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SillaJen
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SillaJen, Inc. is a South Korea-based biotechnology company, with offices in Busan, Yangsan and Seoul, South Korea, and San Francisco, California.

Key Information

Technology

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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

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Pexa-Vec (JX-594)

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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

Partnerships

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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

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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

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