- Imugene Limited (ASX:IMU) continued with the development of its deep product pipeline in 1H FY21.
- The Company made considerable progress in the Phase 2 trial of HER-Vaxx and Phase 1 trial of PD1-Vaxx during the period.
- The Company closed 1H FY21 with a strong cash balance of over ~A$30 million.
Imugene Limited (ASX:IMU) enjoyed an eventful first half of FY 2021, advancing the development of its B-Cell vaccines and oncolytic virotherapy CF33. The Company experienced substantial growth and transformation in its deep product pipeline during the half-year, particularly with regard to its two immunotherapies - PD1-Vaxx and HER-Vaxx.
In 1H FY21, Imugene embarked on the Phase 1 trial of PD1-Vaxx after receiving all the necessary approvals to kick-off the trial in Australia and the USA. Besides, the Company shared encouraging interim data from its ongoing Phase 2 trial of HER-Vaxx during the period.
Let us quickly browse through the vital developments that defined 1H FY21 for the immuno-oncology company:
HER-Vaxx Phase 2 Trial
Imugene is actively progressing with the Phase 2 trial of HER-Vaxx for the treatment of HER-2 positive gastric cancer. During the half-year period, the Company’s management continued to collect data from the ongoing HER-Vaxx Phase 2 clinical trial.
The interim analysis safety and efficacy data from HER-Vaxx Phase 2 trial were investigated at the Independent Data Monitoring Committee (IDMC) meeting in November 2020.
The interim analysis returned impressive results, demonstrating that twice as many patients survived on the HER-Vaxx & SOC chemotherapy treatment arm in comparison to the SOC chemotherapy control arm. This transformed into an overall survival Hazard Ratio (HR) of 0.418 with a statistically significant one-sided p-value of 0.083. Interestingly, there was no difference in safety events between the two treatment arms, indicating that HER-Vaxx does not add toxicity to SOC chemotherapy.
Given the solid signal observed in the data, the IDMC provided guidance that it is scientifically as well as ethically appropriate to decrease the total number of patients needed to finalise the study. Following the IDMC guidance, Imugene reduced the total number of patients under the Phase 2 trial from 68 to 36.
Post the reporting period, Imugene informed that it has completed the recruitment of all patients under the progressing HER-Vaxx Phase 2 clinical trial.
PD1-Vaxx Phase 1 Trial
Imugene is also undertaking Phase 1, multi-centre, first-in-human, dose-escalation study of PD1-Vaxx, which is recruiting patients with non-small cell lung cancer.
In 1H FY21, three sites in Australia obtained Human Research Ethics Committee (HREC) approvals to commence the Phase 1 clinical trial of PD-1 Vaxx. Besides, the first Institutional Review Board approval was received in New Jersey, USA in September last year. Subsequently, in November 2020, PD1-Vaxx received US FDA Investigational New Drug (IND) approval to commence the Phase 1 clinical study.
In December 2020, Imugene dosed its first patient under Phase 1 trial in Australia, completing enrolment in the low dose cohort of patients in January this year. Also, the Company received positive feedback from clinicians running the study, who reported no toxicity, tolerability, or safety issues with the checkpoint immunotherapy candidate during the first low dose cohort of patients.
Interesting Read: Imugene Limited (ASX:IMU) Progressing with PD1-Vaxx Phase I Trial
Recently, the Cohort Review Committee made the determination to dose escalate to the next highest dose in cohort 2 under the Phase 1 clinical trial.
CF33 Clinical Development
During the period, Imugene’s management continued to work towards the clinical development of CF33, which has been developed in two constructs - CHECKvacc (CF33+hNIS+antiPD-L1) & VAXinia (CF33+hNIS).
The Company intends to conduct a first in human Phase 1, open-label, non-randomised, dose-escalating, multi-centre study of ‘VAXinia’ CF33+hNIS as a monotherapy and along with immune checkpoint inhibitors (potentially aPD-1 and aPD-L1). Moreover, the Company is planning to undertake a first in human Phase I, open-label, non-randomised, dose-escalation, single centre study of ‘CHECKvacc’ in patients with metastatic TNBC tumours.
In August last year, Imugene received guidance from the US FDA on the development pathway for VAXinia. The FDA guidance for CHECKvacc was already received in early 2020. Both CF33 oncolytic virotherapies, CHECKvacc and VAXinia, continue their progress to enter into the clinic.
In addition to these developments, Imugene appointed Dr. Rita Lauefle as the Chief Medical Officer to the Company’s team and obtained a core US patent for its cancer growth factor immunotherapy platform in 1H FY21.
Due to a significant increase in clinical trial and research activities, Imugene’s net loss increased to A$6.06 million by the end of the half-year. Meanwhile, the Company’s net assets also rose to A$63 million, comprising cash reserves of ~A$33 million.
Imugene appears to be in a decent capital position with a substantial cash balance of over A$30 million (as on 31 December 2020). The Company’s strong cash reserves, along with the robust leadership team, place it in good stead to deliver on its commercial and clinical milestones in the future.
Imugene shares traded at A$0.10 on 3 March 2021.