Imugene Ltd (ASX:IMU, OTC:IUGNF) has cleared the first cohort of patients of the intratumoral (IT) arm of its VAXINIA metastatic advanced solid tumours (MAST) trial and is now recruiting for cohort 2 of the study’s IT and intravenous/IV arms.
The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard-of-care treatment.
The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.
The combination study to evaluate the safety of novel cancer-killing virus CF33-hNIS, sees VAXINIA administered in combination with Pembrolizumab.
Having cleared cohort 1 of the IT arm of the study, Imugene is now recruiting for cohort 2 of each of the arms (IT and intravenous/IV) in the combination study. This comes in addition to cohort 4 of each of the arms of the monotherapy dose escalation.
The trial commenced in May 2022 and is anticipated to run for around 24 months while being funded from existing budgets and resources. Overall, the study aims to recruit up to 100 patients across about 10 trial sites in the United States and Australia.
Imugene managing director and CEO Leslie Chong said: “We've now seen a very significant number of patients dosed with VAXINIA as part of the MAST study, with those patients suffering as a result of a variety of tumour types. It's exciting that we're getting so close to finding out the impact that this treatment is having for these patients in need.”
New chief medical officer appointed
Imugene has also appointed Dr Paul Woodard as chief medical officer.
Woodard brings an extensive haematology and oncology background gained in academia and industry and has worked on a wide range of drug development projects in solid tumours, haematologic malignancies and non-malignant haematologic disorders.
Most recently, Woodard served as the senior vice president and chief medical officer at Immune-Onc Therapeutics where he played a pivotal part in clinical oversight, notably directing the submission of four novel investigational new drug applications and initiating Phase 1 clinical trials. He also brings experience from Exelixis, Amgen (NASDAQ:AMGN), Genentech and Bellicum.
"Dr Woodard's extensive expertise in clinical development will be a major asset to Imugene and we eagerly anticipate the leadership and insights he will bring to our clinical programs", said Chong.