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Massive Bio Aims to Improve Clinical Trial Enrollment Rates With Oncology Registry, Matching Tool

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NEW YORK (GenomeWeb) –  Healthcare informatics firm Massive Bio has enrolled its first patient in a global registry it launched as part of a new clinical trial matching system that seeks to connect patients to appropriate biomarker-based clinical trials using information such as clinical history and genomic testing results.

Previously, Massive Bio offered its clinical trial matching capability as part of a broader oncology clinical decision support system through which it provides treatment guidance and expert recommendations primarily to oncologists working in community practices. By separating the clinical trial matching component, the company hopes to broaden its market reach, said Massive Bio CEO and Cofounder Selin Kurnaz. The company also hopes the new tool will appeal to contract research organizations, molecular diagnostics companies, and patients themselves.

Furthermore, the company hopes the tool will connect a longer list of patients to a wider pool of possible treatment options for their tumors, she added. Some 85 percent of cancer patients right now are being treated in community-based practices, and many are eligible for clinical trials. "Massive Bio can actually go to these patients in the community practices, screen [them], and put them into the right clinical trials," Kurnaz said. The tool could also help clinical trial researchers reach their enrollment targets faster and select patients that meet their specific criteria.

A key component of the clinical trial matching tool is the so-called Synergy-AI registry, which, according to the company, is the first registry of its kind to use artificial intelligence technology to match patients based on genomic biomarkers and multivariate analyses. The company has trained the system on a number of internally developed clinical pathways generated for about 34 different tumor types.

When a patient opts to enroll in the registry, the system automatically extracts information such as clinical history, comorbidities, testing history, and test results from their medical records. If patients have not had any genetic testing done, the company can offer recommendations. Once all the patient's data is in, proprietary algorithms within the system match patients to trials based on comparisons between the information in the registry and the specific variables and parameters set by the clinical trials investigators. The company has access to lists of clinical trials from several global databases including Clinical Trials.gov as well as trials lists maintained by research institutions.

Furthermore, the company's team of expert oncologists review the recommendations that the system makes and prioritize the suggested trials based on the patient's health profile. The idea here is that "wherever that you are in the world, if you contact us through Synergy-AI, we can match you to the right biomarker-based clinical trial that is in [your] vicinity [and] that is convenient for you to go," Kurnaz said.

Massive Bio's matching system is focused on solid tumors but it could also include hematologic tumors. It has begun testing the system with multiple providers and it expects more providers to sign on to use the system soon, Kurnaz said. She declined to disclose details about pricing but said the company charges per patient and that cost is usually borne by the CRO handling the clinical trial.

The company also continues to optimize and improve the clinical trial recommendations that its system makes. To that end it hopes to enroll a total of 1,500 patients in this phase of the product's development to further train its system and ultimately improve the matches that it makes, Kurnaz said. The added data will also help the company evaluate the feasibility and clinical utility of its matching tool in terms of measurable outcomes such as improved enrollment rates, clinical outcomes, and financial impact.

Specifically, they will be able to compare the results from trials that incorporate Massive Bio's matching algorithms and expert network into their programs from those that did not. The hope is that the results of such comparisons will show that Massive Bio can help pharmaceutical companies, for instance, advance their drug development activities research in a more sustainable fashion. "Right now, unfortunately, biomarker-based clinical trials are not successful because they don't have the right patients [among other] reasons," Kurnaz said. Expanding the patient pool to include patients from community-based oncology practices could help these trials improve their outcomes.

In addition to Synergy-AI, Massive Bio markets its clinical decision support system to oncologists. The system integrates information from patients' electronic medical records including clinical history and workup; results from laboratory tests including sequencing, treatment strategies, and patients' responses to those treatments; evidence-based guidelines; information from clinical trial and drug databases; similar case studies; and molecular information. As part of this service, the company offers access to a virtual tumor board, comprising some 55 oncology experts, who provide guidance to treating oncologists.

As with its clinical trial matching tool, Massive Bio offers its clinical decision support system to community-based oncology practices, academic hospitals, pharmaceutical companies, and payors, with an eye towards helping oncologists in these contexts bring precision medicine to bear on their clinical practices. The company currently counts about 60 community practices as customers, including the Cancer Center and Coagulation/Thrombosis Clinic at Chippewa County War Memorial Hospital.

"We are a true community practice, we serve a large amount of cancer patients with a limited number of sub-specialists and clinical operations staff due to logistics constraints,” Belisario Arango, the center's medical director, said in emailed comments. "Massive Bio's efforts are beyond anything available in the fields of second opinion and precision oncology, connecting academia and community oncology. Their reports are user friendly, and the diagnostic and treatment recommendations, including clinical trials, are really personalized and the most sophisticated." Furthermore, "they are quite resourceful to support us for finding the most promising clinical trials in larger cancer centers that are close to the patient," he added.

The company's target audience also includes CROs. Furthermore, patients themselves can reach out to the company and request that the Massive Bio platform be used in their care.

Once a patient engages the company's services, Massive Bio works collaboratively with treating oncologists to determine the best course of action for the patient including what sort of genomic testing may be appropriate if such tests have not already been done, Kurnaz said. Furthermore, the company does not return test results or recommendations directly to patients. These go to the physician who then reviews the results with the company before sharing them with the patient. Ultimately, "our goal is to make sure that precision oncology penetrates to the patient wherever they are regardless of what the provider does," she said. "We do not want patients to feel marginalized because their provider is not part of Massive Bio's platform."