VAXinia (CF33-hNIS) / Imugene - LARVOL DELTA

hNIS-based imaging to monitor treatment with the novel oncolytic virus CF33-hNIS-antiPDL1 in humans with advanced triple negative breast cancer. (PubMed, Front Oncol) - P1 | "This technology holds promise for noninvasive tracking of systemically administered OVs and other therapies. https://www.clinicaltrials.gov/study/NCT05081492, identifier NCT05081492."

IO biomarker • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

MAST: A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Imugene Limited | Trial completion date: Jan 2025 ➔ Nov 2026 | Trial primary completion date: Dec 2024 ➔ Jun 2026

Monotherapy • Trial completion date • Trial primary completion date • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Imugene Limited | N=33 ➔ 50

Enrollment change • Oncology • Solid Tumor

Imugene granted India patent for oncolytic virotherapy CF33 (Imugene Press Release) - "Imugene Limited...is pleased to announce the grant of a patent in India for its exclusively licensed CF33 oncolytic virotherapy technology. Under patent number 558994, the term of this patent is 20 years from the filing date of 9 August 2017, adding to the patent protection in the United States (granted on September 10, 2024, Pat. No. 12,084,687) and Japan (Patent Application No. 2023-200433), both within the same oncolytic patent family....This newly granted patent reinforces Imugene’s commitment to protecting its CF33 oncolytic virotherapy, a chimeric vaccinia poxvirus developed by Professor Yuman Fong, Chair of Surgical Oncology at City of Hope and a leading expert in oncolytic virus research....Patent provides method of composition and method of use protection until 2037."

Patent • Oncology

Imugene receives substantial capital injection; extends cash runway to end of 2025 in support of ongoing trials (Proactiveinvestors) - "Imugene Ltd...is positioned to raise up to A$46 million via the issue of convertible notes and warrants to CVI Investments, Inc. to support its clinical pipeline...Funds are to be put toward ongoing trials for IMU’s azer-cel, onCARlytics and VAXINIA programs, as the company anticipates key clinical data readouts in the coming 12 months....The issuance involves A$20 million of senior, unsecured, zero-coupon, convertible notes and up to a further A$26 million through the issue of unlisted warrants."

Clinical data • Financing • Hematological Malignancies • Solid Tumor

Imugene VAXINIA achieves complete response in patient two years after bile tract cancer treatment (Proactiveinvestors) - P1 | N=100 | MAST (NCT05346484) | Sponsor: Imugene Limited | "Imugene Ltd...has marked a major breakthrough with its CF33 MAST VAXINIA study, as a patient from the Phase 1 MAST trial has surpassed more than two years in remission, retaining a complete response. The Bile Tract Cancer Expansion part of the trial has also cleared its first cohort after the first three patients were evaluated for safety and received no dose-limiting toxicities (DLTs). The expansion portion of the trial is now open for full enrolment of up to 10 patients."

P1 data • Trial status • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma

A Study of OnCARlytics (CF33-CD19) in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Imugene Limited | N=52 ➔ 33 | Trial completion date: Sep 2025 ➔ May 2029 | Trial primary completion date: Sep 2024 ➔ Jun 2027

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Imugene secures FDA orphan drug designation for bile tract cancer treatment (Proactiveinvestors) - "Imugene Ltd...has been granted Orphan Drug Designation (ODD) by the United States Food and Drug Administration (FDA) for its novel oncolytic virotherapy, CF33-hNIS (VAXINIA), aimed at treating cholangiocarcinoma, a rare and aggressive bile duct cancer....Imugene's ODD application was backed by preclinical and clinical data from its ongoing Phase 1 MAST (Metastatic Advanced Solid Tumours) trial, which is evaluating the safety and effectiveness of VAXINIA."

Orphan drug • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Imugene progresses clinical trials supported by strong cash runway (Proactiveinvestors) - "Imugene Ltd...is in a strong cash position with A$93 million as of June 30, 2024, excluding an expected R&D tax rebate of ~A$11 million, to continue progressing four Phase 1/1b/2 clinical trials which are recruiting in the US, Australia and the UK...This financial position provides a runway to support the company's clinical pipeline and operations into late 2025...Azer-cel continues to enrol in Phase 1b study...Once the Phase 1b study is complete there is potential to start a registrational Phase 2/3 study in 2025 and become the first approved allogeneic CAR T cell therapy for cancer...VAXINIA bile tract cancer trial opened; MAST trial higher dose cohort open for enrolment."

Enrollment status • New P2/3 trial • Biliary Tract Cancer • Diffuse Large B Cell Lymphoma • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Imugene doses first patient for VAXINIA bile tract cancer trial in Melbourne (Proactiveinvestors) - "Imugene Ltd...has dosed the first patient in its trial for bile tract cancer (cholangiocarcinoma) patients. The MAST (metastatic advanced solid tumours) Phase 1 trial has been expanded since early responses were observed in gastrointestinal cancers – particularly cholangiocarcinoma – using Imugene’s cancer-killing virus CF33, known as VAXINIA. The first patient in the trial was treated at St Vincent’s Hospital, Melbourne, Australia, with a total of 10 patients expected to be enrolled....The fifth cohort of both arms of the Phase 1 MAST monotherapy dose escalation trial has now cleared, with the sixth high-dose cohort of each arm now open."

Trial status • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Combination therapy with the oncolytic virus CF33-CD19 and blinatumomab for the treatment of advanced solid tumors. (ASCO 2024) - P1 | "doi: 10.1126/scitranslmed.aaz1863. PMID: 32878978."

Combination therapy • IO biomarker • Metastases • Oncolytic virus • Oncology • Solid Tumor • CD19

Imugene's oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx featured at the AACR Annual Meeting 2024 (GlobeNewswire) - P1 | N=100 | MAST (NCT05346484) | Sponsor: Imugene Limited | "Imugene Limited...is pleased to announce poster presentations featuring its CF33 oncolytic virotherapy VAXINIA...at the American Association for Cancer Research (AACR) Annual Meeting....At the data cut-off of 19 December 2023, there were 31 efficacy-evaluable patients in the MAST study. In the intratumoural (IT) cohorts, 7 of 16 (44%) injected lesions had a reduction in tumour burden and 3 lesions were completely eradicated. Three of the IT treated patients had an objective response: 1 complete response by iRECIST in a patient with cholangiocarcinoma and 2 partial responses by RECIST in patients with melanoma. In the intravenous (IV) cohorts, 9 of 17 (53%) patients achieved stable disease as their best response."

P1 data • Cholangiocarcinoma • Melanoma • Solid Tumor

Oncolytic virus CF33-hNIS for the treatment of advanced cancer (AACR 2024) - P1 | "CF33-hNIS alone or in combination with pembrolizumab is a safe treatment option for advanced cancer patients. Encouraging efficacy has warranted advancement to part 2 of this study with a cohort expansion of patients with cholangiocarcinoma and other tumor types."

Metastases • Oncolytic virus • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor

Bile Tract Cancer expansion study opens following clearance of Imugene’s MAST trial high dose cohort (Imugene Press Release) - "Imugene Limited...is pleased to announce that enrolment has opened for its expansion study in bile tract cancer (cholangiocarcinoma) patients, having completed the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its cancer-killing virus CF33-hNIS (VAXINIA)....The expansion of the MAST (Metastatic Advanced Solid Tumours) Phase 1 trial is planned for 10 patients with bile tract cancers, after early positive responses were observed in gastrointestinal cancers, particularly in cholangiocarcinoma."

Trial status • Biliary Tract Cancer • Cholangiocarcinoma

Imugene granted China patent for Oncolytic Virotherapy CF33 (Investing.com) - "Imugene Ltd...has gained access to the largest pharmaceutical market in Asia with the grant of a patent for its Oncolytic Virotherapy CF33 from the Chinese Patent Office, following earlier grants in Japan and South Korea...The patent...protects the method of composition and method of use of Imugene’s licensed oncolytic virotherapy to 2037, including VAXINIA (CF33-hNIS) and CHECKvacc (CF33-hNIS-antiPDL1)."

Patent • Oncology • Solid Tumor

Imugene has VAXINIA technology selected for presentation at Cholangiocarcinoma Foundation conference (Investing.com) - "The CF33-hNIS (VAXINIA) technology of Imugene Ltd...Imugene Ltd (ASX:IMU, OTC:IUGNF)) will feature at the 2024 Cholangiocarcinoma Foundation Annual Conference, having been selected for a short oral presentation during the Basic Science Research Seminar Abstract Session on Thursday, April 18. The abstract...concludes that CF33-hNIS monotherapy may be an effective and safe treatment option for gastrointestinal (GI) malignancies, including cholangiocarcinoma or cancer of the bile ducts, a rare disease with an unmet medical need."

Clinical • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Imugene Highlights Recent Achievements and Looks Ahead to Key Upcoming Immuno-oncology Catalysts (GlobeNewswire) - "Imugene Limited...highlighted recent progress across the company's immuno-oncology portfolio and provided an update on anticipated upcoming milestones...The Phase 1 MAST trial assesses the safety and efficacy of CF33 administered alone, or in combination with pembrolizumab and either dosed intravenously (IV) or intratumourally (IT); As of January 2024, 34 heavily pre-treated patients had been dosed with VAXINIA...Expansion of cholangiocarcinoma and other indications are planned for 2024."

Trial status • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Oncolytic virus CF33-hNIS monotherapy for the treatment of gastrointestinal (GI) malignancies. (ASCO-GI 2024) - P1 | "CF33-hNIS can replicate within cholangiocarcinoma lesions, as shown by SPECT imaging, and drive immunological changes known to promote antitumor immunity. CF33-hNIS monotherapy may be an effective and safe treatment option for GI malignancies, including cholangiocarcinoma, a rare disease with an unmet medical need. Treatment with CF33-hNIS monotherapy was well tolerated and the study has advanced to examine combination therapy with pembrolizumab."

Monotherapy • Oncolytic virus • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Pancreatic Cancer

Imugene plans Phase 1 VAXINIA MAST trial expansion to target bile duct cancer (Proactiveinvestors) - "Imugene Ltd...plans to expand its Phase 1 metastatic advanced solid tumours (MAST) trial to target bile duct tumours, further advancing the evaluation of its novel cancer-killing virus CF33-hNIS (VAXINIA) following initial successes and a recent FDA Fast Track designation....The Phase 1 trial has continued to progress going into 2024, with the first of 38 patients enrolled to date dosed for both the higher dose monotherapy and combination arms."

Trial status • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Imugene's CF33-hNIS (VAXINIA) & MAST Study Featured at ASCO GI Cancers Symposium (ACCESSWIRE) - P1 | N=100 | MAST (NCT05346484) | Sponsor: Imugene Limited | "Imugene Limited...is pleased to announce further details from its poster presentation at the ASCO Gastrointestinal Cancers Symposium (ASCO-GI)....Conclusions of the poster presentation included: Preliminary data from the first three dose levels demonstrates encouraging anti- tumor activity with CF33-hNIS monotherapy, including one patient with cholangiocarcinoma, treated intratumorally, who achieved an immunological complete response (CR) with no known recurrence after one year. CF33-hNIS monotherapy may be an effective and safe treatment option for GI (gastrointestinal) malignancies and warrants further investigation in biliary tract cancer patients. Immunological changes in CF33-hNIS responding patients show a robust innate and adaptive immune response known to promote anti-tumor immunity and underscores the immunomodulatory potential of this therapy."

P1 data • Cholangiocarcinoma

MAST: A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Imugene Limited

Combination therapy • Metastases • Monotherapy • Oncolytic virus • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Imugene thrilled as VAXINIA granted FDA Fast Track designation (Proactiveinvestors) - "Imugene Ltd...speak with Proactive following the news it’s been granted 'Fast Track' designation from the US Food and Drug Administration (FDA) for its MAST (metastatic advanced solid tumours) clinical program — evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA)."

Fast track designation • Oncology • Solid Tumor

Imugene’s positive initial VAXINIA MAST trial data prompts analyst optimism; 46 cents target (Proactiveinvestors) - P1 | N=100 | MAST (NCT05346484) | Sponsor: Imugene Limited | "Roth MKM has released a research report of Imugene Ltd...following the company’s initial results from its Phase 1 MAST trial evaluating VAXINIA which showed encouraging initial results, particularly in gastrointestinal tumour patients....'Of the 26 evaluable patients, the best responses were one complete response (CR), one partial response (PR) (melanoma patient taking mid-dose VAXINIA), 16 stable disease (SD), and eight progressive disease (PD) as measured by iRECIST and RECIST criteria'. 'Particularly encouraging initial results were seen in gastrointestinal tumour patients (colorectal, bile duct, pancreatic and liver cancer), where six of eight (75%; all six given VAXINIA monotherapy) such patients (seven monotherapy and one combination therapy) had disease control'."

P1 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Melanoma • Oncology • Pancreatic Cancer • Skin Cancer • Solid Tumor

A phase I safety and tolerability study of VAXinia (CF33-hNIS), a novel chimeric oncolytic poxvirus, administered intratumorally or intravenously in adults with metastatic or advanced solid tumors (SITC 2023) - P1 | "4 This study will evaluate the safety and recommended Phase 2 dose (RP2D) of intratumoral (IT) and intravenous (IV) CF33-hNIS alone or in combination with pembrolizumab in advanced or metastatic solid tumors, after progression following ≥2 prior lines of therapy. The study began enrolling patients in March 2022; IV monotherapy cohorts 1–3, IT monotherapy cohorts 1–2, and IV combination cohort 1 have been completed without DLTs. IV monotherapy cohort 4, IT monotherapy cohort 3, IV combination cohort 2, and IT combination cohort 1 are currently enrolling in the US."

Clinical • IO biomarker • Metastases • Oncolytic virus • P1 data • Breast Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

Imugene advances Phase 1 MAST trial for cancer-killing VAXINIA virus (Proactiveinvestors) - "Imugene Ltd...has made progress in its Phase 1 metastatic advanced solid tumours or MAST trial, which has been designed to evaluate the safety and efficacy of the cancer-killing virus CF33-hNIS (VAXINIA)...The trial, which focuses on patients with metastatic or advanced solid tumours, has now successfully cleared cohort 4 of the intravenous (IV) arm of the monotherapy dose escalation study. Cohort 5 is now open for enrolment....Alongside this, IV cohort 2 of the combination study, where VAXINIA is administered alongside the blockbuster checkpoint inhibitor drug pembrolizumab (KEYTRUDA^®), has now been wrapped up and cohort 3 of this combination study is now open."

Enrollment status • Oncology • Solid Tumor