| SillaJen, Inc. | |
| Native Name: | 신라젠 |
| Native Name Lang: | ko |
| 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 (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) |
| Num Employees: | ~100 |
| Subsid: | SillaJen Biotherapeutics Inc. |
SillaJen, Inc. is a South Korea-based biotechnology company, with offices in Busan, Yangsan and Seoul, South Korea, and San Francisco, California.
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.
JX-900 (VVDD):[2] VVDD Platform: Next-gen enhanced oncolytic immunotherapy.[3]
As of June 2018, these are the clinical trials investigating Pexa-Vec.[4] [5] [6] [7] [8]
| 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 SA | NCT03071094 |
| Solid Tumors | I | Recruiting | Combined with Ipilimumab | Investigator | NCT02977156 |
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]
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]