SillaJen

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

SillaJen, Inc.
Native name
신라젠
Formerly
Jennerex, Inc
Public
Traded asKOSDAQ: 215600
IndustryBiopharmaceuticals
Founded2003
Headquarters
Busan
,
South Korea
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)
ProductsPexa-Vec (JX-594)
Number of employees
~100
SubsidiariesSillaJen Biotherapeutics Inc.
Websitewww.sillajen.com

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]

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

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]

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References
  1. INTERNET, CENTUM. "SOLVE® > TECHNOLOGY > Sillajen". www.sillajen.com (in Korean). Retrieved 2018-06-17.
  2. INTERNET, CENTUM. "JX-900 Series > PIPELINE > Sillajen". www.sillajen.com (in Korean). Retrieved 2018-06-17.
  3. 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.
  4. INTERNET, CENTUM. "Development Pipeline > PIPELINE > Sillajen". www.sillajen.com.
  5. "Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone - Full Text View - ClinicalTrials.gov". Retrieved 2018-06-16.
  6. "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.
  7. "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.
  8. "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.
  9. INTERNET, CENTUM. "Pexa-Vec Partnerships > PARTNERSHIP > Sillajen". www.sillajen.com (in Korean). Retrieved 2018-06-16.
  10. 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.
  11. "Jennerex Biotherapeutics Inc". BioCentury – BCIQ. Retrieved 2018-06-17.
  12. "SillaJen Announces Agreement to Acquire Jennerex, Inc". Retrieved 2018-06-17.
  13. 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.
  14. "글로벌첨단바이오의약품". 글로벌첨단바이오의약품.
  15. "215600:KOSDAQ Stock Quote - SillaJen Inc". Bloomberg.com. Retrieved 2018-06-17.
  16. "Sillajen shares dip below IPO price on market debut". Retrieved 2018-06-17.
  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.
  18. 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.
  19. 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.
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