- Sam S. Chang, Professor of Urology at Vanderbilt Cancer Program, to host the program “A Deep Dive with Patrick Soon-Shiong: Next-Generation Immunotherapy for NMBIC”
- Discussion about the basis for ANKTIVA’s Breakthrough Therapy designation and the novel mechanism of how the IL-15 superagonist achieves durable complete responses in BCG unresponsive NMIBC
CULVER CITY, Calif., April 30, 2024 — The Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. (NASDAQ: IBRX), a next-generation immunotherapy company, 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.
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.
About ImmunityBio
ImmunityBio is a vertically-integrated 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. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells, and memory T cells for a long duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. 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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding confirmation, participation and timing, as well as data and results from clinical trials and potential implications therefrom, commercialization plans and timelines, including product availability and shipments, potential regulatory pathways and approval requests and submissions, FDA meetings, timelines and potential results therefrom, the regulatory review process and timing thereof, market and prevalence data, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, information regarding potential benefit to patients, information regarding ongoing pre-clinical studies and clinical trials, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, methods, conference call and webcast timing, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) the risks and uncertainties associated with commercial launch execution, success and timing, (ii) risks and uncertainties related to the regulatory submission and review process, (iii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (iv) the timing and funding of the incremental $100 million of non-dilutive financing following ImmunityBio’s receipt of FDA approval of the BLA, (v) ImmunityBio’s ability to retain and hire key personnel, (vi) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (vii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (viii) ImmunityBio’s ability to successfully commercialize its product candidates and uncertainties around regulatory reviews and approvals, (ix) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its product candidates and future approved products, and (x) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 19, 2024 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.
Contacts:
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media
Greg Tenor
Salutem
+1 717-919-6794
Gregory.Tenor@Salutem.com
