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Vaccines: OncoPep’s FDA Orphan Drug Designation For Multiple Myeloma

October 27, 2014

This is the second Blog Post in a series that reviews FDA Orphan Drug Designations (ODDs) for vaccines.

OncoPep, founded in 2010, is developing targeted immunotherapeutics for oncology indications. OncoPep’s proprietary core technology, licensed from the Dana Farber Cancer Institute, uses:

“ … a unique combination of proprietary peptides to form a therapeutic cancer vaccine. Vaccines developed from this technology are designed to stimulate the patient’s immune system to attack his or her cancer through an optimized combination of disease-specific peptides and adjuvants (substances that stimulate the immune system).

OncoPep’s lead investigational candidate, PVX-410, is a 4-peptide cancer vaccine designed to target specific antigens found on the surface of Multiple Myeloma (MM) cancer cells. PVX-410 receives FDA Orphan Drug Designation (ODD) in June 2013 for this indication. The company is initially developing PVX-410 for the treatment of Smoldering MM (SMM), a precursor to MM.

MM is a blood cancer that affects plasma cells. It is the second most common blood cancer:

•   13% of all hematologic cancers
•     1% of all cancer deaths
•    Median survival is 7-8 years
•    Currently no cure
•    In 2013,about 22,350 new cases were diagnosed (American Cancer Society).

OncoPep is financed by angel groups, individuals, family foundations, and the Leukemia & Lymphoma Society (LLS). In August 2014, OncoPep raises $6.9 million Series B financing to advance novel cancer vaccines and to expand the Phase I/IIa PVX-410 clinical trial  for SMM.

FDA ODD Database For OncoPep’s MM Vaccine

Generic Name: Multi-peptide cancer vaccine
Trade Name: n/a
Date Designated: 06-23-2013
Orphan Designation: Multiple Myeloma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: OncoPep, Inc. 520 Boston Street North Andover, MA 01845



International Myeloma Foundation (IMF)

Leukemia & Lymphoma Society (LLS)

Multiple Myeloma Research Foundation (MMRF)

The Myeloma Beacon.

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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