Imugene Limited

Imugene Limited has cleared the first dose level in the intravenous (IV) combination arm of its Phase 1 onCARlytics #clinicaltrial, following Cohort Review Committee (CRC) approval. The OASIS study targets adult #patients with advanced or metastatic solid tumours and will now proceed to a higher dose level as part of its planned escalation process. This first-in-human trial aims to induce CD19 expression in solid tumours using onCARlytics, an oncolytic virus, thereby making the tumours susceptible to CD19-directed #immunotherapies. The OASIS trial is assessing two administration routes—intratumoural (IT) and intravenous (IV)—of onCARlytics, both alone and in combination with the CD19-targeting bispecific monoclonal antibody blinatumomab (Blincyto®). More at http://ow.ly/h5lG1064tbS #Proactive #ProactiveInvestors #ASX #Oncology #CancerResearch #Biotech

We've cleared the first dose level in the intravenous (IV) combination arm of our Phase 1 onCARlytics trial. The study, known as OASIS, is targeting adult patients with advanced or metastatic solid tumours and is evaluating the safety and efficacy of intravenous and intratumoural administration of either onCARlytics (a CD19-expressing oncolytic virus) alone or in combination with CD19 targeting bispecific monoclonal antibody blinatumomab (Blincyto®), which is a cancer immunotherapy. Dose escalation will continue as we advance towards full recruitment of 40-50 patients across U.S. trial sites. Managing Director and Chief Executive Officer Leslie Chong, said: “CD19 is a very significant target for blood cancers, but solid cancers like breast, lung or gastric do not have a common target on their cell surface, and therefore the aim with onCARlytics is to make available a target for CD19 therapies to treat these solid cancers. As the trial continues to progress and dose escalation is executed, we are eager to learn of the potential impact our treatment is having for patients in need.” Read the full ASX Announcement: https://lnkd.in/gded4C3D #Imugene #onCARlytics #CD19 #Immunotherapy #ASX #CancerResearch #DLBCL #SolidTumours #Biotech #OASISTrial #IMU

𝗠𝗲𝗲𝘁 𝗦𝗵𝗮𝗿𝗼𝗻 𝗬𝗮𝘃𝗿𝗼𝗺 – 𝗘𝘅𝗲𝗰𝘂𝘁𝗶𝘃𝗲 𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿, 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗦𝗰𝗶𝗲𝗻𝗰𝗲 𝗮𝘁 𝗜𝗺𝘂𝗴𝗲𝗻𝗲 Sharon brings extensive experience in oncology drug development, having contributed to therapies like Yervoy, Nivolumab, Nerlynx, and XGEVA. She has worked across academia and industry, earning a Ph.D. in pathology and focusing on treatments for lung cancer, glioblastoma, breast cancer, Ewing’s sarcoma, and lymphomas. Since joining Imugene nearly three years ago, Sharon has played a key role across all clinical programs, shaping study designs, supporting publications, and driving trial execution. She now focuses on azer-cel, where she has developed expertise in cell therapy. Sharon is particularly excited about azer-cel’s IL-2 cohort data, which shows promise in improving CAR-T expansion and persistence, potentially redefining allogeneic CAR-T treatment. As Executive Director of Clinical Science, Sharon helps guide Imugene’s clinical programs from design through to execution, ensuring trials progress. #MeetTheTeam #ClinicalResearch #CAR_T #Immunotherapy #Imugene #IMU #Leadership #Oncology #ClinicalDevelopment Sharon Yavrom, Ph.D.

📣 We're excited to share our March newsletter. This edition includes updates on our key clinical milestones for azer-cel, recent intellectual property milestones, and highlights from our latest Q&A sessions. We also welcome our new CFO, Darren Keamy, and highlight recent media coverage and presentations. Read more: https://lnkd.in/gZtFEXkA #Imugene #IMU #Biotech #CancerResearch #Immunotherapy #CAR_T #OncolyticVirus #MedicalInnovation

In case you missed it – CEO & Managing Director Leslie Chong's presentation at the NWR Communications Healthcare Conference is now available to watch. 🎥 Watch the replay here: https://lnkd.in/gC5vt6H4 #IMU #Imugene #Biotech #ASX #Healthcare

Our CEO & Managing Director Leslie Chong joins Proactive to discuss the FDA’s Fast Track Designation for azer-cel, our allogeneic CAR T-cell therapy for relapsed/refractory DLBCL. With promising response rates and a growing clinical program, this designation supports expedited development for patients with high unmet need. 📺 Watch the full interview here: https://lnkd.in/g4H4Uekm #Imugene #IMU #Biotech #CancerResearch #CAR_T #FDA #FastTrack #DLBCL #Immunotherapy #BloodCancer #MedicalInnovation #Oncology Kerry Stevenson

Imugene secures FDA fast track designation for CAR T-cell therapy azer-cel to combat blood #cancer | Media coverage by Proactive. https://lnkd.in/gvvFkp9Q #IMU #Imugene #ASX #ASXNews #Biotech

We've been granted Fast Track Designation by the U.S. FDA for our allogeneic CAR T-cell therapy, azer-cel, for the treatment of relapsed or refractory diffuse large B-cell lymphoma. This designation is designed to facilitate the development and expedite the review process for therapies addressing serious conditions. It supports our efforts to advance azer-cel as a potential off-the-shelf CAR T treatment for patients with limited options. Managing Director and CEO Leslie Chong said, “Receiving FDA Fast Track Designation is a testament to the transformative potential of azer-cel for patients battling relapsed or refractory DLBCL. We are committed to working closely with the FDA to bring this important therapy to patients as efficiently as possible.” Read the full ASX Announcement here: https://lnkd.in/gtm7rSPS #Imugene #IMU #CAR-T #Biotech #FDA #DLBCL #CancerResearch #ImmunoOncology

REMINDER | Imugene CEO & Managing Director Leslie Chong will present tomorrow (19 March 2025), at 9:00 AM AEDT as part of the NWR Communications Virtual Healthcare Conference. Date: Wednesday, 19 March 2025 Time: 9:00 AM AEDT Register here: https://lnkd.in/gY5tt4_G A recording will be available after the live session. Questions can be submitted on the day or emailed in advance to matt@nwrcommunications.com.au. For more details: https://lnkd.in/gjepqwZP #Imugene #IMU #HealthcareConference #Biotech #InvestorUpdate #Webinar

Imugene CEO & Managing Director Leslie Chong will present on Wednesday, 19 March 2025, at 9:00 AM AEDT as part of the NWR Virtual Healthcare Conference. Date: Wednesday, 19 March 2025 Time: 9:00 AM AEDT Register here: https://lnkd.in/gY5tt4_G A recording will be available after the live session. Questions can be submitted on the day or emailed in advance to matt@nwrcommunications.com.au. For more details: https://lnkd.in/gjepqwZP #Imugene #IMU #HealthcareConference #Biotech #InvestorUpdate #Webinar NWR Communications