- Imugene Limited (ASX:IMU) is presenting on its B-cell immunotherapy - PD1-Vaxx - at the ESMO Congress 2021 Annual Meeting in Paris.
- The recent presentation expands on the latest clinical trial update, which revealed that the Company had started dosing in its third monotherapy cohort of the Phase 1 trial.
- The Company is planning to expand the Phase 1 trial to combine PD1-Vaxx with SOC therapy in the same lung cancer patient population.
Imugene Limited (ASX:IMU) has recently announced that it is presenting on its cancer checkpoint immunotherapy program - PD1-Vaxx - at the ESMO Congress 2021 Annual Meeting in Paris. Imugene is a clinical stage immuno-oncology firm based in Australia, which is developing a range of novel immunotherapies that seek to activate the cancer patients’ immune system to treat & eradicate tumours.
PD1-Vaxx is one such B-cell immunotherapy that has been designed to treat tumours like lung cancer by interfering with PD-1/PD-L1 binding and interaction. Moreover, the immunotherapy has been formulated to produce an anti-cancer effect akin to Keytruda®, Opdivo® and other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.
Image Source: Company Website (Conference Presentations)
Details of presentation
Imugene’s latest presentation is titled as ‘IMPRINTER: AN OPEN LABEL, MULTI-CENTER, DOSE ESCALATION/EXPANSION, PHASE I STUDY OF IMU-201 (PD1-VAXX), A B-CELL IMMUNOTHERAPY, IN ADULTS WITH NON-SMALL CELL LUNG CANCER’.
The IMPRINTER study is an open-label dose escalation/dose expansion study of PD1-Vaxx as a monotherapy treatment for PD-L1 expressing lung cancer. The study aims to evaluate safety, tolerability, and immunogenicity and assess the optimum biological dose (OBD) of PD1-Vaxx to be used for further clinical development.
The recent presentation expands on the latest clinical trial update, which revealed that the Company had started dosing in its third and final monotherapy cohort of the Phase 1 trial. The clinical outcomes continue to indicate that PD1-Vaxx is exhibiting early signs of immune responses in cancer patients, with the development of antibodies to the drug target, PD-1.
Status of PD1-Vaxx’s Phase 1 trial
The Phase 1 trial has fully enrolled into the third dose cohort, with each cohort comprising three patients. The treatment comprises three primary injections (days, 1, 15 and 29), a day 64 vaccination and from there, a maintenance treatment every two months. No dose limiting toxicity, or any significant vaccination-related adverse event have been reported so far.
Overall, the treatment is well tolerated, and the study will therefore move into the expansion cohort enrolling ten patients into the optimal biological dose, to confirm safety response and the development of PD1-antibody in correlation to response.
Imugene is planning to expand the Phase 1 study to combine PD1-Vaxx immunotherapy with SOC (standard of care) therapy in the same lung cancer patient population. This may include either PD-L1 inhibitor or some other immunotherapy agent.
The inclusion criteria will enable patients who have either progressed on their prior therapy or did not have a response to their SOC therapy and are at high risk of progression to enter the trial. Moreover, PD1-Vaxx is currently being evaluated for other tumour indications beyond NSCLC (non-small cell lung cancer).
Imugene shares closed the trading session at AU$0.465, with a rise of 9.4 per cent on 17 September 2021.