START Doses First Patient in Trial of mRNA-4106, a Pan-Tumor Therapy for Solid Tumors

The START Center for Cancer Research dosed the first U.S. patient in Moderna’s Phase 1 trial of mRNA-4106, a multivalent mRNA-based cancer vaccine targeting advanced solid tumors. The study evaluates safety, immunogenicity, and efficacy, alone and with checkpoint inhibitors. START, a global leader in early-phase oncology trials, has supported over 1,000 trials, including 45 FDA/EMA-approved therapies.

Administered by Dr. Amita Patnaik at START San Antonio, mRNA-4106 is engineered to activate a patient’s immune system by encoding multiple tumor-associated antigens that are broadly expressed across a variety of cancers. Unlike conventional single-antigen cancer vaccines, this multivalent strategy aims to outmaneuver tumor heterogeneity and immune evasion, two of the most persistent obstacles in immuno-oncology.

“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,” said Dr. Patnaik following the dosing. “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.”

The study (NCT06880549), now underway, will assess the safety, pharmacodynamics, immunogenicity, and early efficacy signals of mRNA-4106, both as a monotherapy and in combination with checkpoint inhibitors. This dual approach is designed not only to stimulate T-cell activity but to enhance it through synergistic immune modulation, potentially increasing the odds of tumor regression in patients with advanced or metastatic disease.

“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,” said Nick Slack, Chairman and CEO of START. “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.”

A New Chapter in mRNA Therapy

Following the global success of mRNA-based COVID-19 vaccines, biotech leaders like Moderna are expanding the platform into oncology. But cancer presents a more complex target: tumors are adept at concealing themselves from the immune system, and their genetic landscapes can vary dramatically between and within patients.

“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,” said Dr. Rose Loughlin, Executive Vice President of Research at Moderna.  

Community-Based Innovation at Scale

The START Center, with its global network of community-based early-phase oncology sites, plays a pivotal role in bringing these scientific advances closer to patients. With more than 1,000 early-phase trials under its belt—including 45 therapies that have achieved FDA or EMA approval—START has earned a reputation as one of the world’s leading engines of translational oncology research.

While the promise of mRNA-4106 is grounded in strong preclinical rationale, it remains early days. The trial’s primary goal is to establish safety and biological activity—key steps before exploring therapeutic benefit at scale. If successful, mRNA-4106 could become a cornerstone in a new class of immunotherapies, shifting the paradigm from single-target precision to multi-antigen personalization.