BTI 58 | Oncology Therapeutics Pipeline

 

There isn’t a cure for cancer yet, but if everyone can come together, we may find that cure sooner rather than later. One biotech company that is trying to solve cancer is Qualigen Therapeutics. With their oncology therapeutics pipeline, they could be onto something with their leading asset QN-302.

Join Ammon Rivera as he talks to the Chief Medical Officer of Qualigen Therapeutics, Tariq Arshad, MD, about where they are right now in their therapeutics pipeline. Learn why cancer is the greatest injustice and how Tariq is fighting to stop it. Find out more about their research in Qualigen Therapeutics when it comes to killing these cancer cells. Let’s all come together and stop cancer.

Listen to the podcast here

 

Qualigen Therapeutics: How To Develop An Oncology Therapeutics Pipeline From A CMO’s Perspective With Tariq Arshad, MD

Welcome to episode 58. Thank you so much for being here. I’m glad that you’re tuning in and finding value in the show. If you’ve been tuning in to the last couple of episodes, you know that this would be the third and final episode in a series of episodes that we have done, which are focused on featuring Qualigen Therapeutics. It is a company based out of Carlsbad in the San Diego area. They have a therapeutics pipeline with multiple assets in the pre-clinical stage. If you’ve been tuning in, you know what they’re working towards doing, submitting INDs, and moving this therapeutics pipeline forward.

We have the pleasure of interviewing the Chief Medical Officer of the company, Tariq Arshad. He is a physician and also holds an MBA. A quick background on Tariq is that he’s originally from Pakistan. He completed his medical training initially there, and then came here to the US. He completed the USMLEs and became a licensed physician here in the United States.

For those of you that are familiar, you’ll know what I’m about to say. To those of you that are not and that doesn’t have a good understanding of the process of what it takes to become a licensed physician, especially coming from another country where perhaps they have their own medical system and training that’s different is that it’s very difficult to come here and become an ECFMG, which is a foreign-trained medical graduate, and be able to practice in the United States. I’m giving a shout-out to Tariq for going through and completing that because that is a difficult thing to do.

He then transitioned into the biotech/pharmaceutical industry where he gathers his knowledge of what it takes to develop treatments. We get the perspective from the Chief Medical Officer of the therapeutics pipeline and what’s happening with Qualigen from that perspective. He might also give us a little more detail on the medical aspects of what the pipeline is doing.

I have an interesting conversation with Tariq. For those of you that are in the industry, maybe you don’t think this way, but there are lots of people that are in the general public that don’t understand what it takes to create a treatment that is what we call a cure. Some people think that there’s a cancer treatment that’s already been created that can cure all cancers, but it’s being hidden from us because of money. Tariq and I have a conversation about that. It’s pretty cool. It’s a pretty good conversation. He does share some personal details with us about that.

Thank you so much for being here. I want to encourage you to like the episode if you’re tuning to it on whatever platform and you can do that or subscribe if you’ve been tuning in. Also, leave a review and share this on social media with your friends and other connections. I appreciate that. Let’s go ahead, roll that intro, and let you know about Tariq.

Welcome to the show, Tariq. It’s great to be with you again.

Thank you. It’s great to be here.

We’ve had the pleasure of meeting in person in the past. I had this idea to have Qualigen come on, showcase who the leadership is, and what the projects are that they’re working on. I’ve had the opportunity to interview Amy and Michael. Now I get the pleasure of interviewing you. I’m glad to have you here.

Thank you. The pleasure is all mine.

Full disclosure to the audience, I mentioned this in my interview with Amy. As a professional recruiter, all my audience knows that that’s what I do full-time. I had the opportunity to work specifically on a position there for Qualigen and had the opportunity to collaborate with you back and forth on some things. That is how I got to know a little bit more of the inside detail of what was happening with Qualigen. I found it very interesting, so I wanted to peel back the onions a little bit on some of what you got going on. I’m very curious, initially, to understand your background, what led you into medicine, and what led you here. Where did this all start for you?

I’m happy to be here and share my story. With my background, I’m a clinical oncologist. I went to medical school in my country of birth, which is Pakistan. The Pakistan medical system is based on the British medical system. It’s a very hands-on system where you’re encouraged to be with your patient, speak and examine your patient, and find physical findings that aid in diagnosis and treatment. I went through that process and appreciate the training that I received at the time.

The Pakistan medical system is very hands-on. You're encouraged to be with, speak with, and examine your patient. Share on X

I went on to take my USMLE step 1 and step 2 exams and cleared them with the intent of coming to the US. I continued to gain training in oncology in Pakistan. It was a calling at that time. I was in the privileged position of choosing between different specialties, whether it was internal medicine and also surgery. I had the opportunity to look at other specialties as well.

I remember standing in the hospital where I was training and looking at the different units that I could go and join. My feet took me toward the oncology unit. I remember standing outside there, looking at it, and thinking, “This is where I want to be. This is what I want to do.” At that time in Pakistan, oncology was a very new specialty. It was a fledgling specialty. The unit itself was not big, but there was something about the fact that it was new.

I’m talking about the mid-‘90s at this time. It hadn’t been declared as a separate specialty or given the kind of treatment that other specialties like cardiology, urology, gynecology, or ophthalmology were given, especially when I went into the unit, met with the patients, and saw what a condition they were in. These are terminal cancer patients. They were patients with lung cancer, breast cancer, bladder cancer, and prostate cancer. Many of them at the time were advanced or metastatic.

I came to understand the sheer amount of unmet medical needs in this specialty. It was like gravity pulled me in. I couldn’t stay away from it. I decided to go into oncology. I trained in oncology and interned there. I went into advanced training. Subsequently, I joined one of the largest cancer hospitals in the region called Shaukat Khanum Cancer Hospital and trained in pediatric oncology. I delivered hands-on care to patients, both adult and pediatric, and administered chemotherapeutic regimens. I not only learned the technical aspects of clinical care, but also understood the sheer emotional toll that cancer takes on not just the patients, but also their families.

That was it. I was hooked. For the rest of my career, I’ve kept with me that desire to do something for cancer patients and address their needs, which I see as almost an injustice. The disease itself is an injustice in any way, shape, or form. I feel that it is a fundamental right that humans should have access to health and solutions to their diseases or maladies. Of all the injustices, cancer, to me, seems to be the highest injustice where the patient, in many instances, doesn’t even know that they have cancer. For the longest time, they will go from doctor to doctor without an appropriate diagnosis. By the time they get diagnosed, the treatment options are quite limited.

BTI 58 | Oncology Therapeutics Pipeline

Oncology Therapeutics Pipeline: Of all the injustices, cancer is the highest. A patient wouldn’t even know that they have cancer. By the time they get diagnosed, the treatment is quite limited.

 

It is a sorry statement regarding the field that even though I started many years ago when the options were limited then and we’ve made significant and tremendous advances, which we can talk about, the reality is that for the vast majority of cancer patients across the globe, the situation hasn’t changed. Many of them do not get diagnosed until their disease is well-advanced. When it is advanced and they present it to the oncologist, there isn’t much that they can do. That’s my background and the drive I have in the work that I do. I started out with patients and, to this day, keep patients front and center. It’s the fact is that it’s a huge mountain. Cancer is a mountain that all of us have to climb together. We’ve done a lot, but we have a lot more to do.

You being a physician that has administered treatment to patients and has watched patients that put up the good fight but didn’t make it all the way, what do you think is the fundamental disconnect? There are two things I wanted to zero in on that you mentioned. One was the diagnosing early enough. It is something that you can catch before it gets too advanced. Number two is the fundamental disconnect between treatments that we have available and treatments that can put someone into remission without the massive toxicity that comes with it.

Let me try and parse them out. The first thing that you asked about is with regards to the availability of screening technologies. We can only catch cancer early if we’re actively surveilling and screening the population. There are specific types of cancer where in the US, surveillance and screening technologies have been administered on a population-wide basis effectively and have caused reductions in the incidents of cancer. A good example is colorectal cancer where colonoscopies have been administered.

The recommendations have been handed down with regard to regular yearly colonoscopies. Previously, it was above 55. It’s gone down to patients in their mid-40s. We do see if you look at the NCI statistics that colorectal cancer has gone down because it’s been diagnosed earlier. When I say gone down, the mortality associated with colorectal cancer has gone down. That is a great example of how you can get ahead of the curve.

Unfortunately, we don’t have comparable technologies for other types of cancer. There are promising technologies that are emerging. Some of them are fairly advanced, but they haven’t yet been applied as widely, ubiquitously, and concerted away as colonoscopies have. You do see surveillance for prostate cancer, breast cancer, and other types of cancer, but we yet have to get to the point where we’re ahead of the curve. It will take years of a concerted effort across the oncology community and all healthcare providers involved to get to the point where you can start seeing these cases earlier on, screening them, and then treating them so that they don’t progress into advanced disease.

BTI 58 | Oncology Therapeutics Pipeline

Oncology Therapeutics Pipeline: You do see surveillance for prostate, breast, and other types of cancer, but doctors have yet to get to the point where they’re ahead of the curve.

 

Some cancer types are not even amenable to that. A great example of that is pancreatic cancer. That is an area that I focus on and I’m working on in Qualigen Therapeutics where the disease is known as a silent killer. It doesn’t present early on in its progression in terms of a finding that the patient can take to the doctor. The abdominal mass, jaundice or elevated liver enzymes, and other associated symptoms don’t occur until very late in the disease. You need biomarkers that you can use in patients. These need to be cheap and widely available so that you can use them population-wide to start screening. You can prioritize patients who are at high-risk, either because they have a history of Type 2 diabetes or maybe a family history of pancreatic cancer.

You would have to develop that kind of technology and then administer it population-wide in order to start diagnosing these patients earlier. For pancreatic cancer, we’re seeing breakthroughs, for example, with RAS therapies. We do know that in the future, we’ll get very effective therapies for specific types of mutations. Since the patients are presenting in the clinic early on, you don’t know that they exist until the patient has advanced disease. That’s the answer to the first part of your question. Could you remind me of the second part?

The second part was what’s the disconnect between the treatments we have and what we need to be able to put cancer into remission. I know it happens. I know there are instances if they catch it early enough where people can go into remission but there is still a massive unmet medical need. I’m trying to get, from your perspective, what you think is the disconnect between what we have available and what we need.

You’re right when you say we’re scratching the surface. Conquering cancer is not going to be the work of a single lifetime. Conquering cancer will be the work of several lifetimes and several generations. I am sure that by the time your great, great-grandchildren and my great, great-grandchildren walk this Earth, we will conquer cancer.

If you look at the trajectory of cancer research and development and the amount of knowledge, data, insights, and scientific applications that we’ve acquired over the past decades, the curve is exponential. It’s relatively flat in the ‘60s and the ‘70s, but as you go into the ‘80s and the ‘90s with the advent of parallel technologies and IT, especially the development of the ability to sequence the genome, house multiple genomes in the Cloud, and then crunch the data across, all of that is relatively new. With this whole explosion of internet 2.0, our ability to apply sophisticated technologies to understand patterns across the genomes belonging to whole populations is relatively new.

What we’re seeing is the emergence of specific therapies that either is geared toward our human immune system or geared toward specific mutations. A few years ago, there were covers for Time Magazine, Newsweek, and the front page of the Wall Street Journal that talked about how cancer immunotherapy is revolutionizing the way we’re treating cancers.

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Famously, President Jimmy Carter had a case of advanced lung cancer. He was administered what is called a Checkpoint Inhibitor or a PD-1, Programmed cell Death-1 inhibitor. At the time, it was described as if the tumor melted away. We still have President Carter with us. He’s a famous example, but there are hundreds and thousands of examples where immunotherapies have been successfully used employing a biomarker strategy.

That’s based on seminal work done by James Allison who spent his life pursuing the role of the T-cell or T lymphocyte in cancer and how the T lymphocyte could be harnessed and used against human cancer. It is a revolution in the way we consider the immune system and how it can act against cancer within the body. It was unheard of or wouldn’t have been imagined in the ‘90s or the ‘80s. The flip side or the other side of that is that we’ve also made tremendous advantages in targeting specific mutations that belong to cancer.

In precision medicine, you see more therapies that target mutations. For example, the KRAS G12C mutation has seen a surge in compounds that target that specific mutation. That drives a large percentage of non-small cell lung cancer cases. We are seeing good results. We see the durability of the effect with therapies like sotorasib and adagrasib. There are a lot of advances happening to answer your question, but we also know that the mountain is tall and high. There is a lot more that needs to happen before we can truly get to the point where we can say we’ve cured a certain type of cancer.

The last thing I’ll say and answer to the second question you had was that many of our audience and you, yourself, may know about the existence of CAR T therapies or Chimeric Antigen Receptor T cell therapies that do address unmet needs in specific types of cancer. These are bio-engineered T cells that can recognize cancer cells and directly attack them. CAR T cells have been approved for some time in therapies like Kymriah from Novartis.

The disease that they were first approved for Acute Lymphocytic Leukemia, ALL, or Acute Lymphoblastic Leukemia is at the point where if you administer this in its indicated population Kymriah, you will see a 90th percentile response rate. It’s not quite a cure, but almost as good as a cure. The first patient, Emily Whitehead, who was a patient of ALL is alive and healthy. It has been ten years or more than that since she received therapy. She is a symbol of what we can accomplish through the administration of bio-engineered T cells in certain types of cancer.

Between immunotherapy mutation-targeted precision therapy, CAR T therapies, cancer vaccines, and other modalities, we have a bevy, an armamentarium, of tools that we’re using against cancer. It will take not one lifetime, but several lifetimes. When you look back at the 1960s, compare that to where we are, and see that as night and day, when you look to the next 30 to 40 years, we will be at a point where it will be like night and day. Those of our generations who are alive 40 years from now will look back at the work we did and will say that laid the foundation for the cure for cancer.

That’s very interesting. I know we got off getting further into your background, but I love that. I appreciate your insight on that. Most of the readers, if not all of the readers on the show, are industry-focused individuals from leaders to early or middle-staged career individuals. What I’m getting to with that is many of them probably have a similar thought process on the development of treatments.

I occasionally do have individuals from my personal network that I’ll share episodes with. One of the things that I hear often enough from people is this belief and this big conspiracy that the pharma industry has a cure for cancer but they don’t want to release it because they get money from people dying and getting treatments. Most people don’t understand what it takes to take a treatment from discovery all the way into the post-market. They don’t understand everything that happens in between and why certain things happen.

Certainly, there’s room to grow to innovate on the process and how to speed things up in certain areas. I don’t think that they understand why what we have exists, exists in terms of, “This is what we do in phase one. This is why we’re doing it. This is what we do in phase two and what we’re trying to prove to go to phase three. When we get to phase three, we have to prove this to the FDA. If we’ve already proven the safety, we’ve got to prove the significant clinical benefit.” A lot of people don’t understand that. It’s easier to say, “There’s a cure out there. We’re just hiding it because it makes us more money if we don’t have it.”

Let me share something with you and with our audience. This is a little personal, but I feel comfortable sharing it because this is a very select audience that you address. My passion for oncology isn’t only professional. My family has personally been touched by cancer. I lost my mother to renal cell carcinoma several years ago. Earlier this 2022, I lost my father to liver cancer. My wife is alive and kicking and healthy. We’ve been married for 23 years and have three healthy boys. She’s an ovarian cancer survivor. She’s five years disease-free.

I assure you and my audience that if there was a cure for cancer, as an industry insider, I would’ve used it to save my parents. I would’ve used it to save the amount of pain and suffering they went through and my wife went through. Fortunately, my wife survived and is with us. My children still have their mother and I still have my wife. I am here to tell the audience, you, and anyone who’s reading that this is nothing but a conspiracy theory. If there were a cure for cancer, I would’ve known about it as an oncologist and as an industry veteran. I would’ve used it to save my parents. There is no such thing.

What we have ahead of us is a huge amount of work of scientific research and development that we have to do in order to overcome this monster of a disease. That requires disciplined effort, sincere motivation, cooperation, coordination, and a belief that we can overcome this biggest of challenges. That’s what I’ve dedicated my life and my career to.

For anybody who’s reading, I hope this helps them understand that this is the challenge that lies ahead. It’s not insurmountable, but it requires people to sacrifice a lot of their time, energy, and focus in order to address this terrible disease. There is no cure for cancer, but we can get one if we all work together. Maybe our great, great-grandchildren will be the beneficiaries of that.

There is no cure for cancer, but we can get one if we all work together. Share on X

Thank you for sharing that. I can see and feel your passion. That’s good. I love where we got to this conversation so far. Let’s switched back to you trained. Initially, something pulls you in and you see what people are going through and think, “I can do something here.” You end up here in the United States and going into the industry. You switched from clinically practicing to going into treatment development or drug development. What prompted that transition in your life?

It is very simple. I was early on in my career, still in Lahore, Pakistan. I completed my oncology training and was going through the options of what lay ahead of me. I also had a strong passion for public speaking. I was president of the debating society of my medical college. I gravitated towards opportunities where I could get on stage and speak to a public audience.

It so happened that in this international oncology symposium that was held in Lahore, I was asked to be the stage secretary. I was asked to conduct the meeting and run the meeting. I even presented scientific data at the meeting. What I didn’t know was that in some of the dinner sessions or the lighter sessions in the evening, there were members of the pharmaceutical industry that were sitting in the audience. Many of the big pharmaceutical multinational companies, even at the time, had offices in Pakistan.

After the event, I was approached by multiple companies who were interested in hiring me because they felt that I had a good combination of technical and clinical skills but also had the ability to communicate and articulate perspectives with large audiences. Quickly, I found myself in the pharmaceutical industry. The company I joined was Pharmacia at that time. For long-timers in the industry, they know the name, but maybe not so much the newcomers. It was formed as a result of a merger between Pharmacia and Upjohn, which is a European and a US company. It was the company I ended up joining. I stayed with them for quite a while. Even after they were acquired by Pfizer, I ended up staying with them for a long time.

The only reason I know of Pharmacia is that I do interviews like this. I’ve interviewed a couple of people. Someone I spoke to did work with Pharmacia, and then we talked about the Pfizer merger and all that. That happens and then there you are in the industry working towards developing treatments. Fast forwarding that time to where you’re here with Qualigen Therapeutics and working on the projects that you’re on, help us understand a little bit more about Qualigen’s pipeline, maybe perhaps what the status is at this point, and where you’re headed from here.

It will be my pleasure to do that. The first thing I’d like to tell you and the audience is that Qualigen Therapeutics is a company that’s been around for a while, but primarily is a diagnostics company. Michael, the CEO, may have mentioned this to you in your interview with him. He’s the founder of the company and has successfully run the company for many years. The executive management of the team made the decision to pivot into therapeutics.

As a result of that, Amy Broidrick, myself, and then a couple of other people were brought into the therapeutics team. As a result of that process, Michael licensed in some very interesting assets from the University of Louisville. We all together made the decision to license in our lead asset, QN0-302, from the University College of London. I’ll start with that and then work through the pipeline.

The University College of London has a wonderful professor by the name of Dr. Stephen Needle, a tenured professor who spent his life studying the phenomenon known as G-quadruplexes. G-quadruplexes are structures that are derived from double-helix DNA. When double-helix DNA unravels, sometimes, what you see happening is that the single strands form very strong hydrogen bonds between the guanine base pairs. These bonds result in the formation of a quartet-like structure or a four-sided structure. When these quartets are stacked on top of each other, they become what is known as Quadruplexes.

In normal cells, quadruplexes form and temporarily appear and disappear. They aren’t associated with any specific function per se. For the longest time, they were thought of as artifacts that occur in the normal process of DNA replication. With the work that Dr. Stephen Needle did, it became clear that, first of all, G-quadruplexes are expressed in cancer cells and are ubiquitously expressed across different types of cancers. That was a key finding.

The second was that, because Dr. Needle is a professor of Pharmacology, he did something very clever. He discovered a small molecule scaffold that allowed him to start generating molecules that when administered to cancer cells, stabilize these G-quadruplexes. Remember, in normal cells, G-quadruplexes appear and disappear. They’re formed and then they’re unformed.

In a cancer cell, if you can keep the G-quadruplex in place and stabilize it, what it result is cancer death. The cell itself dies. That’s because the G-quadruplex does not unform after it’s formed. QN-302 is the lead molecule in the series of molecules that Dr. Needle formed as part of the work he did at UCL. That is the molecule that we’re taking forward as our lead asset in the Qualigen Therapeutics pipeline. We have a very exciting set of in vivo and in vitro data, primarily in pancreatic cancer.

BTI 58 | Oncology Therapeutics Pipeline

Oncology Therapeutics Pipeline: In normal cells, G-quadruplexes are formed and then unformed. In a cancer cell, if you can keep the G-quadruplex in place and stabilize, you can kill the cancer cell. The cell itself dies.

 

Pancreatic cancer is one of those diseases that you don’t catch early on. If you look at the history of approvals in pancreatic cancer, it is not an easy disease to treat. When we first saw the in vivo data for QN-302 and saw how Stephen Needle’s small molecule effectively targets G-quadruplexes and then shows an anti-tumor effect in these models, we became very excited. We became even more excited when we saw that Dr. Needle had replicated this data in multiple in vivo models. We then decided to license in the asset based on that confidence.

Since then, we have seen additional in vivo data in prostate cancer as well as in vitro data in a rare type of gastrointestinal tumor called GIST or Gastrointestinal Stromal Tumor. We also are actively evaluating other indications for this exciting small molecule G-quadruplex-targeting therapy, which could include other indications such as prostate cancer, esophageal cancer, gastric cancer, pancreatic cancer, and other malignancies.

We’re going to do a phase one study across a wide variety of G-quadruplex-driven indications and expect to have a pre-IND interaction with the FDA by the end of 2022. We expect to submit our IND sometime in the second quarter of 2023 with the intention of proceeding into phase one soon after that. That’s our lead asset. We’re firing on all cylinders and moving rapidly towards achieving our goals there. Everything is on track.

Our second asset is QN-247, which is licensed by the University of Louisville. It is also a small molecule. This is an oligonucleotide aptamer that targets a multifunctional phosphoprotein called Nucleolin. The aptamer is conjugated to embolden the nanoparticle. It almost sounds like science fiction. It is a fantastic construct that’s been created by the University of Louisville.

For those who are not familiar with aptamers, the best visual I can give you are two pieces of a jigsaw puzzle that fit together. Aptamers are molecules that fit together or configure together very nicely. Since they are oligonucleotides, they can be used or conjugated with other nanoparticles or they can sometimes be armed with chemotherapeutic molecules.

In fact, there are some oligonucleotides out there that have warhead chemotherapy molecules that are being developed. In this instance, our lead indication is acute myeloid leukemia. That’s what we’re targeting. We’re also testing QN-247 in a triple-negative breast cancer model and a glioblastoma model. We’re looking at multiple indications where nucleolin is expressed in the cancer cell.

The difference is that nucleolin compared to a normal cell when it’s expressed in a cancer cell is it is expressed on the surface of the cell as well as intracytoplasmic lead. Whereas in a normal cell, as the name indicates, it stays within the nucleolus or the nucleus of the cell. We are excited by QN-247. We expect to see readouts from our in vivo models in the second half of 2022 subsequent to which we’ll make an announcement and declare our plans for the next steps.

BTI 58 | Oncology Therapeutics Pipeline

Oncology Therapeutics Pipeline: Nucleolin, compared to a normal cell when expressed in a cancer cell, is expressed on the cell’s surface. Whereas in a normal cell, it stays within the cell’s nucleus.

 

Last, but by no means least, our third asset is one of our most exciting, which is our RAS-F platform. I’ll reference what I said earlier regarding sotorasib and adagrasib. Sotorasib was approved for the therapy of Non-Small Cell Lung Cancer, NSCLC, advanced by Amgen in 2021. Adagrasib presented data on non-small cell lung cancer at ASCO earlier in June 2022. These are RAS or specifically KRAS-G12C targeted therapies that are very effective in treating advanced lung cancer.

We’re seeing a tidal wave of RAS therapies that are emerging. It is very similar to the immunotherapy revolution that happened a couple of years ago. Now you’re seeing the RAS revolution. I’m excited to say that Qualigen is a participant in that revolution with its platform of small molecules licensed in from the University of Louisville.

The difference here is that our mechanism is that we do not covalently bond to the G12C-specific amino acid. Instead, we inhibit the RAS protein interaction and our inhibition extends beyond the amino acid. We have the ability to act upstream from where sotorasib and adagrasib act. We have the ability to act as a pan-KRAS inhibitor. That’s very exciting because we’ve already started seeing the emergence of resistance. Based on the two-year data for sotorasib, we’ve started seeing the emergence of resistance to RAS therapies in Non-Small Cell Lung Cancer. We have seen extensive discussions happening in scientific forums at ACR and at ASCO regarding the mechanisms of resistance to RAS and how to overcome them.

We believe that in our RAS-F platform, we have a series of molecules that are capable of overcoming that type of resistance. We also have data to suggest that we can combine a RAS inhibitor from our portfolio with an immune checkpoint inhibitor. We can see the synergy between them. That’s also a huge topic. At ASCO, there was a whole session on the mechanistic rationale of using immune checkpoint inhibitors in patients who have a specific RAS mutation.

KRAS, specifically, is considered to be a neo-antigen that converts a “cold” tumor immune environment into a “hot” environment that makes the tumor more amenable to T lymphocyte or T penetration and subsequently responds to immune checkpoint inhibitors. That’s an area where we feel our RAS-F portfolio has the ability to fit into the future. We’re 3 to 4 years away from the point where we can start talking about where we fit in. Mechanistically, we feel that’s what we can do, and we’ll have clinical data to prove that hopefully within a few years.

Since our mechanism is differentiated from some of these approved therapies and we have this potential to address upstream pan-KRAS inhibition, that makes us very excited regarding our portfolio. When you put it together, these are three small molecules, each of which has the ability to be a platform for itself, all licensed from world-class academic institutions. The IP fully belongs to Qualigen Therapeutics. We have the right people, the right team, and the right resources to fully develop and prosecute these assets all the way to their next inflection points. Not only do we have an exciting 2022 ahead of us, but 2023 will be even more exciting as we get our IND for QN-302 approved and we go into the clinic.

That is very interesting. I appreciate you going into some of the detail on that. This is good stuff for people to read. I always love going back and reading these conversations as well. I feel like I can pick up a little more understanding, but also understand the strategy of what you’re working on and what you’re doing, which we’ve had a good conversation about so far.

When I look at the time that I set aside to have these conversations, I want to be cognizant of that for you. I was going to try to get a little bit more into a discussion about being in the stage that you’re at, how would you approach choosing which team members you need, what positions are a must, what positions aren’t, and things like that. You and I can always talk about that another time.

Maybe that can be another episode. We can talk another time about it.

Some of the guests that I’ve had on the show, I’ve had on for a repeat because there’s always so much to learn. We should put that one down. Let’s jump to the couple of final questions that I like to ask all the guests that come on the show. The first one is more of an advice question. It’s getting advice out to the audience. I phrase it in a way that, hopefully, has people thinking a little bit about their past. If you could go back and give yourself any type of advice at the beginning of your career, what advice would you give yourself?

I would go back and tell myself, “Have more confidence in yourself.” I would say to myself, “Back yourself. Don’t doubt what you’re thinking.” That’s all. I hope that’s not too simplistic of an answer to your question. It assumes that I have a time machine, so I love the question. Honestly, I would back myself up and say, “Stand behind what you believe in. Stay firm in your commitment to oncology. Don’t let the vagaries of time, finances, and industry trends move you away from your North Star, which is the patient.” That is what I ended up doing. If there’s one thing I would’ve gone back and told myself, it’s, “You’re on the right track. Keep going.”

That is not bad advice at all. The second question I’m curious to know is are there any books that you’ve read that you recommend or that you feel had an impact on you and you’re like, “Somebody out there should read this book as well.”

There are books that I read in medical school that hugely influenced my thinking about clinical medicine. Those are basic books like Robbins Basic Pathology and Katzung Pharmacology. Pathology is the mother of Medicine. Until I read the book on Pathology, I didn’t understand how the internal structure or the internal histology of an organ reflects the manifestations of the disease. Linking the change on a cellular level to the change on a systemic level allowed me to understand clinical medicine.

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Those are not books that maybe the layman would be interested in reading, but for me, they’re endlessly fascinating books. I keep opening them up and rereading them. In terms of the industry, when I came into the industry and started learning about leadership, management, how you manage teams, and how you achieve results, I was hugely influenced by a book called Execution by Larry Bossidy and Ram Charan that I keep with me and I use as a basis for putting plans together. It’s not only putting them together but how to achieve results.

Another book that I love immensely is written by Daniel Pink. It’s a book called Drive. In a single sentence, Daniel describes the three elements of drive as motivation, autonomy, and purpose. As an employer, if you have those three, then your employee will have drive. If you have 2 but not 3, then you won’t see drive. You’ll see competence, but you won’t see drive in the employee or what we refer to as the fire in the belly. That book influenced me immensely.

BTI 58 | Oncology Therapeutics Pipeline

Drive: The Surprising Truth About What Motivates Us

There are a couple of others that are related to medicine, but not actual textbooks like The Emperor of All Maladies by Siddhartha Mukherjee. I strongly recommend that book to the audience. It’s a magnum opus on the history of cancer. The last one I’ll recommend is a book that I read a couple of years ago. It’s called The First Cell by Dr. Azra Raza who is a practicing hematologist in New York. Her thesis is that she describes the human suffering and pain that’s associated with current-day cancer chemotherapy and how little progress has been made over the years, which is where we started our discussion. Her thesis is that for us to make true progress against cancer, we have to focus on the first cell. When cancer starts developing in the human body, the first cell, the cancerous cell, has to be detected and dealt with early on in order for us to effectively eliminate cancer from the body of that person.

BTI 58 | Oncology Therapeutics Pipeline

The First Cell: And the Human Costs of Pursuing Cancer to the Last

If we continue to focus purely on the other end of the spectrum, which is to develop therapeutics for the disease after the disease occurs, which is predominantly the paradigm the industry has had for the past several decades, we will develop more effective treatments but still require the patient to go through the process of enduring therapy. Her book talks about how you can shift the focus of a big part of the industry to start early surveillance by using biomarkers or other technologies to diagnose cancer earlier on. That’s another book that I would strongly recommend to the audience.

I like that list. I had an audience for the show that I connected with on LinkedIn. We were typing back and forth. She made a comment that she has got a list of all the books that guests recommend. Hopefully, she’ll eventually get through it. I feel the same way. That’s very good. The last question I wanted to ask you is more about the industry climate. Based on the industry climate with the bear market and all those things, what insight would you maybe share with the audience? No one has a crystal ball and no one knows what’s going to happen, but in terms of general insight on the stage where we’re at, what would you tell the audience?

Having had the benefit of being in the industry for many years, I’ve seen a couple of downturns before this, and I’ve lived through them. My advice would be as pedantic as, “This too shall pass.” I hope that’s not underwhelming for the audience, but the reality is that when you think about it, the term biotech bear market, to me, is a non sequitur. It doesn’t make any sense. Why do I say that? It is because there’s no such thing as a disease bear market. There’s no such thing as a disease unless there’s a fantastic treatment for it dropping by 20% or more in its incidence or prevalence. That doesn’t happen. There’s no such thing where we see a variation or a sudden drop in the number of cancer patients for a specific tumor type. That almost never happens.

When we know that the fundamentals of an industry, which is addressing the unmet need driven by or caused by these terrible diseases, remains the same regardless of whether or not we’re in a bull or a bear market, the reality is that these are more sentiment-driven times in our industry. We have to face the reality that for biotech companies that are raising funds in this environment, it’s challenging. It’s not as easy as it was a few months ago are a few years ago.

I’ve seen that this also passes fairly quickly that 6 months from now or 1 year from now, we’ll be back where we were because the patients are still where they were. The patients are always there. The disease is always there. For example, there is a fantastic cure for the Hepatitis C virus that Gilead created that has eliminated Hep-C as a disease wherever the therapy has reached. Unless we create those kinds of therapies, which isn’t all that easy for non-viral diseases, we will be faced with these incidence and prevalence numbers.

All I can say is that it is difficult, but the patient needs us. The patient has always needed us and the patient will need us. For those of my colleagues and friends who are in the industry, hang in there. This too shall pass. We will get to the patient. We will get the medicines to the patient. That will happen regardless of bear markets or bull markets.

I appreciate you coming on. We’re going to have to schedule another episode on the show here. We’ll maybe get some insight into some other aspects of building a biotech company, building a team, and those kinds of things. For everyone reading, thank you for being here with us. You could always go on LinkedIn and look for Tariq Arshad. You could find him there. Don’t forget to like, share, and subscribe. Share this with those in your colleague circle. If you leave a sincere review or you feel like you have some good words to say, that helps the show. I appreciate that. We’ll see you on the other side.

Thank you very much. It’s a pleasure to have been with you on your show. Thank you to the audience.

 

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About Dr. Tariq Arshad

BTI 58 | Oncology Therapeutics PipelineDr. Arshad is an Oncologist, life sciences executive and biotechnology professional with 20+ years of strategic and operational experience in Immunology and Immuno-Oncology research, development and global product launch at blue-chip (Pfizer, Merck, Genentech, BD) and startup biotech companies. He has expertise in the development and commercialization of transformative therapies & enabling technologies for severe, debilitating diseases, including hematological malignancies and solid tumors.