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Amyris, ImmunityBio Join Forces For Next-Gen COVID-19 RNA Vaccine Amyris Inc (NASDAQ: AMRS) has entered into a 50:50 joint venture arrangement with ImmunityBio Inc (NASDAQ: IBRX) to commercialize a next-gen COVID-19 vaccine. The parties have signed a binding term sheet, and a definitive agreement is in process and is expected to be executed within the next month. ImmunityBio will be responsible for manufacturing the vaccine once human trials are completed in South Africa.  Amyris will contribute its RNA technology licensed from the Infectious Disease Research Institute (IDRI).  Amyris will also provide sustainable squalene, an organic compound used to produce the vaccine. Upon completion of human trials, the joint venture's goal is to deliver one billion doses of the new vaccine in 2022. https://m.benzinga.com/article/23955257

ImmunityBio to Present at the Jefferies London Healthcare Conference CULVER CITY, Calif.--(BUSINESS WIRE)--Nov. 4, 2021-- ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced that Founder, Executive Chairman and Global Chief Scientific and Medical Officer Dr. Patrick Soon-Shiong, M.D., will deliver a company presentation at the 2021 Jefferies London Healthcare Conference, which is being held November 16-18, 2021. Dr. Soon-Shiong will present updates on ImmunityBio’s infectious disease and oncology programs. Management will be available during the conference for virtual one-on-one meetings. Presentation Details: Date: November 18, 2021

ImmunityBio, Inc. @ImmunityBio 4 hours ago: “… overall percentage of all patients with cancer who will respond to immune checkpoint inhibitors alone is less than 13%.” This underscores the importance of studies like our LungMAP trial that are looking at ways to bolster checkpoint effectiveness: https://www.science.org/doi/10.1126/scisignal.abc4764

ImmunityBio, Inc. @ImmunityBio 25. Okt. Hoag Hospital (Newport Beach, CA) is part of Nant Cancer Vaccine trial for TNBC, a disease more than 40K women will be diagnosed with this year. Learn more about our research into treatments for TNBC & other types of cancer. https://lat.ms/3b6Ll0M

Billionaire Soon-Shiong on L.A. Times, Vaccine Development https://www.bloomberg.com/news/videos/2021-10-22/billionaire-soon-shiong-on-l-a-times-vaccine-development

ImmunityBio, Inc. @ImmunityBio 17 hours ago Similar to our Nant Cancer Vaccine (https://bit.ly/3b1SCPO), this study conducted by researchers at MIT, the NCI, et al., uses low-dose chemo to cause immunogenic cell death: https://bit.ly/3ni8lzD

ImmunityBio, Inc. @ImmunityBio 22. Okt. The mix-and-match approach to COVID boosters is gaining momentum. We’re currently testing a heterologous prime-boost (hAd5 S+N) in South Africa with the goal of raising T cells and broader antibody response. Learn more: https://nyti.ms/3G9wYr3

ImmunityBio Announces Primary Endpoint Met in a Second Indication in Bladder Cancer Trial with 57% Disease-Free Survival in Patients with BCG Unresponsive Papillary Disease Primary endpoints were met for both Cohorts A and B of Carcinoma in Situ (CIS) and Papillary disease in the 154-patient Phase 2/3 trial studying Anktiva (N-803) and BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) In papillary disease, 57% of patients remain disease free at 12-months and with CIS disease complete response rate is 72% There were zero immune- or treatment-related severe adverse events noted in the combined safety analysis of 154 patients in the trial Key patent allowed covering Anktiva intravesical use in bladder cancer with the term extending to 2035 https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-announces-primary-endpoint-met-second-indication?field_nir_news_date_value[min]=

ImmunityBio, Inc. @ImmunityBio vor 9 Std. Pancreatic cancer has one of the highest mortality rates, claiming almost 50,000 lives/year in the U.S. For late-stage pancreatic cancer patients, survival is measured in months—yet there have been no significant therapies in its treatment for decades.

ImmunityBio Completes Enrollment in Phase 2 Study of Nant Cancer Vaccine for 3rd Line or Greater Metastatic Pancreatic Cancer Patients—90% of Patients Have Exceeded Historical Survival Rates to Date More than 50 participants in third-line cohort of QUILT 88 trial have received the Nant Cancer Vaccine, which includes ImmunityBio’s off-the-shelf, targeted natural killer cells (PD-L1 t-haNK), IL-15 receptor agonist Anktiva (N-803), and Aldoxorubicin, plus low-dose chemotherapy. Of the evaluable patients in the study’s third cohort (third-line or greater disease state), 90% (43/48) have exceeded the historical survival rates of approximately two months with standard-of-care chemotherapy. Of the 48 evaluable patients, approximately half had extremely advanced disease upon enrollment (i.e. had progressed after three to six prior lines of therapy) and, of these patients, 87% (20/23) have exceeded historical survival rates. Mature data is expected in Q1 2022 and the company plans to meet with the FDA in 2022 to discuss the path for the approval of combination therapies for pancreatic cancer. https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-completes-enrollment-phase-2-study-nant-cancer?field_nir_news_date_value[min]=

https://www.google.com/amp/s/seekingalpha.com/amp/article/4459431-immunitybio-demoralization-of-the-bulls-by-deflating-the-share-price

Any indication could make Anktiva a blockbuster product with years of patent protection and exclusivity. If Anktiva is able to pull in a $1B in revenue, we would use the industry’s average price-to-sales of 5X, which would give us a $5B valuation. Considering the company’s current market cap is around $3B-$3.5B, I would say my viewpoint is supported. In fact, I believe the company only needs Anktiva to be approved and only a few indications and claim a small percentage of the market to justify its current market cap. So, any other product candidate could be seen as gravy. My Plan In my previous IBRX article, I discussed how I had started to rebuild my IBRX position by using numerous micro-sized additions over the remainder of 2021 in anticipation of a BLA submission. Although I am extremely bullish on IBRX, the overall market environment and the bearish trend have encouraged me to continue with this strategy until we see where the ATM level is at and/or the sector catches a nice bid. Once the coast is clear, I will return to my previous strategy of “buying on dips and selling on rips” until I see IBRX establish a new "post-merger” pulse or we see a PDUFA date scheduled. Overall, my bullish conviction is at an all-time high for IBRX, and still plan to hold a long-term core position in expectation ImmunityBio will yield numerous best-in-class treatments in a variety of indications.

Smart money wants the retail investor to go through these thought cycles and will push the share price into the “max pain” zone as much as possible to ensure they get the best price and retail gets shaken. I believe they will push IBRX to extreme pain levels because they have to assume that Dr. Patrick Soon-Shiong and the insiders are not going to be ditching the ~75% of the outstanding shares. If funds are going to want to get a sizeable position they are going to have to be accumulating the ATM and hope the remaining shares on the market become available as investors bail. What’s My Point? I believe this sell-off was inevitable because the company needs money and big money wants the best price… which will most likely be way below yours. Therefore, retail investors ought to accept this as a part of the process and it is how the street works. Keep in mind, the company's previous ticker, NK, was trading around $1 per share just a couple of years ago for no apparent reason, so the Street has pulled this move before. Consequently, I suggest investors be patient and wait for an update on the ATM before getting too aggressive with their share sizing. We should see an update in the company's next quarterly filing. A Bullish Point Personally, I believe IBRX is currently undervalued solely on Anktiva’s clinical and commercial prospects. Taking a look back at the company’s quilt trials, we can see Anktiva is involved in a plethora of programs and indications.

Moreover, Anktiva is in several other pipeline programs, so, the company's pipeline would be validated and have an upgraded outlook. Demoralized For two years I have been dumbfounded about how the market repeatedly overlooks and disrespects the company’s potential to change the healthcare landscape. Indeed, market cycles are probably the main culprit, but the ticker has a history of trading well below its intrinsic value. In my previous articles, I have proposed several possibilities why the market allows IBRX (Previously NK) to depreciate and go through extended unjustified sell-offs. I was convinced the Street was apprehensive about NantKwest and Dr. Patrick Soon-Shiong because of the NantWorks structure. In addition, Dr. Patrick Soon-Shiong had just started his legal battle with Sorrento Therapeutics (SRNE). My biggest concern was actually ImmunityBio before the merger and how it had the best product candidates in its pipeline. Obviously, the merger has assuaged my concerns about company hierarchy and the market was very bullish on NK/IBRX leading up to the merger. Unfortunately, the market value of the combined company has been crushed and IBRX is being once again overlooked and disrespected. Why? Well, at first, I was convinced Sorrento was going to sell their 8.19M shares of the combined company due to their legal battle because Dr. Patrick Soon-Shiong is ImmunityBio’s founder and major IBRX stakeholder. Selling those 8.19M shares over the course of the year will definitely hurt the share price considering the number of outstanding shares is 391.16M and 75.37% of them are held by insiders. Since most of the shares are being held by insiders, including Dr. Patrick Soon-Shiong, Sorrento would be hurting the doctor regardless of the outcome of the legal battle. I honestly don’t know if this is the case, but the perpetual selling can only be coming from a few sources. Another potential source of the selling pressure is from the company’s $500M ATM offering, which creates steady selling pressure and puts a dark cloud over the ticker until the company pulls the plug or maxes out the ATM. At the end of June, the company only sold roughly $95M, which leaves ~$402M available to issue. Since IBRX’s trading volume is around 1M shares a day and we have had roughly 70 trading days since the end of Q2, we have to imagine the company has put a significant dent in the ATM. Unfortunately, we probably won’t know until the next quarterly filing and the market will probably keep their distance until they feel the coast is clear. Admittedly, most of these potential sources of bearish sentiment and selling pressure are reasonable. So, I can’t say the sell-off is completely unwarranted… but I feel it is appropriate to say IBRX has been disrespected by the market and the Street. I find it hard to believe that ImmunityBio is essentially an underfollowed company with very little press and has nearly zero analyst coverage. I cover a multitude of healthcare tickers on Seeking Alpha that don’t have a fraction of ImmunityBio’s clinical and commercial potential, yet, the ticker gets covered by several authors. Meanwhile, I am essentially the only one covering ImmunityBio. Keep in mind, ImmunityBio just released updated data that showed Anktiva has the prospects to become an oncology dynamo. Then, add in all of the other company products, and one is left thinking “am I the only one seeing this?” And the answer is no… The selling pressure might have retail investors wondering “what is going on?”… “Wasn’t the data positive?”

Anktiva Bladder Cancer Data ImmunityBio publicized updated data from their BCG-unresponsive non-muscle-invasive carcinoma in situ bladder cancer trial. The QUILT 3.032 study is an open-label, three cohorts, multicenter Phase II/III trial of intravesical BCG plus Anktiva. The primary endpoint for Cohort A was the incidence of a complete response of CIS at any time. The company revealed 72% of patients having a complete response to intravesical BCG along with the company’s Anktiva with a median duration of ~20 months. In addition, the company reported a 59% probability that responding patients would sustain a complete response for more than 12 months. Moreover, 85% of patients in the cohort avoided a cystectomy with a median duration of follow-up of 20.4 months. Furthermore, ImmunityBio reported a 0% treatment-related SAEs, 0% immune-related AEs and 0% grade 4 or 5 treatment-related AEs. Why is this Significant? Investors should be encouraged by these results showing the potential for a higher and longer-lasting rate of complete response than with the current standards of care in patients facing removal of the bladder as an alternative. Unfortunately, none of the FDA-approved products or candidates have come close to Anktiva’s numbers. At best, other products have come close to only 20% of patients are disease-free at 12 months vs. 30% at 18-months for Anktiva+BCG. In addition, the safety profile is superlative considering the currently approved checkpoint therapy has a 21% incidence rate for immune-related adverse events. It is possible that Anktiva+BCG will be approved and will quickly become the standard of care for patients with BCG-unresponsive bladder cancer. If approved, the combination will be looking to take on bladder cancer has a high incidence is the fourth most commonly diagnosed solid malignancy in men and the twelfth for women, which led to 17,980 deaths in the U.S. during 2020. This market is craving for additional therapies considering BCG immunotherapy has been the standard of care for NMIBC for the last 30 years. What is more, the addition of Anktiva to the BCG regimen shouldn’t be a major hassle for urologists because Anktiva is intended to be administered with BCG right in the office. So, we can say there is a significant market for adding Anktiva to BCG therapy and the combination has surpassed expectations and outperformed some of the leading oncology agents on the market. Furthermore, this data should be sufficient for a BLA and approval, which would make Anktiva ImmunityBio’s first approved product.

Company Overview ImmunityBio is a cutting-edge cell and immunotherapy company that has several programs in late-stage clinical trials using next-gen technologies that generate immunogenic responses to defeat cancer and infectious diseases. The company’s immunotherapy platform mobilizes natural killer cells, macrophages, and T cells to generate long-term “immunological memory.” ImmunityBio has an imposing pipeline with more than 40 clinical trials in 19 indications. The company has several impressive product candidates including antibody cytokine fusion proteins, albumin chemo immunomodulators, Adeno and yeast vaccines, and our off-the-shelf natural killer “NK” cell products. The company has established GMP manufacturing capacity with ready-to-scale facilities, and an impressive staff to manage R&D, clinical trials, and regulatory tasks. Overall, ImmunityBio is a comprehensive company that can handle just about anything “in-house.” Background on Anktiva (N-803) The company’s flagship product, Anktiva “N-803” is a cytokine infusion protein and a novel interleukin-15 “IL-15” superagonist complex. Anktiva consists of an IL-15 mutant joined to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta-gamma T-cell receptor binding while avoiding T-reg stimulation. Anktiva has improved PK properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo. Anktiva has received Breakthrough Therapy and Fast Track Designations from the FDA for BCG-unresponsive CIS non-muscle invasive bladder cancer “NMIBC”.