Daily Newsletter

21 September 2023

Daily Newsletter

21 September 2023

Mendus shows early comparability data for its universal cancer vaccine

The immune response demonstrated by vididencel was similar for both acute myeloid leukaemia and ovarian cancer.

Phalguni Deswal September 21 2023

Mendus has announced that the immune response triggered by vididencel was comparable for patients with acute myeloid leukaemia (AML) and ovarian cancer.

The immune response validates the proposed mechanism of action for the vaccine and solidifies vididencel’s applicability across different cancers, as per the company. Two data sets will be presented at the International Cancer Immunotherapy Conference (CICON23) in Milan, Italy, on 22 September.

The first data set showed the clinical data whilst the second data set delved into the mechanism of action for the cancer vaccine, vididencel.

Vididencel is an allogeneic, off-the-shelf, intradermal cancer vaccine that expresses co-stimulatory molecules resembling activated dendritic cells and tumour-associated antigens. It is being evaluated as a maintenance therapy in AML and ovarian cancer.

Mendus’s chief medical officer Jeroen Rovers stated: “The data sets we present at CICON further validate our vididencel programme in two significant ways: First, we continue to elucidate the mechanism of action of vididencel, adding data on how antigen-specific T cell responses following vididencel administration are triggered via indirect priming mechanisms. This makes the product suitable as an off-the-shelf product, avoiding the complications associated with cell-based products which depend on the availability of patient material.”

“Secondly, our findings that comparable, robust immune responses against multiple tumour-associated antigens are observed in different tumour types point towards the potential to use vididencel as a backbone therapy for cancer patients in remission more broadly.”

The first data set compares the vididencel’s data from the AML patients who were in complete remission with measurable residual disease (MRD) that were part of the Phase II ADVANCE II study and ovarian cancer patients enrolled in the Phase I ALISON trial who were at a high risk of relapse after debulking surgery and chemotherapy.

Vaccine-induced responses were demonstrated in 17 (out of 20) and six (out of seven) participants with AML and ovarian cancer, respectively. The primary target for these responses was the tumour-associated antigens (TAAs) expressed by the vaccine.

Mendus noted that the number of observed VIRs correlated with clinical responses and survival benefits in the Phase II AML study, but no such correlation could be determined in the Phase I ovarian cancer trial.

Mendus is also planning to initiate a Phase II trial evaluating the combination therapy of vididencel and oral azacytidine as a maintenance therapy for AML. The trial will serve as a step up to the pivotal stage and begin in H2 2023.

The company has also partnered with NorthX and Swedish investment company Flerie Invest to set up a cell therapy manufacturing plant in Sweden.

Multiple Myeloma (MM) pipeline dominated by CAR-T cells

The success of CAR-Ts in MM has fueled R&D investment into this class of therapy, with more CAR-Ts in development than all other cell and gene therapy classes combined. The approval of the autologous CAR-T cell therapies Abecma and Carvykti sees the CAR-T pipeline mostly constituted of autologous drugs. However, there are also multiple allogeneic CAR-Ts in the pipeline, with these therapies having an “off-the-shelf” advantage over autologous therapies.

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