SillaJen, Inc. Native name
신라젠 Formerly Jennerex , IncCompany type Public KOSDAQ: 215600 Industry Biopharmaceuticals Founded 2003 Headquarters , Number of locations
4 (South Korea, USA) Area served
Worldwide Key people
SillaJen, Inc:
Eun-Sang Moon(Chairman , President , and CEO ) Myung-Suk Song(CFO ) , Hyun-Pil Shin(Chief Strategy Officer )
SillaJen, Biotherapeutics:
Helena H. Chaye(CBO ),
Georg Roth (COO ),
James M. Burke(CMO ) Products Pexa-Vec (JX-594) Number of employees
~100 Subsidiaries SillaJen Biotherapeutics Inc. Website www .sillajen .com
SillaJen, Inc. is a South Korea-based biotechnology company, with offices in Busan , Yangsan and Seoul , South Korea, and San Francisco , California .
Technology
Pexa-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 trials
Pexa-Vec (JX-594)
As of June 2018, these are the clinical trials investigating Pexa-Vec.[ 4] [ 5] [ 6] [ 7] [ 8]
Partnerships
SillaJen has partnered with Transgene , Green Cross , and Lee's Pharmaceuticals and clinical collaboration agreements with Regeneron Pharmaceuticals and the US National Cancer Institute for JX-594.[ 9] [ 10]
History
2003 . 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]
References
^ a b INTERNET, CENTUM. "SOLVE® > TECHNOLOGY > Sillajen" . www.sillajen.com (in Korean). Retrieved 2018-06-17 .
^ INTERNET, CENTUM. "JX-900 Series > PIPELINE > Sillajen" . www.sillajen.com (in Korean). Retrieved 2018-06-17 .
^ Zeh, Herbert J; Downs-Canner, Stephanie; McCart, J Andrea; Guo, Zong Sheng; Rao, Uma N M; Ramalingam, Lekshmi; Thorne, Stephen H; Jones, Heather L; Kalinski, Pawel (2015-01-01). "First-in-man Study of Western Reserve Strain Oncolytic Vaccinia Virus: Safety, Systemic Spread, and Antitumor Activity" . Molecular Therapy . 23 (1): 202– 214. doi :10.1038/mt.2014.194 . ISSN 1525-0016 . PMC 4426804 . PMID 25292189 .
^ INTERNET, CENTUM. "Development Pipeline > PIPELINE > Sillajen" . www.sillajen.com .
^ "Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone - Full Text View - ClinicalTrials.gov" . Retrieved 2018-06-16 .
^ "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" . Retrieved 2018-06-16 .
^ "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" . Retrieved 2018-06-16 .
^ "Immunization Strategy With Intra-tumoral Injections of Pexa-Vec With Ipilimumab in Metastatic / Advanced Solid Tumors. - Full Text View - ClinicalTrials.gov" . Retrieved 2018-06-16 .
^ "Pexa-Vec Partnerships" . www.sillajen.com . Archived from the original on 2017-11-04. Retrieved 2018-06-16 .
^ Inc., Regeneron Pharmaceuticals. "Regeneron and SillaJen Announce Immuno-Oncology Clinical Study Agreement for Combination Treatment in Kidney Cancer" . www.prnewswire.com . Retrieved 2018-06-16 .
^ "Jennerex Biotherapeutics Inc" . BioCentury – BCIQ . Retrieved 2018-06-17 .
^ "SillaJen Announces Agreement to Acquire Jennerex, Inc" . Retrieved 2018-06-17 .
^ Inc., SillaJen. "SillaJen Announces Agreement with the FDA for a Special Protocol Assessment for Upcoming Phase 3 Pexa-Vec Trial in Advanced Liver Cancer" . www.prnewswire.com . Retrieved 2018-06-17 .
^ "글로벌첨단바이오의약품" . 글로벌첨단바이오의약품 .
^ "215600:KOSDAQ Stock Quote - SillaJen Inc" . Bloomberg.com . Retrieved 2018-06-17 .
^ "Sillajen shares dip below IPO price on market debut" . Retrieved 2018-06-17 .
^ "Regeneron and SillaJen Announce Immuno-Oncology Clinical Study Agreement for Combination Treatment in Kidney Cancer (NASDAQ:REGN)" . investor.regeneron.com . Retrieved 2018-06-17 .
^ Inc., SillaJen. "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" . www.prnewswire.com . Retrieved 2018-06-17 .
^ Inc., SillaJen. "SillaJen Announces Collaboration with the National Cancer Institute for Development of Combination Therapy with SillaJen's pexastimogene devacirepvec (Pexa-Vec) Oncolytic Immunotherapy" . www.prnewswire.com . Retrieved 2018-06-17 .
External links