Breaking Barriers: PHASE ONE Funds Promising Immunotherapy Research for Metastatic Pancreatic Cancer
PHASE ONE Foundation has awarded Dr. Arsen Osipov at Cedars-Sinai Medical Center $370,240 to fund a Phase I/Ib trial aiming to sensitize pancreatic cancer to immunotherapy.
Pancreatic cancer is one of the deadliest and most aggressive forms of cancer and is on track to become the second leading cause of cancer-related mortality within the next decade.
51% of pancreatic cancer cases are diagnosed at the advanced stage when the cancer has already metastasized, with most patients succumbing to the disease within the first year after diagnosis, despite treatment.
While surgical removal of the tumor is currently the most effective method for curing this type of cancer, the likelihood of the cancer returning is high, around 80%. In cases where the cancer does recur, systemic therapy, which involves treatment that travels throughout the body, is the only viable option.
Given the challenges posed by the resistant nature of this cancer to existing treatments, there is a pressing need for innovative therapeutic strategies to improve patient outcomes.
To address this, Dr. Arsen Osipov and his team at Cedars-Sinai are investigating a new treatment approach for this difficult-to-treat cancer. Their focus lies in understanding and altering cellular dynamics within the pancreatic tumor microenvironment (TME), transitioning it from a “cold” immune cell barren tumor environment to a “hot” immune abundant one.
Dr. Osipov's team has identified a promising avenue for unlocking the full potential of immunotherapy by blocking a unique protein in the TME, known as C-X-C chemokine receptor 4 (CXCR4).
In the Phase I/Ib trial, researchers plan to combine Balixafortide, a best-in-class CXCR4-targeting drug, with a novel FDA-approved immunotherapy, Cosibelimab. Balixafortide has been extensively studied in Phase I-III trials in multiple other tumor types, particularly breast cancer, and has shown to be safe both alone and in combination with chemotherapy. By combining it with immunotherapy, it could prove to be a safe and well-tolerated regimen with significant potential of decreasing metastasis and increasing anti-tumor effect.
The study will evaluate the safety and potential efficacy signal of this combination therapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have experienced disease progression following standard chemotherapy.
“This study is a critical first step of larger approach of reversing the treatment resistant nature of pancreatic cancer. What we learn in this study will lead to larger combination immunotherapy trials. None of this could be possible without the support of the PHASE ONE Foundation, and for this our team and our patients are forever grateful” –Arsen Osipov, MD, FACP, Assistant Professor, Program Lead, Pancreas Cancer Multidisciplinary Clinic and Precision Medicine Program, Cedars Sinai
This study will also incorporate significant translational science to understand the biology behind the tumor and the impact of these drugs on the TME using tumor biopsies combined with artificial intelligence to better understand treatment resistance and response in PDAC.
Since joining Cedars-Sinai in 2020, Dr. Osipov started the first Pancreatic Cancer Multi-Disciplinary Center on the West Coast, allowing for patients to receive same day scans, see all specialists, receive a treatment plan, and get connected to clinical trials in just one day—transforming a process that typically takes patients four weeks into just four hours.
“Time is of the essence when you have pancreatic cancer, and Dr. Osipov's exciting research in conjunction with the multi-disciplinary center will allow for faster accrual into the trial, offering renewed hope to patients in dire need of new treatment options.” –Marc Lebowitz, PHASE ONE Granting Co-Chair
This is a critical study offering a new form of potentially effective therapy to patients with limited treatment options. If successful, this trial could lay the groundwork for future studies exploring multiple treatments targeting various aspects of the TME. This has the potential to overcome pancreatic cancer's resistance, potentially changing the landscape of its treatment across all stages of the disease and offering a new avenue of hope for all pancreatic cancer patients.
To learn more, click here to watch a video conversation with Dr. Arsen Osipov.