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One of the vaccines in RECOMBIO’s research program is based on a monoclonal antibody of very peculiar characteristics called Racotumomab (1E10). This Racotumomab (1E10) antibody reacts to the idiotype (the term idiotype refers to the recognition zone in antibodies) of another antibody known as P3. Now P3 is quite specific for the recognition of N-glycolyl ceramides of Mono-sialyl Lactose.
Due to this, Racotumomab (1E10) is classified as a so-called anti-idiotype antibody, since it recognizes another antibody’s idiotype, while resembling in its own idiotype the antigen itself. Use of anti-idiotype antibodies is a strategy that provides considerable quantities of immunogen by means of monoclonal antibody technology production. Several Phase I studies have been performed with Racotumomab (1E10), where good tolerance was demonstrated (Table 1). At present an ambitious plan with lung cancer is under way.
Table 1: Racotumomab (1E10) clinical trials
 Phase1. Dose escalating. Code IID RD-EC044
Title: “Active specific immunotherapy using Racotumomab (1E10) anti-idiotype Mab vaccine preparation for treatment of advanced breast cancer patients.”
Patient population: 15
Trial status: Completed.
Objectives: To evaluate humoral and cellular response; toxicity and clinical response.
Conclusions: The vaccine proved to be immunogenic and was well tolerated in both dose levels. |
Phase1: Code IIC RD-EC030
Title: “Active specific immunotherapy using anti-idiotype Mab vaccine preparations in patients with skin and ocular malignant melanoma.”
Patient population: 20
Trial status: Completed.
Objectives: Humoral and cellular response; toxicity.
Conclusions: The vaccine proved to be immunogenic and exhibited a good level of safety. |
Phase 1. Code IIC RD-EC043
Title: "Active specific immunotherapy using Racotumomab (1E10) anti-idiotype Mab/alumina vaccine preparation in SCLC patients."
Patient population: 9.
Trial status: Completed.
Objectives: Humoral response; toxicity.
Conclusions: The vaccine proved to be safe and exhibited a good level immunogenicity. |
Phase 1. ARG EC 001
Title: “Active specific immunotherapy using Racotumomab (1E10) anti-idiotype vaccine for the treatment of advanced breast cancer patients or patients at a high risk of relapse.
Patient population: 20.
Trial Status: Completed.
Objectives: Humoral and cellular response; toxicity.
Conclusions: The vaccine was well tolerated and proved to induce humoral and cellular response effectively. |
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