Bacillus Calmette-Guerin(ImmunityBio)

Prior to 2012, Merck only accounted for around 30% to 40% of the overall TICE BCG supply in the U.S. The company has been working to increase capacity in recent years. With Merck & Co. largely propping up supplies of the bladder cancer-fighting bacteria Bacillus Calmette-Guérin (BCG) in the U.S., ImmunityBio has received the FDA all-clear to help pick up the slack—and provide a boost to its new immunotherapy Anktiva along the way.The FDA has authorized ImmunityBio’s expanded access program (EAP) to bring an alternative source of BCG to the U.S., the company said Wednesday.BCG, in use since 1921 and originally developed as a live vaccine against tuberculosis, also forms a key part of the non-muscle invasive bladder cancer (NMIBC) armamentarium. NMIBC accounts for roughly 80% of an estimated 80,000 new bladder cancer diagnoses each year in the U.S.From 2012 until last April—when ImmunityBio won its first U.S. approval for Anktiva plus the BCG vaccine in certain NMIBC patients—Merck’s TICE BCG stood alone as the sole BCG product in the U.S. For much of that time, Merck was also the country’s only supplier of the bacteria-based biologic.Even without factoring Anktiva into the equation, shortages of Merck’s TICE BCG have already put up a “significant impediment” to bladder cancer treatment in the U.S., ImmunityBio said in a release. The company cited results from a recent Sermo survey which found that 57% of 100 U.S. urologists couldn’t treat patients in the past 12 months thanks to hamstrung TICE BCG access.Merck is certainly aware of the problem and sought to remedy the situation by announcing plans in late 2020 to construct a new TICE BCG plant in North Carolina. Early last year, the New Jersey drug giant said it expected the capacity-tripling facility to be complete by “late 2025 to late 2026.” Prior to 2012, Merck only accounted for around 30% to 40% of the overall TICE BCG supply in the U.S. But, after other manufacturers left the market, the company responded by moving to increase its own production capacity.The prevailing supply issue—despite BCG’s prevalence as a global vaccine—comes down to the manufacturing complexities needed to crank out a biologic using benign bacteria, ImmunityBio explained in Wednesday’s release.Recognizing the supply squeeze on the horizon following Anktiva’s approval, ImmunityBio in May 2024 enlisted vaccine juggernaut the Serum Institute of India for large-scale production of BCG to be used with the company’s IL-15 bladder cancer drug.ImmunityBio continues to rely on SII as the alternative BCG source identified in the FDA’s expanded access program. Specifically, the partners will now be supplying the U.S. with recombinant BCG, which carries two gene modifications designed to improve immunogenicity and safety versus earlier strains and formulations, ImmunityBio explained.“With the increasing threat of supply shortages of essential medicines, the biopharmaceutical industry must innovate and secure new means of ensuring uninterrupted access to vital therapeutics,” Patrick Soon-Shiong, M.D., ImmunityBio’s founder and chief scientific and medical officer, said in a statement.“Our collaboration with the FDA and Serum Institute to ensure a reliable supply of this vital drug for bladder cancer patients underscores ImmunityBio’s commitment to addressing critical access issues that affect so many patients,” he continued.Supplies of the therapeutic are available now, with shipments set to kick off immediately through the FDA’s access program, ImmunityBio said. 

CULVER CITY, Calif.--( BUSINESS WIRE )--ImmunityBio, Inc. ( NASDAQ: IBRX ), a leading immunity therapy company, today announced the Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA. The MHRA will now begin assessing the marketing authorization application (MAA) for ANKTIVA ® (nogapendekin alfa inbakicept-pmln) in combination with bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. MHRA regulates medicines, medical devices and blood components for transfusion in the UK. “MHRA’s acceptance of our marketing authorization application for the UK comes less than three weeks after the European Medicines Agency accepted for review our MAA for the 30 countries covering the European Union, and just 10 months after FDA approval in the United States,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “We are determined to reach as many patients as possible with ANKTIVA and BCG and are encouraged by the momentum of our efforts.” About ANKTIVA ® The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo. ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder’s Vision) and Anktiva.com. 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 CIS 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. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . 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 anticipated timing of the MHRA’s review of ImmunityBio’s MAA and ultimate decision regarding whether to approve ANKTIVA for the treatment of patients with BCG-unresponsive NMIBC CIS in the territory under its jurisdiction, additional regulatory submissions and timing thereof, global expansion efforts, clinical trial data and potential results to be drawn therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, 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,” “is,” “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) risks and uncertainties regarding the MHRA regulatory review process, potential actions required in connection with the same, and whether or not the MHRA will ultimately approve ImmunityBio’s MAA that has been accepted for review, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) risks and uncertainties related to the regulatory submission, filing and review process and the timing thereof, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) whether clinical trials will result in registrational pathways, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) 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, (viii) potential delays in product availability and regulatory approvals, (ix) ImmunityBio’s ability to retain and hire key personnel, (x) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xiii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiv) 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 the Company’s Form 10-Q filed with the SEC on November 12, 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. Indication and Important Safety Information INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours. USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia. For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com . You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482).