The START Center for Cancer Research has dosed the first U.S. participant in Moderna's Phase 1 clinical trial evaluating mRNA-4106, a novel pan-tumor antigen therapy candidate for patients with advanced or metastatic solid tumors. This milestone marks a significant step in bringing innovative mRNA-based cancer immunotherapies to patients through community-based clinical trials.
Dr. Amita Patnaik, who administered the first dose at START San Antonio, emphasized the significance of this development: "mRNA represents a bold new frontier in cancer immunotherapy, and we're proud to provide our patients access to this innovative treatment as part of a first-in-human trial. At START, our mission is to ensure that scientific breakthroughs translate into real-world options for patients—this study is a powerful example of that commitment."
Trial Design and Therapeutic Approach
The Phase 1 trial (ClinicalTrials.gov identifier: NCT06880549) will evaluate multiple aspects of mRNA-4106, including:
- Safety profile and tolerability
- Pharmacodynamic properties
- Immunogenicity
- Preliminary efficacy signals
The study will assess the therapy both as a monotherapy and in combination with checkpoint inhibitors, potentially offering new options for patients with limited treatment alternatives.
What distinguishes mRNA-4106 is its multivalent approach, designed to target antigens commonly shared across different tumor types. This strategy aims to broaden the therapeutic landscape beyond single-targeted immunotherapies that dominate the current market.
Dr. Rose Loughlin, Executive Vice President of Research at Moderna, explained the rationale behind the therapy: "With mRNA-4106, we sought to design an inclusive therapy that encodes for antigens commonly shared across patients and tumor types. We are thrilled to be able to bring this medicine to trial participants, and in partnership with forward-thinking site networks like START, further showcase the promise of mRNA to transform cancer care."
Community-Based Clinical Research
This trial highlights START's role as the world's largest early-phase community-based oncology site network. By conducting advanced clinical trials in community settings, START aims to make cutting-edge therapies more accessible to patients outside of traditional academic medical centers.
Nick Slack, MBE, Chairman and CEO of START, underscored this mission: "This milestone reflects the core of who we are at START - accelerating the next generation of cancer therapies by bringing them directly to patients in the communities where they live. We're proud to support Moderna in advancing this innovation into the clinic, reinforcing our commitment to faster, more accessible early phase trials that expand opportunity and impact for patients and sponsors alike."
mRNA Technology in Oncology
Moderna's application of mRNA technology to cancer treatment represents a significant expansion beyond the company's success with COVID-19 vaccines. The mRNA platform allows for the delivery of genetic instructions that prompt cells to produce specific proteins—in this case, tumor antigens that can trigger immune responses against cancer cells.
This approach offers several potential advantages over traditional cancer therapies:
- Ability to target multiple tumor antigens simultaneously
- Potential for personalization based on tumor profiles
- Relatively rapid manufacturing compared to cell-based therapies
- Possibility of combining with existing immunotherapies to enhance efficacy
START's Track Record
START's involvement in this trial builds on its extensive experience in early-phase oncology research. The organization has conducted more than a thousand early-phase clinical trials, including 45 that led to therapies approved by the FDA or EMA. With ten clinical trial sites globally and the world's largest roster of early-phase Principal Investigators, START has established itself as a leader in community-based cancer research.
The dosing of the first U.S. patient in this trial represents another step in START's mission of "Hope Through Access," bringing innovative cancer therapies to patients worldwide through community-based research centers.
