ImmunityBio Announces FDA Acceptance of Biologics License Application for N-803 in BCG-Insensitive, Non-Muscle-Invasive Bladder Cancer In Situ

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CULVER CITY, Calif.–(BUSINESS WIRE)–The FDA has accepted for review a Biologics License Application (BLA) from ImmunityBio, Inc. (NASDAQ: IBRX), for its antibody-cytokine fusion protein as a treatment for patients with muscle insensitive non-muscle invasive bladder carcinoma in situ (CIS) BCG-bladder carcinoma in situ with or without Ta or T1 disease. ImmunityBio, a leading clinical-stage immunotherapy company, filed the BLA based on positive results from a series of investigational treatment studies, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target date for action is May 23, 2023.

This combination of N-803 with BCG is ImmunityBio’s first BLA to reach this stage of FDA acceptance for review. This marks an important step in furthering ImmunityBio’s vision of transforming the way cancer patients are treated without high-dose chemotherapy, but rather by activating the patient’s innate immune system. If approved, N-803 plus BCG would be the first immunotherapy combination for this indication in 23 years that can be administered directly into the bladder (intravesically) to induce natural killer cells and T cells. a critical step in the clinical demonstration of the Nant cancer vaccine hypothesis proposed by ImmunityBio founder Patrick Soon-Shiong, MD of “Quantum oncotherapeutics: a longitudinal spatiotemporal orchestration towards immunogenic cell death”.

N-803 has a unique mechanism of action that leads to the proliferation of NK and T cells which are cells of the adaptive and innate immune system. Through this action, N-803 provides a secondary boost to the immunological response generated by BCG for bladder cancer, or by a checkpoint inhibitor for other indications. In the QUILT 3.032 study, 71% of patients failing prior treatments showed more than a 50% increase in response and median duration compared to the FDA-approved alternatives valrubicin and pembrolizumab, a systemic checkpoint inhibitor therapy for this indication.

“This acceptance of BLA brings us one very important step closer to being able to offer this promising combination therapy to more people living with NMIBC and ultimately reduce the incidence of cystectomies,” said Patrick Soon-Shiong. , MD, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “This is a compelling example of the power of inducing trained innate immune memory to potentially provide long-lasting, long-lasting effects against serious and life-threatening diseases.”

“We are delighted that the FDA has begun its review, and ImmunityBio is ready to move quickly into manufacturing and commercialization should the Agency approve our therapeutic for this indication,” said Richard Adcock, President and CEO of ImmunityBio. ‘ImmunityBio.

The BLA’s submission is supported by results from ImmunityBio’s bladder cancer trials, including QUILT 3.032, an open-label, three-cohort, multicenter Phase 2/3 study of intravesical BCG plus N-803 in patients with high-grade NMIBC unresponsive to BCG (NCT03022825) which was opened in 2017. The primary endpoint for Cohort A of this Phase 2/3 study is the incidence of complete response (CR) of the CIS at any time. The results of this trial were presented at the 2022 Annual Meeting of the American Society of Clinical Oncology (ASCO 2022). See the link here to the presentation video on PissingToday.

ImmunityBio’s IL-15 superagonist N-803

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance and function of natural killer (NK) and T cells. N-803 is a novel IL superagonist complex -15 consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action is the direct specific stimulation of CD8+ T cells and NK cells by binding to beta gamma T cell receptors (not alpha) while avoiding T-reg stimulation. N-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and increased antitumor activity compared to uncomplexed native IL-15 in vivo.

N-803 has been studied in over 700 patients in multiple Phase 1 and 2 trials in liquid and solid tumors. It is currently being studied in trials in non-muscle invasive bladder cancer, pancreatic cancer, non-small cell lung cancer, non-Hodgkin’s lymphoma and HIV.

N-803 received both Revolutionary therapy and Expressway FDA designations for the treatment of NMIBC CIS that does not respond to BCG, as well as Expressway designation for BCG-unresponsive papillary NMIBC and BCG-naïve CIS NMIBC. However, it is important to note that such designations may not lead to a faster development process or regulatory review and may not increase the likelihood that a product candidate will receive approval. Foundational patents covering intravesical administration of BCG and N-803 have issued (US 11,173,191 B2 and US 9,925,247 B2) providing term coverage through 2035.

About ImmunityBio

ImmunityBio is a clinical-stage biotechnology company that develops next-generation therapies and vaccines that boost the natural immune system to defeat cancers and infectious diseases. The Company’s suite of immunotherapy and cell therapy platforms, alone and together, work to stimulate and sustain an immune response with the goal of creating long-lasting 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 includes 27 clinical trials, 18 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). N-803 (Anktiva™), ImmunityBio’s lead cytokine fusion protein, is a novel interleukin-15 (IL-15) superagonist complex and has received Food and Drugs Breakthrough Therapy and Booster designations. United States Drug Administration (FDA) for BCG-Insensitive Non-Muscle Invasive Bladder Cancer CIS (NMIBC).

The company has established a large-scale GMP manufacturing capability with state-of-the-art cell manufacturing expertise and scale-ready facilities, as well as teams for R&D, clinical trials, regulatory operations and extensive and seasoned development. For more information, 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 clinical trial data for certain of ImmunityBio’s product candidates, the regulatory review process and its timing, potential implications to be drawn from QUILT 3.032 and other studies, whether the described mechanism of action contributes to rate and duration of response, potential commercialization of ImmunityBio’s product candidates, ImmunityBio’s product candidates versus existing treatment options, and clinical trial progress and data, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are generally identified by the use of words such as “anticipates”, “believes”, “continues”, “could “, “estimates”, “expects”, “intends”, “may”, “plans”, “potential”, “predicts”, “indicates”, “projects”, “seeks”, ” should”, “will fly” and variations of these words or similar expressions. Statements of past performance, effort or results of our preclinical and clinical trials, about which inferences or assumptions can be made, may also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are not predictions, promises or 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 construed to indicate that it has conducted a thorough investigation or review of all relevant information potentially available. These statements reflect ImmunityBio’s current views with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions regarding ImmunityBio, including including, without limitation, (i) whether the FDA will approve ImmunityBio’s recently filed BLA and the risks and uncertainties associated with the regulatory approval process and timing thereof, (ii) ImmunityBio’s ability to pursue the planned preclinical and clinical development of its development programs, as well as the timing and success of such further 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 may dates and uncertainties regarding regulatory reviews and approvals, (vi) ImmunityBio’s ability to scale its manufacturing and commercial supply 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 “Risk Factors” in the company’s Form 10-K filed with the Securities and Exchange Commission (” SEC”) of the United States on March 1, 2022 and the company’s Form 10-Q filed with the SEC on May 10, 2022 and in the documents subsequently filed by ImmunityBio with the SEC, which are available on the website of the SEC at www.sec.gov. ImmunityBio cautions you not to place undue reliance on forward-looking statements, which speak only as of the date hereof. ImmunityBio undertakes no obligation to update any forward-looking statements or other information contained in this press release, except as required by law.

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