A randomized, multicenter, pacebo-controlled clinical trial of Racotumomab-alum vaccine as switch maintenance therapy in advanced non-small cell lung cancer patients

Clin Cancer Res 2014; 20(14):1-12

Pivotal, multicenter, placebo-controlled clinical trial show the efficacy and safety of Racotumomab as switch maintenance therapy in patients with advanced NSCLC. 176 patients with stage IIIb/IV NSCLC who have at least stable disease after 1st line therapy, were randomized to receive Racotumomab (87) or placebo (89).The intent to treat median overall survival was 8.23 ​​months for the Racotumomab group versus 6.80 months for the control group (HR 0.63, p = 0.004). Median intent- to-treat progression free survival was 5.33 vs 3.90 months, (HR 0.73, p: 0.039). The product was well tolerated. The most common adverse events were burning and pain at the site of administration, bone pain and asthenia.

A high antibody response against NeuGcGM3 gangliosides was obtained. Patients who devoloped a high level of cytotoxicity had longer survival.

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Combination of platinum standard first front line chemotherapy and Vaxira vaccine in patients with advanced non-smal –cell lung cancer

Poster presentado en LALCA 2014

Clinical study in patients with advanced-stage NSCLC who receive Vaxira combined with the standard first-line chemotherapy (cisplatin/vinblastine).
The treatment had an acceptable safety profile and it was demostrated that chemotherapy didn´ t inhibit Vaxira mediated immune response.

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Safety and Efficacy of Racotumomab-Alum Vaccine as Second-Line Therapy for Advanced Non-Small Cell Lung Cancer

International Journal of Clinical Medicine, 2014, 5, 844-850

This article describes the results of an expanded access program in patients with advanced disease without other therapeutic option after the first line of treatment. The median overall survival was 8.96 months and the survival rates at 12 and 24 months were 42.8% months and 28%, respectively. Those who compleleted the induction phase reached a median OS of 12.1 months

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Glycans in immune recognition and response

Carbohydrate research 2014; 389:115-22)

In this paper the role of glycosylated gangliosides (NeuGc-GM3) is revalidated as a therapeutic target for cancer and racotumomab is mentioned as a target immunotherapy.

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Detection of N-glycolyated gangliosides in non-small-cell lung cancer using GMR8 monoclonal antibody

Cancer Science 2013; 104: 43-47

High expression levels of the glycolylated ganglioside NeuGcGM3 were found in NSCLC samples, which correlated with increased disease progression and reduced patient survival.

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Cancer antigen prioritization: a road map to work in defining vaccines against specific targets. A point of view

Frontiers of Oncology 2012, 2:66. doi: 10.3389

In this review article the NeuGcGM3 ganglioside is ranked among the top antigens to prioritize in the development of cancer vaccines. It highlights its high immunogenicity and therapeutic role.

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Active Specific Immunotherapy with Racotumomab in the Treatment of Advanced Non Small Cell Lung Cancer (NSCLC)

Poster presentado en ESMO meeting 2012.
Abstract: Journal of the European Society for Medical Oncology 2012; volume 23, suppl 9, N°1238

Double-blind, multicenter, randomized (1:1), placebo-controlled study conducted in 176 patients with NSCLC who had their diseases stabilized after chemotherapy. The superiority of Racotumomab versus placebo in overall survival is demonstrated. While the median survival time in the placebo group was 6.9 months, in the Racotumomab group was 10.9 months. The survival rate at two years was 8% in the placebo group, whereas in the Racotumomab group was 22%. The benefit in overall survival increased in those patients that were able to complete the induction phase (>5 doses). Racotumomab immunotherapy was safe and well tolerated.

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Immune response to Racotumomab in a child with relapsed neuroblastoma

Frontiers in Oncology. 2012; 2:195 doi: 10.3389/fonc.2012.00195 (Sampor y col.)

Report on the use of Racotumomab in a pediatric patient with a neuroblastoma refractory to prior cancer treatment. Immunization with of 0.15 mg doses of Racotumomab, was well tolerated and induced a humoral immune response.

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Racotumomab: an anti-idiotype vaccine related to N-glycolyl-containing gangliosides-preclinical and clinical data

Frontiers in Oncology 2012; 2(150):1-6

This review article analyzes the potential of NeuGcGM3 gangliosides as a target for immunotherapy. It briefly describes the process of generating Racotumomab, an anti-idiotypic antibody capable of generating anti-Racotumomab as well as anti-ganglioside responses. It also reviews preclinical research data in three animal species, and clinical data from several phase I studies in numerous indications as well as advance-stage clinical trials in NSCLC.

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Preclinical evaluation of racotumomab, an anti-idiotype monoclonal antibody to N-glycolyl containing gangliosides, with or without chemotherapy in a mouse model of non small cell lung cancer

Front.Oncol, Nov 2012;2:160

This study examines the antitumor activity of Racotumomab in laboratory animals, either alone or in combination with chemotherapy. It provides support for the combination of Racotumomab with chemotherapy (Pemetrexed), and highlights the clinical significance of NeuGc in lung cancer.

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Maintenance treatment with chemotherapy and immunotherapy in non-small cell lung cancer: a case report

Front.Oncol, October 2012;2:152

A case report of a patient with stage IV pulmonary adenocarcinoma (with pleural involvement) who showed partial response to treatment after first-line chemotherapy with carboplatin+paclitaxel+bevacizumab, later underwent maintenance therapy with pemetrexed+bevacizumab until the anti-angiogenic treatment was stopped and continued with pemetrexed and Racotumomab. Both treatments were well tolerated.

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Anti-NeuGcGM3 antibodies, actively elicited by idiotypic vaccination in non-small cell lung cancer patients, induce tumor cell death by an oncosis-like mechanism (Hernandez y col.)

The Journal of Immunology 2011, 186:3735-3744

In this work, the mechanism of cell death induced by Racotumomab immunization is described as oncotic necrosis. It is a very fast process and independent of the complement system. Antibodies induce the formation of large lesions in the cell membrane, causing leakage of the cytoplasm and loss of membrane integrity.

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NGcGM3 Ganglioside: A Privileged Target for Cancer Vaccines (Fernandez y col)

Clinical and Developmental Immunology, 2010, Article ID 814397

This article reviews the role of NeuGc gangliosides and their potential as targets for antitumor therapy. Description of the main results from preclinical and clinical studies with Racotumomab and NeuGcGM3/VSSP.

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Tissue micro array analysis of ganglioside N-glycolyl GM3 expression and signal transducer and activator of transcription (STAT)-3 activation in relation to dendritic cell infiltration and microvessel density in non-small cell lung cancer (van Cruijsen y col)

BMC Cancer 2009; 9:180-9

Glycolylated gangliosides (GM3) were expressed at high levels in 94% of the NSCLC samples tested, as well as the transcription factor STAT-3 (71% of the samples).
Dendritic cell suppression is linked to ganglioside expression rather than STAT 3.

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Characterization of the antibody response against NeuGcGM3 ganglioside elicited in NSCLC patients immunized with an anti-idiotype antibody. (Hernandez y col)

The Journal of Immunology 2008, 181:6625-6634

Racotumomab-immunized NSCLC patients (who had previously received a first line of chemotherapy) generate specific antibodies against tumor glycolylated gangliosides (NeuGcGM3). In vitro incubation of the hyperimmune sera from these patients with tumor cells that overexpresses NeuGcGM3 causes cell death by a mechanism independent of the complement system. The presence of antibodies against NeuGcGM3 in vaccinated patients is associated with longer survival rates.

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1E10 Anti-Idiotype Vaccine in Non-Small Cell Lung Cancer. Experience in Stage IIIb/IV Patients (Alfonso y col.)

Cancer Biology & Therapy 2007;12: 1847-1852

Advanced-stage (IIIb, IV) non-small cell lung cancer (NSCLC) patients who were immunized with Racotumomab showed a median survival time of 9.93 months (95% CI 8.61-11.25) calculated from time they started vaccination. The one-year survival rate of these patients was 34%, higher than those observed in a similar group of patients not treated with Racotumomab. There were no serious or unexpected adverse events.

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Cellular and Humoral Immune Response to N-Glycolyl-GM3 Elicited by Prolonged Immunotherapy with an Anti-Idiotypic Vaccine in High-Risk and Metastatic Breast Cancer Patients (Guthmann y col.)

J Immunotherapy 2006; 29:215-223

A phase I, dose-escalation study showing that administration of Racotumomab is safe and well tolerated. The immunization generated a humoral response against the tumor NeuGcGM3 gangliosides regardless of the dose level, as well as a strong and sustained cellular response (secretion of IFNγ).

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Antitumor properties of an anti-idiotypic monoclonal antibody in relation to N-Glycolyl-containing gangliosides. (Vazquez y col.)

Oncology reports 2000; 7:751-756

This work evaluates the antitumor effect of Racotumomab in laboratory animals. Intraperitoneal immunization of BALB/c mice with subcutaneous Racotumomab reduced growth of mammary carcinoma cells as well as the number of spontaneous lung metastases. I.v. immunization with Racotumomab in mice previously injected with tumor cells produced antibodies that activated an antitumor response and delayed the progression of both the tumors and metastases. It is possible that the anti-idiotype antibody Racotumomab activates more than one antitumor response mechanism.

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Vaxira® is a therapeutic vaccine for the treatment of non-small cell lung cancer. It is composed of Racotumomab and aluminum hydroxide adjuvant.

Racotumomab is an anti-idiotypic monoclonal antibody that induces a potent immune response against specific glycolylated ganglioside (NeuGcGM3) present in the tumor cells.

In controlled trials, Vaxira® increased the survival rate of recurrent or advanced-stage (IIIB/IV) non-small cell lung cancer (NSCLC) patients, compared to best supportive care.

Vaxira® is well tolerated and its safety profile is acceptable. Most common adverse events are localized (in the site of administration), mild and transient.

Even those patients who are immunized with Vaxira® after progression of their disease have shown improvement in overall survival.

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