The US Food and Drug Administration (FDA) has granted fast track designation to Mendus’s cancer vaccine vividencel for the treatment of acute myeloid leukaemia (AML).

The FDA’s decision was based on results from the Phase II ADVANCE II trial (NCT03697707), which investigated the vaccine’s use as a maintenance monotherapy in patients with AML in complete remission.

Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews.

In June, the Swedish company, which was previously known as Immunicum, presented comprehensive immunomonitoring data at the European Hematology Association’s 2023 hybrid congress.

According to Mendus, the vaccine led to increased levels of activated, cancer-killing T cells and reduced levels of immune-suppressive T cells in the majority of the patients in the Phase II ADVANCE II study.

Prior to this, the company published data on the drug’s effects on measurable residual disease response, which was observed in seven patients out of a total of 20. Five subjects converted to negative measurable residual disease while two showed a measurable residual disease decrease, based on a November 2022 Blood article

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The company expects to present a further survival update from the trial in Q4 2023, based on the 8 September announcement.

Vividencel is an intradermal vaccine derived from Mendus’s DCOne leukaemic cell line. During vividencel production, cells out of this line are shifted to a mature dendritic cell phenotype, which creates more immunogenic cells with multiple tumour antigens, based on the company’s website. Vividencel already has orphan drug status in AML both in the EU and the US. The company has co-established cell therapy manufacturing capabilities for the candidate with NorthX Biologics.  

Mendus is also planning to start a Phase II trial that will combine vividencel with Bristol Myers Squibb’s Onureg (azacytidine) in H2 2023. In September 2020, the FDA approved Onureg for use as a maintenance therapy in adult patients with AML in complete remission with incomplete blood count recovery following intensive induction chemotherapy and who cannot complete intensive curative therapy.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

This content was updated on 25 January 2024