TheDanishDude
You don’t have to give it much thought, what drove Philanthropist and Venture Capitalist Bill Malloy to interview Dr. Linda Liau. His wife, Shenell Malloy was treated by Liau at UCLA and her oncology care was managed by Dr. Timothy Cloughesy. After being diagnosed in early 2019, she underwent a craniotomy to remove the tumor, followed by an intense regimen of chemotherapy and radiation.
So he put a spotlight on Liaus work in this article Spotlight on Dr. Linda Liau of UCLA, which he ended.
Dr. Liau is dedicated to her work, and her tireless efforts are saving people’s lives and advancing the fields of oncology and personalized medicine. Thanks to her, we may one day have a cure for glioblastoma and other cancers.
A year later he went on to make this interview with her, that was centered around her work with the DCVax-L vaccine and which I urge you to read.
The following are Linda Liau excerpts from this interview. Golden nuggets if I may say so, that every retailer ought to remember, because there is a great surplus of fud narratives out there currently, that try to blur the truth.
About “whats lacking”.
More and more, I do think you need to think about appropriation therapies, we need to think about timing of treatments and also the whole process of getting therapies adopted through the whole hurdle of FDA approval. For instance, consider the trial that I’ve done for dendritic cell vaccines. For cellular therapies, I think what is lacking is a smooth, operational aspect. Let’s say, if there was a company that could make GMP-grade cells readily and basically, it’s almost like the manufacturing, production, distribution, and coordination of the treatment or clinical trial for approval for a treatment would go much more smoothly.
About the combo trials with Merck and Oncovir
Right now, we’re starting up a trial – the SPORE 1 Combo trial with Keytruda (Pembrolizumab) and DCVax-L (ATL-DC) – which personally I think would be very promising. It’s basically using vaccination in combination with a PD-1 inhibitor. We’re working with Merck on that in combination with Poly ICLC, which is a Toll-like receptor. That’s another company called Oncovir.
About the process patents
So, with a DC vaccine, like I said, we can just make it ourselves. We can’t scale up as an academic institution or a small company, but if that were part of the company we could scale up. To make the vaccine, you just need a manufacturing GMP facility. But the problem there is the autologous dendritic cells are hard to get patented. You could patent it, but it’s hard to defend that because it’s really the patient’s own tumor, right? So, the patents really are process patents and we could file one that tweaks things a little bit, and that’s essentially that’s what Northwest Bio did. They filed multiple patents just on little tweaks of the cocktails that are used to make the cells. The other drugs are already made by other companies and they’re just an agreement. But at the end of the day, it doesn’t really cure GBM unless there’s something a little bit broader. I guess in my heart of hearts, I think what’s going to cure the disease is going to be personalized. It’s going to be something that comes from the person or the tumor itself and I’m not sure how that can be patented other than the idea and the process by which that’s done.
About external trials and placebo
Yeah, I think people have to think about the patient when we design these trials. A lot of times, we design these trials and end-points based on the way we design the mast studies. We have a treatment group and we have a placebo group. Then, at the end we’ll see which group does better. And I don’t think in patients you can do that. And honestly, if I were a patient, I’d hop from one trial to another depending on what sounds promising or what’s available at that time. A lot of patients do that, and then you really cannot necessarily control for that. Let’s say someone took TOPA and then went on another trial. Was there any effect from the virus that they had before? So, I think that’s an issue in terms of when we design these trials, what should we have in mind? We have the patient more in mind. And I think, broadly speaking within the field of neurosurgery and neuroscience and not just brain cancer, a lot of people are advocating for what they call comparative analysis. Not necessary using randomized clinical trials as the gold standard but using real-world data.
About designing trials that are best for patients. The DCVax-L P3 trial.
For instance, I’ll just take what happened with the DCVax. You really want to get clean data. We’ve never allowed for patients to get the vaccine once they failed, because they will. You enrolled in the trial. You had a recurrence, and now you’ll have to try something else. I could tell you patients are fighting to get the vaccine. And even if you tell them, “Well, there’s no proof that this works. This is the whole reason we have to do the trial. I can’t tell you that there’s any benefit.” But I guess the counterargument that I hear quite often is, “well, the side-effects aren’t bad.” And they’re not. So, it’s like, “Well, if it’s not going to hurt me why can’t I have it? Why can’t I try it?” Because of that it’s hard to prove something based on what the FDA requirements are without being a little cold-hearted and saying, “Well, no, you’re not allowed to try that.”
About the NovoCure Optune treatment.
So, a part of it is having the FDA think a little bit differently about what constitutes approval.
On the converse, like the Optune device, that Novocure device, is FDA-approved. But I must say a lot of patients are like, “Well, I don’t really like it.” And I think on the physician side, we just don’t understand how it works and there are a lot of problems with the clinical trial design. There was no true placebo arm, but they did design it in a way that met the FDA checkboxes. So, it was approved, but a lot of us don’t really believe that it works. I think it’s one of these things where if your ultimate goal is to cure GBM, it’s hard to reconcile all these different factors; the regulatory factors, the financial factors, as well as the science and the biology of the tumor itself, which is very complex.
Epilogue
Consider Linda Liaus words carefully, not least her words about “whats lacking” from the first excerpt paragraph and then correlate with the exceptional number of patents NWBO have been securing during a long time. And then have a look at the Press Release from a couple of months ago “Northwest Biotherapeutics Moves From Optimization of Flaskworks Prototype to Fabrication of GMP-Compliant Units For Installation, Validation and Final Testing Prior to Regulatory Certification“, a heading followed by this subheading.
Accompanied by Broad Patent Coverage
To sum it up:
Patent Protection and Strategic Positioning: The broad patent coverage for the Flaskworks system, including a foundational patent and additional new patent applications, positions Northwest Biotherapeutics to build a strong franchise around its innovative manufacturing technology and DCVax-L products.
Four years went from this interview was done. DCVax-L are about to be approved by the MHRA in the UK. FDA have changed their guidance on the use of external controls and real world data. Advent Bioservices have been built into the UK’s perhaps most advanced cell CDMO, with NWBO holding its leash and are in the final stage of building a GMP-compliant (i.e., clinical grade) version of the prototype Flaskwork EDEN machine made with GMP grade materials.’
As Linda Powers said.
“We are also very pleased to have expanded the scope of our patent coverage on the Flaskworks system. We believe this is a valuable asset that will help Northwest Bio build a strong franchise.”
