Celularity and Imugene Enter into Potentially ‘Game-Changing’ Collaboration

Pipeline Report | <b>Pipeline Report: November 2021</b>

Chimeric antigen receptor T-cell therapies are rapidly shifting the treatment paradigm for a multitude of hematologic malignancies.

Chimeric antigen receptor (CAR) T-cell therapies are rapidly shifting the treatment paradigm for a multitude of hematologic malignancies. Celularity Inc and Imugene Ltd hope to further add to this growing treatment strategy with their exclusive strategic partnership aimed at exploring the therapeutic potential of CAR T-cell therapy in solid tumors by combining Imugene’s CF33-CD19 oncolytic virus (onCARlytics) and Celularity’s investigational placental-derived CAR T-cell therapy (CyCART-19).1

“Our platform is geared toward producing the best quality cells with both intrinsic properties and any version of an engineered form of those cells,” said Robert J. Hariri, MD, PhD, founder, chairperson, and chief executive officer of Celularity in Florham Park, New Jersey. “We found that Imugene’s technology and our technology created a unique opportunity to apply what we know about placental T-cells that can be engineered to express a CAR and their long-term applications in areas [such as] solid tumors, which up to this point have been unexploited.”

OnCARlytics uses an oncolytic virus, CF33-CD19, to prepare solid tumor cells for treatment with CAR T-cell therapy. After the virus infects a tumor cell, it replicates and induces CD19 expression on the surface of the tumor cell, enabling it to be effectively targeted with CAR T-cell therapy. The lysis of the tumor cell leads to the release of viral particles, which reinitiates the infection of other tumor cells, restarting the process.2

Imugene exclusively licensed the CF33-CD19 virus from City of Hope in May 2021.3

CyCART-19 is an investigational CAR T-cell therapy that is derived from the placenta and cryopreserved. The allogenic, off-the shelf agent is in development for the treatment of B-cell malignancies and targets CD19. Celularity plans to file an investigational new drug application for the agent in the first quarter of 2022 and commence phase 1 of the study in the first quarter of 2022.1

“Celularity has what we consider to be the best-in-class CAR T-cells because the cell is derived from the human placenta,” said Andrew Pecora, MD, president of Celularity. “It has the advantage of the greatest amount of natural stemness, meaning that it can proliferate per unit time longer, faster, and better than adult-derived cells. It also has a bit of an ability to evade immune detection. It will be potent and hang around longer.”

The partnership anticipates that combining onCARlytics with CyCART-19 will enable solid tumors to be treated with CAR T-cell therapy, an approach that has previously proven unsuccessful because of a lack of expression of a unique target antigen. If effective, the combination could be used in the treatment of most solid tumors, Hariri said. Nonclinical in vitro and in vivo studies examining the combination are expected to commence in 2021.1

“If you can get ubiquitous expression of an antigen across an entire tumor architecture, you might be able to transform how we think about curing solid tumors,” Pecora said. “I can’t underestimate how big a deal this could be if it truly works. This could be game changing. This could be the approach that enables us to go after solid tumors the way we’ve done liquid tumors.”

References

  1. Imugene and Celularity announce an exclusive strategic partnership to develop a novel oncolytic virus - allogeneic CAR T-cell immunotherapy combination for the treatment of solid tumors. News release. Celularity Inc. August 4, 2021. November 10, 2021. bit.ly/3F5oTSU
  2. onCARlytics. Imugene. Accessed November 10, 2021. bit.ly/3C6byaT
  3. Imugene Licenses CD19 Oncolytic Virus From City of Hope to Turn CAR T Therapy Against Solid Tumors. News release. City of Hope. May 18, 2021. Accessed November 10, 2021. bit.ly/30h4Xx3