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

• Collaboration will initially explore the therapeutic potential of a combination of Imugene’s CF33-CD19 oncolytic virus (onCARlytics) and Celularity’s CD19 targeting chimeric antigen receptor (CAR) placental-derived investigational T-cell therapy, CyCART-19

• Nonclinical in vitro and in vivo combination studies to commence in 2021

• Celularity’s off-the-shelf allogeneic CD19 therapy has shown sustained T-cell growth with continuous killing of tumor cells in vivo¹

• Combining Imugene’s oncolytic virus technology with Celularity’s allogeneic CAR T-cell therapy has the potential to become a novel approach to improve outcomes for patients with solid tumors

SYDNEY, Australia and FLORHAM PARK, N.J., Aug. 04, 2021 (GLOBE NEWSWIRE) -- 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 investigational therapy engineered with a CAR that is cryopreserved and will be available off-the-shelf.

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 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.”

For more information please contact:

Imugene Limited
Leslie Chong
Managing Director and Chief Executive Officer
Leslie.Chong@Imugene.com
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.
carlos.ramirez@celularity.com

Alexandra Roy
Solebury Trout
aroy@troutgroup.com

Celularity Media Contact:
Jason Braco, Ph.D.
LifeSci Communications
jbraco@lifescicomms.com

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 investigational therapy engineered with a chimeric antigen receptor (CAR) that is cryopreserved, allogeneic and available off-the shelf. CyCART-19 is in development initially for the treatment of B-cell malignancies, targeting the CD19 receptor. 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

Celularity’s Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,” “will,” “would” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include, statements regarding the anticipated benefits of the research collaboration, the ability to develop an new approach for solid tumors, overcome obstacles in cellular medicine, and create a ‘one-size-fits-all’ therapy, and the timing of IND filing and Phase 1 study, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel cellular therapies, and the clinical trial and regulatory approval process; and risks associated with developments relating to Celularity’s competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s proxy statement/prospectus filed with the Securities and Exchange Commission (SEC) on June 25, 2021 and other filings with the SEC . These risks and uncertainties may be amplified by the COVID- 19 pandemic. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

---

¹ https://celularity.com/t-cell-platform/