Cancer Drug Research: Expanded Phase 1 Program to the Dallas Area Anthony Tolcher MD

Anthony Tolcher, MD, discusses Cancer Drug Research: Expanded Phase 1 Program to the Dallas Area


Cancer Drug Research: Expanded Phase 1 Program to the Dallas Area Anthony Tolcher MD

By Anthony Tolcher, MD

One of the challenges that we all face right now is we are in this golden age of drug development where there's so many new molecules being developed and we probably don't have enough proficient and high quality phase 1 sites in the United States, Europe, and probably the world.


So the issue here is that we are developing in our network multiple sites where we have professional phase 1 programs and clinics so that patients can access them through referral and receive the best of the new agents that are going into clinic from big pharma, small pharma, and biotech, the real innovators of new drug development.


So that's really what the goal is, and so Dallas will get a large number of studies that are, that Next is always approached with every week. And so we should be able to have a fine selection of new agents for the patients in the greater Dallas area.


Can you explain how the Phase 1 program  expansion will work, including the process for patient selection, enrollment, and treatment? 

Currently, we just opened our clinic there. The, we are essentially in a facility in the lass area. All of the staff have been trained here in San Antonio, which is the, mothership you might say of Next Oncology. And just like all our sites usually train here in San Antonio. We bring in standardized and uniform standard operating procedures to make sure that the clinic runs as well as infrastructure and support to make sure that all the right tools for clinical trials are right there in the clinic in Dallas.


Now most of our referrals will come from the private practices around the Dallas Metroplex area. And so we think that this will offer both patients in these large practices, small practices, access to early clinical studies, especially when the current therapies are no longer working for them.


How will Next Oncology ensure the safety and well-being of patients participating in the Phase 1 program expansion?

Phase 1 is all about safety. Sometimes people don't fully appreciate that. But what we do is extensive training of all of our staff and our physicians. In fact, Dr. Sen, who leads the program there spent a fair amount of time both in a phase 1 unit prior to him coming to us and then trained with us here in San Antonio.


And so what we really do is try to make sure that all of our staff from the physicians write down to all the clinical nurses and treatment room staff are clearly versed in the experimental nature of what we do, documenting all of the adverse events that occur and try to make sure that patients are treated in a compassionate manner while at the same time ensuring that the new drugs are tolerable and hopefully effective.


Will there be any particular focus on addressing healthcare disparities or improving access to cancer care for underserved populations in the Dallas area as part of the Phase 1 program expansion? 

It's important to keep in mind several things when it comes to trying to ensure that underserved populations get access to clinical trials. The first is that, We exist within the community practices, and it's actually the community practices that as a rule have generally been those that actually have patients of very diverse backgrounds and financial circumstances.


One of the, challenges for a lot of patients if they want to go to a large academic site is that their insurance might not be accepted. They might have to wait a long period of time. And so it, it's sometimes quite difficult for people to access the the academic sites for us by bringing all these clinical trials to the community practices, we're actually closer to where patients live and ultimately mean that those patients don't have to travel long distances to go on clinical study.


So if you're in the Dallas area, and you're looking for clinical trials. The, issue is sometimes people would travel all the way down to Houston. You and I both know that if you are working to maintain insurance, because you don't have the financial independence to be able to give all that up, you can't afford the time to travel all the way down to, say, MD Anderson.


By having world class phase 1 program right there in the Dallas community we allow greater number of patients to be able to participate. We recently actually looked back at our, our our patient reported demographics and found that actually we fit here in San Antonio and Austin, almost perfectly, the diverse mix of peoples in those two communities and I expect that's gonna be the same in Dallas.


What measures will Next Oncology take to ensure the quality and accuracy of the data collected during the Phase 1 program expansion, and how will this data be used to inform future research and development efforts? 

We use a lot of software tools that really are geared to ensure the quality of the data. We use a very specialized electronic medical record. In that medical record. Not only does it do all the things that an oncology electronic medical record would do, but it also captures. In a categorical way, all of the adverse events that are associated with clinical studies, and it's captured according to the National Cancer Institute common toxicity criteria and the use of this, you, when you open it up, it has all the definitions of the different gradations of these adverse events.


Now, that's key because you don't want people guessing when it comes to documenting the side effects of a new drug. And this is important. So we have through this tool an ability to actually document very carefully all of the adverse events, the grade, the attribution, the start and stop time. The other aspect is we've developed other technologies that help export that so that we can try to eliminate what we call those transcription errors that seem to creep into all forms of clinical research.


Now one of the things at the end of the day is really a, sense of culture and, we try to always make sure people understand that we're in the business of developing drugs that our children will inherit. And so if you keep that in mind all of our staff. Will ensure that we capture everything about these agents, the good and the bad, because you really don't want to be working and having drugs move forward if your kids in the end will inherit that drug and so it keeps you focused and centered on what the role of phase 1 is and how to ensure safety.


How does the Phase 1 program expansion fit into Next Oncology's broader mission and strategy, and what are the company's long-term goals in terms of cancer research and treatment? 

We are a mission-based organization and our mission is to accelerate the development of new drugs and new agents for the treatment and cure of cancer. And we have a very clear vision that we wanna be the most successful and most respected, respected phase 1 unit and early drug and development unit in oncology worldwide.


To do that we really see ourselves as trying to professionalize this whole field and expand. Now we're at six sites now. We have a number of sites we're actually exploring growing into. So we anticipate that we will be somewhere between nine and 12 sites in three to five years. And the long-term vision is to get to the size of 12 to 20 sites worldwide.


That way we can truly accelerate. New drug development and be right across the globe so that cancer research in our sites is going on no matter what day it is, whether the sun is shining in Texas or not. If it's nighttime here, it's daytime, somewhere else in this world, and you can bring about a true transformational change to early drug development.


Are there any challenges or obstacles that Next Oncology anticipates encountering as part of the Phase 1 program expansion, and how does the company plan to address these challenges? 

It's interesting that the greatest challenge that all of us faced was the COVID pandemic, and we were just two years into our founding when that happened and we were able to thrive and expand during that period of time. There's the “unknown, unknowns” as sometimes are referred to, and we were able to survive those challenges.


The biggest challenge, I think, for growing a program such as us is actually recruiting capable people. We have seen since the pandemic a real difficulty, not only for our field, but for many fields outside of healthcare, where it's very difficult to get trained staff. So we really work hard to train our staff here in our program so we can bring them up to a level that we would want.


And I, I'd say that our only limitation right now in terms of growth is finding enough good people so that we can continue this type of growth.


Looking beyond the Phase 1 program expansion, what other areas of cancer research and treatment is Next Oncology exploring or planning to explore in the future?

Right now we, also create very specific tumor models that we collaborate with some contract research organizations. These tumor models reflect, I call it the great unmet need. And really reflect patients who have exhausted standard therapies, and to which we develop new agents that pharma and biotech develop.


And so these models are obtained from leftover tissue specimens, from patients who might have a biopsy now, then subsequently grown in the laboratory, and then ultimately passed on to our, collaborators in this field, who can then disseminate these models widely. What we really need in cancer.


Research is much more representative models of the disease that we're faced with in the clinic. So it's not really needing a, breast cancer model. What you need is a breast cancer model that might be HER2 that's now refractory to a medication like Trastuzumab Deruxtecan. So you need to have models that reflect what the patients who have already received a standard of therapy and now are looking for the next new therapy. And so those types of models are really our goal. We also have a very active area where we try to. Develop certain software solutions. These software solutions are done so that we can accelerate the transfer of data.


It is remarkable, and I always say this, that information technology completely bypasses the healthcare system. And so many of the things that we do in clinical research are still transcribing digital data and turning it back into digital data. Now, this is, quite honestly, foolishness, because how is this possible?


So we have a whole area that works on trying to come up with ways that allow seamless transfer of data from electronic medical records right into the electronic data capture systems that most of our sponsors use.


Is there anything else you would like to add in closing? 

It's just a very exciting time in cancer research, and I, can say that I'm somewhat jealous of the the young people who are entering the field right now because when I started drug development at my fellowship at the NIH (National Institutes of Health) or my host fellowship at the NIH (National Institutes of Health), there are really only two new drugs Taxol and Topotecan.


And now there are over 800 new molecular entities out there. So there is so much more going on and I'm really quite optimistic that in the next decade or two, we are really going to see what we had always hoped for. A great transformation of the most deadly diseases such that we can now treat them and for some of them, perhaps even cure them.


And so this is what I see as the future and really the only limitation we have at this point is just having the number of sites and the patient participation so that we can move these drugs quickly through the clinic.


Anthony Tolcher, MD - About The Author, Credentials, and Affiliations

Dr. Anthony W. Tolcher, M.D., FRCPC, FACP, is a renowned medical oncologist who has dedicated his life's work to the development of new anticancer agents for patients who have exhausted their current cancer therapy options. As the CEO and Co-founder of NEXT Oncology, Dr. Tolcher leads a team that searches the world for the latest and most promising cancer therapies to bring back to their patients and centers.


Dr. Tolcher's passion for advancing cancer treatments began during his studies at the University of British Columbia, where he graduated before completing his residency in internal medicine at the University of Toronto and fellowship in oncology at the University of British Columbia. He also conducted research at the National Cancer Institute in Bethesda, Maryland, during his research fellowship, and as well as, the NIH (National Institutes of Health)


His dedication to excellence in medicine has been recognized through several prestigious awards, including the Murray Muirhead Award for humanitarian and academic excellence and the Goel Prize in Medicine for excellence in the Clinical Disciplines. Dr. Tolcher is a Fellow of the Royal College of Physicians of Canada and a Diplomate of the American Board of Internal Medicine and Medical Oncology. He is also a member of the American College of Physicians, the American Society of Clinical Oncologists, and serves on the American Society of Clinical Oncology Scientific Program Committee and the Cancer Education Committee.


For Dr. Tolcher, the fight against cancer is not just a job; it is a lifelong mission to improve the lives of cancer patients worldwide.