Well said. A good explanation. Simple but profound. Our NK snd T cells have a highly specialized receptor on their surface called IL15. Ankitiva is a protein we have manufactured that is given as a subcutaneous injection and binds to this IL 15 receptor on the surface of these cancer killing cells, and when this happens these protective and cancer killing NK and T cells expand in huge numbers and become activated. That’s the Bioshield. That’s what is needed to kill cancer and to drive what we call Memory T cells. And we measure the levels in your body of these NK and T cells by a simple blood test called ALC. The Absolute Lymphocyte Count. The ALC levels have been hidden in plain sight. So ask your doctor what are your ALC levels ..” What is my ALC” should be a routine question ….and don’t be surprised if your doctor had not looked at it before or know about the term ALC ..It’s not your doctor’s fault because until now, in the history of medicine there was nothing they could prescribe to fix an ALC if it was low for this medical diagnosis called LYMPHOPENIA. We could fix anemia so we routinely looked at hemoglobin levels and oncologists routinely check the Red blood cell levels after chemo therapy. We could fix what we called neutropenia, so oncologists routinely looked at neutrophil levels called ANC ( absolute neutrophil count). So our doctors are very familiar with ANEMIA and NEUTROPENIA all measurable and treatable. But until now we could not fix LYMPHOPENIA as measured by a low ALC below 1000 cells - the most dangerous diagnosis of low NK cells and T cells - so we ignored ALC ( Absolute lymphocyte count) present in the same test, called the CBC. Hope this explanation of all these medical acronyms helps to explain why ALC has been a “ mystery” for so long …,both to our healthcare professionals as well as the patients who need to know. Today it is not just measurable but treatable. Anktiva is today only approved for a small subset of bladder cancer. We have completed our trials that took years to do across 10 different cancers and showed when we increase ALC in patients regardless of tumor types including patients with lung cancer, the results of combining Anktiva changes the course of survival regardless of the cancer type. That makes sense since we were treating the immune system and our NK and T cells kill ALL CANCERS regardless of tumor type. Details of this study has been submitted for peer review. More to come. Education through X! Connecting the dots of a 35 year quest with the epiphany starting from my earliest publication while at UCLA in 1990 that NK cells are the key immune cells to survival and now perhaps even the key to longevity.

Thanks for the thoughtful questions, Mary. You’re absolutely right—ALC is a powerful prognostic marker, and we’ve now demonstrated across >10 tumor types, including lung cancer, that preserving or restoring lymphocytes directly correlates with prolonged overall survival. So from a prognostic marker to a treatable modifiable condition of lymphopenia. Radiation, including targeted radioligands like Pluvicto, can profoundly suppress ALC. What we’ve seen is that administering Anktiva (IL-15 superagonist) both before and during radiation protects and expands CD8⁺ and NK cells, preserving immune competence during treatment. We are actively recruiting patients for our lung cancer and GBM trials and expanding into prostate cancer, including combinations with Pluvicto, to test this “immune shield” concept in mCRPC. We have shown that maintaining ALC above ~1,000/μL during radiation results in rapid drop of PSA levels to undetectable. We’d welcome your input as a radiation oncologist. Happy to arrange a discussion—our team can walk through the trial designs, inclusion criteria, PD-L1 correlations, and planned endpoints for prostate, head and neck and GBM cancers. Appreciate your engagement and scientific curiosity—it’s exactly this collaboration that drives the field forward.

Excitingly it appears that PDL1 levels do not affect the activity of NK cells in our lung cancer trial. Data submitted for publication. More soon

Lori reach out to us at CssIfm.org and we can treat before your husband has radiation. I know this is frustrating but this is also our battle to help you and your husband. We will write to the fda.. one patient at a time. Thats our same frustration that we were asked to wait till the patients ALC drops. Our mission is to help all in need and since you are in LA that makes it easier on your family for us to help.

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Lymphocyte depletion is the floor; functional competence is the ceiling. Ask your doctor, what is my ALC?

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This is my daily struggle! As of now it is available in LA and only for bladder cancer. We are trying desperately to explain to the oncology and regulatory world that our epiphany that NK cells as measured by your ALC matters. Also working hard to explain to FDA why these NK and T cells are as important to flight cancer as red blood cells are for your body to deliver oxygen! Trying hard.

Was able to provide access to Anktiva yesterday ..NK and T cells matter especially when radiation is happening . One patient at a time ..a difficult way but we will continue to work as hard as we can to make this supercharged NK cancer killer available to all who desperately need it.

Scott we can add Anktiva to Pluvicto and have exciting data in Prostate cancer. Please reach out to the clinic @cssifm and we will help you. Raising your NK and T cells can change the course. We have to apply to FDA one patient at a time. But will get that done. Details piped.video/mgZaT-OriO8

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Connecting the dots

Please see @cssifm and complete forms for GBM for the team to evaluate

It is so consistent with decades of reports in the literature that without NK and T cells ( called lymphopenia ) the survival rate of patients, regardless of cancer type, is highly significantly reduced with this lymphopenia. We can now change that course. A simple blood test tells if the patient has Lymphopenia. The epiphany since 1990 is that NK cells within us is the first responder that needs to be activated to change the course of cancer. I will try to connect the dots to show how Anktiva is part of a finely orchestrated cancer Bioshield platform to stimulate both the innate ( NK cells) and adaptive ( T cells) immune system … a complex orchestrated dance of proteins in our body .. 35 years of work to get to Memory T cells. Ask your doctor “what is my ALC?” NK CELLS MATTER. ALC levels have been hiding in plain sight for decades in a routine test called CBC ( to measure your blood levels for anemia and neutropenia) and has been overlooked by us as clinicians because no drug existed until now to reverse lymphopenia as measured by ALC ….until Anktiva was approved. This thread begins my attempt to describe the journey of insight and evolutionary change of how we approach the treatment of cancer .. and how we re think what “immunotherapy” really means …checkpoint inhibitors alone like Keytruda is not enough.

When BCG is given, the tumor finds a way to hide from T cells. So taking off the brakes from T cells using checkpoint inhibitors alone won't work. This study confirms this. NK cells matter and that is how ANKTIVA is different.

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Shortage of BCG has been a problem for a decade now. We solved this with a supercharged BCG @ImmunityBio . Together with the Bioshield it drives memory T cells in patients with bladder cancer.