PRR's CancerVac vaccine appears as though it may be very much more effective than BioMira's vaccine when comparing the respective phase 1B trial results. Both vaccines are based on the MUC1 antigen. While the delivery is different the mechanism of action is identical.
The incremental effectiveness of PRR's vaccine is, I think, probably explained by the fact that PRR's vaccine does not have the complication of liposome delivery.
But, and this is the exciting part, BioMira has made a real breakthrough with its own vaccine (BLP-25). In its recent phase 2B trial, survival in non-resectable lung cancer was shown to have doubled for patients on the vaccine as against best supportive care. But, catch this, as at the end of last year, median survival had not been reached in the vaccine arm - that is, median-survival is still running (23 months and counting for the vaccine arm vs 13 months flat for the control).
We won't know the final result until we have the data from the protocol-specified survival update at the end of this year. But investors should realise that the survival data already generated is simply outstanding.
Avastin, by contrast, despite the hype, only increased survival in lung cancer by a couple of months (note that the finding that Avastin was effective in lung cancer has put on billions in terms of market cap for Genentech). BioMira, however, has achieved a paradigm-shifting extension of survival in this illness (10 months so far, a virtual doubling of survival). This result simply has no equal.
European oncologists presented with BioMira's data at the ESMO conference last year were awestruck variously describing the results as a "Breakthrough" and "Groundbreaking".
Moreover, the Canadian Health regulator (Health Canada) is prepared to consider an early marketing application for BioMira's vaccine on the strength of the phase 2B data.
Note that the FDA has also broken with tradition and allowed BioMira to run a phase 3 trial for this vaccine in a sub-set of patients from the phase 2B trial. Moreover, the FDA has fast-tracked the vaccine for the treatment of stage 3A lung cancer patients despite there being no data as to whether the vaccine is effective in this patient cohort (the phase 2B trial included stage 3B and stage 4 patients only).
This, perhaps, indicates that the FDA is also very impressed with the results from BioMira's phase 2B trial. It is likely that the change in FDA policy reflected in BioMira's phase 3 trial protocol is a product of the FDA's Critical Path Initiative which is designed to accelerate drugs to market.
Note that these antigen-based cancer vaccines have almost zero toxicity while there is patent unmet need in the indications in which they are likely to be effective. This also bodes well for an accelerated path to market as the FDA's risk tolerance for new therapies is inversely related to the seriousness of the disease being treated. But this is only logic. Where you have terminally ill patients the risks that accompany the granting of access to experimental therapies pale in comparison to the gravity of the disease itself.
What does this mean for PRR?
BioMira has done a deal with Merck KGAA on its own cancer vaccine. The deal means that BioMira shares in 50% of US revenues and keeps the Canadian revenues for itself while Merck gets the balance of world-wide rights. In the case of BioMira's option over the CancerVac technology, there is no deal with Merck to consider. Apart from the royalty payment to CancerVac this vaccine is proprietary for BioMira - it retains world-wide rights for itself. Clearly, BioMira faces a diffential incentive to get PRR's vaccine to market with haste.
Now this MUC1 antigen is over-expressed on a very wide range of cancers. Of the 1.3m tumours diagnosed in the US annually, some 800,000 over-express MUC1. This means that PRR's vaccine is likely to be effective in these cancers also.
BioMira is already talking about using PRR's CancerVac vaccine in combination therapy with its own vaccine (BLP-25) despite the fact that PRR's vaccine is currently in trials for ovarian cancer. This indicates that BioMira believes PRR's vaccine will be effective in lung cancer also. Note that lung cancer is an absolutely huge market (174,000 new cases expected in the US alone next year).
My view is that its almost certain that BioMira will elect to excercise its option over the CancerVac technology. To allow the option to expire would be to relinquish rights to a vaccine that BioMira has already proved to be effective - I cannot see this happening.
Moreover, the CancerVac vaccine comes on the heels of both BioMira's and Dendreon's cancer vaccines. These two companies have, in effect, trail-blazed the regulatory path for immunotherapeutic cancer vaccines in advance of PRR's candidate.
The great thing about the recent European Patent grant is that should BioMira need Merck KGAA on side to fund development there is now every incentive for Merck to take an interest in the development - as the European rights to the technology are secure.
When you factor for what this CancerVac vaccine is likely to be worth, further allow for the FC-receptor technology being evaluated by AstraZeneca and Zymogenetics, and allow for the unbelieveable laboratory results from both the second-generation nano-vaccine and the monoclonal antibodies, PRR appears to be screaming buy at these prices.
Moreover, the company has ample cash which is critical in this climate.
Whichever way you twist it, this biotech has some of the best fundamentals in the market.
My view only.
Dogbark.
PRR Price at posting:
0.0¢ Sentiment: LT Buy Disclosure: Held
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