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Native name | [신라젠] Error: {{Lang}}: unrecognized language tag: Korean (help) |
|---|---|
| Formerly | Jennerex, Inc |
| Company type | Public |
| KOSDAQ: 215600 | |
| Industry | Biopharmaceuticals |
| Founded | 2003 |
| Headquarters | |
Number of locations | 3 (USA, South Korea) |
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) |
Number of employees | ~100 |
| Subsidiaries | SillaJen Biotherapeutics Inc. |
| Website | www |
SillaJen, Inc. is a South Korean based biotechnology company, with offices in San Francisco, California and Seoul Korea.
Partnerships
[edit]SillaJen has partnered with Transgene, Green Cross, and Lee's Pharmaceuticals and clincial collaboration agreements with Regeneron and the NCI for JX-594.[1][2]
History
[edit]2003. Jennerex, Inc. (San Francisco, USA) was established.[3]
2014. SillaJen acquires Jennerex, Inc.[4]
2015. In April 2015. SillaJen began a Phase 3 clinical trial of Pexa-Vec in Advanced Liver Cancer.[5]
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."[6]
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.[7][8]
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.[9]
In July 2017, SillaJen received approval from the China CFDA to commence phase 3 clinical trial for Pexa-Vec in liver cancer.[10]
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.[11]
Technology
[edit]Pexa-Vec (JX-594) was developed using the SOLVE (Selective Oncolytic Vaccinia Engineering) platform.[12] 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.[12]
JX-900 (VVDD):[13] VVDD Platform: Next-gen enhanced oncolytic immunotherapy.[14]
Clinical trials
[edit]Pexa-Vec (JX-594)
[edit]Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE(Selective Oncolytic Vaccinia Engineering) platform.
As of June 2018, these are the clinical trials investigating Pexa-Vec.[15][16][17][18][19]
| Indication | Phase | Status | Notes | Sponsor | Ref |
|---|---|---|---|---|---|
| Hepatocellular carcinoma | III | Recruiting | Combined with sorafenib | SillaJen | NCT02562755 |
| Solid Tumors | II | Recruiting | Combined with metronomic cyclophosphamide | Investigator | NCT02630368 |
| Renal Cell Carcinoma 2L | I | Recruiting | Combined with REGN2810 | SillaJen | NCT03294083 |
| Colorectal Cancer 2L/3L | I | Recruiting | Combined with PD-L1(durvalumab) and CTLA4(tremelimumab) | Investigator | NCT03206073 |
| Liver Cancer | I | Recruiting | Combined with Nivolumab | Transgene | NCT03071094 |
| Solid Tumors | I | Recruiting | Combined with Ipilimumab | Investigator | NCT02977156 |
References
[edit]- ^ INTERNET, CENTUM. "Pexa-Vec Partnerships > PARTNERSHIP > Sillajen". www.sillajen.com (in Korean). 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.
{{cite web}}:|last=has generic name (help)CS1 maint: extra punctuation (link) CS1 maint: multiple names: authors list (link) - ^ "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.
{{cite web}}:|last=has generic name (help)CS1 maint: extra punctuation (link) CS1 maint: multiple names: authors list (link) - ^ "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.
{{cite web}}:|last=has generic name (help)CS1 maint: extra punctuation (link) CS1 maint: multiple names: authors list (link) - ^ 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.
{{cite web}}:|last=has generic name (help)CS1 maint: extra punctuation (link) CS1 maint: multiple names: authors list (link) - ^ 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.