Imugene Ltd (ASX:IMU, OTC:IUGNF) has seen the first patient dosed as part of its intravenous (IV) cohort 2 of a trial evaluating the safety of its novel cancer-killing virus CF33-hNIS (VAXINIA).
The multicentre phase 1 metastatic advanced solid tumours (MAST) trial kicked off by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of the standard-of-care treatment.
Notably, the City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in the preclinical laboratory and animal models.
In other news, Imugene has also delivered positive data regarding overall survival results in its HER-Vaxx HERIZON study at the ESMO Asia Congress 2022 held in Singapore.
VAXINIA trials
Once patients in the monotherapy group have been treated with the lowest doses of VAXINIA and acceptable safety has been demonstrated, new study participants will receive combination treatment, CF33-hNIS with the immunotherapy pembrolizumab.
Overall, the study aims to recruit up to 100 patients across around 10 trial sites in the United States and Australia.
The trial is anticipated to run for about 24 months and is funded from existing budgets and resources.
Imugene MD and CEO Leslie Chong said: “As recently noted by Professor Yuman Fong in his visit to Australia, the Imugene team continues to progress development of these assets at an excellent pace, and this announcement is yet another example of that.”
Positive new HER-Vaxx HERIZON data
At the congress, principal investigator Marina Maglakelidze outlined the study design, information regarding demographics and characteristics of the 36 patients in the trial, and data covering safety and adverse events.
Key conclusions of the overall survival benefit of HER-Vaxx included:
- HER-Vaxx + chemotherapy showed a statistically significant 42% overall survival benefit compared to chemotherapy alone (13.9 vs 8.3 months).
- Duration of response is longer in the HER-Vaxx + chemotherapy arm over chemotherapy alone (30 vs 19 weeks).
- Vaccination with HER-Vaxx induced persistent HER-2 specific antibodies which correlated with clinical response as proof of concept for a first-in-class B-cell immunotherapy based on HER-2 peptides.
- No significant additive toxicity was seen when HER-Vaxx was administered in combination with chemotherapy.