Project Cure CRC – Ending Colorectal Cancer in Our Lifetime

In the inaugural event of the Global Cancer Movement, initiated by OncoDaily, Michael Sapienza highlights the urgency of transforming colorectal cancer care through the ambitious $100 million Project Cure CRC campaign. This virtual event, held from December 6-8, 2024, brought together global experts to drive innovative solutions for improving patient outcomes.

First of all, thank you to OncoDaily and the Global Cancer Movement. It’s really exciting to see what the team there have been able to do just in such a short amount of time in helping bring education and awareness to just cancer period, you know, through non-traditional means. So that’s really, really exciting.

I also want to thank Pashtoon. You know, I’ve been listening for the last couple of minutes, as we all know, you know, and you’ll hear in my talk, which was going to be the complete opposite of Pashtoon. He’s way smarter than I am.

But, you know, you’ll see we need new treatments and we need new treatments fast for colorectal cancer. And so that actually is really the title of my presentation, Project Cure CRC Ending Colorectal Cancer in Our Lifetime. So you may or may not know the folks that are that are listening or that will listen, but that the five year metastatic survival rate actually for breast cancer is 35 percent.

And for colorectal cancer, it’s actually 13 percent. And what does that mean? It means that we don’t have enough treatments for colon cancer. We don’t have enough treatments for rectal cancer.

You know, if you’re looking at frontline colorectal cancer, stage four treatment or metastatic treatment, you know, we’ve been using the same standard of care for about 15 to 20 years for most patients. Right. And that’s just unacceptable in my opinion and in the Alliance’s opinion.

And so that’s why we’ve started Project Cure CRC. If you look on the right side here, just in terms of funding for colorectal cancer by diagnosis, first of all, you can see on the left the number of new cases, one hundred and fifty three thousand this this year. Twenty four were ranked fourth overall in in mortality, were ranked second in the United States just behind lung cancer.

And then on the right side here, you can see the overall dollars that are actually spent. This is U.S., not global, but U.S. on all the different cancers. And as you can see, we are second to last.

And as you know, as I just said, more people pass away, unfortunately, from all of from colorectal cancer than all of these other cancers. They get way more research. So Project Cure CRC, what is it? It’s a hundred million dollar two year investment campaign to accelerate a cure.

I’ll give a little bit of background. I don’t know if you those of you that are not in the United States know who Estee Lauder is, but Estee Lauder was the maker of makeup. Basically, the family obviously made a fortune.

And in nineteen ninety four, they gave a hundred million dollars to the breast cancer movement. And what has that done? It has helped three hundred new FDA approval since nineteen ninety four. It’s equated to about four billion dollars worth of philanthropic dollars that have gone into the breast cancer ecosystem.

And as you can see via this last slide, they have a thirty five percent metastatic five year survival rate. We have 13. So this is really why we’re doing this.

The goals, what are our goals? Number one, and I’ll talk a little bit more about this in a bit, but is to create the largest database of colorectal cancer patients in the world. We call the front end of this this project Blue HQ. So this is patient facing, caregiver facing.

The Alliance is the largest colorectal cancer advocacy organization in the world. And so, you know, we reach hundreds of thousands of patients a year. And if we are able to utilize information from those patients to help them in real time, but also to help speed up via data for folks like Pashtoon or small biotech or large pharma that will help bring new treatments to market faster.

So, again, that’s the first goal is building this database. Number two here is fast track new therapies as quickly as possible. So how can we do that and how do we do that fast? And then again, our third goal is just a longer term goal, but is to raise that five year metastatic survival rate from 13 to 35.

So how are we going to do it? Number one, we are going to fund direct research. So we’ve already started this. We launched our RFP in March.

We awarded our first grant in June and we’ve awarded ten million dollars in funding. I’ll go through some of who we have funded and what we have funded in a moment. And you can see the different ways in which we’re doing that.

So early career investigator awards. We’ve been doing a lot of these. These are two hundred thousand dollar awards to help get new ideas into the field.

Right. Most of you who are on this line probably know that, you know, investigators, researchers, et cetera, they follow the money. And if the money isn’t there for young investigators, they’re going to go somewhere else, not maybe GI or not maybe colorectal cancer to continue to study.

Hence why we’ve made advancements in breast cancer. And then the same thing here, senior investigator awards, you know, pharma and small biotech are only doing so much. So how do we get new and better ideas? So, for example, CAR T, it’s not working in colorectal cancer.

For example, as Pashtoon said, it’s mainly not working for MSS colorectal cancer in terms of immunotherapy. Right. We’re looking at vaccines.

None of those things work right now for colorectal cancer for the vast majority of metastatic patients. So how do we get new ideas? And I’ll be perfectly honest, we’ve received a ton of proposals this year. You’ll see in a minute how many.

And there are some in CAR T and there are some immunotherapy. And unfortunately, we’re not seeing the movement that we really want to see moving towards a cure. And so we also think that these team science awards, bringing people together and then also funding small startups is a way to go.

So that’s the first part of how we’ll do this, the direct research funding. The second is influencing research. So from a policy perspective, how can we work with the executive branch, the legislative branch, et cetera, to bring more money into the field from a government funding research perspective? I’m going to talk about this left side here in a moment, but this is a clinical trial ecosystem or a clinical trial protocol.

For those of you that are familiar with I Spy, which is done by Laura Esserman and Quantum Health, is a way to bring new treatments to market fast, have them fail fast or succeed fast, bring multiple arms at the same time. It’s a protocol that is already approved by the FDA. And in a moment, I’ll talk a little bit more about what that looks like, how the benefits are different from traditional clinical trials, et cetera.

And then this last part, again, is about creating this patient facing EHR integrated platform for patients, for oncologists, et cetera, that will store data to make sure that we have enough information to continue bringing new treatments to market. So this, the funding, let’s talk about this for a second. So since March, we’ve had 240 letters of intent, I think about 90, I’m guessing about 90 have been moved on to a second round.

We’ve awarded 17 grants so far, and that’s as of last month, just so everybody knows, and around $10 million in research funding to date. We, you’ll, let me just give you a smattering of what we funded. So we funded a $1.6 million grant for this therapy for MSS disease.

This is helping, you know, create new therapeutic options for, as I was just saying, those 95 to 96% of patients that are microsatellite stable. We’ve been working with Theragnostic with Dr. Manning for BRAF mutations at MD Anderson. Peter Lee is actually looking at a, you know, a non-traditional way of utilizing, you know, immunotherapy for MSS disease, actually the ivermectin.

The next one here, you can see here, I think he’s from University of Miami, improved the mRNA vaccination strategies. This is an early career investigator award. The next one, Katerina Datochova, she’s from the University of Saskatchewan, and this is a targeted radio immunotherapy.

We have a new drug combination for BRAF on the right here from, I think, this University of Kentucky. The Indiana University, we have another one that’s targeting cells, aiding cancer survival in terms of proteins. And then Katerina is looking at body fat and CRC.

We think that this is a really important piece. How do we really identify what is affecting individuals and why they’re being diagnosed earlier, especially young onset individuals, working with UCSF and Julia Carnival and others during, you know, at their CAR-T program, but looking at cutting technology, innovating with the CRISPR. And then the last one here is stopping the spread.

This is David Robbins at Georgetown University, looking at circulating tumor cells and what does that mean and how can we improve overall survival rates from the disease? So, as I said, the adaptive clinical trial piece here. So this is the clinical trial protocol. This is our take on I-SPI, I-SPI for breast cancer, K-SPI for colorectal cancer, and just an executive summary here.

So what does this do compared to others for the following different cohorts? So why would this transform the clinical trial experience for these stakeholders? Patients, number one, personalized care. So it’s adaptive trial design, matching patients to the most promising therapies based on their tumor, you know, biology, the faster access, patients benefit from cutting edge treatments sooner rather than traditional trials. For example, on average, these can be brought into the clinic with about three to six months compared to two years for traditional clinical trials because of the already FDA approved protocol that’s already in the in the overall clinical trial design.

So, two, for small biotech’s, what does this mean? De-risk development, right? It’s rapid insights on biomarker driven efficacy, streamlined drug validation and reduced costs, the regulatory boost, again, this facilitates faster FDA breakthrough or accelerated approval pass. So what does this mean for PIs? So we already have about 27 individuals coming to Miami next week who are already participant sites of I-SPI for breast cancer that will be helping us figure out what are the paths and what clinical trials we’ll be putting in first in K-SPI. So obviously scientific excellence.

So this will be driven by these investigators, not necessarily by large pharma. Yes, there’ll be input from large pharma, but this will be driven in terms of are we doing new adjuvant, are we doing adjuvant, are we doing, you know, looking at, you know, ctDNA, et cetera. So that is really, you know, leveraging the centralized trial coordination to reduce administrative burdens.

And then the last one for our friends in large pharma, how do we do this? Accelerated pipeline. Again, instead of two years, instead of spending, hopefully there’s no big CROs on the call, but faster identification of promising candidates, you know, reduces time to market. And then engaging with all of these leaders to make this happen.

This is going to be led by our chief medical consultant, Dr. John Marshall at Georgetown University and a bunch of other KOLs in this space. So I’m going to skip to, there’s a bunch of different sites here, but I’m going to skip, just want to make the world aware. We have a invitation only Project CURE CRC summit.

We’re bringing together 165 folks. Pashtoon I know will be there next week from the 11th to the 13th. We have about 15 small biotechs who are emerging.

And really the idea is what new ideas, unpublished, et cetera, ideas can we come up with to then insert into our RFP in 2025 to be able to fund hopefully something that will break through with CAR T, break through even more with immunotherapy combination, vaccines, ADCs, whatever it is. And then concurrently a little bit post is our Alicon. So Alicon is our patient conference.

We have about 200 patients from across the country coming into to Miami to to learn from the greatest minds in colorectal cancer. So I know this is untraditional, but this is where I want to end. So actually next week, for those of you that know Dawson’s Creek and what is his name’s James Van Der Beek.

I’m not a pop culture person, but James Van Der Beek was on Dawson’s Creek, unfortunately was diagnosed with colorectal cancer. We are partnering with Fox and Hulu on Monday, December 9th from 8 to 10 p.m. This is Eastern Time in the United States. They will be doing a full episode around cancer detection, getting screened, cancer research.

And the Colorectal Cancer Alliance is their partner of choice. So we’re really excited. And I just wanted to make sure that that everybody saw that.

And then this is the website, colorectalcancer.org slash cure, if anybody wants additional information.