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No, survival is NOT a shortcut. And a new trial wastes lives, money and entire companies and the FDA is reformed to avoid exactly that kind of unnecessary, false traditionalist nonsense that has absolutely no point but to keep only the largest companies in the game.
For taxes.
No one lies. This is your claim and if they did, sue them. Lying is a crime. Alleging they lie, lying, without proof just to affect investor interest aught to be a crime too.
All facts in my post. You have nothing but to shrink and pretend.
Quit bluffing, it was a phase 1 / 2 safety trial, no safety issues. They found systemic response and many patients surviving far beyond when they were supposed to survive. But it was not calculated to give an optimal treatment, as a safety trial.
The patients were unable to get other treatment and were effectively assigned to go to hospice if they could find no other options. They only injected one tumor even if the patients had many. The result was most patients lived longer than expected and some seem to have continued living indefinitely. They had a variety of horrible cancers. They gave different amounts I believe, and different versions of the vaccine.
“Primary Outcome Measures:
Number of patients with adverse events [ Time Frame: 6 months ]”
“Subjects with a histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor malignancy for which primary treatment is no longer effective or does not offer curative or life-prolonging potential per clinician judgment, with the understanding that DCVax-Direct is not intended as a treatment of last resort.
Not eligible for complete resection due to either tumor location, physician's assessment or subject's choice.
Must have completed at least one recent treatment regimen in the metastatic or advanced setting in the disease currently under treatment to reduce tumor burden.
Any steroid therapy >2 mg dexamethasone or equivalent dose should be stopped or have been tapered down 2 weeks prior to the leukapheresis.
At least one measurable tumor mass, i.e. a lesion that can accurately be measured by CT/MRI in at least one dimension with longest diameter = 1 cm, that is accessible for injection either with or without imaging (CT/ultrasound) guidance.
Adequate hematological, hepatic, and renal function,
Adequate blood coagulation parameters
Life expectation of >3 months.”
“Abstract
Purpose: Dendritic cells (DC) initiate adaptive immune responses through the uptake and presentation of antigenic material. In preclinical studies, intratumorally injected activated DCs (aDCs; DCVax-Direct) were superior to immature DCs in rejecting tumors from mice. Experimental Design: This single-arm, open-label phase I clinical trial evaluated the safety and efficacy of aDCs, administered intratumorally, in patients with solid tumors. Three dose levels (2 million, 6 million, and 15 million aDCs per injection) were tested using a standard 3 + 3 dose-escalation trial design. Feasibility, immunogenicity, changes to the tumor microenvironment after direct injection, and survival were evaluated. We also investigated cytokine production of aDCs prior to injection. Results: In total, 39 of the 40 enrolled patients were evaluable. The injections of aDCs were well tolerated with no dose-limiting toxicities. Increased lymphocyte infiltration was observed in 54% of assessed patients. Stable disease (SD; best response) at week 8 was associated with increased overall survival. Increased secretion of interleukin (IL)-8 and IL12p40 by aDCs was significantly associated with survival (P = 0.023 and 0.024, respectively). Increased TNFa levels correlated positively with SD at week 8 (P < 0.01). Conclusions: Intratumoral aDC injections were feasible and safe. Increased production of specific cytokines was correlated with SD and prolonged survival, demonstrating a link between the functional profile of aDCs prior to injection and patient outcomes. Clin Cancer Res; 24(16); 3845-56. ©2018 AACR.”
Not true. Novel claims often require a complex back and forth with a court and defendants before the course of a case is fully set in motion. They are going for something that has not been done before and I believe they will be successful. But the reality is that bold claims can require some back and forth like what is occurring.
Like before it went to $12?
Your insistence that validation does not exist, despite the evidence that it does, and the nature of the trial, disease and apparent very favorable leanings of the U.K. given access in the specials program, is no surprise. It’s just that you have been consistently wrong, in such matters and all you have is really old nonsense.
No, but I would not expect anything other than something so vulgar and excessive as your opinion.
I am not supporting or attacking him. Your behavior is nonsensical, bizarre and has no logic and you’re attacking the orderly structure of a company in which I am invested.
I am not here to facilitate bizarre or bad behavior. And I am here only as another investor. Not here to advocate for you to be invested. If you don’t like something, you don’t have to be invested. No one is begging for you to be invested.
Actually, I did go through the ownership details. I clearly know way more than you. You’re just throwing around false implications and nonsense. Bizarre behavior.
Your knowledge is not critical to the internal decisions of the company on such matters. Some of his shares may not have been allocated your attack on this, randomly, bringing up things unrelated from 2007, when he was not a board member and involving regulatory matters, clearly you’re screaming all over the board without ANY actual information, which is bizarre. Seems like a fake effort to create noise around trying to oust a board member. And that, as I said, usually suggests interests trying to get some sort of leverage. But, in this case virtually all the points are without real information, are falsely made by implication, not facts, are extremely dated, and are literally bizarre. Strange. Not rational.
The Swiss thing was not a “deal”, and he would not have been involved as an analyst. It was a regulatory application.
It also happened in 2007, before LP was an officer and really she took over after that.
Your post digs deep, in terms of years,connects things that are not really connected and attacks board member basically out of the blue.
I am presuming there is some undisclosed motivation. Usually this kind of nonsense suggests an effort to make a move on a company. But in this case, poorly executed.
You can find out by doing your due diligence. I am not here to help people who undermine the company.
You have nothing new!?
That is all water under the bridge. Old news. Not currently relevant. The result of short manipulation and an effort to take over the company most likely on the cheap. Sounds like there might be another attempt…
You guys part of the takeover on the cheap?
Nonsense. It was long ago. It was clearly a mistake of an inexperienced team and before LP took over the CEO position and management of the company. It was a doctor who did not understand Switzerland, and as I explained, the Swiss are something else and often make broad claims that are not accurate when try g to induce people to do business in their country. I love Switzerland. Beautiful country, but very narrow. The cantons think they are their own countries.
When you get compensation in shares, you have taxes. There was an allocation and a lawsuit. I doubt there is any secret involved here. And, by the way, you can sell shares to pay taxes even if they are not from the allocation. But I believe his taxes are related to his shares from the company.
Again, you’re not saying anything for real, just implying things.
My pleasure Gary.
Owning shares does not make them “not independent”, it aligns them with shareholders. And as for your speculation, you haven’t said anything yet, just implied things.
No, I am just saying what I know. I am aware that when he was an analyst he was understandably excited. And then the company, that is 2007, just before the financial crisis, hit a financial challenge just like countless tiny bios at the time. Many went out of business entirely, even with trials and promising drugs still. So, you can pretend to be saying something, without context, but the reality is, you are opening a door that if I were him, I’d make you walk through completely.
For taxes. It’s clearly stated in his disclosure.
He doesn’t pump. I’ve never heard him say anything publicly. He is an experienced person in finance and in the board. I expect he has been invaluable behind the scenes keeping things financed. Just because you and the other shorts do not recall the facts, doesn’t mean there was anything unusual about his options or his shares. You all might do your own research before throwing around the false speculation.
Doesn’t Malik live in the UK? I’d hate to get sued for defamation in the UK. I am sure some people are opening themselves wide open. When you get sued, you not only owe your legal bills, you owe the cost of the victim’s bills. So an innocent victim can hire as expensive a lawyer as they’d like.
There was no “Swiss approval scam” and LP came in after that Dr. Boynton was CEO and President then and given what I know about Swiss overselling what you can do in Switzerland to corporations, I am not surprised if they might have been somehow confused dealing with a Swiss canton or Swiss authorities or even Swiss lawyers. I have been on the opposite side of deals involving international companies with entities in Switzerland including “branches” and the Swiss say a lot of things that just are not true to people trying to get to the bottom of some things. What they really probably often mean, unfortunately, is “no one will know”…. But they don’t say it that way as they want to seem like a completely legit jurisdiction.
So my experience is, you have to get your own lawyer and grill the Swiss side… and a lot of the time they are so narrow, they have no idea what they are talking about in the international context. Switzerland is its own little world and the Swiss thing the sun rises and sets on Switzerland.
Clearly you have nothing to say there but gibberish.
There is little known investment from institutions because it is OTC. The reality is, it will come and these are the people that brought us to the dance. You don’t have control, you won’t have control, and you can’t get control. Stop complaining and move on. Doubtful you own anything or if you do doubtful you’re a constructive force.
So insiders own a small part of a firm, a company with a lot of shares outstanding and you try to manufacture something. Bogus!
If he owned nothing you’d be doing the same thing with the other side of the argument.
Looking into the action of N-803, it is an immune superagonist, stimulating the immune system rather than a checkpoint inhibitor like Keytruda. So the comparison is not appropriate because they do different things.
N-803 might be a better substitute for Poly-ICLC, though apparently they do different things too. But they both stimulate immune response rather than what checkpoint inhibitors do.
They combined it with Bacillus Calmette-Guérin, a live vaccine used for over 100 years as a vaccine first for TB, then discovered to work as an immunotherapy for bladder cancer. Interest has renewed in its efficacy off and on for decades. It is currently used in some vaccines as a stimulant, and is regularly used as a part of the standard of care to treat bladder cancer since at least the 1970s. BCG is the gold standard for bladder cancers, and apparently N-803 gave it a strong kick.
Interesting trial. I’d want to look into it more. I would not say it is better than Keytruda because they are drugs that do different things. A person writing a seeking alpha article might not know that much or even explore the differences and why it may have been helpful specifically in the Phase 3 trial with BCG. But it is interesting.
Ownership report is for these all together:
https://www.sec.gov/Archives/edgar/data/1326110/000119312524001705/d47784dsc13da.htm
All of these are associated with Dr. Patrick Soon-Shiong.
“Item 2 of this Schedule 13D is hereby amended and restated as follows:
(a), (f) This Schedule 13D is being filed jointly by:
(i)
Dr. Patrick Soon-Shiong, a natural person and citizen of the United States;
(ii)
Cambridge Equities, LP, a limited partnership organized under the laws of the State of Delaware (“Cambridge Equities”);
(iii)
MP 13 Ventures, LLC, a limited liability company organized under the laws of the State of Delaware (“MP 13 Ventures”);
(iv)
NantWorks, LLC, a limited liability company organized under the laws of the State of Delaware (“NantWorks”);
(v)
NantMobile, LLC, a limited liability company organized under the laws of the State of Delaware (“NantMobile”);
(vi)
Nant Capital, LLC, a limited liability company organized under the laws of the State of Delaware (“Nant Capital”); and
(vii)
California Capital Equity, LLC, a limited liability company organized under the laws of the State of Delaware (“California Capital”).
The persons and entities listed in items (i) through (vii) above are collectively referred to herein as the “Reporting Persons.””
Great point Gary. One of my concerns about getting too tied up early is the circumstance where a BP has a drug fading in comparison to competition and DCVax-L being somehow tied up, bought out and then offered only paired with their drug.
The reality is there is immense opportunity to stay independent, but the challenge is, they also need money to fund growth and expansion. So the temptation is always to pair up even now with deep pockets. Waiting too long to do it is difficult.
IBRX is not a big pharma and unfortunately, better products are often eclipsed by companies better positioned to market their own product. But I would expect that IBRX might very likely get a lot of interest. Over 80% of the shares are held by insiders. Makes it hard to buy without a very good offer.
There is a sizeable short position versus their actual float, shares available. So it could be difficult to cover. Most shares appear tightly held by a few holding 10% and more, totaling just over 80%.
Recent filings are interesting:
Ownership:
https://www.sec.gov/cgi-bin/own-disp?action=getissuer&CIK=0001326110
39% here:
https://www.sec.gov/Archives/edgar/data/1326110/000119312524001705/d47784dsc13da.htm
https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1326110/000132611024000003/ibrx-20231229.htm
https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1326110/000132611023000147/ibrx-20230930.htm
Last 10K: https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1326110/000132611023000018/ibrx-20221231.htm
It's good to be sure. Usually "days" is total number of days and "Business Days" is the work days excluding weekends and holidays. Do you have a definition or link where there is a specific explanation of the meaning of "days" for that timeline? Or are you just speculating on weekends and holidays?
And just to be sure, I further put the question to ChatGPT. I do not have a relevant FAQ that specifies otherwise though I did look for one. If you have one, that would be great. But otherwise I would take "days" to mean actual days, not business days.
https://chat.openai.com/share/ef2b354e-8772-4804-9800-37833ec67f05
Answer:
The term "days" mentioned in the MHRA (Medicines Healthcare Products Regulatory Agency) timelines for assessment, such as the "150-day assessment timeline," refers to calendar days unless specifically stated otherwise. Generally, in regulatory contexts, "days" without any qualification tends to mean calendar days, which includes all days of the week, weekends, and public holidays.
When agencies or organizations specify "business days," they explicitly exclude weekends and public holidays from their calculations. Since the MHRA guidance does not specify "business days" but just "days," it is reasonable to interpret this as calendar days. This interpretation means that the 150-day timeline includes all consecutive days from the date of submission of a valid application.
However, for absolute clarity, especially in contexts where timing is critical for regulatory submissions and planning, it's advisable to directly confirm with the MHRA or consult the detailed guidance documents they provide. Regulatory bodies often have FAQs or guidance documents that clarify such terms, or they can be directly contacted for clarification to ensure compliance and proper planning.
I agree that Sawston has huge potential like that and that your calculations make sense for the newer facilities they will put in place with Flaskworks. Also, I expect eventually they would ultimately retrofit the old space as well, for Flaskworks. They might need some space for regional development authority obligations but paying off that debt might free them from that as well.
If they have a problem of underutilized space, which I honestly think is unlikely, such space will be used to meet the regional development authority requirements for financing the facility. It all works well. And likely the rest of the facility will be Flaskworks. I expect they will get that financing in line in the not too distant future, given their recent PR, subject to marketing approval.
The entire facility is something like 88,000 sq ft. I believe Larry, but 1B is just phase 2 of the buildout. Larry was just explaining what the company has said so far.
I don’t think 1B is Sawston’s full space, just phase 1B.
People can wish well for people they see in the news and hope the get the vaccine. I do not recall people saying either of those persons received DCVax-L any more than they did for certain with King Charles. What they did see in this instance was coverage that utilized DCVax-L images and said Charles was not interested in traditional chemo but was interested in new treatments that had fewer side effects.
Reasonably, people would want to suggest DCVax-L here, given those factors and preferred parameters.
Of course in the case of people suffering from a brain tumor, investors would want patients to get the best, state of the art treatment even as a compassionate care treatment. People here believe in their investment, unless they are shorts.
Jimmy Carter had melanoma that spread. Those treatments have been successful with Melanoma, which has only limited antigen targets, so it is much easier to treat and not as heterogeneous in terms of antigen targets. So yeah, it’s much easier to treat with key drugs and he has done well. He did not have GBM, or the brain tumors targeted with DCVax-L so far.
None of this reflects on DCVax-L or investors, as much as you might like it to….
Agreed that they are working with NWBO. I have come across the Stanford team before, so I am pretty sure there is definitely some sort of collaboration and then of course this, which is what you are pointing out as well.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173786649
Hi Zadie, no, it is a checkpoint inhibitor. Car-T is a reprogrammed T-cell, a cellular therapy, but often the T cell is highly modified using cellular reprogramming.
Car-T stands for Chimeric Antigen Receptor (CAR) T-cell therapy. It is a type of immunotherapy that involves genetically engineering a patient's T cells (a type of immune system cell) to recognize and attack cancer cells. The process of creating CAR T-cell therapies involves several steps:
1. **Collection of T Cells**: Blood is drawn from the patient, and T cells are isolated from the blood sample using a process called leukapheresis. Basically the same process or very similar to what NWBO does to get the relevant cells for DCVax-L and DCVax-Direct. Some Car-T treatments start with fully reprogrammed universal immune cells, reprogramming original blood cells from one donor or a few donors for a baseline set of cells. The idea is to create an off-the shelf treatment. You have companies like Fate Therapeutics using these cells. And there are others. NWBO might someday go that route, but the challenge is, the more you manipulate baseline cells and program them, the more you have a potential for mutation. One of the recent risks revealed with Car-T therapies. So those companies modify a baseline cell into a universal T Cell that they then program to attack the cancer. But the approved therapies, like DCVax-L are not using original reprogrammed cells but are using the patients own cells generally, and that should reduce the genetic manipulation. But not entirely, because if the next step.
2. **Genetic Modification of T Cells**: The isolated T cells are then genetically modified in a laboratory to express chimeric antigen receptors (CARs) on their surface. These CARs are synthetic receptors that can specifically recognize antigens (proteins) present on the surface of cancer cells. The genetic modification is usually achieved by using a viral vector, which is a virus that has been engineered to be harmless and carry the gene encoding the CAR into the T cells.
3. **Expansion of CAR T Cells**: After the T cells have been genetically modified to express the CAR, they are cultured in the lab to increase their numbers. This process can take a few days to several weeks, during which the T cells multiply and become more specialized in recognizing the cancer cells.
4. **Patient Preparation**: Before the CAR T cells are infused back into the patient, the patient might undergo a process called lymphodepletion. This typically involves treatment with chemotherapy and sometimes radiation to reduce the number of existing immune cells in the patient's body. This step helps create space for the infused CAR T cells to expand and function more effectively.
5. **Infusion of CAR T Cells**: The expanded CAR T cells are then infused back into the patient’s bloodstream through an intravenous (IV) line. Once inside the patient's body, the CAR T cells further multiply and start to recognize and attack the cancer cells that have the specific antigen they were engineered to target.
6. **Monitoring and Support**: After the CAR T-cell infusion, patients are closely monitored for any signs of side effects, which can range from mild to severe. The most notable side effect is cytokine release syndrome (CRS), which can occur when the engineered T cells rapidly release cytokines (chemical messengers) into the blood, leading to fever, fatigue, and in severe cases, organ dysfunction. Other potential side effects include neurologic complications and an increased risk of infections due to the lymphodepletion process.
Recently, the FDA has required manufacturers of CAR-T therapy drugs to add a "boxed warning" - the strongest safety notice - to their labels due to a potential risk of developing secondary blood cancers from this kind of therapy.
The specific concern is the development of T-cell malignancies, including a type called CAR-positive lymphoma, which can be serious and even life-threatening.
CAR T-cell therapy has shown promising results, particularly in certain types of blood cancers such as acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma. It’s really done best in blood cancers so far, not so much in solid cancers.
Keytruda is a checkpoint inhibitor.
Checkpoint inhibitors are a class of drugs used in cancer immunotherapy that work by blocking proteins that inhibit the immune system's ability to destroy cancer cells. Really, the immune system uses these checkpoint proteins to hide cancers, mistaking the immune response to cancer as an auto-immune response. The checkpoint inhibitors inhibit the checkpoint proteins and can also induce severe autoimmune reactions as well, in normal cells.
These checkpoint inhibitor proteins, known as checkpoints, are used by the body to prevent the immune system from attacking normal cells. However, cancer cells seem to exploit these checkpoints to avoid being targeted by the immune system. By inhibiting these checkpoints, checkpoint inhibitors help restore the immune system's ability to recognize and destroy cancer cells.
So for instance, in some cancers, when DCVax Direct turned a “cold” cancer with no immune response, into a hot cancer with an induced immune response, one way they could also tell it was working was that often the immune response then induced a checkpoint response. The expectation is that by adding checkpoint inhibitors, you could keep the immune response going. The immune system is complicated. It does not just consist of a-b, simple stimulus and response. You have what are called secondary and other tertiary immune responses that can be ways that a normal immune system protects a person, but in the context of cancer, it can be counterproductive. Dr. Liau and her team are working on addressing these secondary and then tertiary immune responses to keep the effects of treatments like DCVax-L going, so that more patients can be helped and the immune response can last long enough to eliminate the cancer, keep the cancer from recurring and to keep as many patients as possible, and all, alive, as long as possible, and hopefully cancer won’t be the cause of death but simple old age.
Checkpoint inhibitors work by targeting and blocking the activity of specific immune checkpoint proteins. For example:
- **CTLA-4 Inhibitors**: CTLA-4 is a protein that regulates T-cell activity early in the immune response. Inhibiting CTLA-4 can enhance T-cell activation and proliferation, leading to a stronger immune response against cancer cells.
- **PD-1/PD-L1 Inhibitors**: PD-1 is a protein on the surface of T-cells that, when engaged by PD-L1 on cancer cells, inhibits T-cell activity. Blocking either PD-1 or PD-L1 can prevent this inhibition, allowing T-cells to attack cancer cells more effectively.
By blocking these checkpoints, inhibitors enable the immune system to better recognize and attack cancer cells, leading to reduced tumor growth or even tumor regression in some cases. Checkpoint inhibitors have shown significant success in treating a variety of cancers, including melanoma, lung cancer, kidney cancer, bladder cancer, and Hodgkin lymphoma, among others. However, not all patients respond to these therapies, and research is ongoing to understand why and to develop strategies to overcome resistance.
The challenge with checkpoint inhibitors is they turn off the mechanism by which the immune system allows cancers to hide, but they do not turn on an immune response. So if the cancer is “cold”, the body may not reject the cancer cells.
More in Keytruda:
Keytruda (pembrolizumab) is a checkpoint inhibitor that targets the PD-1 (Programmed Death-1) pathway. It works by inhibiting the interaction between PD-1, a protein on the surface of T-cells (a type of white blood cell involved in the immune response), and PD-L1 (Programmed Death-Ligand 1), a protein expressed on the surface of many cancer cells and some normal cells.
The PD-1/PD-L1 interaction normally serves as a "checkpoint" that helps regulate the immune system's response, preventing T-cells from attacking normal cells in the body. This mechanism is crucial for maintaining self-tolerance and preventing autoimmune reactions. However, many cancer cells express high levels of PD-L1, which binds to PD-1 on T-cells and inhibits their ability to attack and kill the cancer cells.
By binding to PD-1, Keytruda blocks this inhibitory signal, enabling the T-cells to recognize and destroy cancer cells more effectively. Essentially, where there is an actual immune response, Keytruda would work by reactivating the immune system's ability to detect and fight those recognized cancer cells, leading to reduced tumor growth or even regression in some patients. But that assumes the immune system actually sees the tumor and wants to eliminate it or some other tertiary immune response does not interfere and inhibit any immune response to kill the cancer.
Keytruda has been approved for the treatment of various types of cancers, including melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, and others, demonstrating significant efficacy in improving patient outcomes in these settings. Merck also has a general approval for Keytruda where certain biomarkers are detected. Getting a generalized approval that allows a treatment to be given to patients not having a specific location based approval is really where we want to go with immunotherapies, so that we can get approvals that enable a platform to be utilized against many types of cancer, whether they are in the neck, mouth, breast, lung, brain, toe or tongue. That old form of classification was really about the fact that pharmaceuticals were better for a particular application, but the immune system operates entirely differently and is a systemic process for the human body. So programming an immune response is really the holy grail of oncology, in my opinion. Clearly controlling and getting dendritic cells, the generals of the immune system, to mobilize the entire immune system us and will be a major coup against cancer.
The Hospital Exemption program has turned out to just not be a practical program. It was not just in Germany that such programs existed but they've gotten virtually no traction because the programs were set-up poorly and really don't help small companies with new drugs and even big companies don't seem to like the programs all that much. Some of these compassionate use programs, other than the UK Specials program, which is more practical, seemed to really only work for PR. Not that the regulators set them up with that in mind. But the regulators appeared not to set them up with a mind to actually whether the programs would be sustainable or not. Turned out, because of the rules that they put in place with these programs, they simply could not be sustained.
I think they just care about the money they make or are getting paid. Watch that movie Dumb Money. A lot of hedge fund guys are children of investment managers born with a silver spoon in their mouths and destined to manage their own fund from the day they were born, or they married into it. They do not care. To them, it's just all about easy money. And some, maybe they earned it, but they earned it by losing their conscience and doing whatever it takes to maximize their wealth. Making money is easy if you have no pride and are willing to do anything.
We all go to that place, and I believe it is actual reality and this is simply a part of our evolutionary journey as beings or souls with consciousness. May she rest in peace.