Dr. Pat Soon-Shiong

Amazing, a former FDA associate commissioner @peterpitts affirmed that the mechanism of action in the approved label confirms the science of Anktiva, by the FDA itself. @DrJBhattacharya agrees with Dr. Pitts and highlights the new path just released by @DrMakaryFDA of the “Plausible Mechanism of Action” to expedite and accelerate access to the American public. Two senior thoughtful members of the panel, a former FDA senior official and the present NIH/CDC director now affirm that the plausible mechanism of action is the path to rapid access. This is what we have been presenting to the FDA for the past 6 months to desperately allow the 13,000+ requests from Americans to access Anktiva via this pathway. A groundswell of patients desperate for this to happen is growing and I am pleased that @ChrisCuomo promised that this conversation will continue… as it must.

Just received amazingly exciting analysis of the first 20 subjects without cancer but with Lynch Syndrome ( now fully enrolled with 138 randomized to either Anktiva plus our Adeno CANCER VACCINE versus placebo). This first set of biological immune data from NCI ( Dr Jeff Schlom) and his team is so exciting and confirms the immune stimulating effect of Anktiva re ALC. Also it shows that as we age the baseline ALC is low but Anktiva changes that level..really exciting especially in light of the JAMA paper that shows 1 in 5 Americans suffer from lymphopenia and that with a low ALC this results in a significant lower lifespan. More to come! The cancer vaccine trials are underway!

Pleased with the NCCN guidelines for Papillary only disease in non-muscle invasive bladder cancer (NMIBC). Validates the publication in Journal of Urology. Now next step is to provide BCG for all patients who could benefit in bladder cancer. pubmed.ncbi.nlm.nih.gov/40956664/

Love the animation! Killing the tumor from the outside in and releasing the antigens. Special forces

The inertia despite new leadership. As reported in the Senate Aging hearing by Straight Arrow News (SAN): "But several physicians and experts told SAN that the FDA’s unpredictability predated the current FDA leadership." “I started dealing with the FDA committee in 2023. When I talked in my testimony about talking to a brick wall, that was the last administration,” said Schmahmann. “The FDA seems to be carving their own path, regardless of who’s in Congress or the White House.” san.com/cc/physician-t…

$IBRX-Here is the breakdown of the PSS post and the best way to understand it. 1. The "Special Forces" Analogy (The Clinical Edge) The Message: Most cancer treatments (like chemo) are "carpet bombs" that damage everything. ANKTIVA is "Special Forces" it specifically recruits and arms NK Cells and Killer T-Cells. Key Stat: Highlight the Hazard Ratio (HR) of 0.4 for duration of response. This means ANKTIVA-treated patients have a 60% lower risk of cancer returning compared to the standard of care. 2. The "Leonardo" Connection (The Industrial Edge) The Message: PSS is "connecting the dots" between the science and the machine. The NANT Leonardo AI-robotic platform is the factory that makes the "Special Forces." The 1:10 Shift: This is your strongest data point. 1:10 donor-to-dose ratio is no longer a theory it’s a robotic reality that scales globally. 3. Global Geopolitical Signaling The Message: PSS is signaling that while the US regulatory path is a "fight," the rest of the world (starting with the March 15 Saudi Launch) is already embracing the future. The "Enlightenment": He is essentially saying the "BioShield" isn't just a drug; it’s a global infrastructure for cancer care. 4. European Validation (EAU26) The timing of this post, coinciding with the EAU26 (European Association of Urology) congress in London, is a signal of geographical expansion. Global Standard: He is signaling that European clinicians now "understand" that ANKTIVA is not just a secondary treatment but a foundational "Special Forces" unit that can cure cancer by activating the innate and adaptive immune systems simultaneously. 5. Slide in the background The slide in the background of his post emphasizes Key Mechanisms: Long-term Memory: One of the most important signals here is "Promotes durable immune memory without exhaustion." The Message to Shorts: This is a direct counter-narrative to those betting on short-term results. PSS is signaling that ANKTIVA creates a permanent internal defense system (Memory T cells), which is the key to the "curative" potential he mentions. THE ENLIGHTENMENT HAS BEGUN. Dr. Patrick Soon-Shiong (@DrPatSoonShiong) just validated the "Leonardo" robotic thesis. This isn't just a biotech story; it's an industrial revolution. Special Forces: ANKTIVA recruits the elite killers (NK & T-cells) to seek and destroy, while ignoring "Tregs" (the tumor’s shield). Leonardo Robotics: The AI-driven backbone enabling the 1:10 dose yieldand 90% COGS reduction. Global Access: "Certain countries" are already moving. The Saudi launch on March 15 is just the start.Standard of Care is being disrupted in real-time. #IBRX #ANKTIVA #Immunotherapy #ShortSqueeze

At conference - how Europe understands Anktiva. “SPECIAL FORCES”! The power of IL-15 ranked by NCI since 2007 as the number one immunotherapy with the potential to cure cancer. Two decades later enlightenment .

Great presentation today using real-world evidence from the clinicians in Germany and Canada. Duration matters. Look at the HR hazard ratio of CR duration. urosource.uroweb.org/resource-centr…

Incredible, @MK2forU connected the dots that I have been trying for decades to do. I'm glad this comes from a scientist unrelated to @ImmunityBio and speaking about the future of cancer care. The future is here. Certain countries have recognized the opportunity and are eagerly embracing this future. Fighting hard for American patients. Please read this substack analysis. It is deeper than any analyst I have read and connects the dots beautifully of information we have published over time. huggenberg.substack.com/p/the-leonardo…

We have now initiated the process of establishing the WORLD BANK OF NATURAL KILLER CELLS and identified global cancer centers where our robots will be installed. Imagine if this can now be automated so that TRILLIONS OF NK cells can be stored and even engineered as CAR-NK cell therapy for the entire globe as off-the-shelf therapy with Anktiva! Its here. The AI driven manufacturing robot (Leonardo) has been trained with our software and more news to come soon on that... the world of memory cytokine enhanced NK cells or M-ceNK for short. @ImmunityBio

The world bank of natural killer cells is close. Data from production of billions of NK cells and successful cryopreservation from pver 60 healthy volunteers and cancer patients coming soon. The Leonardo AI driven robot will transform the availability of NK cells globally.

$IBRX oh my god, PLEASE you gotta watch this: On the Cuomo show last night with @drpatrick as a guest, an ex-FDA exec basically spilled everything: Total CONFIRMATION of the CHAOTIC MESS INSIDE the FDA and how deep BIG PHARMA’S INFLUENCE really runs. Uncoordinated and bureaucratic is still an understatement — it’s practically by design at this point. And then there’s the bit about Merck and why Keytruda got approved… fascinating, if not a little too telling: “Multibillion dollar company with floors of people that understand the science in very subtle ways and what the most direct streamline path will be to get an FDA novel.” Admittedly there’s supposedly a new way of thinking now within the FDA - the talk of “collaboration,” “accelerated approvals,” etc. But, also, in this round it’s confirmed: real change will still take a while. Meanwhile, patients are still running out of time - this program made that painfully clear (see tweets of patients reports)

Nice

Stephen A. Smith unleashes a raw, emotional rant on cancer research and the medical industry: "Too much money, too much time, too much research... and still no cure. My mother's gone. My father's gone. My uncle's gone. A couple of my aunts are gone." He channels Chris Rock's old line: "Money's in the medicine." With billions poured into pharma, hospitals, chemo, radiation—yet families face exorbitant bills and devastating losses—skepticism grows. Stephen A. doesn't accuse conspiracy; he voices human doubt: When you pay for a trainer or nutritionist, you expect results (muscle gain, better bloodwork). With cancer, we keep hearing "fight," "treatment," but "millions upon millions of lives lost" with no definitive resolution. His personal pain: Every cancer diagnosis triggers prayers and encouragement, but deep down, fear they'll lose—because too often, they do. He's "sick and tired" of it. After decades of contributions (Jimmy V Foundation, Disney/ESPN support, tributes to Stuart Scott, John Saunders, Dick Vitale), he demands: "What are y'all going to do about this?" Powerful, heartfelt call-out from someone who's lost too many. Does the medical industry owe us faster breakthroughs, or is cancer just that complex? What's your experience with cancer—hope in progress, or frustration like Stephen A.'s?

Wow, first I discovered the 2007 NIH workshop that ranked Il-15 the number one immunotherapy to cure cancer, now I find a  2017 lecture on IL-15 by NIH AND NCI describing its power. Building on the shoulders of immunology giants at the NIH and  NCI , the late Drs William E. Paul and Thomas Waldman. This is such an important lecture for all to listen to and to comprehend the future of immunotherapy 2.0. I post the video in my tweet in which we have shortened the introduction to start with the lecture. The full video is here: youtube.com/watch?v=h7qixN… The immense power and value of IL-15 was recognized almost 20 years ago. Amazingly, Dr. Waldman foresaw the need to COMBINE IL-15 (today's ANKTIVA) with a checkpoint inhibitor (today's Keytruda) in order to maximize T cell activity as well as stimulate macrophages (today’s Abraxane). This is what the Saudi FDA scientists and regulators at the SFDA recognized - the power of IL15 and Anktiva as the backbone and that is why we have the world's first approval for ANKTIVA in combination with checkpoint inhibitor in Saudi Arabia. This is such an important lecture that every regulatory authority in the world should study and understand the evolutionary science of the immune system and the importance of appropriate combinations… so important for science to drive regulatory decision-making, especially for the reviewers who may not be trained immunologists and coming to conclusions based on past archaic practices. Oncology and infectious disease is now fundamental immunology. So hopeful that regulatory reviewers around the world watch this... It is such an important educational video of what we have been building at IBRX that I will leave this pinned for a month!!! So inspired to see that we have been independently   pursuing the right strategy for the past decade. The power of immunotherapy 2.0 is clearly spelt out in Dr Walkman’s talk in 2017  where he explains why T cell memory is needed to cure cancer and why orchestrated sequenced combinations are needed. Anktiva which grows and activates T and NK cells, Abraxane that induces DAMPs and activates macrophages, and checkpoint inhibitors that take the brakes off T cells is THE FUNDAMENTAL COMBINATION DESCRIBED by NCI scientists a decade ago in this lecture! Remarkably, Dr. Waldman shows that when administered as single-agents, these molecules did not achieve durable complete remissions but when placed in the correct sequence of combination therapy, magic happens. Quantum oncotherapeutics So please share this video with whomever wants to be enlightened that immunotherapy 2.0 now exists and has been studied in multiple Quantum Oncotherapeutics trials across multiple tumor types under QUILT

Will submit data..coming soon. NCI, NIH and even FDA knew since 2007 that IL15 was a game changer for cancer of all types. Every scientific thought leader ranked it number one ..almost 20 years ago. I hope Marty sits down with the reviewers when the data comes in. Saving patients bladders matter. Prolonging life matters. Quality of life matters. T cell and NK cell expansion matters. Duration matters.

Congratulations GSK

How do you defend a "no" to access for patients desperately seeking treatment, when the package insert affirms the mechanism that Anktiva activates T cells and NK cells? @PeterPitts provides the amazing truthful response that there is no reason. He highlights the mechanism of action in the package insert already approved. Peter also provides insight into the inconsistencies at the FDA when dealing with large pharma regarding approval with single arm trials versus biotech companies with a mission to cure cancer.

Yes T cells don’t have a tumors address. A decade to prove the hypothesis that the triangle offense and the power within our immune system is the paradigm change that is happening with our patients. Inspiring stories of our patients in a book coming soon.

This is the concern about mRNA- it was designed to persist. We are studying the effect of persistence and its potential for continued inflammation and role in increased incidence of cancer..more to come