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Vaccines: FDA Orphan Drug Designations From Immune Response BioPharma

October 13, 2014

 

 

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

Two vaccines receive FDA ODD in February 2014 from the same company, Immune Response BioPharma Inc. (IRBP), for the following two indications:

•   Pediatric HIV/AIDS

•   Pediatric Multiple Sclerosis (MS).

I – PEDIATRIC MULTIPLE SCLEROSIS

IRBP announces in February 2014, that the company’s vaccine NeuroVax is granted FDA ODD for Pediatric MS. NeuroVax is a first-in-class disease modifying, once a month dosing therapeutic vaccine. NeuroVax is a T-Cell Receptor (TCR) peptide vaccine made from three peptides:

•   BV5S2
•   BV6S5
•   BV13S1.

These 3 peptides are overabundant in MS patients. ”The 3 TCRpeptides combined in NeuroVax correspond to one or more TCRgene families which are over expressed in 90% of MS patients.” NeuroVax receives FDA Fast Track designation for SPMS (Secondary-Progressive) MS in March 2014. The following clinical trials have been announced (but are not yet recruiting):

•   Pediatric MS (Phase I trial).

•   SPMS (2 Phase IIb trials)

FDA ODD Record For NeuroVax

Generic Name: T cell receptor (TCR) peptide (BV5S2, BV6S5, BV13S1) vaccine
Trade Name: NeuroVax
Date Designated: 02-06-2014
Orphan Designation: Treatment of Pediatric Multiple Sclerosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Immune Response BioPharma, Inc. 244 5th Avenue Suite 1727 New York, NY 10001 The sponsor address listed is the last reported by the sponsor to OOPD.

 

II – PEDIATRIC HIV/AIDS

Also in February 2014, IRBP announces that the company’s vaccine, REMUNE, receives FDA ODD for pediatric HIV/AIDS.  REMUNE is a first-in-class, quarterly dosing therapeutic vaccine. Here are recent FDA regulatory activities for IRBP’s REMUNE vaccine:

•   FDA grants a SBA (Summary of Basis For Approval) BLA (Biologics License Application) Fee Waiver (April 2014)

•   IRBP announces it will seek FDA Breakthrough Designation (May 2014)

•   IRBP announces that it will seek FDA Approval for Expanded use for HIV Monotherapy (July 2014)

•   IRBP announces it will develop an in-house sales-force for the vaccine’s commercialization (August 2014) once the FDA approves the BLA application.

It is interesting to note that on IRBP’s Press Release website, the following two Press Releases are “pending” :

•   10/15/14 => IRBP files REMUNE FDA IND & Protocol for FDA Breakthrough Therapy Designation (BTD) for pediatric HIV/AIDS vaccine

•   11/15/14  => IRBP files FDA BLA for REMUNE HIV/AIDS vaccine marketing approval for therapeutic HIV/AIDS vaccine.

FDA ODD Record For REMUNE

Generic Name: REMUNE HIV 1
Trade Name: n/a
Date Designated: 02-14-2014
Orphan Designation: Treatment of pediatric HIV/AIDS (age through 16 years)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Immune Response BioPharma, Inc. 1801 Atlantic Avenue Suite 8352 Atlantic City, NJ 08401 The sponsor address listed is the last reported by the sponsor to OOPD.

 

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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