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SillaJen

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SillaJen, Inc.
Native name
신라젠
FormerlyJennerex, Inc
Company typePublic
KOSDAQ: 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

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

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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  1. ^ a b 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. ^ "Pexa-Vec Partnerships". www.sillajen.com. Archived from the original on 2017-11-04. 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. {{cite web}}: |last= has generic name (help)
  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. {{cite web}}: |last= has generic name (help)
  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. {{cite web}}: |last= has generic name (help)
  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. {{cite web}}: |last= has generic name (help)
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