MabVax Therapeutics Initiates Phase II Clinical Trial of Vaccine to Prevent Recurrent Sarcoma

SAN DIEGO, July 22 /PRNewswire/ -- MabVax Therapeutics Inc., a privately held clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address the unmet medical need of preventing recurrent cancer, announces that the first patients have been enrolled in a Phase II clinical trial aimed at assessing the efficacy and safety of its vaccine to prevent or delay the recurrence of sarcoma. The clinical trial will enroll 126 metastatic sarcoma patients, 16 years or older in a randomized, multicenter, double-blind Phase II study of a trivalent vaccine specifically developed to target and kill residual circulating cancer cells and micrometastases thought to cause recurrent cancer.  

In the United States (US), there are approximately 13,200 sarcoma cases diagnosed each year, representing less than 1% of all new cancers.  Prognosis remains poor, with more than 5,200 patients in the US dying of disease each year.  As in other malignancies, disease recurrence and metastasis are common in sarcoma.  Despite undergoing potentially curative surgical resection or combination therapy, the majority of these patients with recurrent sarcoma die as a result of further recurrences.  The addition of chemotherapy to surgical resection has not shown to improve outcome in adult patients with sarcoma. Thus, in the majority of cases, the current standard of care following treatment of metastatic disease and the achievement of disease-free status is expectant management.

The vaccine is a trivalent ganglioside vaccine administered with an immunological adjuvant in a series of 10 subcutaneous injections given over an 84-week period.  The vaccine is intended to instruct the patient's immune system to make antibodies against the three ganglioside antigens present on the surface of sarcoma cells.  The antibodies will then seek out and kill the residual circulating cancer cells and micrometastases with the objective of preventing disease recurrence.  The vaccine was developed at Memorial Sloan-Kettering Cancer Center (MSKCC) where preclinical and early clinical development work was completed in 2009.  MabVax exclusively licensed the sarcoma vaccine, along with additional vaccines targeting other neuroectodermal and epithelial cancers, from the Sloan-Kettering Institute for Cancer Research in 2008.  

MabVax has recruited 12 leading academic medical centers across the country as investigative sites to conduct the Phase II clinical trial.  MabVax expects enrollment to require approximately 15 months. The primary objective is to determine the 1-year Progression Free Survival Rate in patients with metastatic sarcoma who are without evidence of disease and who are treated with the vaccine plus adjuvant or with the adjuvant alone.  Secondary objectives are to determine Overall Survival, Disease Free Survival, and Disease Specific Survival, along with Progression Free Survival at the 3-year time point.  MabVax has engaged Clinsys Clinical Research, Inc. as the contract clinical research organization to help it manage the study.

Patients who would like additional information are directed to the website clinicaltrials.gov where more details can be found.

About MabVax Therapeutics, Inc.

MabVax Therapeutics, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address the unmet medical need of preventing recurrent cancer. The company was formed to exploit key aspects of the work of Dr. Philip Livingston and colleagues at MSKCC who have developed cancer vaccines against gangliosides and other carbohydrate antigens that are the most extensively expressed antigenic targets on the cell surface of certain cancers. The company believes that passively administered or vaccine induced antibodies against selected tumor cell surface antigens are ideally suited for eradication of free tumor cells and micrometastases that remain after initial treatment and cause cancer recurrence.  The company plans to commercially develop distinct vaccines against several different types of cancer over the coming years.  Concurrently, MabVax is leveraging the ongoing Phase I and Phase II clinical programs utilizing the licensed vaccines to create a pipeline of monoclonal antibody products based on the protective immune responses generated from patients who have been successfully immunized against targeted cancers. The company is based in San Diego, CA. MabVax has closed two Series A rounds of venture financing in February 2008 and August of 2009.  

SOURCE MabVax Therapeutics Inc.