Just after the close on Tuesday the United States’ Centers for Disease Control and Prevention (CDC) confirmed the first infection of Ebola Zaire in a patient currently held in strict isolation at a hospital in Texas. A number of Ebola-related stocks are getting continued attention in pre-market trading on Wednesday, including Tekmira Pharmaceuticals (TKMR), Hemispherx Biopharma (HEB), and Sarepta Therapeutics (SRPT).
The individual left Liberia on September 19 and flew into the United States the following day. They developed symptoms on September 24, sought care and were released on the 26th, and were re-admitted and isolated at Texas Health Presbyterian Hospital on Sunday, September 28.
To date, there appear to be three developmental therapeutics that have been used and possibly shown efficacy in humans: Tekmira’s (TKMR) TKM-Ebola, Mapp Bio’s zMapp, and Fujifilm’s Avigan. Although the chances of a large-scale outbreak in the United States are low, and we continue to see the true business opportunity for an Ebola product as small, our view is that the urgency for securing a stockpile of an effective Ebola therapeutic has increased. Best poised to secure a US Department of Defense (BARDA) stockpiling contract would be a company that has demonstrated strong efficacy in preclinical models, safety in humans, and the ability to scale manufacturing.
Tekmira has an edge: the company is already developing TKM-Ebola with DoD funding, an established channel to the government agency. Although we have yet to see summarized outcomes in humans, the current Ebola situation provides an opportunity for developers to observe a therapeutic – traditionally developed under the Animal Rule – in affected humans. TKM-Ebola has been administered to a number of individuals infected with Ebola, including Dr. Sacra, who recovered from the virus after receiving TKM-Ebola and convalescent serum (blood and antibodies from a compatible individual who recovered from Ebola infection). The company is considering a controlled clinical trial in Africa (according to analysts at RBC), to begin yet this year.
Below, we summarize why we view Tekmira as the leading contender if BaRDA moves forward with a stockpiling agreement:
- Robust evidence of safety and efficacy in Ebola Zaire non-human primate models
- Encouraging signs of safety in single ascending dose portion of TKM-Ebola phase I clinical trial
- Potential signs of efficacy in Ebola-infected humans
- In-house cGMP manufacturing with ability to manufacture more TKM-Ebola ‘within months’
Of note: Avigan is an FDA approved drug and has shown some intriguing data in mouse models supporting its use in Ebola; it’s worth keeping an eye on.
Read more about Tekmira in PropThink’s previous coverage.
One or more of PropThink’s contributors are long TKMR, SRPT.
