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ImmunityBio to Present ‘Quality of life in QUILT 3.032 study: Patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15R⍺Fc superagonist N-803 plus BCG’ at ASCO GU
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ImmunityBio, Inc. (NASDAQ: IBRX) announced that Dr. Karim Chamie from UCLA will present findings from the QUILT 3.032 study at the ASCO GU conference in San Francisco from February 16-18. This study assesses the quality of life for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving N-803 combined with BCG. Results showed improved physical function among responders and highlighted a favorable risk/benefit ratio. The FDA is reviewing the Biologics License Application for N-803, with a PDUFA date set for May 23, 2023.
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A positive difference in physical function in responders versus non-responders was noted
The study indicates a favorable risk/benefit ratio and quality of life following N-803 plus BCG is comparable to BCG alone
CULVER CITY, Calif.--(BUSINESS WIRE)--
ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced Dr. Karim Chamie, Associate Professor of Urology at UCLA, will be presenting “Quality of life in QUILT 3.032 study: Patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15R⍺Fc superagonist N-803 plus BCG” at the ASCO Genitourinary Cancers Symposium (ASCO GU) conference in San Francisco, February 16-18. The Food and Drug Administration (FDA) is currently reviewing the Biologics License Application (BLA) for ImmunityBio’s N-803 plus BCG for the treatment of NMIBC CIS with a Prescription Drug User Fee Act (PDUFA) date of May 23, 2023.
Participants are also invited to attend ImmunityBio’s Medical Affairs booth (#65). For full session details and scientific presentation listings, please see the ASCO GU online program.
About ImmunityBio
ImmunityBio is a vertically-integrated, 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.
N-803 (Anktiva™), ImmunityBio’s lead cytokine fusion protein, is a novel 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). N-803 is currently under review by the FDA for this indication with a Prescription Drug User Fee Act (PDUFA) target date of May 23, 2023.
The company has established GMP manufacturing capacity at scale with cutting-edge cell therapy 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
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 the development of therapeutics for cancers and infectious diseases and related business strategies, potential regulatory pathway for certain of ImmunityBio’s product candidates and target indications, data from the clinical trials for certain of ImmunityBio’s product candidates, clinical trial enrollment and results, clinical trial design and protocols, the regulatory review process and timing thereof, timing of regulatory submissions, potential implications to be drawn from clinical trials, potential commercialization of product candidates, and ImmunityBio’s product candidates 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 the regulatory submission, review and approval process, (ii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, (iii) ImmunityBio’s ability to retain and hire key personnel, (iv) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (v) ImmunityBio’s ability to successfully commercialize its product candidates and uncertainties around regulatory reviews and approvals, (vi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its product candidates and future approved products, (vii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies, and (viii) the unknown future impact of the COVID-19 pandemic on certain clinical trials or their milestones and/or ImmunityBio’s business operations or operating expenses. 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 1, 2022 and the Company’s Form 10-Q filed with the SEC on November 9, 2022, 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.
What is the significance of the QUILT 3.032 study presented by ImmunityBio at ASCO GU?
The QUILT 3.032 study, presented by Dr. Karim Chamie at ASCO GU, focuses on the quality of life for patients with BCG-unresponsive NMIBC receiving N-803 plus BCG.
What were the key findings from the QUILT 3.032 study regarding N-803 and BCG?
The study reported a positive difference in physical function in responders versus non-responders and indicated a favorable risk/benefit ratio for N-803 plus BCG.
When is the FDA expected to make a decision on ImmunityBio's N-803?
The FDA's Prescription Drug User Fee Act (PDUFA) date for ImmunityBio's N-803 is May 23, 2023.
Where and when is the ASCO GU conference taking place?
The ASCO GU conference is scheduled in San Francisco from February 16-18, 2023.
Who is presenting the QUILT 3.032 study at ASCO GU?
Dr. Karim Chamie, an Associate Professor of Urology at UCLA, is presenting the QUILT 3.032 study at the conference.
