One of the big milestones coming for Danish Evaxion Biotech in 2022 is the phase IIb trial initiation with cancer immunotherapy EVX-01. The company has now received clearance from the Australian regulatory body, and the study is expected to start in the second quarter this year. BioStock reached out to Niels Iversen Møller, Co-founder and CBO, to learn more.
The AI platform technology developed by Evaxion Biotech is designed to translate vast amounts of data about the human immune system to make the understanding of its biological processes easier. So far, the technology has been used to derive four drug candidates, where the main candidate EVX-01 is targeted towards the treatment of metastatic melanoma.
EVX-01 is a so-called patient-specific cancer neoepitope immunotherapy. All patients are different, and the treatment with EVX-01 is tailored to each specific patient using information on his or her unique DNA and biology. Combined with a PD1 checkpoint inhibitor in a previous phase I/IIa trial, the treatment has shown an antitumour effect with an objective response rate of 67 per cent in metastatic melanoma, where 22 per cent of the participants achieved a complete response.
Phase IIb trial set to start
The next step for Evaxion Biotech is to evaluate the candidate in a phase IIb-study, where it will be combined with Merck & Co’s blockbuster anti-PD-1 therapy Keytruda. The company previously announced a collaboration agreement with the Merck & Co-subsidiary MSD, which will supply Evaxion Biotech with Keytruda for the trial.
You can learn more about the agreement here.
Evaxion Biotech has now gotten the green light from the Australia Therapeutic Goods Administration to start the phase IIb-trial and the company expects initiation in the second quarter of 2022. The trial is to evaluate efficacy and safety of the EVX-01/Keytruda-combination in approximately 100 patients with unresectable or metastatic melanoma, where the primary endpoint will be overall response to the treatment.
BioStock reached out to Evaxion Biotech Co-founder and CBO Niels Iversen Møller to learn more.
Firstly, given the results you saw with EVX-01 in the phase I/II study, what are your expectations for phase IIb?
– The phase IIb clinical trial is designed to show a robust and meaningful clinical benefit for patients with metastatic melanoma who receive Keytruda as standard therapy. Based on the data on EVX-01 in the phase I/IIa, we expect to see more patients achieving reduction of their tumour and more patients achieving a stronger antitumor response, ideally a complete or partial response.
– There is still a very high medical need for the group of patients we are addressing in this clinical trial. We hope with the results from this study will show that more patients will live longer or even be cured from their metastatic melanoma. With the focus of the trial, EVX-01 is addressing a multi-billion USD market.
With the phase IIb trial set to start in Q2, when can we expect topline results?
– We expect to recruit patients fast, as we have some of the best and largest melanoma centers collaborating on the trial. Therefore, we expect to be able to report interim data in the second half of 2023 and to have a one-year follow-up in 2024.
The start of the trial is of course one of the major milestones for you in 2022. What other milestones can we expect from Evaxion Biotech this year?
– Yes, this regulatory clearance is important to Evaxion as the regulatory hurdle for entering phase IIb is associated with some risk. We are pleased that we have moved beyond this hurdle. In 2022 we will also file a regulatory filing for the phase IIb for EVX-02/03 and expect first patient in this study in the second half of the year. We are also looking forward to selecting our lead viral-vaccine target coming out of the RAVEN platform in the second half of 2022.
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