Dr. Pat Soon-Shiong

My inspiration since 2008, when I picked up his chapter and his struggles of seminal discovery that was considered "laboratory artifact". When in fact, it can change mankind by this enlightenment. See Dr. Joseph G. Sinkovics. Change requires patience. But cancer is a war against time. "With the discovery of T cell growth factor (interleukin-2), the road for lymphocyte therapy of human cancers appeared wide open. Then emerged the “large granular lymphocytes”. These cells occurred not only in patients with cancer, but in healthy cancer-free individuals. The author of this article served as “negative (healthy) control” in the cytotoxicity assays in the late 1960s and early 1970s. Some project site visitors of the National Cancer Institute could not comprehend that “immune reactions could exist without pre-immunization” and referred to the phenomenon as an “in vitro artifact” (worse than that: they canceled grant support for its study)." link.springer.com/chapter/10.100… "...he discovered that cancer cells could be killed by large granular lymphocytes without first immunising the host organism. This phenomenon he first observed in his own blood. Initially the NCI could not see the significance of what he had found so denied him funding to pursue the project further. This decision was later reversed in the early 1970s following the discovery 'natural killer cells' by other NCI scientists." whatisbiotechnology.org/index.php/peop…

The more we learn about the power of IL-15 and the literature that exists decades ago (since 2010!) and never exploited is so exciting. Sepsis is responsible for over 200,000 deaths annually in the United States. We are planning a trial in community acquired pneumonia and sepsis. What is remarkable is the finding that Pseudomonas, a bacterial infection induces apoptosis (cell death) of NK cells, dendritic cells and CD8+ T cells contributing to mortality. More remarkable is the finding that IL-15 blocks this killing of these protective NK and CD8 T cells and improves survival. In this paper the final conclusion: "IL-15 prevents two immunopathologic hallmarks of sepsis, namely, apoptosis and immunosuppression, and improves survival in two different models of sepsis. IL-15 represents a potentially novel therapy of this highly lethal disorder." The more we learn, the more wondrous is this IL-15 cytokine molecule in our body! Our Sepsis Trial: ResQ218B-CAP clinicaltrials.gov/study/NCT07492… pubmed.ncbi.nlm.nih.gov/20026737/

Capital in place.Approvals in 34 countries. Indication expansion globally in motion. Pipeline of combination trials cooking. Immunotherapy 2.0. Never give up.

Strengthening the balance sheet. Recharging for global expansion. Stay tuned.

Excited to be invited by a health minister in Europe to visit to establish immunotherapy2.0 ….global expansion of the power of NK and T cells. The need to address the rising number of cancer in younger patients is being realized around the world.

Another milestone in our BCG Naive randomized trial (QUILT-2.005) reached in which 50% of enrolled patients reached an evaluable time point for efficacy, triggering an Independent Data Monitoring Committee (IDMC) review to evaluate statistical power of the adequacy of the sample size (N=366) to detect clinically meaningful differences between ANKTIVA + BCG versus BCG alone. Determination by IDMC of whether we need to enroll more patients or whether the 366 completely enrolled is sufficient to detect the pre-specified clinically meaningful differences between the two arms. Stay tuned. Our hypothesis that IL-15 is a key immunotherapy cytokine and the quest continues.

This is how we build the 'World Bank of NK Cells' and make Immunotherapy 2.0 accessible to all of humanity. Our M-ceNK Phase 2 clinical trials ongoing with process development from over 60 healthy volunteers and patients with cancer completed to date. The future of growing natural killer (NK) cells to fight cancer and protect our immune systems is being assembled right now (NANT Leonardo), the first AI machine driven, cell therapy robotic manufacturing system landing soon!

I developed Abraxane and fought for years after it was acquired that the dose should be lowered. It was hard to convince the value of low dose metronomic Abraxane and finally it was lowered for pancreatic cancer and given weekly. It was ( and still is) difficult to have busy oncologists understand that the fundamental difference between Abraxane ( delivered in a naturally occurring Albumin nanoparticle ) and Taxol ( delivered in a castor oil) that the biology completely changes…Abraxane is transported via a GP60 mediated transport mechanism through the blood vessel wall to the tumor micro environment and activates macrophages to kill the tumor as well as “ exposing” the tumor through a process called DAMPS to enable NK and T cells to recognize and kill. So it’s not that we ignore the use of chemo, it’s how we use it to activate the immune system while protecting and activating the lymphocytes with Anktiva. Connecting the dots is tough but I will keep trying!

Amen

Like the Triangle Offense in human biology!

Global expansion-first approval in Asia!! Anktiva now approved in Macau, China today. Paradigm change of treating the immune system unstoppable.

Great announcement today by HHS and NCI to support cancer vaccine trials. We have spent the past decade collaborating with 2 amazing thought leaders at the National Cancer Institute (NCI) in the field of cancer vaccine, Dr James Gulley and Dr Jeffrey Schlom. Together we have completed Phase 1 & 2 trials across multiple tumor types showing how our Adeno vaccine plus Anktiva generates tumor specific T cells. The randomized trial to PREVENT cancer in subjects with Lynch Syndrome which affects over a million Americans (1 in 278) is fully enrolled and the early data so far shows that Anktiva and the Adeno vaccine increases NK and T cells in these subjects, even in subjects aged 65 wsj.com/articles/hhs-h…

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…