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Monday, July 28, 2014 6:04:59 PM
With 50% legion regression and 40% viral clearance, BP knows the addition of IL-12 will greatly enhance CIN 2/3 results. What if BP doesn’t want to partner P3 without an adjunct. What if BP wants the entire HPV product line. Wants VGX- 3112 for cervical cancer and CIN2/3, and the rights to H&N and anal.
Partner VGX-3112 for Cervical cancer (P1, P2, P3) and P3 CIN 2/3, rights to Head & Neck and anal. Petition FDA to allow a cross-over to use IL-12 in the P3. Can point to safety profile using IL-12 in the HIV Therapeutic P1. If they need more data, get VGX-3112 P1 done ASAP (maybe why started already). Could also point to the prostate cancer P1 safety data when available, as well as the ONCS DNA-based IL-12 safety profile using electroporation.
Cash up front, milestone payments for cervical cancer, and start of P3 CIN 2/3, and of course healthy royalties for the product line. INO uses the cash to proceed with the development of the rest of their extensive pipeline, which includes a universal cancer vaccine and large markets for contagious diseases, mAbs, other immune activators and checkpoint inhibitors.
The key to this is the “cross-over” of course. Can anybody add some color here?
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