Delving into the Latest Updates on Racotumomab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

1E10 anti-idiotype vaccine therapy, Anti-idiotype antibody 1E10, Vaxira

+ [2]

Target

GM3

Action

inhibitors, stimulants

Mechanism

GM3 inhibitors(G(M3) Ganglioside inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Immunostimulants

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Non-Small Cell Lung Cancer

Inactive Indication

Advanced Lung Non-Small Cell CarcinomaBreast CancerColorectal Cancer+ [2]

Originator Organization

Center For Molecular Immunology

Active Organization

Elea SpA

Center For Molecular Immunology

Inactive Organization

Recombio SLLaboratorio Elea Phoenix SA

License Organization-

Drug Highest PhaseApproved

First Approval Date

Cuba (23 Jun 2013),

Non-Small Cell Lung Cancer

Regulation-

Login to view timeline

Structure/Sequence

Sequence Code 9931020H

Source: *****

Sequence Code 9931003L

Source: *****

The Covid-19 pandemic has brought about rapid change in medical science. The production of new generation vaccines for this disease has surprised even their most optimistic supporters. Not only have these vaccines proven to be effective, but the importance of this disease and pandemic situation also significantly shortened the long-standing process of validating such products. Vaccination is a type of immunotherapy. Researchers have long been looking at vaccines as a possible treatment for cancer (Geynisman et al., 2014). In the same way that vaccines work against infectious diseases, attempts are being made to develop vaccines to identify specific proteins on cancer cells. This helps the immune system recognize and attack cancer cells. Cancer vaccines may help: I) Prevent the growth of cancer cells (Bialkowski et al., 2016), II) Prevent recurrence of cancer (Stanton and Disis, 2015), III) Destroy cancer cells left over from other treatments. The following types of cancer vaccines are being studied: Antigen Vaccines. These vaccines are made from specific proteins or antigens of cancerous cells. Their purpose is to stimulate the immune system to attack cancer cells (Tagliamonte et al., 2014). Whole-Cell Vaccines. A whole-cell vaccine uses the entire cancer cell, not just a specific molecule (antigen), to generate the vaccine. (Keenan and Jaffee, 2012).Dendritic Cell Vaccines. Dendritic cells help the immune system identify abnormal cells, such as cancerous cells. Dendritic cells are grown with cancer cells in the laboratory to produce the vaccine. The vaccine then stimulates the immune system to attack cancer. (Wang et al., 2014; Mastelic-Gavillet et al., 2019). DNA Vaccines. These vaccines are made from DNA fragments of cancer cells. They can be injected into the body to facilitate immune system cells can better respond and kill cancer cells (Gatti-Mays et al., 2017).Other Types of Cancer Vaccines. such as Anti idiotype vaccines. This vaccine stimulates the body to generate antibodies against cancerous cells. An example of an anti-idiotype antibody is Racotumomab or Vaxira (Cancer, 2016). However, conditions and considerations after Corona does not seem to be the same as before. The current pandemic situation has also led to major changes in the pharmaceutical and Vaccine production process and international protocols. Some of the most critical issues that can accelerate the introduction of cancer vaccines are: 1. Typical drug and vaccine development timeline. A typical vaccine needs 5 to 10 years and sometimes longer to design secure funding, and get approval (Figure 1). Less than 10 percent of new drugs, which are entered in the different phases of clinical trials, are advanced to approval by the Food and Drug Administration (FDA)(Cancer, 2020a). However, now the situation is not normal. Dozens of Covid 19 vaccines are starting clinical trials. Some of them use RNA and DNA technology, which delivers the body with missions to produce its antibodies against the virus. There are already at least 254 therapies and 95 vaccines related to Covid-19 being explored. However, it seems that the experiences gained in this pandemic, and advances in technology, may be effective in shortening the production path of other vaccines and drugs and the process of its approval at the national and international levels in the future. In Figure 2, the time course of production of conventional vaccines in comparison with Covid 19 vaccines (Cancer, 2020b) is shown.2. The introduction of messenger RNA (mRNA) technology into the field of prevention and treatment. Over the past decades, this technology has been considered an excellent alternative to conventional vaccination methods. Proper potency and low side effects, the possibility of fast production and relatively low production cost are its advantages. However, until recently, the instability of this molecule has been a major problem in its application. This research was started many years ago by two companies that played a significant role in developing the first Covid vaccines, so BioNTech and Moderna were able to quickly transfer their experience in the field of Covid vaccine development (Pardi et al., 2018; Moderna, 2020). Figure 3 shows how mRNA vaccines work. Bout Pfizer – BioNTech and Moderna mRNA vaccines were more than 90 % effective in preclinical stages. Millions of doses of these two vaccines are currently being injected into eligible individuals worldwide. 3. Considering the use of artificial intelligence in assessing the effectiveness of vaccines. There are always doubts about the effectiveness of the new drug in treating the disease. Once the vaccine is widely available, we will know more about its effectiveness versus it works under carefully controlled scientific testing conditions. Vaccines will continue to be monitored after use. The data collected helps professionals understand how they work in different groups of people (depending on factors such as age, ethnicity, and people with different health conditions) and also the length of protection provided by the vaccine. Artificial intelligence (AI) is an emerging field, which reaches everywhere and not only as a beneficial industrial tool but also as a practical tool in medical science and plays a crucial role in developing the computation vision, risk assessment, diagnostic, prognostic, etc. models in the field of medicine (Amisha et al., 2019). According to the wide range of AI applications in the analysis of different types of data, it can be used in vaccine production, safety assessments, clinical and preclinical studies and Covid 19 vaccines adverse reactions (CDC, 2019). Indeed, most cancer vaccines are therapeutic, rather than prophylactic, and seek to stimulate cell-mediated responses, such as those from CTLs, capable of clearing or reducing tumor burden. There are currently FDA-approved products for helping cancer treatment such as BREYANZI, TECARTUS and YESCARTA for lymphoma, IMLYGIC for melanoma, KYMRIAH for acute lymphoblastic leukemia, and PROVENGE for prostate cancer. Over the past decade, most of BioNTech's activities have been in the field of cancer vaccine design and production for melanoma (two clinical trials), breast cancer (one clinical trial), and the rest concerning viral and veterinary vaccines (two clinical trials). Also Maderno company has been working on Individualized cancer vaccines (one clinical trials), and vaccines for viral infections such as Zika and Influenza and veterinary vaccines (several clinical trials) (Pardi et al., 2018). Therefore, it can be said, mRNA technology that has been the subject of much research into the treatment of cancer has been shifted and rapidly used to produce and use the Covid 19 vaccine. The current pandemic situation has necessitated the acceleration of Covid 19 vaccines and drugs and national and international protocols for their approval. If the currently produced vaccines can continue to be as successful as the preclinical and early phase studies, these changes and evolution have raised hopes for accelerating the use of these technologies and mechanisms in the field of cancer and other diseases vaccines, including HIV and influenza.

29 Jun 2020·Journal of OncologyQ4 · MEDICINE

Prognostic Significance of Tumor Tissue NeuGcGM3 Ganglioside Expression in Patients Receiving Racotumomab Immunotherapy

Q4 · MEDICINE

ArticleOA

Author: Baloglu, Huseyin ; Teomete, Mehmet ; Molinas Mandel, Nil ; Ozkan, Metin ; Berk, Barkın ; Dogan, Ender ; Ayla, Sule ; Aydıncer, Cenk ; Yazar, Aziz ; Uskent, Necdet ; Yergok, Hale

Expression of N-glycolyl GM3 (NeuGcGM3) ganglioside was detected in the tumor specimens of patients who were on Racotumomab anti-idiotype vaccine maintenance treatment, and prognostic significance as a biomarker was investigated. No statistically significant association was observed in the multivariate analysis between overall survival and tissue NeuGcGM3 IHC levels. Although numerically there was a difference favoring less intense IHC for better prognosis, this did not reach statistical power. However, there was a strong correlation between Racotumomab doses and overall survival (OS). Mean OS of the patient with more than 10 Racotumomab application was significantly longer than the patient who had less than 10 injections (70.7 months vs. 31.1 months, p<0.001). We propose that, regardless of staining intensity, the presence of NeuGcGM3 in patient tissues might be an indicator of benefit in Racotumomab treatment.

01 Oct 2019·Applied Microbiology and BiotechnologyQ3 · ENGINEERING & TECHNOLOGY

Identification of three linear B cell epitopes against non-structural protein 3ABC of FMDV using monoclonal antibodies

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Chang, Yanyan ; Chang, Huiyun ; Liu, Wei ; Chen, Danian ; Zhang, Yongguang ; Shao, Junjun

Foot-and-mouth disease virus (FMDV) has led to serious losses in the farming industry worldwide, particularly in cattle and swine. In developing countries, the control and eradication of FMD rely upon vaccination, in which the inactivated vaccine is predominant. In the preparation of inactivated vaccine, a series of purification methods were used to remove non-structural proteins (NSPs). It is necessary to develop a quantitative detection method of residual NSP and confirm a threshold value for the evaluation of the vaccine. Meanwhile, it is also important to develop a sensitive and rapid diagnostic method to distinguish infected animals from vaccinated animals (DIVA). In this study, three monoclonal antibodies (MAbs) against NSP 3ABC, designated 2G5, 9E2, and 1E10, were used. Subsequently, a series of overlapping peptides were expressed using a prokaryotic expression system to determine the minimal epitopes identified by the MAbs. Three linear B cell epitopes (BCEs), "⁹²EYIEKA⁹⁷" "²³EGPYAGPLE³¹" and "²⁰⁹EPHH²¹²", were identified by MAbs 2G5, 9E2, and 1E10, respectively. Alanine-scanning mutagenesis analysis confirmed the critical amino acid in these epitopes. The epitope "⁹²EYIEKA⁹⁷" is located in 3A, which is deleted in some natural deletion mutants that result in a change in virus tropism. MAb 9E2 that identified the epitope "²³EGPYAGPLE³¹" reacted with 3B1 and 3B2, but did not react with 3B3. In combination with sequence alignment analysis, the epitope "²³EGPYAGPLE³¹" is highly conserved among different FMDV isolates. Preliminary screening using the known positive and negative sera indicated the MAb 9E2 has the potential for the development of a diagnostic method for DIVA. The residual NSP in inactivated vaccines can be detected using 9E2-HRP, which indicated the MAb 9E2 is able to evaluate inactivated vaccines. The four-amino acid epitope is the first reported to date that is recognized by 1E10. These results provide valuable insight into the diagnosis of DIVA and the NSP residual evaluation in inactivated vaccines.

100 Deals associated with Racotumomab

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	Racotumomab	L01XC	DB13045

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Cuba	Center For Molecular Immunology	23 Jun 2013

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Indonesia	Laboratorio Elea Phoenix SA	01 Sep 2010
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Philippines	Recombio SL	01 Sep 2010
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Thailand	Laboratorio Elea Phoenix SA	01 Sep 2010
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Singapore	Recombio SL	01 Sep 2010
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Brazil	Laboratorio Elea Phoenix SA	01 Sep 2010
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Argentina	Laboratorio Elea Phoenix SA	01 Sep 2010
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Singapore	Laboratorio Elea Phoenix SA	01 Sep 2010
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Argentina	Recombio SL	01 Sep 2010
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Cuba	Recombio SL	01 Sep 2010
Advanced Lung Non-Small Cell Carcinoma	Preclinical	Philippines	Laboratorio Elea Phoenix SA	01 Sep 2010

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


RPCEC0000017 (ESMO2018)	Phase 3	Advanced Lung Non-Small Cell Carcinoma Second line \| Maintenance	743	Racotumomab-alum	(gjyyktwovz) = rzaumjuvpq rogionjzsv (ffnetldssw, 3.7 - 5.9)	Negative	20 Oct 2018
				Nimotuzumab	(gjyyktwovz) = liuqhtdgdk rogionjzsv (ffnetldssw, 4.0 - 5.3)
WCLC2017	Not Applicable	Advanced Lung Non-Small Cell Carcinoma Adjuvant	12	Racotumomab	(lutayfsgxl) = oapwtdzjsj qgalhwspny (eihnjdaifg, 8 - 21)	-	16 Oct 2017
ASCO2013	Not Applicable	-	180	Racotumomab	hhjstsfmjz(uopotmfryr) = xyemiajwjg xulpkhmxrl (csdwlzqnvx ) View more	Positive	20 May 2013
				Racotumomab (Control group)	hhjstsfmjz(uopotmfryr) = hletayytsw xulpkhmxrl (csdwlzqnvx ) View more

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.

login

or

view full example data

Understand key drug designations in just a few clicks with Synapse.

Racotumomab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation