Shares of Tekmira are up over 15% midday on news the FDA has authorized the company to provide the drug TKM-Ebola for treatment of subjects with confirmed or suspected Ebola virus infections under expanded access protocols. Tekmira has long been the subject of speculation over approval of its drug for the treatment of Ebola. The stock has risen about 70% in the last 3 months.
President and CEO Dr. Mark J. Murray says a framework for use of TKM-Ebola in multiple patients has been established with regulators in the United States and Canada. The FDA has granted expanded access use of TKM-Ebola under Tekmira’s IND. Health Canada has established a similar framework. The drug has been administered to several patients. Repeat infusions have been well tolerated.
Dr. Murray notes that drug supplies are limited. This will likely limit the number of patients Tekmira will be able to treat. Keep in mind the expanded access program does not constitute a controlled clinical trial, and is being conducted under a partial clinical hold.
All supplies of the first investigational drug given to patients, ZMapp, made by Map pharmaceuticals were quickly exhausted.
Amgen today announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for its investigational bispecific T cell engager (BiTE), blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
If approved, blinatumomab will be a first of its kind bispecific antibody, originally developed by Micromet. It is designed to simultaneously bind T-cells to cancerous B-cells, leading to tumor cell killing. This new immunotherapy has received both orphan drug and breakthrough therapy designation from the FDA for the treatment of ALL.
Even as Amgen is seeking Accelerated Approval on positive Phase II results, the filing has been a long time coming. When Micromet was acquired by Amgen in January 2012, it already had 4 ongoing studies in ALL, 3 of which were in Phase 2.
Author has no position in stocks mentioned