Racotumomab
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Racotumomab (trade name Vaxira) is a therapeutic cancer vaccine for the treatment of solid tumors that is currently under clinical development by Recombio, an international public-private consortium with the participation of the Center of Molecular Immunology at
Havana Havana (; Spanish: ''La Habana'' ) is the capital and largest city of Cuba. The heart of the La Habana Province, Havana is the country's main port and commercial center.
,
Cuba Cuba ( , ), officially the Republic of Cuba ( es, República de Cuba, links=no ), is an island country comprising the island of Cuba, as well as Isla de la Juventud and several minor archipelagos. Cuba is located where the northern Caribbea ...
(CIM) and researchers from
Buenos Aires University The University of Buenos Aires ( es, Universidad de Buenos Aires, UBA) is a public research university in Buenos Aires, Argentina. Established in 1821, it is the premier institution of higher learning in the country and one of the most prestigi ...
and
National University of Quilmes The National University of Quilmes ( es, Universidad Nacional de Quilmes, UNQui) is an Argentine national university and the most important one in the Quilmes area. The National University of Quilmes was founded on October 23, 1989. Located in Be ...
in
Argentina Argentina (), officially the Argentine Republic ( es, link=no, República Argentina), is a country in the southern half of South America. Argentina covers an area of , making it the second-largest country in South America after Brazil, th ...
. It induces the patient's immune system to generate a response against a cancer-specific molecular target with the purpose of blocking tumor growth, slowing disease progression and ultimately increasing patient survival. Racotumomab triggers an immune response against the tumor antigen N-glycolyl (NGc) GM3 (NGcGM3), a type of
ganglioside A ganglioside is a molecule composed of a glycosphingolipid (ceramide and oligosaccharide) with one or more sialic acids (e.g. ''N''-acetylneuraminic acid, NANA) linked on the sugar chain. NeuNAc, an acetylated derivative of the carbohydrate si ...
present on the cell surface of malignant cells from lung and breast, melanoma, as well as neuroectodermal pediatric tumors. Racotumomab has successfully completed a proof-of concept clinical trial in advanced non-small cell
lung cancer Lung cancer, also known as lung carcinoma (since about 98–99% of all lung cancers are carcinomas), is a malignant lung tumor characterized by uncontrolled cell growth in tissues of the lung. Lung carcinomas derive from transformed, malign ...
(NSCLC) and is currently being tested in a large, multinational study for the same indication.


Mechanism of action

Gangliosides are concentrated on the surface of mammalian cells and play an important role in cell growth and differentiation. NGc gangliosides, however, are practically undetectable in healthy human tissues and fluids due to a genetic deletion in the human gene that encodes the enzyme responsible for the synthesis of NGc, the CMP-N-acetyl hydroxylase. Nonetheless, the NGcGM3 ganglioside is highly expressed in several human cancers, including lung, breast, melanocytes, colon and neuroectodermal pediatric tumors, making this neoantigen an attractive target for cancer therapy. Racotumomab is an anti-idiotypic mouse
monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ...
that mimics NGc gangliosides, thus triggering an immune response against the tumor antigen NGcGM3. Therefore, rather than being a passive antibody therapy, Racotumomab acts as a therapeutic vaccine. In melanoma, breast, and lung cancer patients, Racotumomab was able to elicit a specific immune response that recognized and directly killed tumor cells expressing the neoantigen by a mechanism of oncotic necrosis. The specific expression of NGcGM3 in malignant cells reduces the potential risk of an immune cross-reactivity that could cause serious adverse effects.


Treatment administration and side effects

Racotumomab is administered in patients who have previously received the oncospecific treatment established in the oncological therapeutic standards (surgery, chemotherapy and radiation therapy). A Racotumomab- alum solution is administered by intradermal injection every 14 days for the first 2 months (5 doses), followed by monthly booster doses. Racotumomab is well tolerated by patients. The overall toxicity of the vaccine has been classified as grade 1 and 2, according to the NCI
Common Toxicity Criteria The Common Terminology Criteria for Adverse Events (CTCAE), formerly called the Common Toxicity Criteria (CTC or NCI-CTC), are a set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. The CTCAE sys ...
(version 3.0). Treatment is mostly associated with mild to moderate injection-site reactions (local erythema, induration and pain), which disappear within 24–48 hours. Systemic reactions, such as flu-like symptoms and chills are less frequent, reversible, and self-limited.


Approvals and indications

Racotumomab has been approved in two countries, Argentina and Cuba, for the treatment of recurrent or advanced NSCLC, or NSCLC independent of the disease stage when no other standard therapy can be administered.


Clinical trials

A randomized, multicenter, phase III study of active specific immunotherapy with Racotumomab plus best support treatment, versus best support treatment in patients with advanced NSCLC who have achieved an objective response (partial or complete) or stable disease with standard first-line treatment is underway in Argentina, Brazil, Cuba, Indonesia, Philippines, Singapore, Thailand and Uruguay. 1,082 patients with NSCLC in stages IIIA (non-resectable), IIIB or IV will be evaluated in the study. The study is sponsored by Recombio in collaboration with Elea Laboratories (Argentina), CIM (Cuba), Europharma Laboratories (Brazil), Innogene Kalbiotech (Singapore) and several public research institutions.


References

{{monoclonals for tumors Monoclonal antibodies