Acute myeloid leukaemia has one of the highest rates of recurrence after initial remission, and treatment options are limited. Immuno-oncology company Immunicum is addressing the issue by developing a cancer relapse vaccine, DCP-001. The company will present positive preclinical data at the CIMT meeting suggesting that DCP-001 works in synergy with conventional acute myeloid leukemia treatments to amplify the therapeutic effects. In parallel, the company is also on schedule to present novel clinical data on DCP-001 as a monotherapy later this quarter.

Acute myeloid leukemia (AML) is one of the most common forms of leukaemia in adults. The disease mainly affects the bone marrow and leads to a severely inhibited blood formation. Today, AML patients are often treated with intensive chemotherapy treatments associated with serious side effects where the bone marrow is weakened. Patients today need repeated blood transfusions and are at high risk of suffering from septic fever.

Even after achieving complete remission with initial chemotherapy, the risk of recurrence is high. Between 40 and 50 per cent of younger patients relapse into disease, and the risk is even higher among older patients. After relapse, the five-year survival rate is estimated at about 30 per cent overall, with rates dropping to about 10 per cent for patients older than 65.

Immunicum tackles tumour recurrence

With a focus on developing cancer immunotherapies, Immunicum is tackling the issue of tumour recurrence. Lead candidate DCP-001 is a cell-based cancer vaccine comprising a wide range of tumour-associated antigens combined with a mature dendritic cell profile aimed at stimulating the immune system.

Currently, the DCP-001 is being evaluated in phase II with AML patients who are in complete remission but have persistent measurable residual disease (MRD), thus being at high risk for tumour recurrence. As the trial progresses, Immunicum continues to study the candidate’s mechanism of action (MoA) and its role in presenting antigens to the killer T-cells of the immune system. 

Preclinical progress

At the end of 2021, preclinical MoA data was published in the peer-reviewed journal Cells. Read more. This week, the company announced that it will present a poster relating data on DCP-001 at the 20th Cancer Immunotherapy (CIMT) Annual Meeting, being held from May 10-12, 2022. The poster presentation will reflect in vivo and in vitro results showing that DCP-001 enhances effect of conventional AML treatments, 5’-azacitidine (5-AZA), a hypomethylating agent, and venetoclax (VEN), a BCL2 inhibitor, in a preclinical setting. These data support the evaluation of DCP-001 as a potential combination therapy with 5-AZA+VEN in AML and related hematological malignancies

Immunicum’s CSO Alex Karlsson-Parra commented:

»The preclinical data that will be presented at the upcoming CIMT meeting provides a promising snapshot of the therapeutic potential of combining relapse vaccination using DCP-001 with a highly active treatment regimen especially for elderly AML patients. The use of DCP-001 in this setting could broaden the positioning of DCP-001 beyond the AML maintenance setting with a focus on supporting patients reaching complete response. We expect to further build upon this preclinical data with updated clinical data from the ADVANCE II study in the near term, which evaluates DCP-001 as monotherapy in the AML maintenance setting. Together, these data sets will add to the growing body of data to further validate this program and its potential for the treatment of AML.«

AML Maintenance Therapy

The AML maintenance market is divided in roughly half of the patients undergoing high-dose chemotherapy treatment and another half being unfit for high-dose chemotherapy.

About half of the patients in the high-dose chemo patient population are eligible for a potential life-saving hematopoietic stem cell transplantation. In Immunicum’s ongoing phase II study, ADVANCE II, the company’s goal is to develop DCP-001 as a potential novel maintenance treatment for the other half of patients who are not able to undergo such a procedure and for whom the treatment options are limited to recently introduced maintenance therapy with oral AZA. 

Meanwhile, for patients who cannot undergo high-dose chemotherapy, the AZA and VEN combination has been become standard of care. The preclinical data that will be presented by Immunicum at CIMT shows that DCP-001 has strong potential as a combination therapy with these drugs.

Bright future ahead

To top things off, Immunicum is also on schedule to present novel clinical data on DCP-001 as a monotherapy later this quarter. Overall, the company has strong forward momentum with its lead candidate as both preclinical and clinical results continue to come in. Furthermore, Immunicum estimates the annual revenue potential in the broader AML maintenance market, where DCP-001 will be positioned, to be around 1 billion EUR.