By Maxine Bookbinder

February 16, 2022 | A leader in precision medicine and AI-enabled clinical trial enrollment for oncology patients has launched a program designed to simplify the enrollment process and open clinical trial access to all cancer patients. The goal of Massive Bio’s new 100K Singularity Program, which uses artificial intelligence (AI) and real-time access, is to transform the current clinical trial enrollment process from what founder and CEO Selin Kurnaz, Ph.D, describes as a cumbersome, generic system to one that is efficient, defined, and available to all cancer patients regardless of income or location. 

“Pre-screening clinical trial enrollment is moving from mom-and-pop to the Amazon level,” says Kurnaz. “We are going big and bold working with patients, physicians, pharmaceuticals, and payers to connect the dots and eliminate the pressure points in the enrollment process. We want to make a change to enroll large numbers of patients and to show this is possible to do at scale with the right data, technology, and services.”

Globally each year, approximately 14,000 oncology clinical trials enroll participants; also each year, more than 18 million people are diagnosed with cancer. Yet, according to the National Center for Biotechnology Information (NCBI), only 1 in 20 adult cancer patients, or less than 5%, participate in clinical trials.

The 100K Singularity program, which is free of charge, was created to help close this disparity by connecting eligible patients to the right trials within 72 hours, making enrollment faster, cheaper, more efficient, at scale, and available to all cancer patients, regardless of income level or address. Its initial focus is on lung, cervical, breast, prostate, gastric, GE junction, and pancreatic cancers, and non-Hodgkin lymphoma, myelofibrosis, CNS tumors, pediatric tumors, melanoma, multiple myeloma, and specific advanced cancers driven by potentially actionable biomarkers, such as gene fusions.

100K Singularity currently has 33,000 patients enrolled through its Customer Relationship Management (CRM) system and has collaborations with 17 pharmaceuticals, four contract resources, and three health systems, with plans to expand.

Kurnaz says one of 100K Singularity’s unique features is its meticulous, singular focus on oncology. “We have connected all the dots and optimized every angle for prescreening and customization for oncology. You need data, technology, and a network specific for oncology. We have fundamentally changed the industry. You need to activate many different channels to identify, prescreen, and enroll.”

Physicians can identify and refer patients to 100K Singularity for enrollment; patients can also learn about the program through patient referral call centers, advertisements, virtual and live Massive Bio nurse oncology seminars and prescreening events, and Massive Bio patient ambassador programs.

Massive Bio spent two years perfecting its prescreening precision points to match patients’ clinical and genomic information, using 125 parameters to structure details and ensure accurate matches. Patients are prescreened for hundreds of oncology trials listed in ClinicalTrials.gov, accomplishing in minutes what used to take weeks.

A critical component of accomplishing this is the SYNERGY-AI Oncology Clinical Trial Command Center (OCTCC), which expedites the enrollment process using advanced predictive analytics, real-time information, artificial intelligence (AI), and a communication network between patients, sites, and pharmaceutical companies. It also provides instant patient identification through 24 direct and indirect patient identification channels, privacy-compliant AI-based patient pre-screening, enrollment concierge, and just-in-time site activation. OCTCC searches for the two closest matches. A Massive Bio clinician and the patient’s oncologist then discuss the pros and cons of the results with the patient. 

But finding the perfect match is just the beginning of the patient’s clinical trial journey. “People don’t realize how long it takes to enroll a patient not already at the (clinical) site,” says Kurnaz. “We are bringing data and transparency, while trying to identify, enroll, prescreen, obtain records, and schedule a clinical site visit all within 72 hours. We are really trying to change the way this thing has been done. We are working very hard, innovating, bringing a lot of the pieces of the puzzle in a way never done before.” 

This requires collaboration. For example, a 100K Singularity representative will contact a physician who has not immediately forwarded medical records. If a patient needs financial assistance to reach a clinical trial site, a representative will try to clear that obstacle, such as asking the sponsor to subsidize the patient. The company also works with insurance companies, encouraging them to either cover or reduce costs; optimally, Kurnaz would like to see payers offer free pre-screenings.

Sometimes, illness prevents cancer patients from traveling, while others are hesitant to leave familiar surroundings for the unknown, and still others don’t know about trials. “We are raising a flag,” says Kurnaz. “We recognize that 85% of cancer is treated at community-based practices. We want to bring expertise of clinical research to those community practices. We want to make sure those patients get the same access and opportunity as others. We are trying to make sure that patients within a, say, 20-mile radius of a clinical trial don’t miss out because their physicians don’t know about trials. Trials shouldn’t be just for certain communities. They should be for everyone.”

One of Massive Bio’s endeavors is to work with research sponsors and sites to select potential investigators for “just in time” activation. The community site then becomes a research site once a patient is eligible to enroll. The company also collaborates with oncologists and monitors patients in decentralized trials who are enrolled from home.

Just making patients and their oncologists aware in real time of what studies are available can be difficult. “This can be easily overcome by solutions like Massive Bio using AI technology and concierge services at scale,” says Arturo Loaiza-Bonilla, MD, MSEd, Massive Bio’s co-founder and Chief Medical Advisor. We want to make their lives and treatment options easier to navigate, and there is clearly a mismatch in trial offerings.”

“We want to work out the operational issues and remove logistical and financial issues a patient might face so that he can participate. We can say to a site investigator, ‘We have an eligible patient who can’t reach your site. Can you subsidize a bus ticket?’”

100K Singularity currently has participants in clinical trials in 12 countries; however, all the clinical trial sponsors are in the US. Its current goal is to reach 20% enrollment, surpass 100,000 enrolled patients, and continue until every cancer patient who wants to participate in a clinical trial has the opportunity to do so. “Our goal is to get every cancer patient who is diagnosed with advanced cancer to have access to trials, to let everyone know this is an option and if the payer doesn’t cover costs, that either the insurance will allow exceptions or pharma will cover the cost.”