RE:RE:Accelerated Approval
Jaro1977 wrote: I think that is good for us. Even if we don't hit 67% we would be higher than Ketruda cr% (which I beleive is 12-17% for a certian cancer). Remeber, even though the first 12 patients doses were screwed up by as much as 84-137% we still, STILL somehow had a cr of 25%. amazing
To be honest, Keytruda isn't even on my competition list based on their suboptimal response rates. However, Anktiva (formerly known as N-803 under privately-owned co. ImmunityBio) will be our primary competitor based on their 72% CR & reported probability of a 42% durable response rate (rate at 12 months). ImmunityBio reverse merged with Nasdaq-listed NantKwest in 12/2020, & I believe a BLA filing could happen later this year. The compound had also received a BTD in late 2019 based on promising Ph 1 data.
So, we definitely have to continue to aim high & always keep our eyes on both front & rear-view mirrors. With optimized treatments, TLT could certainly achieve a comparable or better % CR & durable response imo.
A big advantage of Theralase's ACT is the fact that the treatment protocol is so much simpler with only two treatments. It ultimately will be significantly less expensive & likely achieve relatively higher treatment compliance. Anktiva, which is "combined" with BCG & given via bladder instillation in BCG-unresponsive patients, requires multiple induction & maintenance treatments (too many to count & treatments continue for beyond 1 year). This drug is also being studied in combination with BCG for "BCG-naive" patients.
If all goes well, we will still be in the driver's seat based on our simpler, optimized protocol. Best case scenario, we become the gold standard for BCG-unresponsive NIMBC. Worst case scenario, we share the driver's seat & become the gold standard combo or adjuvant therapy for this particular indication. JMHO. GLTA...