TKM-PLK1 in the context Alny opt in rights and litigation
The last comments about PLK1 results were that they were expected to be released before years end 2011. They have usually delivered on such timelines and this is slightly unusual for them. I wanted to start a discussion of this relating to Alnylmas opt in rights and litigation as I believe this has played a factor.
Some context based on my understanding:
As part of the deal that allowed tekmira license to Alnylams InterfeRx IP picks (PLK1 included) and allowed Alnylam access to Tekmiras LNP delivery technology, Alnylam has opt in rights of 50% of the development and commercialization to the PLK1 program that must be exercised before the start of phase II trials.
Alnylam has 2 similar products of its own in ALN-VSP and ALN-VSPII. They have the same desired outcome with but with different targets than PLK1. VSP showed very positive results in phase I but it was using an older LNP delivery technology. VSPII is based on the newer LNP formulation but has not completed phase I trials yet. Last conference call they fielded some questions as to the fate of each as it would be assumed VSPII would fair better in terms of safety. The key question was, "are you going to wait for results of VSPII or go ahead right away to phase II with VSP?" They basically said they were undecided. As it stands now, VSP is not being advanced into phase II and is listed as waiting to partner. This indicates a "wait and see" approach.
Given they have significant opt in to Tekmiras very similar PLK1 program, in my view they would like to have the data from phase I before making a decision on how to best use their money - VSPI, VSPII or PLK1. It paints a clear picture on how to best allocate their resources.
As I posted on earlier this week, targeting PLK1 has many advantages. It is a valid target for other cancers including breast cancer. Also, the PLK1 program can be reach tumor tissues outside the liver - very exciting. The potential is bigger for PLK1 and if it returns good results Alnylam may want to opt in.
Im not implying that alnylam would abandon VSP I & II if they exercised their rights to opt in, but it would sure help to have a complete picture before any decision is made. I think Tekmira knows this and is holding off on the information as a tool at the bargaining table. It is my belief that Alnylam has probably informally offered to buy out Tekmira in the litigation at terms that were unacceptable to Tekmira. This could be another tool in the chest to put pressure on them.
There are certainly other valid reasons why we don't have results, but its something to consider and digest.
ALNY can opt in with the start of phase 2, as it stands now both companies don't have the money to do this, or at least, better options.
VSP has other problems, I suggest you look at the litigation. ALNY has better programs already with less risk.
I expect TKMR to just continue the phase 1 and if there are signs that the target is right and interesting they will probably do another phase 1 with a new generation LNP, and probably with a partner. But maybe by that time TKMR is no longer.
You are incorrect regarding the timeline for the PLK trial results. Tekmira has said it will release data in the first qtr. 2012, and you can confirm this with Tekmira IR if you are doubtful. David Sandler