Immunicum announces the recruitment of the first patient in phase I
June 23, 2021
Immunicum Ad Registration of First patient in phase I ALISON Study Assess cancer Relapse DCP-001 vaccine candidate in ovarian cancer
– Ffirst study evaluating cancer relapse vaccine candidate DCP-001 among the sick with solid tumors –
Immunicum A B (pub) announced today this the first one patient has been registered in the Phase I ALISON clinical study the evaluation of DCP-001, the VSthe company’s main vaccine candidate against cancer relapse, in patients with high-grade serous ovarian cancer (HGSOC) following standard primary care treatment. ALISON study is made by Professeur Hans NOTijman and his research group in Groningen, tin the Netherlands, and survey DCP-001 capacity at trigger the immune system to control cancer cells that may have remained in the body after surgery and treatment with chemotherapy to prevent or shrink the tumor recidivism. It’s the first study using Immunicum Cancer relapse vaccine approach to target a solid tumor indication and will assess the safety, feasibility and immunogenicity of DCP-001.
“The start of the Phase I ALISON study with the first patient recruited marks an important step 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 an indication of solid tumor. , ” commented Jeroen Rovers, Medical Director of Immunicum. “Other immunotherapies such as checkpoint inhibitors have shown relatively weak responses in ovarian cancer. This study builds on our promising preclinical data showing a significant reduction in tumor growth after administration of DCP-001 and will further assess the immunogenicity of our cancer relapse vaccine candidate in patients with solid tumors for the first time. “
Hans W Nijman, MD, PhD, Principal Investigator at ALISON study and professor at the University of Medicine Center in Groningen, the Netherlands, added: “Tumors tend to develop ways that allow them to evade the body’s immune response against them, making tumors resistant to many therapies. Immunicum’s relapse vaccine candidate contains allogeneic dendritic cells that can stimulate various key elements of the immune system against several tumor antigens, potentially making it essential in the fight against tumor recurrence and clinical relapse in female patients. with ovarian cancer.
The ALISON Phase I Study is an open-label, single-center study evaluating the safety and efficacy of DCP-001 in patients with high-grade serous ovarian cancer (HGSOC). HGSOC is a unique type of epithelial cancer characterized by the loss of function of the tumor suppressor protein, p53, which can lead to resistance to chemotherapy and relapse of the disease. The vaccination schedule with DCP-001 will be scheduled after the standard treatment, which includes chemotherapy before or after reduction surgery, and will start 6 weeks after 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. Patients will be followed up for 24 months. The primary endpoint of the study is the change from baseline of DCP-001 vaccine antigen-specific T cells in peripheral blood after treatment. The main secondary endpoints include safety and tolerability after repeated administration of DCP-001 as well as recurrence-free survival (RFS) and overall survival (OS) during the follow-up period.
DCP-001 is a cell-based “off-the-shelf” cancer relapse vaccine candidate based on a proprietary cell line and manufacturing process developed by Immunicum to treat cancer patients with solid and hematogenous tumors. The cancer vaccine candidate contains endogenous tumor associated antigens that are highly immunogenic and can recruit and 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 stimulate 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 also currently being evaluated in an ongoing international phase II clinical trial in patients with acute myeloid leukemia (AML).
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ABOUT IMMUNICUM AB (PUBL)
Immunicum leverages its unparalleled expertise in dendritic cell biology to develop new, ready-to-use cell therapies for solid and hematogenous tumors. With complementary therapeutic approaches in phase II clinical development based on intratumoral vaccination and cancer relapse, the company aims to improve survival outcomes and quality of life for a large population of cancer patients. Based in Sweden and the Netherlands, Immunicum is listed on Nasdaq Stockholm. www.immunicum.com
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