SCIENTIFIC DEVELOPMENT OF A PUBLIC-PRIVATE CONSORTIUM
Therapeutic Vaccine against Lung Cancer available to Patients
for the First Time

It activates the immune system to attack the tumor. Results were presented at the annual
meeting of the American Society of Clinical Oncology that was held in Chicago, United States,
May 31st to June 4th.
 Argentina is the world’s first country in which it will be available. It was also approved in Cuba
and it has been licensed for 25 countries in the American and Asian continents. Brazil, Mexico,
Uruguay and Turkey are closest to initiating the approval process and roll out.
 It is the greatest scientific breakthrough for this type of cancer treatment in the last 10 years to
become a drug readily available to patients.
BUENOS AIRES, ARGENTINA. Scientists and clinical researchers introduced a ground-breaking
therapeutic vaccine, racotumomab (Vaxira®), entailing a new option for non-small cell lung cancer, the
most frequent type of lung cancer. It is indicated for advanced stage lung cancer patients that have
undergone chemotherapy and radiotherapy treatment as well as those that have had no response to
the first line of treatment.
The new vaccine has tripled the number of patients with a two-year survival rate after treatment
initiation, according to a study presented at the ESMO (The European Society for Medical Oncology)
annual meeting held last year in Vienna, Austria. More results on racotumomab were submitted at the
annual ASCO (American Society of Clinical Oncology) meeting in Chicago, USA, from May 31st to June
4th. ESMO and ASCO are the two most relevant international oncology scientific meetings that gather
physicians, scientists and the pharmaceutical industry from all over the world. Studies presented at
these meetings have to be previously approved by a peer-review committee.
This innovative therapeutic vaccine induces an immune response against tumor cells. For this reason, it
received the support from two relevant scientists, independent from the project, who are renowned
experts on immunology. “Immunotherapy has nowadays an important place in oncology treatment.
The major advantage of this type of strategy is the specific targeting of tumor antigens, which implies
less toxicity and side effects compared to conventional therapies. Research on anti-idiotypic cancer
vaccines has greatly evolved over the past decades; they are capable of inducing an immune response
more robust since it is formed of humoral but also cellular component. These advantages allow
foreseeing a bright future for this type of vaccine strategy. The recent release of Vaxira (Racotumomab)
is a good example of this progress. I also believe that this development has wider applications that will
influence future treatment and therapeutic strategies that will enhance health and well-being,” stated
Dr. Christopher Branford-White, Ph.D., Director of the Health Institute at London Metropolitan
University, UK.
Also, Dr. Olivera Finn, Ph. D., Leader of the Cancer Immunology Program at the University of
Pittsburgh Cancer Institute, USA, said: “Cancer immunotherapy is not associated with the many
drawbacks of chemotherapy, radiotherapy and surgery, such as high toxicity, morbidity and short
duration. The field of cancer immunotherapy is progressing at an exciting pace giving us hope for the
advent of effective treatment modalities that will enhance the quality of life in patients with malignant
disease and prolong tumor free survival or lead to complete cures. Vaxira (Racotumomab), monoclonal
antibody that serves as an anti-cancer vaccine is a good example of the advance of immunotherapy for
cancer.”
On the other hand, biochemist Silvia Gold, director of the Research, Development and Innovation
Consortium that developed the drug, explained, “It is a ground-breaking vaccine because we are
dealing with a new therapeutic type of drug, which aims at a new target. Nowadays, it provides an
alternative treatment to lung cancer patients, and it holds the potential to be studied and applied to
other tumors that have this same target.”
This new therapeutic vaccine shall be available in Argentina as of July and it was also approved in Cuba.
In addition, it has been licensed in 25 countries in the American and Asian continents under the Vaxira®
trademark. In South America, Elea Laboratories shall have the exclusive rights to sell it in Argentina,
Eurofarma has the exclusive license in Brazil, and semi-exclusive rights for the rest of the continent. On
the Asian continent, Innogene Kalbiotech has the license to roll out the drug in Korea, Taiwan and
India, as well as in Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Singapore, Thailand and the
Philippines. In Europe and the rest of American and Asian countries, Recombio is the holder of the
license. Mexico, Brazil, Uruguay and Turkey are close to roll out. Racotumomab also enjoys patent
protection worldwide.
“The therapeutic vaccine has shown very significant results because, in controlled clinical trials, it
tripled the percentage of patients with a two-year survival rate after its administration. The objective
of the scientific and medical community is to change the paradigm of cancer treatment, for it to
become a chronic and controllable disease, by means of different types of targeted therapies, so that
patients can have a better quality of life. This is the first new treatment for this indication available to
oncologists in ten years,” added doctor Hugo Sigman, CEO of the Insud Group, Recombio partner and
founder of the public-private consortium that developed the drug.
Racotumomab is the result of 18 years of work by a public-private research consortium with the
participation of over 90 scientists from leading research and cancer treatment scientific institutions in
Argentina, such as the Roffo Institute, the University of Buenos Aires, the National Quilmes University,
Garrahan Hospital, and the National Council for Scientific and Technical Research together with the
Molecular Immunology Center (Havana, Cuba), the originator of this project. It also received the
support from the Ministry of Health and the Ministry of Science, Technology and Product Innovation of
Argentina.
“The new therapeutic vaccine is administered via an intradermal injection: the first five induction
doses are applied every 14 days, and then a maintenance booster shot is repeated every 28 days. The
drug has an innovative action mechanism that triggers a specific powerful immune response against
ganglioside antigens, such as NGcGM3, only present in tumor cells. This mechanism reduces adverse
effects. The identification of the therapeutic target and its action mechanism are a true scientific
breakthrough. It stops the formation of new blood vessels that nurture the tumor thus generating a
cellular death mechanism described as “oncotic necrosis”,” explains Dr. Daniel Alonso, scientific
director of the Research, Development and Innovation Consortium. “It is important to highlight that
this therapy is to be combined with existing ones in advanced stages of the disease, and not to be
considered a preventive vaccine,” he adds.
Lung cancer is the leading cause of cancer deaths worldwide, with almost 1.38 million deaths per year
according to the World Health Organization (WHO), and an 86% mortality rate amongst those affected
by the disease. The most common type of lung cancer, accounting for 70% of all cases, is non-small cell
lung cancer, for which this new therapeutic vaccine is indicated.
About Recombio - www.recombio.com
A research, development and product innovation company that focuses on immunotherapy for chronic diseases
such as cancer and infectious diseases. The company seeks to contribute to better health. It comprises
pharmaceutical companies and Cuban institutions and it´s the owner of racotumomab internationally to countries
in which is not licensed.
About the Research, Development and Innovation Consortium - www.consorcioinnovador.com.ar
The Public-Private Research and Development Consortium for new molecular base therapies for cancer is part of
a public-private research, development and innovation network. Its new cancer research areas include
antiangiogenic compounds, antisignaling agents and oncologic vaccines.
National Quilmes University - www.unq.edu.ar
The Oncology laboratory at NQU is specialized in the design of antitumor strategies, research and development of
antitumor products and molecular diagnosis systems. This university took part in the therapeutic target
identification stage and in pre-clinical trials.
Angel Roffo Oncology Institute - www.institutoroffo.com.ar
This institute reports to the University of Buenos Aires and is dedicated to research, diagnosis and treatment of
cancer. It took part in the characterization of the therapeutic target and clinical safety and efficacy studies.
Garrahan Hospital - www.garrahan.gov.ar
It is the leading pediatrics hospital and oncology center in Argentina, with half of all cancer cases in the country.
Its participation was focused on target characterization and identification as well as on safety and immune
response studies.
Conicet - www.conicet.gov.ar
The National Scientific and Technical Research Council is the main organization dedicated to the promotion of
science and technology in Argentina.
Researchers from the Immunogenetics Laboratory of the Buenos Aires University (UBA) Teaching Hospital took
part in the immune response study, preclinical trials and safety studies.
Molecular Immunology Center - www.cim.co.cu
The Molecular Immunology Center is a Cuban biotechnology institution dedicated to research, development and
production of mammal cell culture-based products.
This institution participated in the compound research and development as well as clinical trials.
Insud Group - www.grupoinsud.com
Insud is a family holding of locally-owned Argentine companies. Its main and traditional activity is focused on life
sciences.
Its participation in this endeavor was through its Innovation and Technology Development Division, in the area of
technology coordination of the project.
Highlighted scientific publications
-
A multicenter, sequential, placebo-controlled, randomized, double-blind efficacy clinical study
called “Active Specific Immunotherapy with Racotumomab for Vaccine Development for the
Treatment of Advanced Nonsmall Cell Lung Cancer (NSCLC) Patients”. ESMO, Vienna, 2012.
Presented at the annual meeting hosted by The European Society for Medical Oncology (ESMO,
Vienna, 2012). Published in the Journal of the European Society for Medical Oncology; volume
23, issue supple 9, N°1238 (2012).
-
Anti-NeuGcGM3 Antibodies, Actively Elicited by Idiotypic Vaccination in Nonsmall Cell Lung
Cancer Patients, Induce Tumor Cell Death by an Oncosis-Like Mechanism; The Journal of
Immunology, 2011.
-
Racotumomab: an antiidiotype vaccine related to N-glycolyl-containing gangliosides-preclinical
and clinical data, Frontiers in Oncology, 2012.
-
Anti-idiotype antibodies in cancer treatment: the pharmaceutical industry perspective,
Frontiers in Oncology, 2012.
Studies to be presented at ASCO (Chicago, United States, 2013)
-Prospective, randomized, multicenter, open-label study on active specific immunotherapy with
racotumomab vaccine with the best support treatment, vis-à-vis the best support treatment in
advanced non small cell lung cancer patients.
-Active immunotherapy study in patients with progressive disease after first line of treatment: the
racotumomab experience.
Press contact information
Lucas Guagnini lguagnini@grupoinsud.com
Communications Manager – Insud Group
(5411) 4872 1264
Lorena Sueiro lsueiro@grupoinsud.com
Press and Communications – Insud Group
(5411) 4872 1154