)
compared to existing anticancer drugs, and especially showed
excellent efficacy in patients related to lung cancer through lung
targeting. The phase 1 clinical trial has been completed, IND for
phase 2 has been approved in Korea, and global clinical trials are
scheduled to begin after IND approval for phase 2 in the US and
Europe in the second half of this
year. Following small cell lung cancer and pancreatic cancer,
attempts are being made to expand its indications to other solid
cancers such as colon cancer, gastric cancer, and biliary tract
cancer, and will be verified through phase 2 clinical trials.
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]
The development name, SNB-101, is the world's first anticancer
drug developed from SN-38 as nanoparticles. SN-38 is an active
metabolite of Irinotecan which is gaining attention for its use in
drug-antibody conjugates (ADCs) such as Enhertu® and
Trodelvy®. Tolerability and safety have been
dramatically improved compared to existing products, and it is
expected to be effective in lung cancer, pancreatic cancer, and
gastric cancer, were not the indications before. Scale-up
production, the biggest barrier that prevented existing nano-cancer
drugs from entering the clinical stage, was successful, and
clinical trial products are produced at a facility dedicated to
anticancer drugs with EU GMP.
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SOURCE SN BioScience Inc