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SU2C-Lustgarten Pancreatic Cancer Convergence Dream Team Progress Update

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SU2C-Lustgarten Pancreatic Cancer Convergence Dream Team Progress Report

Transforming Pancreatic Cancer to a Treatable Disease

Funding: $8 million

Leader: Elizabeth M. Jaffee, MD, Johns Hopkins University School of Medicine
Co-Leader: Robert H. Vonderheide, MD, DPhil, University of Pennsylvania


Fast Facts on Pancreatic Cancer:

  • As the fourth leading cause of cancer death in the United States, pancreatic cancer remains one of the most deadly forms of cancer.
  • About 70 percent of people diagnosed with pancreatic cancer die within one year of diagnosis.
  • The overall 5-year relative survival for pancreatic cancer for 2005-2011 was 7.2 percent. (SEER)

Fast Facts on Prevention Tips:

  • Tobacco use is the most important avoidable risk factor for pancreatic cancer, accounting for up to 30 percent of the cases.
  • Exercise lowers the risk of pancreatic cancer. Obese people and those who have limited physical activity are more likely to develop exocrine pancreatic cancer.
  • Individuals who consume 3 or more drinks of hard liquor a day are more likely to die of pancreatic cancer.

 

Project Background

Pancreatic ductal adenocarcinoma (PDA) is resistant to most forms of therapy and is one of the most deadly types of cancer. The environment that surrounds cancer cells is referred to as the tumor microenvironment, and studies in mice and humans have shown that the PDA tumor microenvironment has unique characteristics that are thought to limit how well treatment works. By understanding the obstacles that prevent the tumor from responding to treatments, it should be possible to develop therapeutic agents to eliminate these barriers resulting in the effective treatment of PDA.

Cancer immunotherapy based on immune cells called T cells has shown promise for the treatment of a variety of cancer types and was hailed as “Breakthrough of the Year” in 2013 by the journal Science. Despite its emerging promise, clinical efforts for immune therapy in PDA have lagged behind. Recent advances in PDA mouse models and in technologies to study cancer-associated immune processes at tumor sites have revealed that major anti-PDA immune responses can occur if anti-tumor T cell- generating approaches are combined with drugs that block the tumor’s ability to suppress immune function. Based on promising initial clinical trials, this Dream Team’s goal is to “re-program” the tumor microenvironment to fuel clinically meaningful anti-cancer immune responses in patients with PDA.

The Dream Team will use a “convergence” approach by bringing together leading individuals in the fields of immunotherapy, genetics, informatics, biostatistics, regulatory/clinical trials, cancer biology, and pathology. This group of experts will apply their efforts toward understanding and treating PDA.

The Dream Team will conduct clinical trials using a combination of drugs and establish what molecules, or biomarkers, can be measured as a read out of tumor microenvironment reprogramming. Trials will focus on new ways to reverse immune suppressionin the tumor, either in combination with a vaccine that activates anti-cancer T cells or with chemotherapy. These trials will also establish a national PDA biobank for identification of immune biomarkers. Laboratory studies in mice will be conducted to establish novel multi-agent approaches and to develop biomarkers that will drive the next generation of clinical trials.

Status Update:

6 Month Progress:
During the first 6 months, the Stand Up To Cancer-Lustgarten Pancreatic Cancer Convergence Dream Team have made progress on all of their specific aims.

  • Five pancreatic cancer clinical trials have been designed
  • One clinical trial has begun enrolling patients,
  • One is IRB approved,
  • Three are rapidly moving toward regulatory approval.
  • Biomarker assays, and the associated performance sites, have been established; and a set of standard operating procedures will drive the procurement, processing, and analysis of biosamples across all trials.
  • Standard operating procedures for mouse studies have been established.
  • The computational biology working group, which will help catalog all the data generated by the Dream Team, is being established.

During the next 6 months, the Dream Team will continue the advancement of their five clinical trials. The biomarker development will continue and this group will work with the computational biology group to ensure that the results from the experiment can be shared. This Dream team will also begin the drug combination trials in mice to test new therapeutic approaches.

12 Month Progress:
During the 7-12 month reporting period, the Stand Up To Cancer-Lustgarten Pancreatic Cancer Convergence Dream Team has made progress on all of their specific aims.

  • Five pancreatic cancer clinical trials have been designed
  • Two clinical trials are actively enrolling patients;
  • One is completing the optimization of the drug dosing phase;
  • Two have IRB approval;
  • Secured additional funding to perform an enhanced analysis called RNA-Seq on tumor biopsies from one of the clinical trials before and after patients receives treatment.
  • Assays to measure biomarkers, and tools to analyze the results, were developed.
  • Mouse studies to determine which drug combinations should be tried in humans are currently being conducted.
  • A database to capture the clinical and preclinical data is under development.

During the next 6 months, the Dream Team will continue the advancement of their five clinical trials. Biomarker assays on human specimens will be tested and the samples will ultimately be conducted in batches. The Computational Biology group will continue to work on supporting all groups and pilot their data software for sharing information.

18-month Progress
This Dream Team continues to progress on all subprojects. The major advances within the last 6 months made by this Team are highlighted below.

  • The Team’s five clinical trials, testing one or more agents that have been shown in laboratory studies to alter a novel immune suppressive pathway in PDA, are all open and enrolling patients.
  • One of the studies has banked enough patient samples to begin biomarker identification work.
  • Laboratory studies are being conducted alongside the clinical trials to establish novel combination treatment approaches and to develop biomarkers that will drive the next generation of clinical trials.
  • The Team’s central data repository, LabKey, used for storing clinical, correlative, and laboratory data and protocols is being enhanced and refined.

In the next 6 months, the Team will continue patient enrollment. In addition, patient sample banking will continue to perform analyses.

24-month Progress
This Dream Team continues to progress on all subprojects. The major advances within the last 6 months made by this Team are highlighted below.

  • All five clinical trials are open and actively enrolling patients.
  • Biomarker analyses are underway for all clinical trials and the first dataset should be available this fall and will be released to the public via a scientific journal publication.
  • Laboratory studies are being conducted alongside the clinical trials to establish novel combination treatment approaches and to develop biomarkers that will drive the next generation of clinical trials.
  • The preclinical mouse studies are active and producing data that suggests rational drug combination strategies combining immune checkpoint inhibition with the current drugs that are being tested by this Team.


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