Imugene and Eureka Therapeutics Announce Strategic Collaboration to Accelerate Advancement of Oncolytic Virus and T-Cell Therapy in Solid Tumours

• The Collaboration will evaluate Eureka’s anti-CD19 ARTEMIS^® T-cell therapy in combination with Imugene’s CD19-expressing oncolytic virus onCARlytics in solid tumours
• Potential to address lack of tumour-specific targets in solid tumours for T-cell therapies by using oncolytic virus to force tumours to express CD19

SYDNEY & EMERYVILLE, Calif.–(BUSINESS WIRE)–Imugene Ltd (“Imugene”) (ASX: IMU), a clinical stage immuno-oncology company, and Eureka Therapeutics, Inc. (“Eureka”), a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumours, today announced a strategic collaboration to evaluate Imugene’s CD19 oncolytic virus onCARlytics technology in combination with Eureka’s anti-CD19 ARTEMIS^® T-cell therapy for the treatment of solid tumours.

Oncolytic viruses in combination with T-cell therapies represent a novel and promising approach to treat solid tumours. In preclinical studies conducted by the City of Hope Comprehensive Cancer Center, scientists combined CAR-T therapy with an oncolytic virus to eliminate solid tumours in mice. The virus enters the tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for anti-CD19 T-cells to pursue and kill. Imugene licensed the patents covering City of Hope’s oncolytic virus technology in May 2021.

“By combining oncolytic virus and CAR T-cell therapies, we have developed a ‘mark and kill’ approach to treating solid tumours with T-cell therapies,” said Saul Priceman, Ph.D., Assistant Professor in the Department of Hematology and Hematopoietic Cell Transplantation at City of Hope and co-inventor of the platform. “In our animal studies, we were able to express CD19 in triple-negative breast, pancreatic, prostate, ovarian, and head and neck cancer, as well as brain tumours.”

“T-cell and CAR-T therapies have not achieved much success in solid tumours in part because of a lack of tumour-specific targets. By using our proprietary oncolytic technology to force the tumour to express the CD19 target, we now have the ability to address this shortcoming. We believe the synergy between our onCARlytics platform and Eureka’s anti-CD19 ARTEMIS^® T-cells has the potential to shift the cellular medicine paradigm in treating solid tumours,” said Leslie Chong, Managing Director & Chief Executive Officer of Imugene.

“We are delighted to be working with Imugene on tackling solid tumours using this innovative approach,” said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. “We believe our ARTEMIS^® T-cell platform to be the ideal one to evaluate this combination. In head-to-head pre-clinical studies against CAR-T cells, our ARTEMIS^® T-cells demonstrated superior efficacy, enhanced tumour infiltration, and less T-cell exhaustion. In the clinical context, our ARTEMIS^® T-cells have demonstrated reduced cytokine release syndrome (CRS) and other cytokine-related toxicities compared to CAR-T cells, potentially improving the efficacy and safety of a combination approach.”

About Eureka Therapeutics, Inc.

Eureka Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel cancer T-cell therapies to treat cancers. The company is developing potentially safer and more effective T cell therapies for the treatment of solid tumors and hematologic malignancies using its ARTEMIS^® CELL RECEPTOR platform and E-ALPHA^® antibody discovery platform. ET140203 and ECT204, the company’s lead assets, are currently in Phase I/II US multi-center clinical trials in patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. Eureka is headquartered in the San Francisco Bay Area. For more information, please visit: www.eurekatherapeutics.com. Follow us on Twitter at @EurekaThera.

About Oncolytic Virus Technology

Researchers first created an oncolytic virus (CF33-CD19) in the lab of City of Hope’s Yuman Fong, M.D., to get into tumour 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-tumour immunity. Solid tumours don’t express CD19 on their cell surface, therefore introducing the CF33-CD19 allowed for CD19 to be present on the solid tumour cell surface, as well as helped to reverse the tumour’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 tumours.

About Imugene (ASX: IMU)

Imugene 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 tumours. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our 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 tumours. We are 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.

Our 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, we believe Imugene’s immuno-oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market.

Release authorised by the Managing Director and Chief Executive Officer

Imugene Limited, Level 3, 62 Lygon Street, Carlton, VIC, 3053, Australia

Contacts

For more information, please contact:

Imugene Limited

Leslie Chong

Managing Director and Chief Executive Officer

Investor Enquiries

[email protected]

Media Enquiries

Matt Wright

[email protected]

Follow us on Twitter @TeamImugene

Like us on Facebook @Imugene

Connect with us on LinkedIn @Imugene Limited

Eureka Therapeutics, Inc.

Natalie Liu

Investor Relations

510-318-9215

[email protected]