In a big week for ITUS, the Company announced outstanding results on a study undertaken with Memorial Sloan Kettering Cancer Center (MSK) and Serametrix, along with the issuance of another key patent.
MSK is a premier cancer center and their validation of the technology being jointly developed by ITUS and Serametrix is a very impressive endorsement. Excellent results like those shown today, along with a solid IP protection strategy, has ITUS positioned to be a leader in the developing field of liquid biopsies. We had a chance to discuss the recent announcements with ITUS’ CEO, Dr. Amit Kumar…
Tailwinds Research (TR): The obvious first question is about the results you just announced in conjunction with The Memorial Sloan Kettering Cancer Center and Serametrix. Can you provide us with any more detail about the findings and their implications for ITUS going forward?
Dr. Amit Kumar (AK): We all know about MSK. It is one of the top cancer research and treatment centers in the world, so I need not go into detail about them. Serametrix is a very innovative, private company that provides certain services to top academic centers, biotech and pharmaceutical companies. Their primary offering to their partners is a service that profiles Myeloid Derived Suppressor Cells (MDSCs), the same cells on which we focus.
Serametrix’s focus is on using MDSC profiling to monitor how cancer patients are responding to immunotherapy in clinical trials. We feel that our AI based cancer detection technology could be very helpful in this endeavor to help identify responders to therapy early. So we were talking to Serametrix about coupling our technology with theirs to develop additional products and establish partnerships with pharma companies and top academic centers to evaluate this option. During these discussions, we decided to do a small project on the MSK prostate cancer samples. The study served two purposes. First, we wanted to demonstrate to Serametrix the power of our technology. We also wanted to demonstrate to MSK and others that our technology worked well with third party samples done in a blinded manner. We accomplished both goals.
This study was originally undertaken by MSK and Serametrix to determine if they could distinguish prostate tumor-bearing patients from healthy individuals through a simple blood test. As it turns out this is exactly what our Cchek does. The blood samples form MSK were sent to Serametrix, where they were profiled using flow cytometry in a manner similar to what we do at ITUS. Serametrix profiled the samples by specifically evaluating one type of MDSC, the cells on which we focus.
Unfortunately, the standard methods of analysis, used by Serametrix and MSK, did not enable good discrimination between cancer patients and healthy individuals. We decided that we would re-evaluate the data using Cchek.
Serametrix presented us with a challenge, which we accepted. They would send us a number of samples with the biopsy verified calls to train our neural network, and then they would send us blind samples – meaning samples for which only they know who had cancer and who did not. We would make the calls with Cchek in this blinded manner and then we would un-blind the data and see how Cchek did.
When we did this, the results were spectacular. While these patient samples were later stage prostate cancer patients, the conventional methods of analysis were not able to make the calls effectively, while Cchek demonstrated both sensitivity and specificity of 92% each. Such a spectacular result is unheard of for any test for prostate cancer.
Serametrix was so impressed that we consummated an alliance to work together and bring our combined technologies and capabilities to some top academic institutions and pharma companies. Obviously, Serametrix would not agree to do this if they were not excited with the performance of our technology.
TR: Continue with that thought and describe what else you can about the partnership with Serametrix. Can you talk about their business model and how Cchek fits in with what they are currently offering to customers?
AK: First of all Cchek was designed to analyze flow cytometry data and answer biological questions. The first question is whether someone has cancer or not. We have now shown that the signal enabling the answer to that question is embedded in the patterns we are measuring by analyzing MDSCs and other white blood cells. But we think the Cchek platform is even more powerful.
We believe that we might be able to answer an important question that drug companies, doctors and cancer patients want to know- “Will this drug work against my cancer?” Serametrix has extensive experience in trying to answer that question for their pharma partners by monitoring MDSCs through flow cytometry. Both Serametrix and ITUS believe that combining Cchek with Serametrix’ flow cytometry services will potentially make it possible to answer that question effectively.
If we are able to answer that question either before someone begins therapy or very quickly after they begin, this could be a very meaningful technology and product. Cancer therapies cost hundreds of thousands of dollars per patient, and, if a patient takes a course of therapy for 6 months or a year, and it does not work, the patient has spent precious time on a drug that did not abate the cancer.
It is therefore both personally beneficial to the patient and economically beneficial to find out quickly whether a therapy will work or is working. So far there are really no effective ways to evaluate this question. It is not possible to biopsy the patient on a frequent basis, and various imaging techniques do not show results until months or years. If Cchek can effectively answer this question, it will be revolutionary for the large and rapidly growing immunotherapy industry. In fact, we might even be able to save drugs that have failed after hundreds of millions or billions in investment.
With Serametrix, we will work to establish business relationships with corporate and academic partners to evaluate this opportunity. When there is revenue from these relationships, we and Serametrix will share that revenue.
We are very excited about this partnership, and we believe it will enable additional partnerships and studies besides the announced study with MSK. People should stay tuned.
TR: Cchek is powered by an Artificial Intelligence (AI) engine, and that is such a hot topic these days. Who is responsible for your algorithms and how exactly do they work?
AK: Artificial Intelligence is a buzz word today. Getting into a discussion about AI in general is probably beyond the scope of our interview. Many others have written and spoken about AI and how it will impact technology, labor, productivity, and of course healthcare; I can really only speak to what we at ITUS are doing.
First, for our context, AI or neural networks in our case, can be classified into two categories. The first category is comprised of applications that try to, in an autonomous way, do things that humans can already do well. The goal is to do them better, faster, eliminate human error, etc. For example, applications such as facial recognition or autonomous driving fall into this category.
The second category covers applications that human cannot do at all. For example, analyzing complex, multidimensional data is something computers can do and humans cannot. In our case, we have an immense amount of data for each patient. We take multiple measurements on tens of thousands of cells for each patient. Our Neural Network (NN) is analyzing millions of data points for each individual. And we are comparing hundreds of patients’ data at the same time; eventually we hope to be analyzing thousands or millions of patients.
This is a task that humans cannot even contemplate undertaking. And the signal for answering the biological question of interest – does the patient have cancer? – is embedded in the data if it can be analyzed appropriately. Since the signal is there, the NN is able to pull out the answer where humans cannot. That is why, in one of our earlier PRs, I had made the statement that our AI is better at making the calls than any highly trained scientist or physician. And, as the NN processes more patients, with known outcomes, it learns from these results and continually improves. As a side note, I and others believe that, over the next few years, there will be more and more situations where AI will be able to make decisions better than the best trained humans.
Our AI team consists of two engineers in our company, John Roop and Anthony Campisi. While I may have had the original idea about monitoring the immune system to evaluate cancer status, it was the AI that John and Tony developed that really made it work to the superior level of performance that we have reported. Their contribution has been tremendous, along with that of our lead Sr. Scientist George Dominguez and our academic collaborators.
TR: Speaking about your progress in AI, on Monday you announced that the USPTO issued you a patent. What does that mean for you?
AK: In general, I don’t like to talk in detail about patents publicly, but I can say a few things. The USPTO had given us a Notice of Allowance (NOA) in November of last year. Now it has issued and there is a US patent number. You might ask, what is the distinction. Before, when we had been notified of the NOA we knew that our claims were allowed, but when we had discussions with potential partners, we felt we needed them to sign a Confidentiality Agreement (CDA) before showing them the patent. Some potential partners are reluctant to sign CDAs. Now that it has issued, the patent is public and accessible to everyone.
Our potential partners, who might not sign CDAs in the early stage of partnerships discussions, can now look up the patent and review it from the public database. We hope and expect this issuance to facilitate many partnership discussions. As you know, I have stated that our goal is to work with one or more strategic partners for commercialization. We can’t count on one until the documents are signed, but I am hopeful we can consummate a significant partnership in the near future.
TR: Shifting gears here, we haven’t heard much from ITUS regarding your CAR-T therapeutic. Can you give us an update on the progress at Moffitt? Do you have increased visibility into when we might see some trial results and/or expect a filing with the FDA?
AK: The work at Moffitt is going well. Our goal is to complete the studies permitting us to submit an IND, an Investigational New Drug application, to the FDA. That is the first step needed to enable the FDA to approve our entry into human clinical testing.
The work is going well, and we have not announced anything because it is standard laboratory work to support the IND application. Mostly its continued testing in animals. We have to complete an appropriate amount of animal testing before we can begin human testing. We have also requested a preliminary meeting with the FDA to help us answer some specific technical questions we want to address early on in the program. Our goal is to file the IND sometime in the second half of 2019. We may be able to do it sooner, but we will see.
TR: I find it so interesting that you have these two amazing, yet very diverse, programs going on, which speaks to your unique business model. The ITUS’ platform is noteworthy in that, since you outsource most of the development of your products, you have great bandwidth to look at a broad range of opportunities. I might also add that the list of partners you’ve established in a very short time is impressive for a small company and demonstrates that some critical thought leaders are excited to work with ITUS. Does the Company have plans to look at other markets for opportunities to broaden your product portfolio?
AK: I am glad that you asked that question. Biotech companies are very capital intensive endeavors. Laboratories requiring equipment and scientists and physicians are expensive. I have built companies like that before, and have decided to do it differently. We want to try and work with existing infrastructure at all stages of technology development.
Our Cchek technology is partnered with The Wistar Institute and other partners and we do not have to build the expensive labs and hire the expensive personnel. Our CAR-T program is partnered with Moffitt, where we benefit from the infrastructure they have built, and of course as we go forward we plan to establish additional partnerships for the later stages of development and commercialization.
But, I do not want to give the impression to anyone that we do not need more capital. We may not need as much capital as a conventional biotech, but we do need capital. Our goal is to try and raise as much of that capital through strategic partnerships in the least dilutive manner possible.
Having capital has many benefits that are often overlooked. In addition to having money to continue funding the collaborative programs, one of the most important reasons to have a strong balance sheet is to be in a better negotiating position when discussing strategic deals. Potential corporate partners are good, smart businesses, and they will try to strike the best deal for themselves. If we have capital, it enables is to strike much better terms in a deal.
Now to answer your question, we do look at other programs, but we are very selective. We first make sure the program is scientifically and commercially valid, but we have to be sure that developing that program will fit our business model. Therefore, even if we find something with scientific and commercial merit, the development has to be possible with modest capital.
I can tell you that there are a number of program we have seen that we liked, but because they required a lot of capital, we passed. We want to be selective since we feel this approach is the best way to create value for our shareholders, including management as we are shareholders also.
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