Imugene and Celularity Announce an Exclusive Strategic Partnership to Develop a Novel Oncolytic Virus – Allogeneic CAR T-Cell Immunotherapy Combination for the Treatment of[...]

Sydney, Australia & Florham Park, N.J., August 05, 2021: Imugene Ltd ('Imugene') (ASX: IMU), a clinical stage immuno-oncology company and Celularity Inc. ('Celularity') (Nasdaq: CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, today announced they have entered into a research collaboration in 2021. As part of the partnership, Imugene and Celularity will initially collaborate 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. CYCART-19 is a placental-derived T-cell therapy engineered with a CAR that is cryopreserved, allogeneic and available off-the-shelf to clinicians.

Imugene exclusively licensed the CD19 oncolytic virus technology from City of Hope, a world-renowned independent cancer research and treatment center near Los Angeles. Imugene's novel 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.

'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 & Chief Executive Officer of Imugene. '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, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity, said, '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 CD 19 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.

For more information please contact:

Imugene Limited
Leslie Chong
Managing Director and Chief Executive Officer
[email protected]
Follow us on Twitter @TeamImugene
Like us on Facebook @Imugene
Connect with us on LinkedIn @Imugene Limited

Celularity Inc
Celularity Investor Contacts:
Carlos Ramirez
Celularity Inc.
[email protected]

Alexandra Roy
Solebury Trout
[email protected]

Celularity Media Contact:
Jason Braco, Ph.D.
LifeSci Communications
[email protected]

OnCARlytics

Researchers first created an oncolytic virus (CF33-CD19) in Fong's lab to get into tumor cells and start producing CD19. They did this successfully in triple-negative breast, pancreatic, prostate, ovarian, head and neck, and brain cancer cell lines. CF33-CD19 oncolytic virus was then combined with CD19 CAR T cells in vitro and in vivo mice studies. Researchers showed significant activity with mice being cured of their cancer with the CF33-CD19 and CAR T-cell combination, as well as prolonged protective anti-tumor immunity. Solid tumors don't express CD19 on their cell surface, therefore introducing the CF33-CD19 allowed for CD19 to be present on the solid tumor cell surface, as well as helped to reverse the tumor's harsh microenvironment, making it receptive to receiving CAR T-cell therapy. The first clinical trial is anticipated to start in 2022 and will evaluate the safety and efficacy of CF33-CD19 in combination with CAR T therapy in patients with solid tumors.

CYCART-19

CYCART-19 is a placental-derived T-cell therapy engineered with a chimeric antigen receptor (CAR) that is cryopreserved, allogeneic and available off-the shelf to clinicians. CYCART-19 is in development initially for the treatment of B-cell malignancies, targeting the CD19 receptor. Unlike adult peripheral blood mononuclear cell derived T-cells, placental-derived T-cells are mostly naïve (CD45RA+), expand readily ex vivo, express markers of stem cell memory and have lower expression of effector or exhaustion markers, allowing for greater proliferative potential in vivo. Celularity intends to file an investigational new drug application (IND) in the fourth quarter of 2021 and commence Phase 1 of the study in the first quarter of 2022.

About Imugene (ASX: IMU)

Imugene Limited is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. Imugene's unique platform technologies seek to harness the body's immune system against tumors, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Imugene's product pipeline includes multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T's for solid tumors. Imugene is supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets.

Imugene's vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Imugene is well funded and resourced, to deliver on its commercial and clinical milestones. Together with leading specialists and medical professionals, Imugene believes its immuno-oncology therapies will become foundation treatments for cancer. Imugene's goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market.

About Celularity (Nasdaq: CELU)

Celularity, Inc. (Nasdaq: CELU) headquartered in Florham Park, N.J., is a clinical stage biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies, including unmodified natural killer (NK) cells, genetically-modified NK cells, T-cells engineered with a CAR (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs) targeting indications across cancer, infectious and degenerative diseases. In addition, Celularity develops and manufactures innovative biomaterials also derived from the postpartum placenta. Celularity believes that by harnessing the placenta's unique biology and ready availability, it will be able to develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.

Release authorised by the Managing Director and Chief Executive Officer
Imugene Limited, Level 3, 62 Lygon Street, Carlton, VIC, 3053, Australia

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