SAN DIEGO, Sept. 25, 2014 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (OTCQB: TELKD), a clinical stage oncology drug development company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company's vaccine intended for the treatment of the childhood cancer neuroblastoma. In the U.S., the designation carries significant incentives for the development of drugs to treat rare and difficult diseases. The Company is preparing to commence a Phase 2 clinical trial with the vaccine in 2015. MabVax's neuroblastoma vaccine is a bivalent vaccine that elicits an antibody response targeting the two most common antigens on neuroblastoma cells with the objective of killing residual cancer cells that can cause recurrence.
Neuroblastoma is a rare extracranial solid tumor cancer in childhood with only about 650 to 800 cases diagnosed each year in North America. Approximately 90% of neuroblastoma patients are younger than 5 years at diagnosis and the cancer is responsible for 12% of all cancer deaths in children less than 15 years of age. In particular, 60% of children diagnosed with neuroblastoma after 1 year of age have high-risk disease and less than half of these patients are cured even with the aggressive multi-modal regimens currently in use. Patients who relapse typically die from their disease. Children who do survive, especially those who received multimodality therapy, face severe long-term outcomes, such as blindness, hearing loss, paralysis, and learning disabilities.
J. David Hansen, Chief Executive Officer of MabVax, said, "There is a significant medical need to develop new therapies aimed at preventing recurrent disease in this childhood cancer. The orphan drug designation provides MabVax with substantial development incentives such as exclusivity, tax credits, PDUFA fee exemptions, and the opportunity to apply for grants to offset clinical expenses. The designation also allows the Office of Orphan Products Development and MabVax to collaborate more closely to facilitate development of the vaccine."
The results of a Phase I trial with the neuroblastoma vaccine conducted at Memorial Sloan-Kettering Cancer Center were published recently in Clinical Cancer Research. The study report describes a highly encouraging study result with a small cohort of difficult to treat patients who had repeatedly relapsed prior to treatment with MabVax's vaccine. The vaccine is intended to be given to patients with relapsed or recurrent high-risk neuroblastoma in remission or with limited residual disease after best available treatment. The vaccine is intended to elicit a targeted immune response that can kill the remaining cancer cells that can cause disease recurrence.
MabVax has already received a $125,000 Phase 1 Small Business Innovation Research Grant (SBIR) from the National Cancer Institute (NCI) to support the manufacture and testing of the neuroblastoma vaccine. The Company is expecting to finalize the manufacturing and testing of the vaccine before the end of 2014. MabVax has also received a $400,000 grant from the Solving Kids Cancer Foundation/ Neuroblastoma Children's Cancer Alliance UK for a modified Phase I trial to test the addition of an immunostimulatory agent to the treatment regimen.
About MabVax
MabVax Therapeutics Holdings, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company's proprietary vaccines.. The therapeutic vaccines were developed at MSKCC and are exclusively licensed to MabVax Therapeutics. MabVax has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials in addition to the neuroblastoma vaccine program. MabVax merged with Telik, Inc. on July 8, 2014 and is currently evaluating development programs that were under way at Telik prior to the merger, in addition to plans to continue developing the existing pipeline at MabVax. Additional information about the Company is available at www.mabvax.com.
Forward Looking Statements
This press release contains "forward-looking statements" regarding matters that are not historical facts, including statements relating to the development of therapeutic agents with MSKCC, the clinical development programs, and the merger with Telik, Inc. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "anticipates," "plans," "expects," "intends," "will," "potential," "hope" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon current expectations of the Company and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in Telik's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its annual report on Form 10-K for the fiscal year ended December 31, 2013 and in the Proxy Statement dated July 25, 2014, as amended and supplemented from time to time and Telik's quarterly report on Form 10-Q for June 30, 2014. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
SOURCE MabVax Therapeutics Holdings, Inc.
For further information: David Hansen, President and CEO, 11588 Sorrento Valley Road, Suite 20, San Diego, CA 92121, 858-259-9405, [email protected]; Investors: Stephanie Carrington, ICR, 646-277-1282, [email protected]