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Evaxion receives phase IIb go-ahead from FDA


Evaxion receives phase IIb go-ahead from FDA

16 January, 2023

Evaxion Biotech started 2022 with a green light from the Australian authorities to conduct a phase IIb study with lead drug candidate EVX-01 in metastatic melanoma. 2023 for the Danish immunotherapy company begins with the FDA-approval to expand the phase IIb study to the US. BioStock contacted CEO Per Norlén to learn more about what this means for the project.

Copenhagen-based Evaxion Biotech has developed an AI platform designed to translate vast amounts of data about the human immune system and exploit them to develop personalised cancer immunotherapies. The company’s lead candidate EVX-01, discovered through the PIONEER AI platform, is a so-called patient-specific cancer neoepitope immunotherapy for the treatment of metastatic melanoma.

The company has so far demonstrated promising results with the drug candidate in a phase I/IIa study. Now, in combination with Merck’s blockbuster PD1 checkpoint inhibitor Keytruda, EVX-01 is being evaluated in a phase IIb trial. The study will be conducted at clinics in the US, Europe and in Australia, and the aim is to include up to 80 patients with unresectable or metastatic melanoma, with the primary endpoint being the overall response to the treatment. The company hopes to be able to present interim results from the study towards the end of this year. Read more.

Evaxion Biotech gets FDA nod

Evaxion Biotech received the green light for conducting the trial from the Australia Therapeutic Goods Administration and the first patient was recruited in September 2022. In November, an Investigational New Drug application was sent to the US Food and Drug Administration (FDA), together with a Fast Track designation application. Now, starting off the new year, the company has announced receiving approval from the FDA to initiate the study in the US.

With regards to the Fast Track designation, the company anticipates getting a reply from the authorities in the first half of 2023.

Comments from the CEO

BioStock contacted Evaxion Biotech CEO Per Norlén to learn more.

Per Norlén, CEO Evaxion
Per Norlén, CEO Evaxion

First and foremost, what is your reaction to the positive response from the FDA regarding the phase IIb study with EVX-01?

– It was expected, but even so, it is a boost for our personalised cancer vaccine program, and it serves as a strong validation of our product candidate and of the clinical trial. The FDA approval will allow us to move forward more quickly with EVX-01 in malignant melanoma and is, of course, increasing our exposure to potential US partners.

You started recruitment in Australia in September. How many patients have been recruited so far?

– Enrolment is going very well, and our Australian sites have delivered beyond what we hoped for. And with approvals in Europe and the US, we expect recruitment to accelerate further. We are confident that we will be able to meet all milestones in this program and will present interim trial data in H2 of 2023.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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