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.
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.
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