Lankenau Institute for Medical Research is 1st site in U.S. for trial of novel cryoimmune cancer therapy
Wynnewood, PA — Lankenau Institute for Medical Research (LIMR), part of Main Line Health, is the first clinical trial site in the United States for a novel investigational therapy aimed at treating advanced and metastatic prostate cancer, which has limited treatment options and often a high mortality rate.
The phase 2a LEGION-100 trial seeks to evaluate the safety and effectiveness of the SYNC-T/SV-102 combination therapy for treating metastatic castration-resistant prostate cancer (mCRPC) and to identify the maximum tolerated dose. This type of late-stage cancer does not or has stopped responding to hormone therapy.
Syncromune, Inc., a company with ties to LIMR, developed SYNC-T. It is a combination immunotherapy that uses a novel approach to treating mCRPC. First, a probe is inserted directly into the primary or metastatic tumor to freeze a portion of it. The freezing causes the tumor cells to rupture, releasing cellular contents that help to activate the immune system. Next, SV-102, a combination of four immunologic agents, is infused directly into the area that was frozen to heighten the immune system's ability to eradicate cancer cells not only at the treated site but also at other sites throughout the body.
In a phase 1 trial of the combination therapy, 11 of 13 patients responded to treatment. Five patients had a complete response, meaning every tumor visible through imaging was eradicated, while the other six patients had a partial response. This broad response in a limited number of metastatic prostate cancer patients with advanced disease compares favorably to other known or experimental treatments.
“We are proud to be the first site in the country to offer this clinical trial to our patients,” said George Prendergast, PhD, President and CEO of LIMR and a member of Syncromune’s Scientific Advisory Board. “If this treatment proves successful, it will open up the door for a new treatment approach for advanced cancers. Freezing a portion of a tumor appears to stimulate the immune system and works synergistically with the subsequent injection of four immunotherapeutic agents. The combination functions to empower the immune system to identify and attack cancer wherever it may have metastasized.”
The phase 1 trial initial results prompted the American Association for Cancer Research to select Charles J. Link, MD, a LIMR Adjunct Professor and Co-Founder and Executive Chairman of Syncromune, to present the data at its 2024 annual meeting.
In the presentation, Dr. Link explained that SYNC-T is designed to simultaneously stimulate the immune system and block immune suppression. The therapy aims to activate T-cells to proliferate and circulate throughout the body, destroying cancer cells.
“By infusing the drugs directly into the tumor, we are hopeful that the relatively small doses will effectively target cancer cells with minimal side effects,” Dr. Link said.
Lankenau Medical Center medical oncologist Arezoo Ghaneie, MD, will lead the trial at LIMR as principal investigator. Ricky Tong, MD, an interventional radiologist at Lankenau Medical Center, part of Main Line Health, will participate in data analysis for the trial. Gregory McMahon, DO, a urologist, will help lead the trial at LIMR as well.
LIMR faculty members Margaretha Wallon, PhD, Ned Carp, MD, and Jennifer Sabol, MD, and Robin Ciocca, DO, of Main Line HealthCare have been working to further define the mechanisms of the cryoimmune therapy. Their critical research showed that destruction of cancer cells occurred at the tumor site as well as throughout the body.
For more details about the trial and contact information, please visit the LIMR website. Visit the U.S. online database for the national LEGION-100 page.
Disclosure: LIMR President and CEO George Prendergast is paid for his services on Syncromune’s Scientific Advisory Board.
About Lankenau Institute for Medical Research
Lankenau Institute for Medical Research (LIMR) is a nonprofit biomedical research institute located on the campus of Lankenau Medical Center and is part of Main Line Health. Founded in 1927, LIMR's mission is to improve human health and well-being. Using its ACAPRENEURIALTM model that integrates academic and entrepreneurial approaches, faculty and staff are devoted to advancing innovative new strategies to address formidable medical challenges including cancer, cardiovascular disease, tissue regeneration, gastrointestinal disorders and autoimmune diseases such as diabetes and arthritis. LIMR's principal investigators conduct basic, preclinical and clinical research, using their findings to explore ways to improve disease detection, diagnosis, treatment and prevention. They are committed to extending the boundaries of human health through technology transfer and training of the next generation of scientists and physicians.