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https://www.sec.gov/ix?doc=/Archives/edgar/data/1326110/000132611022000064/ibrx-20220831.htm

ImmunityBio: Compelling Data In Bladder Cancer, Yet Funding Issues Remain https://seekingalpha.com/article/4531181-immunitybio-compelling-data-in-bladder-cancer-funding-issues-remain?mailingid=28647565&messageid=2800&serial=28647565.654&source=email_2800&utm_campaign=rta-stock-article&utm_medium=email&utm_source=seeking_alpha&utm_term=28647565.654

https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-fda-acceptance-biologics-license?field_nir_news_date_value[min]=

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

ImmunityBio is also part of a consortium developing self-amplifying mRNA vaccine against Covid, but it’s not clear that this is intended to be variant-proof. There is a preprint of preclinical results, and a phase 1/2 trial for self-amplifying mRNA vaccines began in May 2022.

A third report includes 2 injections of AdS+N and/or a self-amplifying mRNA vaccine they developed (called SASA S) in mice. SASA S is based on original SARS-CoV-2 as well as the D614G mutation. They tested for immune responses in the blood to original SARS-CoV-2, Beta, Delta, and Omicron. SASA S, alone or in combination with AdS+N, had better results, including similar responses to all the strains. However, 2 doses of AdS+N did not always reach an adequate response, and although response was good when it was used as a second dose after SASA S for other strains, response against Omicron was weaker by one measure. On the other hand, the “N” in AdS+N broadened responses that the developers believe could be valuable for future variants. Overall, the developers concluded that combination vaccination (heterologous) most broadens potential responses. The June 2021 preprint for phase 1 clinical trial results includes an analysis of immune responses to variants – including Alpha, Beta, and Gamma. The trial was done in the US. (Delta didn’t become dominant there till July.) The preprint focuses on T-cell results in a high dose group, rather than a full report of the trial. The whole trial was for 34 participants in 6 groups, getting different dosages, in 2 subcutaneous injections, or an injection followed by an oral dose, 3 weeks apart. The developers concluded that the vaccine could potentially be a universal booster. That trial began in October 2020 in the US. Another 2 phase 1 trials started in early 2021: a trial of different dosages and combinations of injection and oral AdS+N for 26 people in the US, and a trial of different dosages for 35 people in South Africa. The company announced in July 2021 that they had regulator approval in South Africa to start a phase 1/2/3 trial of AdS+N as a boost for healthcare workers who had the J&J vax in South Africa’s Sisonke trial – no further news since then.

ImmunityBio: Results in primates and non-primates, 2 small phase 1 trials fully recruited – some results for one – and 1 small phase 1 trial still recruiting The ImmunityBio Covid vaccine is based on a human adenovirus 5 vector (Ad5), with some parts deleted (genes encoding several proteins). This is meant to bypass any existing immunity to the adenovirus. The vaccine, AdS+ N, is a bivalent vaccine, that’s dual antigen – it targets the SARS-CoV-2 spike, as other vaccines do, and another protein (the viral nucleocapsid protein). That’s the reason the developers believe it will be more variant-proof and durable than first-generation Covid vaccines. They are also testing mucosal versions – both oral and intranasal – which might help protect against infection. The developers first publication reports on results of mice being vaccinated with 4 versions of vaccine, in injected, oral, or intranasal form: one made with standard SARS-CoV-2 protein, one with modified spike (S-Fusion), one with the second protein and enhanced T-cell stimulation (N-ETSD), and a bivalent version (S-Fusion + N, called AdS+N for short). They concluded the bivalent version was superior. Their second publication reports on vaccinating macaques with a subcutaneous injection of AdS+N, then 2 oral doses, or 2 injections and a single oral dose. The primates were challenged with original SARS-CoV-2.

Front-Runners in the Race for Variant-Proof and All-Coronavirus Vaccines July 9, 2022 Hilda Bastian Covid-19 https://absolutelymaybe.plos.org/2022/07/09/front-runners-in-the-race-for-variant-proof-and-all-coronavirus-vaccines/#immunitybio

Dr. Pat Soon-Shiong @DrPatSoonShiong Jul 19 Now we combining this with self amplifying rna. That combination just published this week in Frontiers of immunology ( see figure 8) .. protection across multiple variants with TCells… doing this on our own with zero Gov funding!

Dr. Pat Soon-Shiong @DrPatSoonShiong Jul 19 So frustrating. We have been advocating this since 2020. Our trials in SA with first nasal spray completed phase 1 last year.

ImmunityBio, Inc. @ImmunityBio Antiretrovirals for HIV cost an average of $36,000/year in the U.S. ImmunityBio wants to change that by developing immunotherapies using a “Kick-and-Kill” strategy to cure HIV.

BioSpace @biospace Dr. Patrick Soon-Shiong, M.D. and his company, @ImmunityBio, are on the final leg of what they hope will be @US_FDA approval of their drug, N-803, for the treatment of bladder cancer. #ImmunityBio #FDA #BioSpace

8-K Vote – ImmunityBio, Inc. (0001326110) June 14 https://marketnewswire.live/index.php/2022/06/14/8-k-vote-immunitybio-inc-0001326110-june-14/?amp

Op-Ed: Course Correction, Paradigm Shifts And A Profound Truth "...However, the speech that resonated the most with me was the keynote address at dinner by Dr Patrick SoonShiong, the South African-born scientist, entrepreneur and billionaire. Dr Soon-Shiong’s journey is well-documented and has been a lifetime in the research and development of cancer-related Abraxane and then many other ventures including his current NantHealth and NantWorks that are focused on using his vast experience and resources to find a sustainable cure for cancer. He advocated the prioritization of healthcare in Africa, specifically building cancer centers, diagnostics and manufacturing in SA and perhaps over time, other parts of Africa. Of all the projects showcased, this one would unquestionably find financial backers including the African Development Bank that could easily underwrite the venture. It has to be seen whether the SA government steps up and accords approvals for expeditious implementation as this project could be a strategic pilot project that would inspire many others to follow. Another important message from Dr Soon-Shiong’s talk was his emphasis on self-reliance, particularly in the manufacturing of vaccines and medicines. Indigenization has been talked about for many years by almost all governments but the implementation ends up in vain as vested interests and unnecessary regulatory minefields prevent the setting up of sustainable projects in Africa." https://www.forbesafrica.com/opinion/op-ed/2022/06/07/course-correction-paradigm-shifts-and-a-profound-truth/

ImmunityBio (IBRX) Stock Price: $10 Target And Overweight Rating https://www.google.com/amp/s/pulse2.com/immunitybio-ibrx-stock-price-10-target-and-overweight-rating/amp/

ImmunityBio, Inc. @ImmunityBio We’re looking forward to participating in the #JefferiesHealthcare conference on Friday at 8:15 am ET. We will be discussing our therapeutic portfolio and clinical progress across a range of highly challenging cancer types including bladder, pancreatic, and lung.