Precision Clinical Trial Matching Drives Cancer Research Forward

In the effort to bring about new insights in cancer research, clinical trials are an indispensable tool. Indeed, well-designed clinical trials are a universal win for all involved. For cancer patients that are not responding to traditional treatments, clinical trials are a lifeline, providing access to the latest, potentially life-saving treatment breakthroughs. For researchers, the clinical trial process is the best and most efficient way to refine novel therapies and gain invaluable insights into new avenues for cancer research.

Despite having a central role in the development of novel cancer treatments, clinical trials are only just beginning to reach their full potential. There are many longstanding obstacles, and M2GEN is stepping in to help improve outcomes of clinical trials by providing precision matching solutions to the benefit of researchers and cancer patients alike.

Challenges Associated with Clinical Trial Matching

To recognize how M2GEN is helping modernize clinical trial design, it is important to first understand the obstacles that researchers have faced for decades. Historically, patient enrollment in clinical trials has been very low. And while some improvements have been made in patient accrual, several factors have continued to suppress enrollment rates. This, in turn, causes delays in the development of new, life-saving therapies. Fortunately, this roadblock is far from insurmountable. Perhaps the most significant factor contributing to low enrollment is lack of information. Many patients are simply not informed about new drug trials from which they might benefit, and researchers have no way of identifying and contacting such patients.

Of course, increased awareness alone is not enough to ensure the expeditious recruitment of qualified patients in clinical trials. Modern drug trials are often highly targeted, requiring the enrollment of patients with specific genomic characteristics and clinical histories. This poses a major challenge, as researchers often have to struggle to sort through disjointed and disparate data only to find that the number of qualified participants falls short of what is required to constitute a robust clinical trial.

How M2GEN Is Advancing Clinical Trial Matching

As a leading oncology-focused bioinformatics company, M2GEN has spearheaded the one-of-a-kind Total Cancer Care^® (TCC) research initiative. Through the patented TCC protocol and the Oncology Research Information Exchange Network^® (ORIEN), M2GEN has brought together clinicians, scientists, and patients to enable clinical trial matching with never-before-seen precision. Our success in breaking down the barriers that researchers face in finding qualified clinical trial participants is due to:

Our Partnerships

Precision clinical trial matching requires extensive collaboration among the key stakeholders in cancer research. The ORIEN network—an alliance of the nation’s top cancer centers—is actively involved in fostering discovery through ORIEN Intermember Projects and Research Interests Groups, which encourage collaborative research opportunities and provide a forum for experts to exchange ideas and address unmet needs. Most important for our research partners is M2GEN’s participation in the ORIEN Clinical Trials Network (OCTN). Managed by M2GEN, the OCTN utilizes a centralized Scientific Review Committee (SRC) and a centralized Institutional Review Board (IRB). These partnerships have been forged to reduce the burden on researchers to identify and enroll patients in clinical trials. Our role is to rapidly find and activate patients based on our partners’ exact criteria, thereby improving clinical trial efficiency while reducing study timelines and lowering costs.

Our Clinical & Molecular Data

With the TCC protocol, patients consent to sharing their data throughout their lifetimes. This includes everything from clinical information, such as patient demographics and medical histories, to genomic data, such as the presence of specific biomarkers and the results of whole exome and RNA sequencing. More than 300,000 patients have participated thus far, allowing M2GEN to establish a longitudinal data pipeline that is unrivaled in its size and scope. Additionally, the bioinformatics experts and scientists at M2GEN unleash the full power of our ever-expanding cache of patient data. For example, we can create advanced comparator cohorts by identifying robust cross-sections of patients that meet highly specific criteria. Additionally, because patients agree to be recontacted, it is easier than ever to rapidly identify and enroll qualified patients in clinical trials through the OCTN.

Precision Clinical Trial Matching in the Real World

In partnership with Moffitt Cancer Center and AbbVie Inc., M2GEN recently participated in a collaborative study that underscores the importance of precision clinical trial matching. Entitled “Ex Vivo Drug Sensitivity and Functional Genomics Platform Identifies Novel Combinations Targeting Intrinsic and Extrinsic Apoptotic Signaling Pathways in Multiple Myeloma” (our “MM Drug Sensitivity Study”), this study identifies eventual drug resistance as a critical obstacle in the treatment of multiple myeloma (MM).

Our MM Drug Sensitivity Study was based on the established research that tumor cell death initiated through the activation of the intrinsic (mitochondrial) and/or extrinsic (death receptor) apoptotic signaling pathways is an effective strategy in the treatment of MM. We created an ex vivo platform to determine the sensitivity of individual tumor cells to single-agents as well as drug combinations. This included the use of a co-culture system of bone marrow (BM)-derived MM and stromal cells to assess the sensitivity of MM patient tumor cells. We also performed paired whole exome sequencing (WES) and RNA sequencing (RNA-seq) analyses.

Using an ex vivo functional genomic screen of MM patient specimens, we demonstrated the usefulness of our approach in identifying candidate drug combinations and discovered new mechanisms of drug sensitivity. Additionally, we discovered potential predictive biomarkers, which are prime candidates for further study in clinical trials.

Historically, identifying patients for clinical trials with specific predictive biomarkers, such as those uncovered in our MM Drug Sensitivity Study, has been extraordinarily time- and resource-intensive. However, through the OCTN, quickly establishing a robust group of participants that meet a narrow set of criteria is much simpler. No longer are our researchers bogged down with the hands-on management of precision clinical trial matching, which frees up valuable resources that can be directed to developing life-saving therapies.

To learn more about how M2GEN is helping bring about a new generation of cancer therapies by advancing precision clinical trial matching, contact us today.