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Business Wire
11-08-2025
- Health
- Business Wire
ImmunityBio Announces Houston's Michael E. DeBakey VA Medical Center Is Among the First VA Hospitals to Administer ANKTIVA ® to Bladder Cancer Patients
CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the Michael E. DeBakey Department of Veterans Affairs (VA) Medical Center in Houston recently became the first VA hospital in the Houston region and one of the first in the U.S. to provide treatment with ANKTIVA ® (nogapendekin alfa inbakicept-pmln) to a veteran with bladder cancer. ANKTIVA, the first of its kind immune-boosting, lymphocyte stimulating agent, is approved by the U.S. Food and Drug Administration (FDA) in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). A 2024 study found military exposure to carcinogenic agents was associated with a higher risk for bladder cancer among veterans, making this treatment especially vital for those at the VA. Nationally recognized urologic oncologists at the Houston VA, Dr. Jeffrey Jones and Dr. Jennifer Taylor, were instrumental in bringing this novel treatment to veterans. They are strong advocates for advancing care for those battling bladder cancer. In addition, Dr. Jones, who is also affiliated with Baylor College of Medicine, led efforts to enroll the facility in ImmunityBio's Expanded Access Program (EAP) for rBCG. 'We are honored to see ANKTIVA reaching our nation's veterans,' said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. 'Drs. Jones' and Taylor's leadership and commitment to innovation are exactly what's needed to expand access to transformative treatments like ANKTIVA across the VA system. This milestone at DeBakey underscores the real-world impact of our mission.' 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 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15Rα, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA, which confers stability and longer half-life than recombinant or native IL-15, mimics the natural biological properties of the membrane-bound IL-15Rα, 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 use in the United States with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors. For more information, visit (Founder's Vision) and About ImmunityBio ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies 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 NK 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 (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 clinical trial data and potential results and implications to be drawn therefrom, treatment of patients at VA Medical Centers and in certain geographic locations and potential implications 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 alone or in combination with other therapeutic agents for the prevention or reversal of lymphopenia, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents across multiple tumor types and indications and for potential applications beyond oncology, potential regulatory pathways and the regulatory review process and timing thereof, the application of the Company's science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that has the potential to change the paradigm in cancer care, 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 FDA regulatory submission, filing and review process and the timing thereof, (ii) risks and uncertainties regarding commercial launch execution, success and timing and market access initatives, (iii) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (iv) whether clinical trials will result in registrational pathways and the risks, (v) whether clinical trial data will be accepted by regulatory agencies, (vi) 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, (vii) potential delays in product availability and regulatory approvals, (viii) ImmunityBio's ability to retain and hire key personnel, (ix) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (x) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xi) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xii) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiii) 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 the Company's Form 10-Q filed with the SEC on August 5, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at ImmunityBio cautions you not to place undue reliance on any forward looking statements, which speak only as of the date hereof.
Calgary Herald
01-07-2025
- Climate
- Calgary Herald
Canada Day in Calgary marked by pride, reflection amid global tensions
Thousands of Calgarians flocked to Canada Day festivities across the city on Tuesday, with many saying the occasion felt especially meaningful this year amid growing global tensions and political unrest south of the border. Article content For some, the day was about more than waving flags and watching fireworks — it was a moment to reflect on what it means to be Canadian in the face of ongoing U.S.-Canada tensions, tariffs and 51st-state taunts. Article content Article content Article content 'It's very front of mind (this year) to be proud of our heritage and who we are — making sure that we keep our own special identity present,' said Jennifer Taylor, who spent the day at Heritage Park with her children. 'We figured what better way to celebrate Canada's birthday than being part of its history?' Article content 'I don't want to go to the U.S. until (U.S. President Donald) Trump leaves (office) or resigns,' said Caroline, who immigrated to Canada from the Philippines in 2011. 'That's my way of supporting our country peacefully . . . silently protesting.' Article content Cars lined up along Heritage Drive on Tuesday as thousands descended on Heritage Park, which was celebrating both Canada Day and the park's 61st birthday. Visitors enjoyed family-friendly activities, live music, cultural performances and a vintage car show. Article content Article content Hot, sunny weather made for an ideal Canada Day at the park, where families sought shade under trees and slathered sunscreen on children to beat the heat. A heat warning was in effect for Calgary, with temperature expected to reach 29 C on Tuesday and Wednesday, according to Environment Canada. Article content 'It's very busy today,' said Eirin Bernie, communications manager at Heritage Park. 'It seems to be a lot busier than it has been for the past couple of years, so we're super excited.' Article content 'The weather turned out for us, too,' she added. 'Last (year) it was raining, so already we have a better Canada Day.'
BBC News
10-06-2025
- BBC News
Cambridge guided busway could introduce safety barriers
A council that was fined £6m after three deaths on its guided busway has proposed installing fencing and barriers along the entire 16-mile (26km) County Council said it was in "full acceptance" of "historical failures" relating to its busway, which runs from Huntingdon to Taylor, Steve Moir and Kathleen Pitts died after collisions on the route between 2015 and council said a "new and robust" safety regime had been in place since the authority was sentenced at Cambridge Crown Court in April, prompting it to recommend more safety measures as a result. In a report being presented to councillors on 17 June, the authority estimated it could cost £4.7m to install a fence or barriers along the guided busway, which is the longest of its kind in the world.A permanent fence on a section of the busway between Cambridge railway station and Long Road Bridge was installed in April 2024, which the council said was proving to be authority also said it wanted to tackle flooding on sections of a path that runs alongside the busway between the Holywell crossing and Fen Drayton, to prevent people from using other routes that could be said solutions such as a pontooned walkway were estimated to cost £5m but that more design work was needed. 'Greatest safety' The council also recommended not to go ahead with plans to widen the footpath and cycle path along a section of the route between Cambridge railway station and Trumpington Park and was first recommended by the engineering firm Mott MacDonald in June 2022 and a £2.9m budget was approved by councillors the following the council pointed to "pinch points" along the route and said the costs would not be possible within the budget, instead recommending additional signs, markings and Beckett, the chair of the authority's highways and transport committee, said: "The council accepted full responsibility for the historical failings and officers have been looking at what other measures we could explore to try and reduce any risks further."A lot of work has gone into looking at what we can do, which will not only benefit the people who cycle, walk and run alongside the busway, but which will also bring the greatest safety benefit in a way which delivers value for money."If approved, the works would go ahead a plan to install alongside new signage and markings, as well as a campaign to promote safety along the busway. Follow Cambridgeshire news on BBC Sounds, Facebook, Instagram and X.
The Independent
13-03-2025
- The Independent
Council had ‘entrenched mismanagement' of busway safety, court hears
A county council showed an 'entrenched mismanagement of safety' for its public transport system which was involved in the deaths of three people, a court has heard. Jennifer Taylor, 81, Steven Moir, 50, and Kathleen Pitts, 52, all died in separate incidents with Cambridgeshire Guided Busway between 2015 and 2021, and a boy sustained life-changing injuries. The busway, which involves a modified bus being guided along a track, is a 16-mile route which uses old rail routes to link Cambridge, Huntingdon and St Ives. Cambridgeshire County Council, which runs the busway, was prosecuted by the Health and Safety Executive (HSE) last year in connection with the incidents. It admitted two charges under Section 3 of the Health and Safety at Work Act 1974 last September, relating to the public trying to cross the busway at designated crossings and being struck while moving alongside the busway. Prosecutor Pascal Bates told Cambridge Crown Court on Thursday the busway was involved in 'a number of very serious injuries', including to two children, between the summer of 2011 and spring 2023, but the council 'kept going despite numerous warning signs'. '[There was] an unpreparedness properly to ask itself relevant safety questions,' Mr Bates said. The council did not tell the HSE of the risks it identified with the system until 2022, six years after it conducted an initial assessment, the court heard. Cambridgeshire Guided Busway opened in August 2011 and busways are still 'relatively new and rare concepts' in the UK, the prosecutor said. The council proposed the creation of the busway and currently runs it, including organising maintenance and control of its infrastructure. Mr Bates said the council 'never operated the busway fully in compliance with safety law' up to 2023, and that it felt any criticisms of its safety procedures were 'illegitimate'. Until 2021, the buses travelled at a 'lane speed' of 56mph, meaning it would cover 25 metres a second. Their routes pass through a variety of rural and urban areas and can often become extremely cramped and in very high demand, the court heard. The buses are also silent, 'far more quiet' than a bus on tarmac, Mr Bates said. The court heard a female passenger fractured her skull aboard one of the buses in October 2011, after the driver performed an emergency stop to avoid a cyclist. Mr Bates said the incident was not reported to the HSE at the time, and HSE was not told about it until 2023. 'We say this should have been a wake-up call,' the prosecutor added. The council then 'appeared to write off' three other incidents, in which cyclists were admitted to hospital, in 2012, 2013 and 2014, by suggesting the cyclists were to blame, Mr Bates said. A number of road safety audits were conducted by the council but the quality of these was 'very bad', Mr Bates told the court. In a statement last September, after the council pleaded guilty to the charges, Cambridgeshire County Council's chief executive Dr Stephen Moir said it was 'truly sorry' for having fallen 'far short' of the appropriate health and safety standards on the busway. Family members of the three people who died attended the hearing, sitting in the public gallery.
Yahoo
13-03-2025
- Yahoo
Council did not manage guided busway risk, judge told
A council prosecuted after accidents on a guided busway "mismanaged safety", a judge has been told. Cambridgeshire County Council has been prosecuted by the Health and Safety Executive (HSE) after three people died and a teenager was seriously hurt on the busway during a six-year period. The council has admitted breaching health and safety legislation. A judge has been taking evidence at a sentencing hearing at Cambridge Crown Crown. Jennifer Taylor, Steve Moir and Kathleen Pitts all died after collisions on the busway, serving Cambridge, Huntingdon and St Ives, between 2015 and 2021. Barrister Pascal Bates, who is leading the HSE legal team, outlined evidence on Thursday as relatives of people who died watched from a public gallery. He said guided busways were rare. "This case is about the management of risk," Mr Bates told Judge Mark Bishop. "The incidents in this case are related to incidents where that management did not work." He said one charge related to crossing the busway and one charge to people being alongside. Mr Bates said the case concerned the "mismanagement of safety" and added: "Central to the case was unpreparedness by the council." He told the hearing the council had repeatedly refused to ask itself "relevant questions". Mr Bates also said there had been "warnings" and told the judge: "It persisted, with inadequate justification, in not doing what it should have been doing all along." He said buses running on the busway were "relatively silent". "They are modern machines and they whisper along," Mr Bates added. He told the hearing the "line speed", or maximum speed, for guided buses was 56mph (90km/h). He said between 2011 and 2023 there had been three deaths and a number of "serious injuries" to "innocent" members of the public. In 2011, a bus had made an emergency stop and a passenger had hit her head and fractured her skull. Mr Bates said the incident had not been reported to the HSE. Guided Busways Guided busways are tracks which enable buses to travel at speed. They have been built along former railway lines The Cambridgeshire busway is one of the best-known in Britain - one also runs between Luton and Dunstable On Monday 5 March 2007, then Transport Secretary Douglas Alexander opened a manufacturing plant at Longstanton, near Cambridge, which aimed to produce the 6,000 concrete beams for the guided bus route between St Ives and Cambridge The Cambridgeshire busway required Government approval and the Cambridgeshire Guided Busway Order 2005 came into force on 11 January 2006 The hearing is due to end on Friday. The judge was shown footage of two incidents. Both involved people trying to cross the busway. Mr Bates said one incident resulted in a woman's death and, in the second, a teenage boy was badly hurt. Judge Bishop has indicated that he will announce decisions on sentencing at a later date. A lawyer had said at an earlier hearing that a commercial organisation convicted of the same offences would expect a seven or eight-figure fine. In September 2024, council chief executive Dr Stephen Moir apologised. "We fully recognise and accept that during the historic operation of the guided busway, when these incidents occurred, that we fell far short of meeting these standards," he said in a statement released by the council. "For that we are truly sorry." In October at an earlier court hearing, the council admitted two breaches of the 1974 Health and Safety at Work Act. The breaches were: Failing to ensure members of the public were not "exposed to risks" when using "designated crossing points" Failing to ensure members of the public were not "exposed to risks" when in the "vicinity of, or seeking to travel alongside" the busway Barrister Ben Compton KC, who represented the council, had told the judge at an earlier hearing that the authority's "financial circumstances" would have to be considered before sentence was passed. Follow Cambridgeshire news on BBC Sounds, Facebook, Instagram and X. Judge due to sentence council after busway deaths Cambridgeshire County Council Busway HSE
