23 June 2021
Immunicum Announces Enrollment of First Patient in Phase I ALISON Study Evaluating Cancer Relapse Vaccine Candidate DCP-001 in Ovarian Cancer
– First study evaluating cancer relapse vaccine candidate DCP-001 in patients with solid tumors –
Immunicum AB (publ) today announced that the first patient has been enrolled in the Phase I ALISON clinical study evaluating DCP-001, the Company’s lead cancer relapse vaccine candidate, in High-Grade Serous Ovarian Cancer (HGSOC) patients following primary standard of care treatment. The ALISON study is carried out by Professor Hans Nijman and his research group in Groningen, the Netherlands, and investigates the ability of DCP-001 to trigger the immune system to control cancer cells that may have remained in the body after surgery and treatment with chemotherapy in order to prevent or reduce tumor reccurence. This is the first study using Immunicum’s cancer relapse vaccine approach to target a solid tumor indication and will evaluate the safety, feasibility and immunogenicity of DCP-001.
“The start of the Phase I ALISON study with the first patient enrolled marks an important milestone in our clinical development strategy, as ovarian cancer is a completely new indication for Immunicum and the study is the first evaluation of DCP-001 in a solid tumor indication,” commented Jeroen Rovers, Chief Medical Officer at Immunicum. “Other immunotherapies such as checkpoint inhibitors have shown relatively low responses in ovarian cancer. This study builds on our promising preclinical data showing significant reduction in tumor growth following DCP-001 administration and will further evaluate the immunogenicity of our cancer relapse vaccine candidate in patients with solid tumors for the first time.”
Hans W Nijman, MD, PhD, Principal Investigator of the ALISON study and Professor at University Medical Center in Groningen, the Netherlands, added: “Tumors tend to develop ways that allow them to evade the body’s immune response against them, hence making the tumors resistant to many therapies. Immunicum’s relapse vaccine candidate contains allogeneic dendritic cells that can boost various key elements of the immune system against multiple tumor antigens, potentially making it a vital component in the fight against tumor recurrence and clinical relapse in ovarian cancer patients.”
The Phase I ALISON study is a single-center, open-label study evaluating safety and efficacy of DCP-001 in High-Grade Serous Ovarian Cancer (HGSOC) patients. HGSOC is a unique type of epithelial cancer that is characterized by the loss of function of the tumor suppressor protein, p53, which can lead to chemotherapy resistance and disease relapse. The vaccination regimen with DCP-001 will be scheduled after standard of care treatment, which includes chemotherapy either before or after debulking surgery, and will start 6 weeks following the last cycle of chemotherapy. Patients will receive 4 bi-weekly vaccinations with 25 million cells per DCP-001 vaccination and 2 additional booster vaccinations with 10 million cells per vaccination. Patient follow-ups will be conducted for 24 months. The primary endpoint of the study is change from baseline of DCP-001 vaccine antigen-specific T cells in peripheral blood after treatment. Key secondary endpoints include safety and tolerability after repeated DCP-001 dosing as well as recurrence free survival (RFS) and overall survival (OS) during the follow-up period.
DCP-001 is an “off-the-shelf”, cell-based, cancer relapse vaccine candidate that is based on a proprietary cell line and manufacturing process developed by Immunicum to treat cancer patients with solid and blood-borne tumors. The cancer vaccine candidate contains endogenous tumor-associated antigens that are highly immunogenic and can recruit as well as activate the patient’s own immune cells to prime specialized immune cells called T cells to target multiple tumor antigens and attack the tumor. DCP-001 has the potential to boost the immune system to control residual disease and prevent or reduce tumor recurrence. It has already shown an excellent safety profile in clinical studies and is currently also being evaluated in an ongoing international Phase II clinical trial in acute myeloid leukemia (AML) patients.
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ABOUT IMMUNICUM AB (PUBL)
Immunicum is leveraging its unparalleled expertise in dendritic cell biology to develop novel, off-the-shelf, cell-based therapies for solid and blood-borne tumors. With complementary therapeutic approaches in Phase II clinical development that are based on intratumoral priming and cancer relapse vaccination, the company aims to improve survival outcomes and quality of life for a broad population of cancer patients. Based in Sweden and the Netherlands, Immunicum is publicly traded on the Nasdaq Stockholm. www.immunicum.com