- Imugene Limited (ASX:IMU) has released its quarterly activities and cashflow report for the March 2021 quarter.
- The Company continued to progress with the development of its B-cell immunotherapies – HER-Vaxx and PD1-Vaxx – during the quarter.
- Imugene closed the quarter with a robust cash balance of AUD 29.4 million.
Continuing its practice of delivering strong quarterly performance, Imugene Limited (ASX:IMU) has released another set of solid results for the quarter ended March 2021. During the quarter, the immuno-oncology player achieved several significant milestones while forging ahead with its HER-Vaxx and PD1-Vaxx clinical trials.
The quarter also saw Imugene’s addition to the ‘All Ordinaries Index’, which represents the 500 largest companies by market capitalisation in the Australian equities market.
The Company conducted a substantial expenditure of AUD 3.9 million on the research and development activities during the quarter and held AUD 29.4 million cash balance as of 31 March 2021. The robust cash balance places the Company in a strong position to support its near-term clinical milestones.
Here are the key HER-Vaxx and PD1-Vaxx developments reported by the Company over the March quarter:
Having received the approval from the Cohort Review Committee (CRC), Imugene advanced to the second dose cohort in the Phase 1 clinical study of PD1-Vaxx during the quarter. At mid-dose (50µg) level, PD1-Vaxx was deemed safe with no serious adverse reactions and no dose-limiting toxicities observed.
Subsequently in April 2021, Imugene progressed its Phase 1 clinical trial of PD1-Vaxx to the next step and proceeded to third and final highest dose (100µg) cohort. This was done after clinicians reported no toxicity, safety, or tolerability issues with PD1-Vaxx during the mid-dose cohort 2 of patients at the CRC meeting held on 4 April 2021.
Currently, the Company’s Phase 1 trial is enrolling the patients in the final highest dose cohort following CRC’s approval. Interestingly, Mayo Clinic in Arizona, USA, has also received approval from the Institutional Review Board (IRB) to conduct Phase 1 human trial of PD1-Vaxx.
Generally, the Phase 1 trials are designed to seek tolerability, safety, and early response signals to ascertain the optimal dose for further development. Imugene is encouraged to see positive signals at such an early stage of its Phase 1 trial of PD-1 Vaxx, even in the late-stage patients.
During the quarter, Imugene completed the recruitment of patients under the Phase 2 trial of HER-Vaxx following the Independent Data Monitoring Committee’s review of interim analysis efficacy and safety data. The committee observed no safety concerns and deemed Phase 2 interim analysis data as strongly in favour of Imugene’s HER-Vaxx survival effect.
Subsequently, the Company achieved a significant clinical milestone for HER-Vaxx in April 2021, meeting the second clinical endpoint for Phase 2 trial, i.e., Progression Free Survival (PFS).
After the end of the March quarter, Imugene’s Chief Medical Officer Dr Rita Laeufle also delivered a presentation on the HER-Vaxx cancer immunotherapy program at the 2021 Annual Meeting of American Association for Cancer Research (AACR). She expanded on interim analysis data, which was previously presented on HER-Vaxx in 2020.
Besides Dr Laeufle, City of Hope’s Dr Yanghee Woo also delivered a presentation on Imugene’s lead oncolytic virus, CF33, at the AACR Annual Meeting. She shared important pre-clinical data on CF33 oncolytic virus program, which demonstrated strong preclinical activity against many solid tumours.
Looking forward, Imugene expects to read out the final tumour response, correlation of antibodies with tumour response, and final Progression Free Survival and Overall Survival data in 2021.
As at 11:58 AM AEST, Imugene shares are trading at AUD 0.190.