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Tekmira CEO Discusses Ebola Therapy Development at 2014 BIO Investor Forum

October 7, 2014
Today at the 13th Annual BIO Investor Forum, Tekmira CEO Dr. Mark Murray participated in a conversation with Phyllis Arthur, BIO’s Senior Director for Vaccines, Immunotherapeutics, and Diagnostics Policy. Tekmira has been in the spotlight recently due to their experimental Ebola therapy, TKM-Ebola. Recently, they announced that FDA has allowed them to provide TKM-Ebola for treatment under expanded access protocols, and that they have joined an international consortium to conduct clinical trials of Ebola virus therapeutics in West Africa.

Tekmira is a platform development company trying to harness a cellular mechanism called RNA interference (RNAi) to meet unmet medical needs. RNAi is a mechanism that exists inside mammalian cells that cells use to eliminate unwanted proteins. Tekmira has developed a way to harness that mechanism by delivering into cells molecules which will trigger the elimination of a protein or agent in the cell. With TKM-Ebola, they deliver into the cell two trigger molecules that lead to the destruction of proteins that the virus needs for replication, throwing a wrench into the viral replication process.

Dr. Murray emphasized that Tekmira is not a biodefense company, although early this year they had established a separate division within the company specifically committed to working on medical countermeasures (MCMs), because the funding, regulatory pathway, and commercialization process for MCM products is very different from the main areas of their business.

Discussing the possibility of clinical trials for TKM-Ebola, Dr. Murray noted that there are opportunities as well as significant challenges in the present environment. On the one hand, it is very rare to have an outbreak in which it is possible to test infected patients with an experimental therapy. On the other hand, the FDA needs to have a control group in the trials. Another difficulty is that the medical system in West Africa has been brought to its knees by the current crisis. These “ethical considerations and practical realities” are very difficult to address.

They have been relying on experts at the World Health Organization, many of whom have significant experience in dealing with outbreaks, as well as conversations with the FDA to guide their development plans, as they want to ensure that any trial design is acceptable to FDA and would result in data which they would be able to interpret.

When asked what advice he would have for companies considering entering this space, Dr. Murray warned that it is “shark infested water” and to tread carefully. In many cases, your partner or funder (if it is a government agency) will have a completely different culture from what you are trying to create in your business. You will also be faced with skeptical investors whom it will be difficult to convince that there is a clear commercial value in the space. Companies will need to be aware that there are special concerns and be prepared to address them.