SillaJen Announces First Patient Enrolled in Part 2 of Renal Cell Carcinoma Trial with Pexa-Vec in Combination with Regeneron's Libtayo® (cemiplimab-rwlc)
- Category: DNA RNA and Cells
- Published on Friday, 07 June 2019 09:41
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SAN FRANCISCO, CA, USA and SEOUL, South Korea I June 6, 2019 I SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, announced the first patient has been enrolled in Part 2 of JX594-REN026, a Phase 1b clinical trial of Pexa-Vec (pexastimogene devacirepvec) in combination with Libtayo®(cemiplimab-rwlc), for the treatment of renal cell cancer (RCC). Enrollment of Part 1 (dose-escalation phase) of the trial was completed in March 2019 without significant safety concerns, and the first seven patients in Part 2 were enrolled in South Korea, with expansion to sites in the United States and Australia anticipated over the coming weeks.
SillaJen is collaborating with Regeneron to evaluate Pexa-Vec, SillaJen's lead clinical candidate, in combination with Regeneron's Libtayo®, an anti-PD1 monoclonal antibody Regeneron is developing in collaboration with Sanofi. The aim of the trial is to assess the safety and efficacy of the combination in patients with unresectable or metastatic renal cell carcinoma. The study will also investigate the immune modulating potential of Pexa-Vec given concurrently with checkpoint inhibitor therapy by evaluating multiple blood and tissue biomarkers.
"We are encouraged to see positive safety data from the dose escalation phase of the REN026 study. Part 2 of this study is designed to reinforce the rationale of Pexa-Vec in combination with Libtayo®," stated Francis Hyukchan Kwon, M.D, Ph.D., chief medical officer at Sillajen.
About Pexa-Vec and the SOLVE™ Platform
Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program, and over 300 cancer patients have been treated with Pexa-Vec to date. Pexa-Vec was engineered to target common genetic defects in cancer cells by deleting their thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express granulocyte-macrophage colony stimulating factor (GM-CSF) protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack. Pexa-Vec has been shown to be effective when delivered both intratumorally and systemically by intravenous administration. Pexastimogene devacirepvec (Pexa-Vec) is currently being evaluated in a worldwide Phase 3 clinical trial for advanced primary liver cancer, and more information can be found at: http://www.pexavectrials.com.
SillaJen, Inc. is a South Korean based biotechnology company headquartered in Busan South Korea, with satellite offices in Seoul, South Korea and San Francisco, CA. The company is focused on the development and commercialization of oncolytic immunotherapy products using the SOLVE™ platform, including its lead product Pexa-Vec, which is currently in Phase 3 trials for the treatment of advanced primary liver cancer. Additional information about SillaJen is available at www.sillajen.com.
This press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans and projections regarding the Company's financial position, results of operations, market position, product development and business strategy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and SillaJen undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.