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NCCN Announces First Patient Dosed in NCCN-Peregrine Pharmaceuticals Collaborative Study of Bavituximab

An NCCN ORP-funded study, examining effectiveness of bavituximab combination in patients with newly diagnosed glioblastomas, enrolled its first patient at Dana-Farber Cancer Institute in Boston, Massachusetts.

[FORT WASHINGTON, PA — September 7, 2017] Glioblastoma is the most common malignant primary brain tumor and is a uniformly fatal disease with five-year survival rates less than four percent despite aggressive treatment with surgery, radiation, and chemotherapy.1 Consequently, new therapies for this patient population are desperately needed.

The National Comprehensive Cancer Network® (NCCN®) today announced the dosing of the first patient in its Oncology Research Program (ORP)-funded study to investigate the effectiveness of bavituximab with radiation and temozolomide in patients with newly diagnosed glioblastomas.

The study, initiated by Elizabeth Gerstner, MD, Massachusetts General Hospital Cancer Center, is one of three studies funded through a collaboration between NCCN ORP and Peregrine Pharmaceuticals—this patient marks the first enrollment into an NCCN ORP-funded investigator-initiated bavituximab trial.

“NCCN ORP congratulates Dr. Gerstner and Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center for initiation of this study, as well as the other investigators who will soon embark on their research of bavituximab in patients with cancer,” said Susan Most, MBA, RN, Director, Clinical Operations, NCCN ORP. “The fact that Peregrine Pharmaceuticals has entrusted the NCCN ORP with these investigator-initiated studies is an honor, and we are happy that patients at our esteemed institutions will have access to this novel immunotherapy.”

The following researchers received funding through a grant from Peregrine Pharmaceuticals:

  • Elizabeth Gerstner, MD, Massachusetts General Hospital Cancer Center, “Phase II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma”
  • Jessica Frakes, MD, Moffitt Cancer Center, “A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for First Line Treatment of Unresectable Hepatocellular Carcinoma”
  • Ranee Mehra, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, “Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck”

Drs. Frakes and Mehra will begin enrolling patients in the coming months.

“We are hopeful that results from this trial, as well as from the two additional studies at NCCN Member Institutions, will continue to support our belief that bavituximab works to create a more immune active tumor microenvironment in which other therapies are able to have a greater anti-tumor effect,” said Joseph Shan, MPH, Vice President, Clinical and Regulatory Affairs of Peregrine. “We look forward to following this important study at the Massachusetts General Hospital Cancer Center, as well as the planned trials at the Moffitt Cancer Center and The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.”

Bavituximab is an investigational immune-modulatory monoclonal antibody that targets phosphatidylserine (PS), a phospholipid that inhibits the ability of immune cells to recognize and fight tumors.  Bavituximab is believed to reverse PS-mediated immunosuppression by blocking the engagement of PS with its receptors, as well as by sending an alternate immune activating signal.2 According to Peregrine, PS-targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses. This mechanism may play an important role in allowing other cancer therapies to more effectively attack tumors by reversing the immunosuppression that limits the impact of those treatments.

Importantly, bavituximab has also demonstrated a favorable safety and tolerability profile across several clinical trials conducted to date, which may offer the compound a key advantage as the evolving cancer treatment landscape continues to shift to a combination therapy approach. 

The awardees responded to a Request for Proposals issued by ORP to the NCCN Member Institutions and their affiliate hospitals. Submissions were peer reviewed by the NCCN Bavituximab Scientific Review Committee. The funded concepts were selected based on several criteria, including scientific merit, existing data, and the types of studies necessary to further evaluate the efficacy of bavituximab.

NCCN ORP draws on the expertise of investigators from NCCN Member Institutions and their affiliated hospitals to facilitate all phases of clinical research. The research is made possible by collaborations with pharmaceutical and biotechnology companies in order to advance therapeutic options for patients with cancer.

For more information about NCCN ORP, visit NCCN.org/ORP.

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About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.

The NCCN Member Institutions are: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children’s Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.

Clinicians, visit NCCN.org. Patients and caregivers, visit NCCN.org/patients. Media, visit NCCN.org/news.

 

 

1CBTRUS (2008) Statistical report: primary brain tumors in the United States, 2000-2004. Central Brain Tumor Registry of the United States.

2Yin Y, Huang X, Lynn KD, Thorpe PE. Phosphatidylserine-targeting antibody induces M1 macrophage polarization and promotes myeloid-derived suppressor cell differentiation. Cancer immunology research 2013 Oct; 1(4): 256-268.

 

 

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives. For more information, visit NCCN.org.

The NCCN Member Institutions are:

  • Abramson Cancer Center at the University of Pennsylvania
  • Fred & Pamela Buffett Cancer Center
  • Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute
  • City of Hope National Medical Center
  • Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center
  • Duke Cancer Institute
  • Fox Chase Cancer Center
  • Huntsman Cancer Institute at the University of Utah
  • Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  • Mayo Clinic Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Moffitt Cancer Center
  • The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute
  • Roswell Park Comprehensive Cancer Center
  • Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
  • St. Jude Children's Research Hospital/The University of Tennessee Health Science Center
  • Stanford Cancer Institute
  • University of Alabama at Birmingham Comprehensive Cancer Center
  • UC San Diego Moores Cancer Center
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • University of Colorado Cancer Center
  • University of Michigan Rogel Cancer Center
  • The University of Texas MD Anderson Cancer Center
  • University of Wisconsin Carbone Cancer Center
  • Vanderbilt-Ingram Cancer Center
  • Yale Cancer Center/Smilow Cancer Hospital