News, infos and good to know WKN: A2QQ2E ISIN: US45256X1037 Kürzel: IBRX Forum: Aktien User: Lirumlarum1

"I am optimistic that the FDA will evaluate ImmunityBio's BLA favorably. If it has any reservations on this important therapy with its solid safety record, it should resolve them in favor of approval to give patients a chance to access this important life altering therapy. I have noticed an aura of mistrust on comment streams addressing FDA decisions. I have never given the suspicions much credence. Here we have a therapy where the little guy, ImmunityBio's anktiva, is set to challenge Merck's (MRK) KEYTRUDA (pembrolizumab) after having bested it in clinical trials. It will be interesting to see how it unfolds."

Seeking Alpha: ImmunityBio: PDUFA Pending https://seekingalpha.com/article/4546925-immunitybio-pdufa-pending

ImmunityBio to Participate in the Jefferies London Healthcare Conference https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-participate-jefferies-london-healthcare-conference?field_nir_news_date_value[min]=

On August 31, 2022, ImmunityBio, Inc. (the “company” or “we”) entered into a series of transactions including, in part, a new debt financing resulting in $125.0 million of gross proceeds, along with the amendment and restatement of the company’s nearest term debt maturity to extend the maturity from December 17, 2022 to December 31, 2023 and an adjustment to the interest rate to match the new debt issuance, and the amendment and restatement of the company’s fixed-rate debt maturing September 30, 2025 to add an equity conversion feature, in each case as further described below. New $125.0 million Variable-Rate Promissory Note On August 31, 2022, we executed a $125.0 million promissory note with Nant Capital, LLC (“Nant Capital”), an entity affiliated with Dr. Patrick Soon-Shiong, our Executive Chairman and Global Chief Scientific and Medical Officer. This note bears interest at Term Secured Overnight Financing Rate (“Term SOFR”) plus 8.0% per annum. The accrued interest shall be payable quarterly on the last business day of March, June, September and December, commencing on September 30, 2022. The outstanding principal amount and any accrued and unpaid interest are due on December 31, 2023. We may prepay the outstanding principal amount, together with any accrued interest at any time, in whole or in part, without premium or penalty. We received net proceeds of $124.4 million from this financing, net of a $0.6 million origination fee paid to the lender, which we intend to use for commercialization efforts, clinical trials, working capital and general corporate purposes. Amendment and Restatement of Variable-Rate Promissory Note due December 17, 2022 As of June 30, 2022, we had a $300.0 million variable-rate promissory note with Nant Capital. This note bore interest at Term SOFR plus 5.4% per annum, which was paid quarterly. We may prepay the outstanding principal amount, together with any accrued interest at any time, in whole or in part, without premium or penalty. In the event of a default on the loan (as defined in the promissory note), including if we do not repay the loan at maturity, the company has the right, at its sole option, to convert the outstanding principal amount and accrued and unpaid interest due under this note into shares of the company’s common stock at price of $5.67 per share. On August 31, 2022, the terms of the variable-rate promissory note were amended and restated to extend the maturity date of the loan from December 17, 2022 to December 31, 2023, increase the spread on the loan from 5.4% to 8.0% per annum, and reset the quarterly interest payment date from the 17th to the last business day of March, June, September and December, commencing on September 30, 2022. No other material terms or conditions of this variable-rate promissory note were modified as part of this amendment and restatement.

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