The CAI is a new, groundbreaking project designed to shorten the time from clinical trial concept to launch using a Lustgarten-developed process based on the best available science and employing cutting-edge biomarkers.
These “smarter” clinical trials will generate large volumes of data that scientists can use now and in the future. Even if a trial fails, the data will be used to inform and improve future clinical trials and expedite new treatments.
The newly formed Translational Advisory Group, led by Chief Medical Advisor Elizabeth Jaffee, M.D., will guide the Clinical Accelerator Initiative by identifying, reviewing and developing the best translational projects to impact patient care in the clinic. This group includes renowned experts who are identifying the most innovative concepts and potential therapeutic approaches for all stages of pancreatic cancer and accelerating the testing of these new concepts.
The Translational Advisory Group is building a network of sites to execute the proposed research in small clinical trials of 10-20 patients each. These science-driven studies could dramatically inform research, enabling investigators to quickly determine if patients are responding to specific treatment approaches and why—information that will help us to continually enhance our approach in clinical trials and ultimately, clinical care.
In FY2020, the Lustgarten Foundation laid the groundwork for the first two trials to be conducted through the CAI. These exciting new clinical trials are focused on improving treatments and outcomes for patients with late-stage pancreatic cancer.
Researchers are working to maximize the response to standard, first-line chemotherapy and to improve patient outcomes by comparing two standard-of-care chemotherapy regimens (Gemcitabine and Abraxane, and modified FOLFIRINOX). For each trial participant, researchers develop an organoid—a 3D cell culture of a patient’s specific tumor—and analyze its genetics, biology and drug sensitivity to determine the most effective chemotherapy regimen for each patient. If successful, this trial can pave the way for the use of organoids to personalize therapies for metastatic pancreatic cancer patients.
The critical organoid work for this trial is being conducted at the newly opened, state-of-the-art clinical testing facility at the dedicated Lustgarten Pancreatic Cancer Research Laboratory at Cold Spring Harbor Laboratory.
Immunotherapies have had limited success in treating pancreatic cancer. Now, however, researchers are focusing on combinations of drugs that may overcome the barriers limiting the effectiveness of these drugs in pancreatic cancer. One example is a trial testing previous research suggesting treatment with a stem-cell mobilizer (Plerixafor) in combination with a PD-L1 inhibitor (Cemiplimab) will activate a patient’s own tumor-killing T cells to shrink pancreatic tumors. This trial has started enrolling patients and will open the door to more promising immunotherapy treatment options for pancreatic cancer patients. The trial is based on research led by Lustgarten-funded Distinguished Scholar Dr. Douglas Fearon.
While 2020 was a daunting year for many—especially for pancreatic cancer patients who needed treatment during a global pandemic— Lustgarten researchers rallied together to continue the progress that’s been made in pancreatic cancer research for patients and their loved ones. Scientists and staff members at our dedicated labs did everything they could to ensure their groundbreaking work continued, from coordinating a complicated tangle of staff schedules and lab space to maintain distance and safety, to handling complex logistics and resources for testing and analysis, to collaborating via email or over Zoom.
Pancreatic cancer research is moving faster than ever before, and Lustgarten-funded researchers are at the forefront of the most promising breakthroughs. The Lustgarten Foundation is the only non-profit to fund five Dedicated Pancreatic Cancer Research Labs, including the newest clinical lab at Johns Hopkins added in 2020. These labs are united in their shared goals of increasing collaboration between world-renowned pancreatic cancer researchers, exploring promising avenues for understanding and treating pancreatic cancer and improving patient outcomes.
The Pancreatic Cancer Collective, a joint initiative of the Lustgarten Foundation and Stand Up To Cancer, is making groundbreaking progress in identifying new ways to treat pancreatic cancer and improving outcomes for patients. The Collective is conducting nearly 30 clinical trials led by more than 400 research investigators at approximately 70 participating institutions.
A new, interactive tool on the Collective’s website, created in 2020, provides details and locations of clinical trials around the country, enabling pancreatic cancer patients and their loved ones to easily find information on current and ongoing research for which they may be a candidate.
Four projects supported by the Collective’s “New Therapies Challenge” grants have made it through the second round of funding, enabling researchers to take potential treatments into clinical trials and accelerate the discovery of new therapeutic options. These innovative ideas represent a bold step forward in helping patients and will support nine new clinical trials, five of which are already underway. The projects are:
Principal Investigators: Alan D’Andrea, M.D. and James Cleary, M.D., Ph.D., both from the Dana-Farber Cancer Institute
Principal Investigators: Robert Vonderheide, M.D., D.Phil., Abramson Cancer Center at the University of Pennsylvania, Elizabeth Jaffee, M.D., Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and Beatriz Carreno, Ph.D., University of Pennsylvania
Principal Investigators: Julie Sutcliffe, Ph.D. and Richard Bold, M.D., both from the University of California, Davis
Principal Investigators: René Bernards, Ph.D., Netherlands Cancer Institute, Hana Algül, M.D., Ph.D., Technical University of Munich and Emile Voest, M.D., Ph.D., Netherlands Cancer Institute
These projects encompass several different approaches, from targeted delivery of radiotherapies (Drs. Sutcliffe and Bold), to vaccines against mutant KRAS, the mutation found in more than 90% of pancreatic cancers (Drs. Vonderheide, Jaffee and Carreno), to combination strategies to address mutations with DNA damage repair deficiencies (Drs. D’Andrea and Cleary), to KRAS activation (Drs. Bernards, Algül and Voest).
The Collective also awarded two grants for computational approaches using artificial intelligence to mimic human reasoning and identify individuals in the general population who are at high risk for pancreatic cancer.