Theralase Technologies Inc. V.TLT

BioImmune ... Their path to Breakthrough designation

[ScienceFirst]

BioImmune was granted FastTrack designation in 2017 and Breakthrough designation in December 2019:

The FDA granted Fast Track Designation to the pivotal trial based on Phase I data in 2017.

In December 2019, the FDA granted ImmunityBio Breakthrough Therapy Designation (BTD) based on interim Phase 2 data indicating the primary endpoint of the trial was already met.  (Source: ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in NMIBC)




April 1, 2022, it announced this (note: results have already been posted here earlier):



ImmunityBio Provides Updated Status of Biologics License Application (BLA) for VesAnktiva Plus BCG for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma in Situ

April 01, 2022 04:15 PM Eastern Daylight Time

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that it has achieved a major milestone with over 80 subjects in the QUILT-3.032 study completing at least 12 months of follow-up as of January 14, 2022.

All data for QUILT-3.032, which is studying VesAnktiva™ plus BCG in subjects with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), have been locked and analyzed. The results continue to demonstrate a clinically meaningful benefit that is sustained. The BLA has been compiled and, following final quality review, is expected to be submitted to the U.S. Food and Drug Administration (FDA) this month.
 

 “With 71% of the participants in this study having a complete response(CR) and a median duration of response of 26.6 months, we believe we have a clinically meaningful therapeutic alternative for patients suffering from NMIBC in which the only option remaining is total cystectomy.”

 

[ScienceFirst]

So in about 3 months, BioImmune should receive a FDA approval as per this April 1, 2022 statement: They have more treatments than us and are used in combo with BCG.  The BLA has been compiled and, following final quality review, is expected to be submitted to the U.S. Food and Drug Administration (FDA) this month.  

[ScienceFirst]

More treatments than our 2-doses treatment. From the cllnical trial record: Drug: N-803 and BCG BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment

[LaserStock29]

I remember the sesen comparison before this trial started or a bit after. Anyway I believe this was part of the reasoning behind doing 2 doses. Oh yeah it was the PowerPoint presentation done by the good doctor. Paraphrase. There is medical precedent for 2 doses Theres is also commercial benefit for 2 doses. Aka. $$$. 1 dose might not be attractive enough to say that photodynamic have evolved. 2