Theralase Technologies Inc. V.TLT

Immunity Bio Biologics Licence Application to FDA

[Eoganacht]

This month Immunity Bio will submit it's BLA for VesAnktiva Plus BCG for the treatment of BCG unresponsive NMIBC carcinoma in situ. I'm guessing they will be approved as 71% of trial participants achieved a CR and 42% of trial participants maintained a CR at 12 months. This is much better than Merck's Keytruda results of 41% CR at any time and 18.75% at 12 months and these results were enough for FDA approval.

It looks like 42% CR at 12 months will be the results Theralase's treatment must outdo.

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

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

 

“We are excited to announce that the comprehensive compilation of our BLA is essentially written,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “With 71% of the participants in this study having a complete response 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.”

 

About ImmunityBio

 

ImmunityBio is a clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

 

ImmunityBio’s clinical pipeline consists of 26 actively recruiting clinical trials—17 of which are in Phase 2 or 3 development—across 13 indications in liquid and solid tumors (including bladder, pancreatic, and lung cancers) and infectious diseases (including SARS-CoV-2 and HIV). Anktiva™, ImmunityBio’s lead cytokine fusion protein, is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).

 

The company has established GMP manufacturing capacity at scale with cutting-edge cell manufacturing expertise and ready-to-scale facilities, as well as extensive and seasoned R&D, clinical trial, and regulatory operations, and development teams. For more information, please visit: www.immunitybio.com

[Rumpl3StiltSkin]

Yeah Eoga, TLT should have no problem beating 42% CR at 1 yr. But even if it were 30% Most Docs might just push this to many patients since it is so safe, non-toxic and only takes a 3-4 hour treament once every 6 months. Sure going through this treatment is an ordeal but so are the umpteen Immunity Bio's treatments.

[Tapps21]

With all the recent literature it has left me and probably others confused and anxious. There seems to be many companies after the golden grail and up until recently I thought we were in the clear and just waiting for BTD leading to commercialization to be granted. I still have deep faith we will move forward with NMIBC and other indications but the wait is agonizing to say the least.  I

[Eoganacht]

In my opinion we'll do much better than 42% at 12 months. Also, Immunity Bio went from 71% CR to 42% CR in the space of 9 months. I think the Theralase treatment will be more likely to maintain a durable response.

[DJDawg]

I find that the survival curves for Immunity bio data suggest continuous fall off with time. They are not like some where everyone who is going to be cured is cured and the relapsers have relapsed. It looks lke the % just keeps dropping off the further out you go. From the 12 m mark, 50% of the remaining paitients fall off by 24m. Slide 12 of the Feb presentation.