tmrw more News additionally to Figs&Fins to be expected!
CEO Kirkman´s last Conference from 5th of June was promising:
...PX-866 to point out that we are still conducting Phase II trials with this product and that the two randomized trials in squamous cell carcinoma of head and neck are expected to readout close to the end of this year. So, there is a lot going on.
Our pipeline remains quite full. And let me turn the floor upto talking a little bit about our most recent transaction with. So I think this is just an overview on those slide and positive on breast cancer. This is probably a pretty familiar territory with most of you. We all know that this is a highly validated target in breast cancer. It's treated both with multiple antibody approaches and with small molecule approaches of which have relatively modest single agent activities but works quite well in combination.
...ARRAY 380 has demonstrated significantly improved activity compared to other HER2 targeting small molecule and getting into the brain and in treating metastatic disease in that area. So here is just some of the I am going to show you three preclinical data slides, I am going to show you the clinical data data that we have with us and then I will describe the collaboration that we put in place last week. So what you can see on this slide are the IC50 data for ARRAY380, for neratinib and for the approved agent Apatinib and you can see that we've very potent HER2 inhibitor essentially equivalent to neratinib but we don't inhibit EGFR at all. There is about 500 full difference we believe in the potential side effect profile for this compound.
...Once we get done with the proof-of-concept studies then it's a joint development program thereafter in which we're going to share costs, that cost there is a mechanism for us to recoup the money we put at risk in this program through asymmetric cost sharing in Phase 3 and later on in sharing profits. ARRAY does have overall responsibility for commercialization. Oncothyreon has a 50% co-promote right in the U.S and we have the 50-50 profit share in the U.S. Outside of the U.S we have structured this as a very significant royalty that's designed to be the economic equivalent of the 50-50 sharing that's easier from a lot of perspectives to manage particularly if we end up with the marketing partners.
...And I would love to give you a definitive answer to that question. My partner for this product Merck Serono is in the process of discussing these data with regulatory authorities both in the U.S and Europe meeting with a lot of key opinion leaders. Lot of that happens this at ASCO and making a determination about what they are going to do next, if anything.
They are continuing all of the other trials with this product. So there is another Phase III trial in Asia called the INSPIRE trial that's being modified to only include concurrent chemoradiation. There is a completely enrolled Phase II trial in Japan which has about 170 patients there almost all of them hadconcurrent chemoradiation that probably will read out some time late next year or early the following year.
...I believe that before that my partner will have made their decision about what they are going to do to go forward I do think that this data provides strong validation of the validity of more quality target for intervention with the therapeutic vaccine non-small cell lung cancer and in that regard again that Oncothyreon has wholly owned the follow on vaccine to.
It's something we call ONT-10 talk about this previously. This is also vaccine, targeted vaccine, it has a somewhat different, it's a little bit bigger, it's quite, it has proprietary adjuvant. LBLP25 uses MPL from the adjuvant and is proprietary to us and is a fully synthetic for agonist which we think as a number of advantages and mile systems that we've presented to you before we know that in comparison to LBLP25 we see -- to antibody response to ONT-10 which is not a problematic part of the immune response to LBLP25.
..We think the LBLP25 data that was presented yesterday at ASCO do validate MUC1 as a target and for intervention with the therapeutic vaccine with our highly clinically relevant and statistically significant survival advantage in a very large group of patients. We are waiting for Merck Serono to announce the next step and I can't give you a definitive timing on that today. In the meantime, we are moving ahead as rapidly as we can with the follow on vaccine, ONT-10 , which is in terms of its adjuvant and its improved mechanism.
We will have additional data for our PI-3 kinase inhibitor late this year and have lung cancer which is our preclinical data showed the best results. We are adequately and well funded at the moment but we reported cash of just under $77 million at the end of Q1. We gave guidance for this year that we're going to spend about 30 million, $30 million to $33 million. We are on track for that in the first quarter and with the collaboration we announced with ARRAY for this for ARRAY380 requires us to change that guidance for the current year.
