How to Find the Right Cancer Clinical Trial for Your Diagnosis

June 22, 2022 Brian McCloskey and Brad Power “The way that you've built your whole value chain is one of the more complete solutions that I've seen.” – Brian McCloskey

Selin Kurnaz, PhD, Co-founder and CEO, and Czerny Cohen, Vice President of Clinical Operations, Massive Bio, shared their experience in helping cancer patients in "Finding the Best Clinical Trial". The “best clinical trial” is the one that is the best fit, based on each patient’s unique profile.

Their mission is to increase access for patients to explore all of their treatment options, not just standard of care therapy, but also clinical trial options.

That means that Massive Bio must help each patient assemble all of that patient’s relevant health data, and also provide clinical coordination, helping patients fill in any gaps in their health information, such as helping them get a DNA sequencing of their tumor tissue if they don’t already have it, and overcoming financial and logistical issues to get access to the clinical trial (the “last mile”).

Massive Bio’s services are especially valuable to help patients who do not have easy access to academic research cancer centers, and to reduce the burden of pursuing additional treatment options when the patient just got the overwhelming stress of an intial cancer diagnosis or a relapse diagnosis. Trial awareness: Patients may be steered to the standard of care, overlooking other valuable options, such as new treatments in clinical trials.

Massive Bio provides education to patients on what additional options clinical trials make possible. Data collection: The patient’s health records, which are critical to treatment selection, and often spread out among different healthcare providers. Massive Bio gets a fews bits of personal contact information and authorization from the patient, then pulls the relevant detailed data from the patient’s medical records.

Tests: Tests, especially genomic sequencing, are often required to meet clinical trial enrollment, and many patients haven’t had these tests. Massive Bio helps patients get the basic tests needed for clinical trial access. Trial matching: There are many clinical trial options, making selection a complex decision.

Massive Bio finds the best fit for the patient using their software, taking into account inclusion and exclusion criteria for the clinical trials and the number of visits the patient will need to make. gov to review detailed descriptions of the clinical trials, some of which are provided by their pharmaceutical partners. Travel distance: The willingness and ability of a patient to travel to a clinical trial site can vary greatly.

Massive Bio establishes a travel radius up front and enters it into the matching process. Trial enrollment: After selecting a clinical trial, patients need to communicate with five contacts to enroll. Massive Bio handles these communications on behalf of the patient. Sometimes this extends to being an advocate for the patient to accelerate the enrollment process.

Travel and accommodation : The patient may have trouble getting to the site and spending time there, including paying. Massive Bio works with the patient to find solutions to logistics problems. Advanced prostate cancer patient Brian McCloskey went through Massive Bio’s process, and they identified three clinical trials that fit him, one of which his oncologist is the lead investigator on.

He was very impressed with the ease of interaction in working with Massive Bio. ” The information and opinions expressed on this website or platform, or during discussions and presentations (both verbal and written) are not intended as health care recommendations or medical advice by Cancer Patient Lab/Prostate Cancer Lab, its principals, presenters, participants, or representatives for any medical treatment, product, or course of action.

You should always consult a doctor about your specific situation before pursuing any health care program, treatment, product or other course of action that might affect your health.

Meeting Notes SUMMARY KEYWORDS patient, clinical trials, clinical, oncologist, therapy, journey, patient advocates, trial, NGS, bio, medical records, enrollment, terms, company, matching, site, questions, information, massive, imaging SPEAKERS Arturo Loaiza-Bonilla MD, Anonymous Caregiver, John Powers, Aubrey Kelly, Brian McCloskey, Czerny Cohen, Selin Kurnaz Brian McCloskey 00:05 Welcome everybody. I'm Brian McCloskey of the Prostate Cancer Lab.

I'm pinch hitting for Brad Power. Today, I'm excited to have Selin Kurnaz, who is the Co-Founder and CEO of Massive Bio. Massive Bio is an AI-powered oncology platform that connects patients to clinical trials, while improving patient participation rates for Big Pharma.

They capture all relevant patient data, including complete medical history, genomic profiling, plus clinical trial preferences, such as geographical location, to recommend the best fit clinical trials for patients to discuss with their medical oncologists. Additionally, they offer clinical coordination, continuous monitoring, and community support to help patients navigate the complexities of the clinical trial process.

So as a patient, I went through their impressive matching process just a couple of weeks ago. I'll present their clinical trial recommendations next week to my oncologist. And I'm looking forward to hearing her feedback and working through the journey with Massive Bio. So I'm really excited to have Selin join us. She's going to talk about why she created Massive Bio, and what Massive Bio has to offer to patients.

Selin, thank you so much for joining us. Selin Kurnaz 01:56 Thank you very much Brian for the opportunity to speak today. I'm the Co-founder and CEO of Massive Bio. Before I talk about the journey, I'd like to introduce my VP of Clinical Operations, Czerny Cohen. You know why I founded the company, but I think the real star here is Czerny.

She's going to describe our patient process, and how we care about the patients, and how we manage their journey. Why don't you introduce yourself, and I'll provide a brief intro about myself, the company, and then we'll move forward? Czerny Cohen 01:56 Hello, everyone. My name is Czerny Cohen. I am Massive Bio's Vice President of Clinical Operations.

What that means is that I oversee all our nurses in case management and the “last mile”, which is the AI matching portion, as well as the enrollment concierge portion of the company. I oversee all of our patient interactions, and I have ownership for all of the enrollment. My background is in hematology nursing with bone marrow transplant, both auto and allogenic, as well as clinical trial infusions.

I will be talking later about the rest of Massive Bio's onboarding process, as well as our services, after Selin. Selin Kurnaz 03:27 Thank you so much, Czerny. You're going to hear a lot from Czerny about her journey with patients. I come from a very heavy engineering background. After going through a lot of engineering, I spent about 14 years in strategy, operations, and transactions.

My role prior to founding Massive Bio was one of the co-founders of Ernst and Young Private Equity Value Creation. At that time, I thought that I was going to open my own investment management firm and invest in growth stage businesses. I had a very well- articulated vision seven years ago about what my future was going to look like, but God had a completely different plan. God's plan was that my uncle was diagnosed with prostate cancer.

So until that point in time, cancer did not hit the family. That was definitely an earth-shattering journey for us. And I lost my aunt to cancer six months ago. This is not just a business for us; this is really a personal passion. That's the reason why we are getting together with patient communities to try to explain why we have been in this field. We founded the company about seven years ago based upon that personal frustration.

On-my-knees frustration with cancer care. You're going to three different places. You're getting three different results. There is no clarity in terms of how you're going to prescreen to a trial. And if you are eligible, what are you going to do? That can be very, very frustrating. In the last seven years, we have been trying to empower cancer patients to get access to clinical trials, regardless of their location or their financial stability.

We are really engineering the patient enrollment value chain. We are capturing patient identification and then we get a consent from the patient, which is not a consent for a particular study. That consent is for us to be able to collect their medical records. If they have NGS tested-that's great. But if they have not been NGS [next generation sequencing] tested, then we help the patient to get NGS tested to the extent it's available.

After we do base pre-screening, we do the last mile. In the last mile, we set up the appointment with the site and we look at any logistical issues that need to be resolved. Or, we look at any financial issue that needs to be resolved in order to "de-bottleneck" the system from identification to enrollment.

We're seeing the inclusion/exclusion criteria [for the clinical trial] must be fulfilled, but at the same time, you lose 75% of the patients in the funnel of the journey of clinical research when those patients are struggling from operational, logistical or financial matters. So those are the things that we are focusing on. We are patient advocates in that sense, but we are not the patient advocates on the emotional aspect of this.

We're supporting patient advocates with evidence-based medicine and providing a scale infrastructure to make sure that whatever the patient wants to do in their clinical trial enrollment journey, we provide the foundation for them to get there, instead of an exercise in their mind that they would like to do. We are 70 people as a company. We are operating in 12 countries in addition to the US.

In addition to the US and Canada, we are in France, Italy, Germany, Spain, Poland, Romania, Israel, Greece, Brazil, and Turkey. We have people that are speaking the local language so that the patients have that local vibe when they're interacting. In terms of the organization, we have people that are on the marketing side, and the digital engagement side, and then patient advocates.

When the patients are onboarded to our call center, they are speaking with the patient advocates to talk about the importance of the clinical trial, and what the journey is that awaits them. After that, they're in the medical records collection and in case management. After that, they're in the last mile. So that's kind of more on the patient journey side. In addition to that, we have the provider journey.

We also have a dedicated team that is working directly with the physicians of the patients or the referring physicians that will refer the patients to the clinical trial. I appreciate everyone's time and the opportunity, and I'll pass the baton to Czerny for her clinically-oriented insights and analysis. Czerny Cohen 14:00 Czerny Cohen 14:07 I want to go over step-by-step what really Massive Bio is all about.

Selin did a very thorough job talking about our vision and our mission. My only addition is that the clinical staff who are at Massive Bio right now really came to the company because we saw this issue that Selin saw personally while working in the system. I worked for a big cancer research center in California for most of my career, but then I had to move to South Carolina to a community practice.

I had patients who did not know what a bone marrow transplant was. That is something that is already part of the standard of care. So the patient would not know what clinical trials were. It was very real to me to see the discrepancy between the access of someone living near a big cancer center and near a community hospital. Unless you're living near City of Hope, MD Anderson, or MSK, the patient really has very limited resources.

So the issues that we're trying to solve here are really two pronged: we want to make sure that all oncology patients have the capacity to explore all of their options, not just standard of care therapy, but also clinical trial options. I think we have to remember that all of the standard of care therapy also came from being in clinical trials. Anything that's leading edge right now will be from any clinical trials.

The other prong is the concierge enrollment. Our AI was built to take in any patient's medical record. We #14] I think we have to remember that all of the standard of care therapy also came from being in clinical trials. We look at all of the diagnostic factors, whether that's lines of therapy, the types of therapy that they've had, their pathology, and their comorbidities.

The AI takes all of those factors and screens it against the inclusion and exclusion criteria of all of these clinical trials based on their cancer type. Our limiting factor would be the travel radius the patient sets. We have patients who are willing and able to travel all throughout the United States. If you're a US patient, we give a very comprehensive report, but we also accommodate the patient to the degree possible.

There are patients who only want to travel 75 miles because they don't want to be that far away from their family. Depending on the complexity of their disease and of their history, we can tailor it based on that probable radius.

But the other issue with the healthcare system right now is that even if a patient knows about clinical trials, and they know exactly what kind of clinical trial, they find it hard to even get referred or enrolled to these trials.

There are at least five people you have to speak to, and for a patient to even fully grasp which individuals they need to contact to get referred to these clinical trials is difficult for someone already in such a vulnerable position. It's just heartbreaking the amount of work they need to do to be screened for any clinical trials that they want to participate in. So, the second part of our services is exactly that.

Once we give that matching report, and go over that with them or with their oncologists, they pick one. ” We do the rest of the work from there. We figure out who the points of contacts are, we're the ones who do the outreach. We're the ones who do the scheduling of the appointment for the screening, which does take quite a bit of effort in terms of pulling together several different individuals to get this going.

Our goal is to make sure that the patient doesn't do anything other than be present at that screening. Here is a patient example. We have a 55-year-old male diagnosed with prostate cancer. They went through Leuprolide and Enzalutamide plus EBRT as their first line therapy. Their PSA started to trend down. But then in 2020, their PET scan showed lymph node involvement. Then they changed it to abiraterone and leuprolide.

The PSA remained a little bit stable, but then around February 2022, the PSA started to increase. Now the PET scan is showing bone lesions.