Bavituximab Oncology PDF Print E-mail

About Bavituximab: An Experimental Immuno-Oncology Candidate

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but "flips" and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor. These data detailing the immune-stimulatory mechanism of action of PS-targeting antibodies, such as the company's lead drug candidate bavituximab, are the subject of a manuscript published in the October 2013 issue of the American Association for Cancer Research (AACR) peer-reviewed journal, Cancer Immunology Research . Bavituximab is currently being evaluated in several solid tumor indications, including non-small cell lung cancer, breast cancer, liver cancer and rectal cancer with a trial in advanced melanoma anticipated to initiate in the near future.

Bavituximab has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of second-line non-small cell lung cancer (NSCLC).

Learn about bavituximab's mechanism of action.

SUNRISE Phase III Trial of Bavituximab Launched in Second-Line NSCLC

In December, 2013, we announced the opening to enrollment of the SUNRISE (""Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE II Lung Cancer Study") trial of our lead clinical immunotherapeutic candidate bavituximab at leading oncology centers in the United States. SUNRISE is a pivotal Phase III clinical trial comparing the company's investigational immunotherapy bavituximab plus the chemotherapy docetaxel against placebo plus the chemotherapy docetaxel in patients with second-line non-small cell lung cancer (NSCLC). Patients with stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients will be randomized into 1 of 2 treatment arms. All patients will receive up to six 21-day cycles of docetaxel (75mg/m2) plus weekly infusions of either bavituximab (3mg/kg) or placebo, until progression or toxicity. The primary endpoint of the trial will be overall survival. This trial will enroll approximately 600 patients from more than 100 medical centers worldwide.

This follows reaching agreement with the U.S. Food and Drug Administration (FDA) in May 2013 on the design of the SUNRISE trial which was supported by promising data from a Phase IIb trial in patients treated with bavituximab plus docetaxel.

For additional information about the SUNRISE trial please visit www.SunriseTrial.com or ClinicalTrials.gov using identifier NCT01999673.

 

Clinical Data

2014 Society of Surgical Oncology Cancer Symposium

  • Combination of Bavituximab and Sorafenib Inhibits HCC Growth: Results of Preclinical Data and a Phase I Study. View presentation slides

2013 ASCO Annual Meeting Posters:

  • Randomized, blinded, placebo-controlled phase II trial of docetaxel and bavituximab as second-line therapy in locally advanced or metastatic non-squamous non-small cell lung cancer.
  • Phase I clinical trial of bavituximab and paclitaxel in patients with HER2-negative metastatic breast cancer
  • Randomized, open-label, phase II trial of gemcitabine with or without bavituximab in patients with nonresectable stage IV pancreatic adenocarcinoma.
  • Additional Bavituximab Clinical Data

  • Second-line NSCLC: Final results from our Phase II trial, reported in June 2013, showed an improvement in median overall survival (OS) of 11.7 months in the 3 mg/kg bavituximab plus docetaxel arm compared to 7.3 months in the combined control arm  (docetaxel plus 1 mg/kg bavituximab or placebo) with a persistent separation in the Kaplan Meier survival curves (HR=0.662).  In addition, overall survival subgroup analyses of key patient characteristics favored the bavituximab 3 mg/kg arm, including age, gender, ECOG status, ethnicity and prior treatment.  The results also indicated that the 3 mg/kg bavituximab plus docetaxel combination was well-tolerated with no significant differences in adverse events between the trial arms. Investors are reminded not to rely on clinical data that the company disclosed on or before September 7, 2012 regarding this trial.
  • Front-line NSCLC:: In June, 2013, Peregrine completed an analysis of overall survival (OS) data from its Phase II clinical trial comparing bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in front-line patients with Stage IIIb and Stage IV NSCLC. This analysis, with less than 60% of survival events, indicated that while the bavituximab containing treatment arm currently demonstrates a median overall survival of over 14 months, there was not a meaningful enough difference in survival between the two arms of the trial that would support the advancement of this combination. Full results from the trial will be presented at a future scientific meeting or through publication.
  • Pancreatic Cancer: In June, 2013, we reported results from a randomized Phase II trial of bavituximab plus gemcitabine in patients with non-resectable Stage IV pancreatic cancer. Patients in the bavituximab arm of the trial demonstrated more than a doubling of the overall response rate (ORR) and an improvement in overall survival (OS), including a delayed separation in the Kaplan-Meier survival curve that is commonly seen in clinical studies of promising cancer immunotherapies.
  • Front-line breast cancer: Interim data presented in June 2013 from a Phase I trial evaluating bavituximab plus paclitaxel therapy in patients with HER2-negative metastatic breast cancer (MBC) showed that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response (CR) measured in accordance with RECIST criteria.
  • Second-line breast cancer: In August 2011, we reported promising 20.3 month median OS from a trial evaluating bavituximab in combination with docetaxel. This compares favorably to 11.4 month median OS from a separate historical control trial in a similar patient population using docetaxel alone. Median OS is consistent with earlier encouraging data presented at ASCO 2010, including ORR of 61%, versus historical control data of 41% ORR using docetaxel alone.