Another vaccine developing as a RECOMBIO project consists of a preparation combining NGcGM3’s potent immunosuppressive capacity with a wide range of molecule-stimulating signals from the outer membrane protein complex of Neisseria meningitides pathogenic bacteria. Our proprietary technology enables us to build a nanoparticle complex where the present active components retain their original structure (Fig. 2). This vaccine is called NGcGM3/VSSP (VSSP stands for very small sized proteoliposomes). Several Phase I and Phase II trials have been carried out with this vaccine and have demonstrated good tolerance and preliminary evidence of antitumoral effect (Table 2).

Table 2: Clinical trials with N-glycolyl GM3/VSSP

Phase I. 1 Pilot trial. Code IIC RD-EC027 Title: "N-glycolyl GM3 vaccine preparation for the treatment of breast cancer patients". Patient population: 21. Trial status: Completed. Objectives: Reactogenicity and immunogenicity. Conclusions: NGcGM3/OMP/Montanide ISA 51 vaccine was well tolerated in patients with advanced breast cancer and did not produce severe or very severe adverse events according to OMS criteria. Vaccine NGcGM3/OMP/Montanide ISA 51 induced a response against NGcGM3 in advanced breast cancer patients.

Phase I. Dose escalating. Code IIC-RD EC049 Title: “Active specific immunotherapy using NGcGM3/VSSP Montanide ISA 51 vaccine preparation for the treatment of advanced breast cancer patients. Patient population: 18. Trial status: Completed. Objectives: Evaluation of immunogenicity and toxicity. Conclusions: Vaccine proved to be immunogenic and safe at all dose levels.

Phase I: Dose escalating. Code IIC-RD EC047 Title: Phase I/II Clinical Trial with N-Glycolyl GM3/ VSSP/ Montanide ISA 51 vaccine preparation for the treatment of advanced melanoma patients. Patient population: 20. Trial status: Completed. Objectives: Humoral and cellular immunogenicity; toxicity; clinical antitumoral response. Rate of immune response to survival or progression; rate of clinical response to survival or progression. Conclusions: NGcGM3 vaccine proved immunogenic for disseminated melanoma patients at all dose levels studied. Cellular immunity stimulation was demonstrated. Vaccine demonstrated an adequate toxicity profile at doses under evaluation. Occurrence of vitiligo, evidence of stable-disease periods and survival in patients immunized with 0.2 mg all suggest that this is the optimal biological dose. Depigmentation phenomena and vitiligo were observed and interpreted as clinical evidences of antigen dispersion triggered by repeated immunization with 0,2mg of vaccine preparation.

Phase II. Code IIC-RD EC058 Title: “Active specific immunotherapy with NGc/GM3/VSSP/ Montanide ISA 51 vaccine preparation for the treatment of metastatic breast cancer. Phase II”. Patient population: 80. Trial status: Ongoing. Objectives: Evaluation of survival and time to progression; toxicity; immunogenicity and rate of survival/ progression to immune response. Conclusions: Evaluation of the first 34 patients shows a strong tendency towards longer survival in the vaccine group as compared to the control group. Immunization also determined a very marked increase in time to progression.

Phase I.  Dose escalating. Code IIC-RD EC066. Title: “Clinical Trial with NGcGM3/VSSP vaccine applied by subcutaneous route for the treatment of patients with metastatic cutaneous melanoma. Phase I/IIa.”  Patient population: 20. Trial status: Ongoing. Objectives: To define optimal vaccine dose (subcutaneous route, dose 150 to 900 μg) according to toxicity and to humoral /cellular immune response.

Phase I. Dose escalating. Code IIC-RD EC06. Title: “Clinical Trial using NGcGM3/VSSP vaccine by subcutaneous route for the treatment of advanced breast cancer patients.” Patient population: 35. Trial status: Ongoing. Objectives: To evaluate safety and immune response of increasing subcutaneous doses (150 to 1.500 μg).