FDA Breakthrough Therapy: TaiMed Biologics’ HIV And Atara Biotherapeutics’ T-Cell Therapy
The FDA recently grants 2 FDA Breakthrough Therapy Designations (BTDs):
• TaiMed Biologics’ Ibalizumab for HIV/AIDS
• Memorial Sloan Kettering Cancer Center (MSKCC) and Atara Biotherapeutics’ EBV-CTL, T-Cell Therapy for complications tied to bone marrow transplants.
I – TaiMed Biologics’ Ibalizumab For HIV/AIDS
TaiMed Biologics, a Chinese biotechnology company, receives last week, the FDA BTD for Ibalizumab (TMB-355) for the treatment of HIV/AIDS. WuXi PharmaTech, TaiMed Biologics’ Shanghai-based manufacturing partner, plans on filing a rolling FDA Biologics License Application (BLA). The FDA approved Ibalizumab in May 2014 for the treatment of patients on expanded access.
This is the first Chinese drug to receive a FDA BTD. No Asian company has received a FDA BTD, except for Japan’s Takeda Pharmaceutical, which receives in December 2014, a FDA BTD for Ixazomib, for the treatment of relapsed or refractory systemic light-chain Amyloidosis (AL).
Ibalizumab is a humanized monoclonal antibody (mAb) and part of an emerging class of HIV therapies known as viral-entry inhibitors. The drug works by binding to the CD4 molecule, the primary receptor for HIV infection, thereby interfering with the penetration of the virus into the cell. It is the first entry-blocking humanized mAb to treat HIV/AIDS. If Ibalizumab is approved by the FDA, it will be the first biologic product manufactured in China to be launched in the US market.
II – MSKCC And Atara Biotherapeutics T-Cell Therapy
On March 2nd, Atara Biotherapeutics and partner MSKCC, announce that the FDA BTD is granted to Atara Biotherapeutics’ optioned cytotoxic T lymphocytes activated against Epstein-Barr Virus (EBV-CTL). This is for the treatment of rituximab-refractory, EBV-associated lymphoproliferative disease (EBV-LPD), a type of malignancy occurring after allogeneic hematopoietic cell transplantation (HCT). Allogeneic HCT is also commonly called a bone marrow transplant.
In September 2014, Atara Biotherapeutics, a San Francisco-based company, forms an alliance with MSKCC for developing and commercializing allogeneic T-Cell therapies for the treatment of certain cancers and viral infections. Atara Biotherapeutics executes a $55 million IPO in October 2014.
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