Immunity Bio Biologics Licence Application to FDAThis 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 4
1% 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