CellxLife, Inc. (CellxLife or the Company), a clinical-stage biotechnology company developing precision dendritic cell immunotherapies for cancer, announced that it has entered into an exclusive licensing agreement with Mayo Clinic for a novel dendritic cell cancer vaccine in two Phase II clinical trials for ovarian cancer.
The licensing agreement builds on CellxLife’s existing proprietary dendritic cell platform, which has demonstrated long-term durability in preventing relapse in pediatric patients with metastatic bone cancer in a Phase I clinical study conducted at leading institutions in Europe. While 80% of these young patients typically die within 5 years of diagnosis, those receiving the CellxLife cellular immunotherapy showed signs of surviving significantly longer. The Company is moving forward with a Phase II trial.
The modality is expected to apply to a wide range of solid tumors, and a Phase II basket trial is being planned for glioblastoma, lung, pancreatic, colorectal, and cervical cancer. Both CellxLife and Mayo Clinic immunotherapies focus on prevention of relapse as well as potential treatment, though by two distinct technologies.
“This licensing agreement marks a significant milestone for CellxLife,” stated Eric von Hofe, PhD, Chief Executive Officer of CellxLife. “The FRα-targeting vaccine, pioneered by Keith Knutson, PhD, and Matthew Block, MD, PhD, of Mayo Clinic, complements our existing proprietary dendritic cell platform and extends our reach into ovarian cancer — an indication with significant unmet medical need. With its high recurrence rates after standard of care surgery and chemotherapy, ovarian cancer remains one of the deadliest gynecologic malignancies. We are eager to advance this promising vaccine to address a patient population that urgently needs more effective options to reduce relapse and prolong survival.”
In an earlier Phase I Mayo Clinic study, approximately 40% of patients remained cancer-free for 10 years, compared to a historical benchmark closer to 10%, thus positioning the therapy as a potentially transformative approach in a malignancy with severe unmet need.
“We are encouraged by the high percent of patients with a prolonged cancer-free survival,” said Eric von Hofe, PhD.
Ovarian cancer cells overexpress FRα — a protein expressed at negligible levels in normal tissue — leveraging it to import folate essential for rapid tumor growth and metastasis. Tumors simultaneously recruit immunosuppressive regulatory T cells (Tregs) to silence anti-cancer immune responses. The immunotherapeutic vaccine exploits both vulnerabilities in tandem: it directs cytotoxic immune activity against FRα-expressing tumor cells while inducing Th17 T cells that actively counteract Treg-mediated immunosuppression — a mechanistic duality that distinguishes this approach from conventional cancer vaccines.
The ovarian cancer drug market, estimated at $3.8 billion in 2024, is projected to nearly double to $7.4 billion by 2034, according to Nova One Advisor market research, reflecting the high recurrence rates after current standards of care.
Highlights and Key Findings
-
- Approximately 40% of evaluable patients remained cancer-free for at least 10 years in a Phase I study, suggesting genuine immunological memory rather than transient tumor suppression;
- The therapy was shown to be capable of inducing strong tumor antigen-specific immune responses that correlated with cancer-free survival;
- The platform utilizes a patient-specific manufacturing process in which immune cells are collected from the patient, engineered into the dendritic cell vaccine, and reintroduced to activate targeted anti-cancer responses.
Given the use of personalized tumor-associated antigens employed in the CellxLife platform, the Company anticipates clinical translation for its use across high-prevalence cancers, including non-small cell lung cancer, colorectal cancer, and breast cancer — indications that collectively represent the largest segments of the global oncology market. The immunotherapeutic vaccine licensed from Mayo Clinic adds a complementary and distinct mechanism — active suppression of tumor immune evasion via Th17 induction — creating a pipeline with two reinforcing but mechanistically differentiated technologies.
“The advancement of the folate receptor dendritic cell vaccine platform toward commercialization represents an important milestone, not just for our work, but for the field as a whole. Cancer vaccines are rapidly transitioning from concept to reality, and the opportunity to potentially improve outcomes for patients has never been greater,” said Keith Knutson, PhD, Immunologist and Professor of Immunology, Mayo Clinic, and a pioneer in the development of next generation cancer vaccines designed to treat and prevent the recurrence of breast, ovarian and lung cancers.
“This program, together with CellxLife’s dendritic cell vaccine development efforts, positions the Company to contribute meaningfully to the advancement of cancer vaccines,” Eric von Hofe, PhD, added.
Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.