ImmunityBio Announces First Dosing of Recombinant BCG (rBCG) in the U.S. and 60 Sites Are in the Process of Launching

Rhea-AI Summary

ImmunityBio (NASDAQ: IBRX) has initiated dosing of recombinant BCG (rBCG) in the U.S. through its FDA-authorized Expanded Access Program (EAP). U.S. Urology Partners is among the first providers to offer this alternative BCG treatment, with 60 sites preparing for launch.

The program addresses critical TICE® BCG shortages affecting bladder cancer treatment nationwide. A recent survey of 100 U.S. urologists revealed that 57% couldn't treat patients in the past year due to BCG access issues.

The rBCG, manufactured by the Serum Institute of India, has shown promising results in European clinical trials, demonstrating potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG formulations. The EAP is being managed by Anova Enterprises, Inc., providing an essential alternative source for this standard-of-care treatment in bladder cancer.

Positive

• FDA authorization received for Expanded Access Program
• 60 sites preparing for rBCG launch across the U.S.
• Partnership with world's largest vaccine manufacturer
• Improved safety profile demonstrated in European trials

Negative

• Current product still in expanded access phase, not fully approved
• Dependent on external manufacturing partner for supply

Insights

Financial Analyst

ImmunityBio's announcement of first patient dosing of recombinant BCG (rBCG) represents a significant commercial opportunity addressing a critical market gap. The FDA's authorization of their Expanded Access Program (EAP) positions the company to capture market share in an underserved area where 57% of surveyed urologists reported inability to treat patients due to TICE BCG shortages.

This development creates an immediate revenue pathway through the EAP while potentially establishing ImmunityBio as a key player in the bladder cancer treatment landscape. The rapid site activation (60 centers in process) indicates strong market demand and physician adoption. Strategic partnership with the Serum Institute of India - the world's largest vaccine manufacturer by volume - provides robust manufacturing capabilities essential for addressing nationwide shortages at scale.

European clinical data showing potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety profile suggests this product may offer advantages beyond merely filling a supply gap. This could strengthen ImmunityBio's competitive positioning even if TICE BCG supply issues eventually resolve.

This launch represents a textbook case of identifying an acute market inefficiency and rapidly executing a solution with regulatory support. For ImmunityBio, successfully addressing this shortage could establish brand recognition among urologists nationwide while generating near-term revenue from a product addressing a pressing medical need.

• U.S. Urology Partners is one of the first providers to offer patients ImmunityBio’s recombinant Bacillus Calmette-Guérin (rBCG)
• The FDA recently authorized ImmunityBio’s EAP for rBCG to address U.S. shortages and provide an alternative source of BCG, a critical standard-of-care in bladder cancer
• Multiple urology centers across the U.S. are in the process of activating their sites to administer rBCG

CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced U.S. Urology Partners, one of the nation’s largest independent providers of urology and related specialty services, is one of the first providers to participate in ImmunityBio’s Expanded Access Program (EAP) for recombinant Bacillus Calmette-Guérin (rBCG) to address the current shortage of TICE^® BCG in the U.S.

“The shortage of BCG has real consequences, especially in many rural communities across the country where supply shortages have impacted the treatment of patients with bladder cancer,” said Christopher M. Pieczonka, M.D., Chief Executive Officer and Director of Clinical Research, Associated Medical Professionals, an affiliate of U.S. Urology Partners. “I’m pleased U.S. Urology is at the forefront of offering rBCG and would like to thank ImmunityBio for their initiative to seek and secure authorization from the FDA for expanded access to this vital BCG alternative.”

Supply shortages of TICE BCG in the U.S. have become a significant impediment to the treatment of bladder cancer patients. In a recent Sermo survey of 100 U.S. urologists, 57 percent indicated they were unable to treat patients in the last 12 months due to a lack of access to TICE BCG. Providers who are unable to source TICE BCG are able to access rBCG through the ImmunityBio EAP.

“It is gratifying to see the rapid uptake and interest in the rBCG Expanded Access Program, which was authorized by the FDA just recently,” added Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “Participation by a major national provider like U.S. Urology Partners is a testament to the critical importance of rBCG and the need for an alternative supply of this essential medicine.”

“This is an incredibly exciting opportunity to expand the BCG supply to allow more patients to receive the full course of their cancer treatment, saving bladders and extending lives,” said Dr. Eugene B. Cone, Co-Director of Clinical Research, Urology of Indiana, an affiliate of U.S. Urology.

The Serum Institute of India, ImmunityBio’s collaboration partner, is the world’s largest manufacturer of vaccines by volume. In bladder cancer clinical trials in Europe, the recombinant BCG vaccine has demonstrated potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG strains and formulations. Clinical research organization, Anova Enterprises, Inc. (Anova) is helping ImmunityBio manage the rBCG EAP.

“Constrained BCG supply has improved stewardship of a limited resource but has come at a high cost to our patients,” said Dr. Chad Reichard, Co-Director of Clinical Research, Urology of Indiana. “rBCG represents a long overdue potential alternative but does not abrogate responsibility to ongoing diligence and discipline in BCG delivery.”

About Recombinant BCG (rBCG)

BCG is a benign bacterium originally developed as a live vaccine against tuberculosis (TB). It is based on the well-known Mycobacterium bovis (M. bovis) Bacillus Calmette-Guérin (BCG) strain. It has been in use since 1921 and administered to more than 4 billion individuals worldwide. BCG given via intravesical instillation (delivery to the bladder via a catheter) has been the standard of care for patients with non-muscle invasive bladder cancer (NMIBC) since 1977. BCG induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients.

Two gene modifications have been implemented in rBCG to improve its immunogenicity and safety in comparison to earlier strains and formulations of BCG. Recombinant rBCG has completed Phase 1/2 human clinical studies in Europe as an immunotherapy in patients with NMIBC. The findings from those studies demonstrate rBCG is well-tolerated when administered intravesically with a safety profile similar to placebo, and reduced rates of adverse events observed in earlier strains and formulations of BCG.

Supportive clinical data of rBCG as a TB vaccine are available from four clinical trials. Two studies in healthy adult volunteers and one Phase IIa study in healthy newborn infants were performed with rBCG. Additionally, a Phase II clinical trial was conducted with rBCG in HIV-unexposed and HIV-exposed, BCG-naïve newborn infants for clinical bridging. Clinical trials have also been conducted to assess the effect of rBCG vaccination on TB recurrence and on the susceptibility or severity of respiratory diseases during the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) pandemic.

BCG is one of the most widely used vaccines worldwide. However, because BCG is a biologic drug that uses benign bacteria, it is more complicated to manufacture than many other types of drugs. Serum Institute of India is the largest manufacturer of BCG vaccines in the world, while Merck & Co., based in New Jersey, currently is the only manufacturer of BCG (TICE^® BCG) in the U.S.

ImmunityBio has been awarded multiple patents covering the composition and methods of use for the combination of BCG plus ANKTIVA in bladder cancer (US 11,173,191 Β2; US 11,679,144 Β2; US 11,890,323 B2).

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 U.S. Urology Partners

U.S. Urology Partners is one of the nation’s largest independent providers of urology and related specialty services, including general urology, surgical and robotic procedures, advanced cancer treatment and other ancillary services. The U.S. Urology Partners clinical network consists of more than 50 locations throughout the East Coast and Midwest, including affiliate practices Associated Medical Professionals of NY, Central Ohio Urology Group, Florida Urology Center, Greater Boston Urology and Urology of Indiana. U.S. Urology Partners was formed to support urology practices with an experienced team of healthcare executives and resources, and is backed by NMS Capital. The U.S. Urology Partners corporate office is in Nolensville, Tennessee, just outside of Nashville. For additional information about U.S. Urology Partners, please visit www.us-uro.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 participation in the EAP, the expectation that the EAP will enable ImmunityBio to reliably bring an alternative source of BCG to patients in the U.S., the utility of rBCG to improve immunogenicity and safety in comparison to earlier strains and formulations of BCG, intellectual property coverage, 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 its and its collaborators’ 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 ImmunityBio’s ability to establish and maintain a reliable source of BCG under the EAP as an alternative to TICE BCG, (ii) risks and uncertainties regarding ImmunityBio’s ability to supply adequate quantities of rBCG for purposes of the EAP and its other initatives and maintain appropriate regulatory approvals, (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) the risks and uncertainties associated with third party collaborations and agreements, including that with the Serum Institute of India, (x) ImmunityBio’s ability to retain and hire key personnel, (xi) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xiii) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xiv) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xv) 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 3, 2025, 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).

View source version on businesswire.com: https://www.businesswire.com/news/home/20250313741835/en/

ImmunityBio Contacts:

Investors

Hemanth Ramaprakash, PhD, MBA

ImmunityBio, Inc.

+1 858-746-9289

Hemanth.Ramaprakash@ImmunityBio.com

Media

Sarah Singleton

ImmunityBio, Inc.

+1 415-290-8045

Sarah.Singleton@ImmunityBio.com

U.S. Urology Partners Contact:

Sarah Faisal, Vice President of Research, U.S. Urology Partners

sarah.faisal@us-uro.com

Source: ImmunityBio, Inc.

FAQ

What is the purpose of ImmunityBio's rBCG Expanded Access Program?

The EAP aims to address the current TICE® BCG shortage in the U.S. by providing an alternative BCG source for bladder cancer treatment.

How many U.S. urologists reported BCG supply issues affecting patient treatment?

57% of surveyed urologists reported being unable to treat patients in the last 12 months due to TICE BCG access issues.

What clinical benefits has IBRX's rBCG shown in European trials?

The rBCG demonstrated potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG strains.

Who is manufacturing IBRX's recombinant BCG vaccine?

The Serum Institute of India, the world's largest vaccine manufacturer by volume, is ImmunityBio's collaboration partner for rBCG production.