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$1.75 viralytics limited

Hope they know what they're doing . Would hate to see all the...

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TassieTwo

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11/07/17

21:03

Post #: 25803534
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Originally posted by Lopez ↑

Hi,
Viralytics thought enough of this to post it on their site.

BGB-A317 is potentially the third PD-1 inhibitor drug and the eighth overall checkpoint inhibitor. Ultimately there will be room for more than one immunotherapy drug, however, the combination with other agents is likely to set their performance apart as well as drive revenues.
If Celgene were to attempt an approval study with BGB-A317 as a monotherapy, by the time a phase III study is completed, it is likely that competitors will have improved survival rates with competing drug combinations. We believe it is unlikely that any monotherapy will have a long term place in the treatment landscape for cancers, hence Celgene cannot simply rely on BGB-A317 alone and expect to capture market share.
The leading combination therapies today are Cavatak (CVA-21) in combination with both Pemrolizumab and Yervoy. Also of interest is Incyte Pharma’s Epacadostat in combination with the same two checkpoint inhibitors.
For Celgene, in our view its first priority is likely to be getting the new drug to market, in any indication. A first approval may be in combination with another agent and in fact this is more likely given the rate of progress in treating the more common cancers over recent years. It’s competitors are already well ahead with studies in a range of cancers and in various combinations, hence we expect Celgene to continue to move with haste.
We hypothesise Viralytics is contemplating an approval study for CVA21 in combination with BMS’s Yervoy in melanoma patients refractory to prior checkpoint therapy. No other combination has shown any interest (or efficacy) in this difficult to treat group. Despite this, Viralytics is not committed to any approval study at this point and in fact has only a handful of patients in the phase 1b MITCI study (7 patients as last reported)1.
In our view, Celgene could do a lot worse than to consider a competing study to MITCI combining BGB-A317 with CVA-21 with a view to having its drug approved in combination with CVA-21 rather than a competitors. This hypothesised study would have to involve Viralytics as there is no other way to get access to CVA21.
The major unknowns – we don’t know what else Celgene has in its drug cabinet to combine with its new PD1. We also don’t know what the efficacy rates are for BGB-A317 as a monotherapy.
Our overall conclusion, subject to the unknown items above, we cannot see any damage to Viralytics competitive position. More optimistically, another buyer for CVA21 has potentially just emerged.
If Celgene were to attempt an approval study with BGB-A317 as a monotherapy, by the time a Phase III trial is complete, the treatment landscape is highly likely to have shifted again

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Hope they know what they're doing . Would hate to see all the good work done over the years unravel if things don't go so well in a new trial . The market can be very unforgiving .

VLA Price at posting: 96.5¢ Sentiment: Hold Disclosure: Held
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