SAN FRANCISCO and SEOUL, South Korea, Feb. 23, 2018 /PRNewswire/ -- SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, presented new renal cell carcinoma (RCC) clinical data at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium last week in San Francisco, CA.
The presentation summarized the single agent activity of Pexa-Vec administered intravenously (IV) on a weekly schedule in patients with metastatic RCC.
A disease control rate (stable disease plus complete response) was achieved in 76 percent of the 17 treated patients. This anti-tumor activity included complete responses (CR) and tumor shrinkage in approximately half of the subjects. Notably, a patient who experienced a CR remains in remission at 5.5 years following treatment. In an exploratory analysis, a subset of patients who benefited from therapy also developed anti-tumor immune responses to known tumor antigens. All patients completed the protocol specified five weekly treatments with 71 percent continuing on to every three week maintenance dosing. The treatment was generally well tolerated with only one patient experiencing a Grade 3 treatment-related adverse event and no patients experiencing Grade 4 or 5 treatment-related adverse events.
"These initial data in heavily pretreated patients with RCC are quite intriguing in that they highlight the ability of Pexa-Vec to elicit reductions in tumor size, including CRs, using intravenous administration while inducing anti-tumor immunity. Our upcoming study of Pexa-Vec plus anti-PD1 antibody REGN-2810 in RCC, which will start this year, will further explore the oncolytic and immunotherapeutic potential of Pexa-Vec," stated James Burke, MD, chief medical officer of 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 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.
SillaJen Forward-Looking Statements:
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.
SOURCE SillaJen, Inc.