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IMUGENE LIMITED — Capital/Financing Update 2024
Nov 10, 2024
65124_rns_2024-11-10_ca612501-c0a5-4dd5-8c95-64c23d2d637b.pdf
Capital/Financing Update
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ASX Announcement
Phase 1 onCARlytics Trial Doses First Patient in Intratumoural (IT) Combination Arm
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First patient dosed in the intratumoural (IT) injection combination arm of the OASIS trial
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The colorectal cancer patient was dosed at Northwestern University
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OASIS combines a CD19-expressing oncolytic virus with a CD19-targeting drug, and is expected to recruit up to 40 patients with advanced solid cancers that have spread
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The onCARlytics trial is designed to convert hard-to-treat “targetless” tumours to CD19-expressing solid tumours that can be targeted
Sydney, Australia, 11 November 2024: Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, has announced the dosing of the first patient in the intratumoural (IT) combination arm of its Phase 1 onCARlytics (CF33-CD19) clinical trial. This development is part of the OASIS trial, which is designed to assess the safety and efficacy of Imugene's CD19 oncolytic virotherapy in patients with advanced or metastatic solid tumours.
The OASIS trial is a Phase 1 dose escalation study that explores two routes of administration, intratumoural (IT) injection and intravenous (IV) infusion. onCARlytics, a CD19-expressing oncolytic virus, is being investigated both as a monotherapy and in combination with the CD19-targeting bispecific antibody blinatumomab, an established cancer immunotherapy.
Imugene Managing Director & CEO Leslie Chong said: “We are pleased to have dosed the first patient in the intratumoural arm of our OASIS trial. With CD19 being a well-established target in blood cancers, we are optimistic about the effectiveness it could show in solid tumours. onCARlytics has the potential to induce expression of CD19 on the surface of
IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM [email protected]
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solid tumours and allowing existing CD19 therapies to recognise and attack the cancer. We’re pleased to continue advancing this prospective new treatment option for those in need."
OASIS is currently being conducted at seven sites in the U.S. including City of Hope, University of Cincinnati, and MD Anderson Cancer Center, with the potential to open a total of 10 sites to recruit up to approximately 40 patients with advanced solid cancers that have spread. The primary objective of the trial is to evaluate the safety and efficacy of onCARlytics, either by IT injection or IV infusion, either alone, or in combination with blinatumomab. In February, the first patient with bile tract cancer was dosed in the IV monotherapy arm of the trial at City of Hope in California. Subject to the rate of patient enrolment, preliminary IT and/or IV combination status is expected in the fourth quarter of 2024.
The trial is titled: “A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors.” See https://clinicaltrials.gov/study/NCT06063317
For more information please contact:
Leslie Chong Managing Director and Chief Executive Officer
General Investor Enquiries
Media Enquiries
Matt Wright [email protected]
Connect with us on LinkedIn @Imugene Limited Follow us on Twitter @TeamImugene Watch us on YouTube @ImugeneLimited
IMUGENE LIMITED ACN 009 179 551
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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 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 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.
IMUGENE LIMITED ACN 009 179 551
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