Imugene and Celularity to Develop Solid Tumor Treatment

Imugene Ltd, a clinical stage immuno-oncology company and Celularity Inc., a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, have entered into a research collaboration to develop the combination of Imugene’s CD19 oncolytic virus technology and Celularity’s CD19 targeting allogeneic chimeric antigen receptor (CAR) T cellular therapy, CyCART-19, for the treatment of solid tumors, according to an Aug. 5, 2021, announcement from the companies.

Imugene exclusively licensed the CD19 oncolytic virus technology from the California-based City of Hope cancer research and treatment center. Imugene’s strategy to treat solid tumors uses an oncolytic virus to prime the tumor cells for destruction by eliciting the expression of a validated tumor marker, CD19, that can then be used as a target for CAR T cellular therapy, the company reports.

CyCART-19 is a placental-derived T-cell investigational therapy engineered with a CAR that is cryopreserved and will be available off-the-shelf, the company reports. The therapy is in development initially for the treatment of B-cell malignancies, targeting the CD19 receptor. The company plans to file an investigational new drug application in the fourth quarter of 2021 and begin Phase I trials in the first quarter of 2022.

“We believe the synergy between Celularity’s placental derived cells and our OnCARlytic platform has the potential to shift the cellular medicine paradigm,” said Leslie Chong, managing director and chief executive officer of Imugene in a press statement. “In preclinical studies Celularity’s cellular therapies have shown the ability to overcome limitations that have hindered other approaches, including increased proliferation and persistence in vivo, resistance to T-cell exhaustion and low immunogenicity, which allows for repeated dosing. These unique characteristics perfectly align with our vision for a combination treatment strategy, and we look forward to closely working together to bring this treatment strategy to the clinic and patients in need.”

Robert J. Hariri, MD, PhD, founder, chairperson and chief executive officer of Celularity, also noted in the press statement, “We are excited to initiate this research collaboration, which we believe will lay the foundation for a new approach to the treatment of solid tumors. Most solid tumors have variable targetable antigens, limiting CAR T-cell therapy efficacy. This treatment strategy with Imugene has the potential to apply to a new range of indications by enabling CD19 targeted cellular medicine to expand from its current effective usage in CD19 positive lymphomas and leukemia and potentially become applicable to a variety of solid tumors through inducing uniform expression of CD19 in solid tumors.”

The companies report research showed mice being cured of cancer with the CF33-CD19 and CAR T-cell combination. The first clinical trial, planned for 2022, will evaluate the safety and efficacy of CF33-CD19 in combination with CAR T therapy in patients with solid tumors.

Sources: Celularity and Imugene