IVX037 / ImmVirx - LARVOL DELTA

Phase I study of intratumoural (IT) IVX037, a novel CD55-targeted oncolytic RNA virus, in advanced microsatellite stable (MSS) colorectal cancer (CRC): Serum biomarkers, viral kinetics, and KRAS mutation analysis (ESMO 2025) - P1 | "Such findings support further investigation of IVX037, including KRAS-mutant MSS-CRC as a potential enrichment cohort based upon this preliminary data and ongoing studies in combination with sintilimab (anti-PD1) in MSS-CRC. Legal entity responsible for the study ImmVirX Pty Ltd. Funding ImmVirX Pty Ltd."

Biomarker • IO biomarker • Metastases • Oncolytic virus • P1 data • Colorectal Cancer • Oncology • Solid Tumor • CD55 • CEACAM5 • KRAS

Phase 1b open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 in combination with sintilimab (anti-PD1) in patients with advanced microsatellite stable (MSS) colorectal,gastroesophageal or ovarian cancer (AACR 2025) - P1 | "Pt recruitment commenced in October 2024, with currently 4 MSS-CRC pts enrolled and no DLT's. The Phase 1b trial is continuing as planned.Clinical Trial identifier: NCT05427487"

Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Gastric Cancer • Oncology • Ovarian Cancer • Solid Tumor • CXCL10 • KRAS • PD-L1

Novel oncolytic RNA viruses, IVX037 and IVX055, demonstrate potent antitumor activity (AACR 2025) - P1 | "The promising preclinical anti-tumor activity of IVX037 and IVX055 against a wide range of human malignancies warrants further clinical evaluation in combination with novel immunotherapy strategies. To this end, IVX037 is currently being investigated in an ongoing Phase 1b combination trial with sintilimab (anti-PD-1) in patients with advanced MSS-CRC, gastroesophageal, and ovarian cancer (NCT05427487). Future plans for IVX055 include evaluation in combination with immune checkpoint therapy in patients with advanced non-small cell lung cancer (NSCLC) bearing metastatic liver disease."

IO biomarker • Oncolytic virus • Bladder Cancer • Colorectal Cancer • Gastric Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSLN • PD-L1

Innovent Biologics' Partner ImmVirX Announces First Patient Dosed in Phase Ib Clinical Trial to Explore IVX037 in Combination with Sintilimab for the Treatment of Advanced Colorectal, Gastric, and Ovarian Cancers [Google translation] (bydrug.pharmcube.com) - "Innovent Biologics Inc...and its partner ImmVirX Pty Limited...announced that the first patient has been dosed in its Phase Ib clinical study CP-IVX001...The clinical study aims to evaluate the anti-tumor activity and tolerability of ImmVirX's oncolytic virus candidate IVX037 in combination with Innovent's anti-PD-1 therapy Tyvyt (sintilimab injection) in patients with advanced colorectal, ovarian and gastric cancer, which are the most common types of cancer worldwide. The study plans to enroll a total of 45 patients at eight clinical centers in Australia."

Trial status • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: ImmVirx Pty Ltd | N=40 ➔ 70 | Trial completion date: Sep 2024 ➔ Nov 2026 | Trial primary completion date: Sep 2024 ➔ Sep 2026

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSI

ImmVirX and Innovent Enter into Clinical Trial Collaboration to Investigate the Combination of IVX037 and Sintilimab in Difficult-to-treat Cancers (ImmVirX Press Release) - P1a | N=40 | NCT05427487 | Sponsor: ImmVirx Pty Ltd | "ImmVirX is conducting a first-in-human Phase 1 clinical trial (NCT05427487) in Australia of intratumoral IVX037. Initial results from Part 1a of IVX037 as a monotherapy indicate that multiple injections of IVX037 have been well tolerated with early signs of induction of potentially beneficial inflammatory cytokines/chemokines such as CXCL10 and with anti-tumour activity observed in some individual injected lesions."

P1 data • Oncology • Solid Tumor

ImmVirX and Innovent Enter into Clinical Trial Collaboration to Investigate the Combination of IVX037 and Sintilimab in Difficult-to-treat Cancers (ImmVirX Press Release) - "ImmVirX Pty Limited...is pleased to announce it has entered into a clinical trial collaboration and supply agreement with Innovent Biologics, Inc. ('Innovent')...to evaluate the combination therapy of ImmVirX’s investigational oncolytic virus IVX037 with Innovent’s TYVYT (sintilimab injection), the Chinese market-leading anti-PD-1 (programmed death receptor-1) inhibitor...ImmVirX is conducting a first-in-human Phase 1 clinical trial (NCT05427487) in Australia of intratumoral IVX037....Part 1b is planned to begin in mid-2024, to assess the anti-cancer activity and tolerability of intra-tumoural administration of IVX037 in combination with intravenous sintilimab injection in patients with advanced colorectal, ovarian and gastric cancer. Approximately 45 patients will be enrolled. Under the collaboration agreement, Innovent will provide clinical drug supplies of TYVYT (sintilimab injection) in this multi-center trial in Australia."

Licensing / partnership • Trial status • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

ImmVirX receives $3.77M R&D tax refund for FY23 (ImmVirX Press Release) - "ImmVirX Pty Limited...has received a $3,771,296 Research and Development (R&D) tax refund as part of the Australian Federal Government’s R&D Tax Incentive programme. This amount is based on the R&D undertaken by ImmVirX in the financial year ended 30 June 2023...The refund received by ImmVirX will contribute to the development of its investigational products IVX037 and IVX055 as well as other discovery programmes. IVX037 is progressing in the clinic with a Phase 1 study which is active across multiple clinical sites in Australia and will progress into an evaluation of IVX037 in combination with an immune checkpoint inhibitor therapy mid-CY24....'this funding will support the continued expansion of our research team in Newcastle and allow us to broaden and accelerate our clinical programme with the goal to eventually develop new therapies for patients with colorectal, gastric, ovarian and liver cancer.'"

Financing • Trial status • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Phase 1a open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 in patients with advanced microsatellite stable (MSS) colorectal, gastroesophageal or ovarian cancer (SITC 2023) - "1, with the first response assessment occurring at Day 50. Several biomarker effects of IVX037 administration in peripheral blood and tumor tissue addressing tumor infiltrating lymphocytes and cellular target expression levels for immune checkpoint therapies will be assessed."

Clinical • IO biomarker • Metastases • P1 data • Colorectal Cancer • Gastric Cancer • Oncology • Ovarian Cancer • Solid Tumor • CXCL10 • PD-L1

Trial enrolls first patient in colorectal, gastric, and ovarian cancer study (Mirage News) - "Newcastle biotechnology company ImmVirX Pty Limited has treated the first cancer patient in the clinical trial of its bio-selected oncolytic virus, IVX037....During the first-in-human, Phase 1a part of the study, IVX037 will be assessed in patients with late stage colorectal, gastric or ovarian cancer, three of the most prevalent cancer types globally."

Trial status • Colorectal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: ImmVirx Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSI

Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: ImmVirx Pty Ltd | Initiation date: Sep 2022 ➔ Feb 2023

Metastases • Trial initiation date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSI

Study of Intratumoral IVX037 in Patients With Advanced or Metastatic Solid Tumours (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: ImmVirx Pty Ltd

New P1 trial • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSI