On April 30, 2024 The Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. (NASDAQ: IBRX), a next-generation immunotherapy company, reported that it will discuss the implications of the recent FDA approval of ANKTIVA (nogapendekin alfa inbakicept-pmln) for use in combination with bacillus Calmette-Guerin (BCG) for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors at the American Urological Association Annual Meeting (AUA 2024) this week in San Antonio, Texas (Press release, ImmunityBio, APR 30, 2024, View Source [SID1234642462]).
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Patrick Soon-Shiong, M.D., will discuss the company’s novel FDA-designated Breakthrough Therapy ANKTIVA, and its potential as an alternative therapy to radical surgery for patients with advanced cases of bladder cancer that have failed to respond to the current standard of care of BCG adminstered alone. Dr. Soon-Shiong will describe how the tumor evades BCG therapy and how ANKTIVA rescues BCG when combined with ANKTIVA, revealing details of ImmunityBio’s Cancer Moonshot strategy of transforming "MHC Negative" (cold) bladder cancer cells as a mechanism of tumor evasion from BCG, to "MHC Positive" (hot) tumors via ANKTIVA’s activation of NK and T cells, resulting in complete durable response.
"The realization that this transformation of MHC- to MHC+ could rescue exhausted or immune-evaded T cells was the basis of our Cancer Moonshot announced in 2016. Our QUILT program provided insight that this strategy of transforming MHC- to MHC+ applies to all tumor types that have entered the escape phase, and the approval of ANKTIVA marks our first step to the next evolution of immunotherapy by orchestrating both the innate and adaptive immune system. I very much look forward to elaborating on the details with Dr. Sam Chang at the AUA conference," said Dr. Patrick Soon-Shiong.
Hosting Dr. Soon-Shiong will be Dr. Sam S. Chang, M.D., Professor of Urology and Chief Surgical Officer of the Vanderbilt Ingram Cancer Center. Dr. Chang was a principal investigator for ImmunityBio’s QUILT 3.032 study, which produced the data on which the FDA approval was based. The fireside chat, titled "A Deep Dive with Patrick Soon-Shiong: Next Generation Immunotherapy for NMIBC," will take place Friday, May 3, 2024 at 3:15 CDT in the Learning Lab, located in the AUA Square, in front of the Science & Technology Hall of the Henry B. González Convention Center in San Antonio, Texas.
In addition, at the AUA Annual Meeting, ImmunityBio’s Chief Medical Officer Sandeep "Bobby" Reddy, M.D., will present the latest findings from the Company’s QUILT 3.032 and QUILT 2.005 studies.
MP16-03: N-803 plus BCG Complete Response rate in NMIBC CIS subjects: BCG refractory, relapsed, checkpoint failure, and chemotherapy failure; updated results (QUILT 3.032). Friday, May 3, 2024 from 1:00 to 3:00 in Room 221B
QUILT 2.005: A comparison of intravesical Bacillus Calmette-Guerin (BCG) in combination with the IL-15 superagonist N-803 to BCG alone in patients with BCG-naïve NMIBC. Sunday, May 5, 2024 from 10:32 to 10:40 am in the Learning Lab.