Pfizer’s upcoming PD1 and India/Danish BCG?
Just some thoughts.
NWBO stated they have a (unnamed) backup for their DCVax-Direct ingredient (Merck’s) TICE BCG (only about one million doses made each year). I assume, but do not know, it could be India’s (makes almost a billion doses per year) or Denmark’s respective form of BCG. NWBO has stated it has demonstrated its backup is equivalent.
Interestingly, in the pivotal Pfizer Phase 3 CREST trial, Sasanlimab combined with BCG reduced the risk of event recurrence or death by 32% compared to BCG alone in patients with high-risk, BCG-naïve non-muscle invasive bladder cancer (NMIBC).
If approved this spring, it would be the first PD-1 inhibitor this approved for BCG-naïve patients (patients who haven't tried BCG yet). Keytruda (Merck) is currently only approved for BCG-unresponsive patients (those who already failed BCG). This allows Pfizer to jump ahead of Merck and treat patients earlier.
Sasanlimab is subcutaneous (a quick injection under the skin), whereas Keytruda requires an IV infusion. This is a massive selling point for urology clinics that don't want to deal with IV chairs.
By rationing TICE, Merck may have forced NWBO to look elsewhere.
Is Pfizer helping? Yes, by generating the massive clinical data set that proves to the FDA "Non-Merck" BCG is safe and effective, paving the regulatory road for NWBO to use Indian/Danish supply.
Is Indian BCG better? For NWBO’s specific purpose (waking up immune cells), it is very likely equivalent or superior to TICE.
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