| 词条 | SillaJen | ||||||||||||||||||||||||||||||||||||||||||
| 释义 |
| name = SillaJen, Inc. | logo = | image = File:SillaJen building.jpg | native_name = 신라젠 | native_name_lang = Korean | former_name = Jennerex, Inc | type = Public | traded_as = KOSDAQ: 215600 | industry = Biopharmaceuticals | foundation = 2003 | hq_location_city = Busan | hq_location_country = South Korea | locations = 4 (South Korea, USA) | area_served = Worldwide | key_people = SillaJen, Inc: Eun-Sang Moon SillaJen, Biotherapeutics: Helena H. Chaye(CBO), Georg Roth (COO), James M. Burke(CMO) | products = Pexa-Vec (JX-594) | services = | revenue = | operating_income = | net_income = | assets = | equity = | num_employees = ~100 | divisions = | subsid = SillaJen Biotherapeutics Inc. | acquired_by = | homepage = {{URL|www.sillajen.com}} | intl = }} SillaJen, Inc. is a South Korea-based biotechnology company, with offices in Busan, Yangsan and Seoul, South Korea, and San Francisco, California. TechnologyPexa-Vec (JX-594) was developed using the SOLVE (Selective Oncolytic Vaccinia Engineering) platform.[1] This platform may be used to optimize virus targeting to specific cancer types, to select transgenes to include into the viral genome, and to optimize viral infection and/or replication selectively through targeted mutations.[1]JX-900 (VVDD):[2] VVDD Platform: Next-gen enhanced oncolytic immunotherapy.[3]Clinical trialsPexa-Vec (JX-594)As of June 2018, these are the clinical trials investigating Pexa-Vec.[4][5][6][7][8]
PartnershipsSillaJen has partnered with Transgene, Green Cross, and Lee's Pharmaceuticals and clinical collaboration agreements with Regeneron and the US National Cancer Institute for JX-594.[9][10] History2003. Jennerex, Inc. (San Francisco, USA) was established.[11]2014. SillaJen acquires Jennerex, Inc.[12]2015. In April 2015. SillaJen began a Phase 3 clinical trial of Pexa-Vec in advanced liver cancer.[13]2015. In October 2015, SillaJen is selected as the major developer for the Government project of “Global State-of-the-art technology development for biomedical products."[14]2016. In January 2016, SillaJen announces first patient randomized in its global Phase 3 trial for Pexa-Vec in Advanced Liver Cancer. In December 2016. SillaJen is listed on KOSDAQ market in South Korea.[15][16]2017. In May 2017, SillaJen signs a clinical collaborative agreement with Regeneron Pharmaceuticals to conduct a combination study with Pexa-Vec and Regeneron's immune checkpoint inhibitor cemiplimab for renal cell carcinoma.[17]In July 2017, SillaJen received approval from the China CFDA to commence phase 3 clinical trial for Pexa-Vec in liver cancer.[18] In Aug 2017, SillaJen signs a cooperative research and development agreement (CRADA or CRDA) with the National Cancer Institute to conduct a clinical study in combination with Pexa-Vec and AstraZeneca's checkpoint inhibitors durvalumab and tremelimumab.[19] References1. ^1 {{Cite web|url=http://www.sillajen.com/eng/sub/eng_sub.aspx?s_code=0301000000|title=SOLVE® > TECHNOLOGY > Sillajen|last=INTERNET|first=CENTUM|website=www.sillajen.com|language=ko|access-date=2018-06-17}} 2. ^{{Cite web|url=http://www.sillajen.com/eng/sub/eng_sub.aspx?s_code=0202000000|title=JX-900 Series > PIPELINE > Sillajen|last=INTERNET|first=CENTUM|website=www.sillajen.com|language=ko|access-date=2018-06-17}} 3. ^{{Cite journal|last=Zeh|first=Herbert J|last2=Downs-Canner|first2=Stephanie|last3=McCart|first3=J Andrea|last4=Guo|first4=Zong Sheng|last5=Rao|first5=Uma N M|last6=Ramalingam|first6=Lekshmi|last7=Thorne|first7=Stephen H|last8=Jones|first8=Heather L|last9=Kalinski|first9=Pawel|date=2015-01-01|title=First-in-man Study of Western Reserve Strain Oncolytic Vaccinia Virus: Safety, Systemic Spread, and Antitumor Activity|journal=Molecular Therapy|volume=23|issue=1|pages=202–214|doi=10.1038/mt.2014.194|issn=1525-0016|pmc=4426804|pmid=25292189}} 4. ^{{cite web|url=http://www.sillajen.com/eng/sub/eng_sub.aspx?s_code=0203000000|title=Development Pipeline > PIPELINE > Sillajen|last=INTERNET|first=CENTUM|website=www.sillajen.com}} 5. ^{{Cite news|url=https://clinicaltrials.gov/ct2/show/NCT02562755?term=pexa-vec&draw=4&rank=3|title=Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone - Full Text View - ClinicalTrials.gov|access-date=2018-06-16|language=en}} 6. ^{{Cite news|url=https://clinicaltrials.gov/ct2/show/NCT02630368?term=pexa-vec&draw=2|title=A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX) - Full Text View - ClinicalTrials.gov|access-date=2018-06-16|language=en}} 7. ^{{Cite news|url=https://clinicaltrials.gov/ct2/show/NCT03071094?term=pexa-vec,+opdivo&rank=1|title=A Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC) - Full Text View - ClinicalTrials.gov|access-date=2018-06-16|language=en}} 8. ^{{Cite news|url=https://clinicaltrials.gov/ct2/show/NCT02977156?term=pexa-vec,+YERVOY&rank=1|title=Immunization Strategy With Intra-tumoral Injections of Pexa-Vec With Ipilimumab in Metastatic / Advanced Solid Tumors. - Full Text View - ClinicalTrials.gov|access-date=2018-06-16|language=en}} 9. ^{{Cite web|url=http://www.sillajen.com/eng/sub/eng_sub.aspx?s_code=0507000000|title=Pexa-Vec Partnerships > PARTNERSHIP > Sillajen|last=INTERNET|first=CENTUM|website=www.sillajen.com|language=ko|access-date=2018-06-16}} 10. ^{{Cite web|url=https://www.prnewswire.com/news-releases/regeneron-and-sillajen-announce-immuno-oncology-clinical-study-agreement-for-combination-treatment-in-kidney-cancer-300452718.html|title=Regeneron and SillaJen Announce Immuno-Oncology Clinical Study Agreement for Combination Treatment in Kidney Cancer|last=Inc.|first=Regeneron Pharmaceuticals,|website=www.prnewswire.com|language=en|access-date=2018-06-16}} 11. ^{{Cite web|url=https://bciq.biocentury.com/companies/jennerex_biotherapeutics_inc|title=Jennerex Biotherapeutics Inc|website=BioCentury – BCIQ|language=en|access-date=2018-06-17}} 12. ^{{Cite news|url=https://www.businesswire.com/news/home/20131125006331/en/SillaJen-Announces-Agreement-Acquire-Jennerex|title=SillaJen Announces Agreement to Acquire Jennerex, Inc.|access-date=2018-06-17|language=en}} 13. ^{{Cite web|url=https://www.prnewswire.com/news-releases/sillajen-announces-agreement-with-the-fda-for-a-special-protocol-assessment-for-upcoming-phase-3-pexa-vec-trial-in-advanced-liver-cancer-300066952.html|title=SillaJen Announces Agreement with the FDA for a Special Protocol Assessment for Upcoming Phase 3 Pexa-Vec Trial in Advanced Liver Cancer|last=Inc.|first=SillaJen,|website=www.prnewswire.com|language=en|access-date=2018-06-17}} 14. ^{{cite web|url=http://www.cogib.kr/0403.php|title=글로벌첨단바이오의약품|website=글로벌첨단바이오의약품}} 15. ^{{Cite web|url=https://www.bloomberg.com/quote/215600:KS|title=215600:KOSDAQ Stock Quote - SillaJen Inc|website=Bloomberg.com|access-date=2018-06-17}} 16. ^{{Cite news|url=http://www.theinvestor.co.kr/view.php?ud=20161206000557|title=Sillajen shares dip below IPO price on market debut|access-date=2018-06-17|language=en}} 17. ^{{Cite web|url=http://investor.regeneron.com/releasedetail.cfm?releaseid=1025264|title=Regeneron and SillaJen Announce Immuno-Oncology Clinical Study Agreement for Combination Treatment in Kidney Cancer (NASDAQ:REGN)|website=investor.regeneron.com|language=en|access-date=2018-06-17}} 18. ^{{Cite web|url=https://www.prnewswire.com/news-releases/sillajen-and-lees-pharmaceutical-announce-approval-by-the-china-cfda-to-commence-phase-3-clinical-trial-for-oncolytic-immunotherapy-pexa-vec-in-liver-cancer-300492124.html|title=SillaJen and Lee's Pharmaceutical Announce Approval by the China CFDA to Commence Phase 3 Clinical Trial for Oncolytic Immunotherapy, Pexa-Vec, in Liver Cancer|last=Inc.|first=SillaJen,|website=www.prnewswire.com|language=en|access-date=2018-06-17}} 19. ^{{Cite web|url=https://www.prnewswire.com/news-releases/sillajen-announces-collaboration-with-the-national-cancer-institute-for-development-of-combination-therapy-with-sillajens-pexastimogene-devacirepvec-pexa-vec-oncolytic-immunotherapy-300505741.html|title=SillaJen Announces Collaboration with the National Cancer Institute for Development of Combination Therapy with SillaJen's pexastimogene devacirepvec (Pexa-Vec) Oncolytic Immunotherapy|last=Inc.|first=SillaJen,|website=www.prnewswire.com|language=en|access-date=2018-06-17}} External links
1 : Biotechnology companies of South Korea |
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