The application is strategically important because Bristol Myers already has a broad combination therapy patent for its CTLA4 inhibitor ipilimumab, which competes with tremelimumab, the Pfizer drug of the same mechanism of action.
In October 2011 AstraZeneca subsidiary MedImmune in-licensed treme from Pfizer. MedImmune assumed global development rights, while Pfizer retained rights for certain combination therapies. To put the backdrop of this in-license deal and the growing Provectus-Pfizer relationship in context, there are several events to consider chronologically:
- The Australia melanoma conference occurred in November 2010,
- Pfizer sought partners for treme in 2010 and 2011,
- Dr. Eagle joined Provectus' corporate advisory board in August 2011, and
- While the Provectus-Pfizer patent was filed in March 2012, its priority data date was October 3, 2011 (the same date, coincidentally, as the MedImmune PR).
Provectus management -- knowing PV-10 and treme's respective mechanisms of action (as well as ipi's) -- saw the opportunity to link PV-10 to the Pfizer drug. As a result, Provectus locked up Pfizer should it decide to launch a treme combination therapy.
There also has been much discussion about combining PV-10 and ipilimumab. We could learn more about this combination when Moffitt releases more data and results, which is inbound and, perhaps, imminent, and Craig speaks at the Society for Immunotherapy of Cancer Annual Meeting in late-October.
Amgen's T-vec or OncoVex and Vical's Allovectin were among those caught in Provectus' combination therapy net. Imagine being scooped by "4 guys from Knoxville." Significant kudos are due Jaimie Singer on this and the synthesis patent applications, among other things she contributes to Provectus.
So, as far as the relationship ("corporate legal," the name business unit line folks may give to the men and women at a corporation's HQ's legal department, hates the word "partnership") goes, we have:
- A patent application filed in March 2012 and made public in September 2012, but likely worked on as late as Spring or Summer 2011, and possibly earlier (i.e., 1H11)
- An industry-wide respected senior oncology executive (respected for both his technical and commercial acumen) in Pfizer's Dr. Eagle added to Provectus' corporate advisory board in August 2011 (i.e., 3Q11), and
- A rumored $7 per share all cash bid for the company by Pfizer in Fall 2011 (i.e., 2H11).
Anything else? Hmmm...
A quick reminder for folks who might be confused, since all these drugs sound the same: Onyx Pharmaceuticals and Bayer's sorafenib (Nexavar) will be combined with PV-10 for the contemplated HCC Phase 2/3 trial and compared with sorafenib alone. Pfizer's sunitinib (Sutent) failed a late stage liver cancer trial when compared to Nexavar.