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Orphan Drug Designation: Vaccine For Childhood Cancer Neuroblastoma

September 26, 2014

MabVax Therapeutics Holdings Inc. is a San Diego-based biopharmaceutical company developing vaccine and monoclonal antibody-based therapeutics for the treatment of cancer. MabVax Therapeutics announces September 25th that the FDA grants Orphan Drug Designation (ODD) to the company’s vaccine for the treatment of childhood cancer neuroblastoma. The company’s vaccine is developed at Memorial Sloan-Kettering Cancer Center (MSKCC), New York City, and exclusively licensed to MabVax Therapeutics.

Neuroblastoma is:

“ … a very rare extracranial solid tumor cancer in childhood with only about 650 – 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 …”

MabVax Therapeutics is planning on starting a Phase II clinical trial with the vaccine in early 2015.

FDA ODD Database Record For MabVax Therapeutics

Generic Name: MV-NB-02, its bivalent ganglioside vaccine consisting of GD2-lactone and GD3-lactone each covalently conjugated to keyhole hemocyanin
Trade Name: n/a
Date Designated: 09-23-2014
Orphan Designation: Treatment of Neuroblastoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: MabVax Therapeutics, Inc. 11588 Sorrento Road Suite 20 San Diego, CA 92121 The sponsor address listed is the last reported by the sponsor to OOPD.

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MabVax Therapeutics Business Developments

•   Merged with Telik Inc. in July 2014

•   Receives $125,000 Phase I Small Business Innovation Research Grant (SBIR) from the National Cancer Institute (NCI), to support manufacturing and testing of the neuroblastoma vaccine

•   Receives $400,000 grant from the Solving Kids Cancer Foundation/Neuroblastoma Children’s Cancer Alliance UK, for modified Phase I trial testing the addition of an immunostimulatory agent to the treatment regimen

•   Establishment of a relationship with a consortium of 13 academic hospitals that have neuroblastoma treatment programs – New Advances in Neuroblastoma Therapy (NANT).

Please Note : “Vaccine” by John Keith (Photographer) [Public domain, NIH], via Wikimedia Commons | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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