- Imugene Limited (ASX:IMU) has released another set of robust quarterly results for the September 2020 quarter.
- The healthcare player received three local ethics approvals to initiate the Phase 1 clinical trial of PD1-Vaxx in Australia during the period.
- Western Institutional Review Board approved the initiation of PD1-Vaxx’s Phase 1 study in the US in September this year.
- The Company also obtained the clinical guidance from the US FDA on the development pathway for its lead oncolytic virotherapy, VAXinia.
- Rita Lauefle was also appointed as the Chief Medical Officer of Imugene during the September quarter.
- Imugene is actively proceeding with its four clinical programs associated with VAXinia, CHECKvacc, PD1-Vaxx and HER-Vaxx.
Post delivering a solid performance in the June 2020 quarter, Imugene Limited (ASX:IMU) has released another set of robust quarterly results for the September 2020 quarter. During the quarter, Imugene achieved several significant milestones with regards to its oncolytic virotherapy (CF33) and B-cell vaccine candidates.
The Company conducted significant expenditure of $4.2 million on research and development activities during the last quarter. Moreover, it held cash and cash equivalents worth $26.6 million as on 30 September 2020.
Let us quickly browse through the key developments reported by the immuno-oncology company over the quarter:
Three Ethics Approval for PD1-Vaxx
Imugene received three ethics approvals from the Human Research Ethics Committee (HREC) during the period to initiate the Phase 1 clinical trial of PD1-Vaxx in Australia. The three approvals were provided to:
The approvals validated that Imugene has completed all crucial pre-clinical efficacy and safety assessment of PD1-Vaxx required to start human clinical trials. The Company is progressing with PD1-Vaxx’s Phase 1 study, which is currently screening patients to join the clinic trial in Australia.
WIRB’s Approval for PD1-Vaxx
Imugene obtained the first Institutional Review Board approval for PD1-Vaxx in the US in September this year. New Jersey-based Hackensack University Medical Center received the Western Institutional Review Board’s (WIRB) approval to initiate Phase 1 clinical study of PD1-Vaxx in the US.
Following the receipt of the approval, Imugene informed that the US component of the Phase 1 study will be conducted under the FDA’s Investigational New Drug process. The Company intends to progress with the patient recruitment and site activation post attaining FDA IND clearance, planned for Q4 2020.
US FDA’s Clinical Guidance for VAXinia
During the last quarter, Imugene obtained the clinical guidance from the US FDA on the development pathway for its lead oncolytic virotherapy, VAXinia. The healthcare player received feedback on the development plan for VAXinia Phase 1 study design on the following aspects:
- the proposed patient population,
- Phase 2 study in combination with immune checkpoint inhibitors,
- strategy for reviewing drug exposure during the trial, and
- safety monitoring plan.
While the clinical guidance for VAXinia was received in August 2020, the guidance for CHECKvacc construct was obtained in early 2020. At present, both VAXinia and CHECKvacc constructs are progressing to enter into the clinic.
Addition of Deep Experience to Leadership team
Dr. Rita Lauefle was appointed as the Chief Medical Officer of Imugene during the September quarter. Dr Laeufle has been hired to lead the Company’s regulatory, global clinical development, and medical monitoring activities.
She is a board-certified scientist and a surgical oncologist, who holds extensive clinical development experience in immuno-oncology studies from Phase 1 to 3 in breast and gastrointestinal cancers and registration pathways.
In addition to these developments, Imugene secured an agreement with its existing institutional shareholders to raise $5.6 million during the quarter. The agreement was signed to underwrite the balance of the options not exercised before 30 November 2020.
Earlier this month, the Company also notified about the receipt of growth factor B-cell immunotherapy combination patent in the US - world’s largest pharmaceutical market.
Imugene is now actively proceeding with its four clinical programs associated with VAXinia, CHECKvacc, PD1-Vaxx and HER-Vaxx. For HER-Vaxx, the Company is preparing and validating all data to plan the second interim analysis, which will be reviewed by the Independent Data Monitoring Committee (IDMC) upon completion of the soft data lock.
Imugene (ASX:IMU) shares traded at $0.057, up 1.8% on 28 October 2020.