First Patient Enrolled in Non-Pharmaceutical Multi-Center, Triple-Negative Breast Cancer Clinical Trial

Blood
Blood Cells

In late May, medical technology company Immunicom enrolled the first of 170 triple-negative breast cancer (TNBC) patients in a clinical trial of Immunopheresis™, a non-pharmaceutical solution for treating stage IV metastatic cancer. The trial is being conducted at the Jagiellonian University Medical College – Hospital in Kraków, Poland.

Awarded Breakthrough Device Designation by the U.S. Food and Drug Administreation (FDA), Immunopheresis™ its new non-pharmaceutical, blood-filtering immunotherapy treatment, with the potential to effectively treat a wide variety of cancer types more effectively and with fewer side effects, including those that have failed response to other treatment approaches.

The technology works by removing cancer-produced proteins that inhibit the body’s natural immune defenses from recognizing and attacking tumors, potentially enabling a patient’s own body to effectively battle the disease.

Elevated levels of specific proteins called soluble TNF receptors (sTNF-Rs) have been found in cancer patients due to their overproduction by tumor tissue. Following observations of cancer patient’s which tumors regressed after plasmapheresis, scientists found that the anti-cancer effects could be specifically attributed to the removal of sTNFRs. sTNF-Rs inhibit immune responses by binding and blocking the activity of TNF, a molecule known for its anti-cancer effect.[1]

Pre-clinical study

In a pre-clinical canine cancer study using a novel single-chain TNF-alphabased affinity column used in combination with a Terumo Optia‘s industry-leading therapeutic apheresis, cell processing and cell collection, platform. In this system blood was pumped into the apheresis system which separated the plasma from their cells by continuous centrifugation.

During each treatment, a column device was placed into the plasma flow line to capture sTNF-Rs from the plasma which was then recombined with the previously separated cells and returned. [2]

In this pre-clinical study, most of the dogs with stage III or IV cancer had failed standard therapeutic approaches. However, the overall results of this pre-clinical study showed that 50–60% of the treated animals treated were observed to have either stable disease or partial responses by RECIST Criteria during treatment with one canine having experienced a complete response with clearance of metastases. In over 300 treatments, throughout the study, the devices appeared to be safe with no adverse events that were attributable to their use. [2]

How it works: Immunicom’s revolutionary blood-filtering technology has the potential to effectively treat a wide variety of cancer types including those that have not responded to other treatment strategies including other drug and biological-based immunotherapy options with possibly fewer side effects.

Clinical trial

In the first randomized, multi-center, TNBC clinical study conducted in Kraków, Poland, scientists compare Immunopheresis alone and its use in combination with low-dose paclitaxel and carboplatin weekly chemotherapy, versus a control arm of low-dose chemotherapy. Clinical trial results, which include endpoints of progression free survival (PFS) and objective response rate (ORR), will be used by Immunicom to pursue global regulatory approvals and European CE marking.

The trial is being conducted under the direction of Principal Investigator, Piotr Wysocki, MD, Ph.D, who serves as Department Head of Oncology at the Jagiellonian University – Medical College Hospital in Krakow and President of the Polish Society of Clinical Oncology. Professor Wysocki is a renowned leader in immunotherapy and breast & genitourinary cancer research having authored more than 100 published textbook chapters and scientific articles.

“I am extremely pleased to serve as the Principal Investigator for this groundbreaking clinical study” Wysocki noted.

“While I continue to see exciting advancements in the field of immuno-oncology, most involve expensive new drug therapies which are financially out of reach for many health systems and patient populations. Every week, patients from all over the Europe who have failed all available treatments are coming to my department looking for last chance therapies such as combinations of metronomic chemotherapy and molecularly targeted approaches, we have been developing for many years. In this context, we hope, Immunopheresis may become the ultimate and universal therapy of choice we have been all waiting for.” Wysocki further noted.

I am really optimistic that the results of this trial will demonstrate Immunopheresis alone or in combination with existing, low-cost, low-toxic standard of care chemotherapy can be an effective, affordable treatment option for TNBC patients,” he added.

According to Amir Jafri, Founder and Chief Executive Officer of Immunicom, said that successfully completing the first patient treatment in this pivotal TNBC study is an incredible milestone for the company. “And, with this trial being the first of multiple international clinical studies planned to begin enrollment in 2019, this achievement demonstrates the strong momentum our organization and outstanding team of partners and advisors have created,” he concluded.

Reference

[1] Immunotherapeutic Plasmapheresis, “Immunopheresis” Josephs SF, Segal R, Panahi M, Ong M, Kunkle M, Howell M, Jafri A, Foster JD, Ogilvie GK. [Poster presentation]

[2] Josephs SF, Ichim TE, Prince SM, Kesari S, Marincola FM, Escobedo AR, Jafri A. Unleashing endogenous TNF-alpha as a cancer immunotherapeutic. J Transl Med. 2018 Aug 31;16(1):242. doi: 10.1186/s12967-018-1611-7. [Article]