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Imugene (ASX:IMU) Doses First Patient in Pioneering Phase 1 onCARlytics Trial

Jane Morgan Management 3 mins read

Sydney, Australia, 24 June 2024: Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, is thrilled to announce the dosing of the first patient in the intravenous (IV) infusion combination arm of its Phase 1 onCARlytics (CF33-CD19) clinical trial. This groundbreaking trial, named OASIS, is being conducted at City of Hope in California and is designed to transform the treatment landscape for patients with advanced solid tumors.

The OASIS trial is a world-first, combining a CD19-expressing oncolytic virus with a CD19-targeting drug. The trial aims to recruit 40-45 patients with advanced solid cancers that have metastasized, with preliminary early combination data expected in the fourth quarter of 2024.

Key Highlights of the OASIS Trial:

  • First Patient Dosed: The first patient with cholangiocarcinoma, a bile duct cancer, has been dosed in the IV combination arm.

  • Innovative Combination: The trial uniquely combines the CD19-expressing oncolytic virus onCARlytics with the CD19-targeting bispecific monoclonal antibody blinatumomab (Blincyto®), a cancer immunotherapy.

  • Expanding Treatment Horizons: The onCARlytics trial aims to convert "targetless" solid tumors to CD19-expressing tumors, making them amenable to existing CD19 therapies.

  • Multiple Sites: The trial is being conducted at three prestigious U.S. sites – City of Hope, University of Cincinnati, and MD Anderson Cancer Center – with plans to expand to a total of 10 sites.

Leslie Chong, Managing Director & CEO of Imugene, remarked, "We are pleased to enroll the first IV combination patient and further advance our OASIS trial, which combines our CD19 oncolytic virus with the already approved and marketed CD19 bispecific in patients with advanced solid cancers. While CD19 has been a powerful target for blood cancers, no such targets currently exist for solid cancers. We aspire to change that with onCARlytics, which causes cancers to display CD19 on their cell surface so that an approved CD19 therapeutics can target and kill the cancer. If successful, onCARlytics could open up 90 percent of the market as CD19 products are only approved in blood cancer and provide a new treatment option for patients with solid tumors.”

The primary objective of the OASIS trial is to evaluate the safety and efficacy of onCARlytics, either by intratumoral (IT) injection or IV infusion, alone or in combination with blinatumomab. The trial aims to address the unmet need for effective targets in solid tumors, which represent approximately 90% of all cancers. By making these tumors express the CD19 marker, Imugene hopes to extend the benefits of CD19-targeting therapies, currently approved only for blood cancers, to a broader range of cancer patients.

About us:

About Imugene (ASX)

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 tumors. Our 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. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also 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. 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.


Contact details:

Media Enquiries

Jane Morgan

+61 405 555 618


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