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10 antibody drugs that will receive regulatory approval in the US and Europe by 2020 (II)

Narsoplimab
Narsoplimab is a fully human IgG4 monoclonal antibody that targets mannose-binding lectin-associated serine protease 2 (MASP-2) and was developed to treat thrombotic microangiopathy (HSCT-TMA) related to hematopoietic stem cell transplantation. MASP-2 is an effector enzyme of the lectin pathway of the complement system. The lectin pathway is activated primarily by tissue damage or microbial infection. Importantly, unlike other complement-targeted drugs on the market or under development, the inhibitory effect of narsoplimab on MASP-2 does not interfere with the classical complement pathway, which is a key component of the immune response to acquired infections. The role of narsoplimab is to prevent complement-mediated inflammation and endothelial damage without affecting the function of other innate immune pathways.

Developed by Omeros, narsoplimab has been granted breakthrough drug status in the United States for the treatment of high-risk HSCT-TMA patients. Currently, narsoplimab is also in phase III clinical development and is being developed for the treatment of IgA nephropathy (IgAN) and atypical hemolytic uremic syndrome (aHUS). Previously, it was also granted orphan drugs and breakthrough drugs for IgAN in the United States, fast-track qualification for aHUS, and orphan drugs for IgAN in the European Union.

REGN-EB3
REGN-EB3 is a mixture of three fully human IgG1 mAbs, and is used for the treatment of Ebola virus infection. Ebola virus is the culprit causing Ebola hemorrhagic fever (EHF), an acute viral infectious disease with symptoms including fever, headache, joint and muscle pain, fatigue, diarrhea, vomiting, stomach pain, loss of appetite and abnormal bleeding. In the United States and the European Union, REGN-EB3 has been granted orphan drug status and has been awarded Breakthrough Drug Status (BTD) in the United States. In addition to REGN-EB3, a therapeutic mAb -mAb114- has also been awarded orphan drug status and BTD.

Isatuximab
Isatuximab is an anti-CD38 IgG1 chimeric monoclonal antibody developed for the treatment of multiple myeloma (MM). The drug targets specific epitopes of CD38 receptors in plasma cells and can trigger a variety of unique mechanisms of action, including promoting programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is expressed at high levels on MM cells and is a target for cell surface receptors for antibody therapy in MM and other malignancies.

Isatuximab was developed by Sanofi, and its applications for marketing for relapsed or refractory MM are under review by the US FDA and EU EMA. In the United States and the European Union, the drug is licensed as an orphan drug for relapsed or refractory MM. In a pivotal phase III ICARIA-MM study, isatuximab combined with pom-dex (pomalidomide + dexamethasone) significantly reduced the risk of disease progression or death by 40% and improved overall response compared to standard care. Currently, Sanofi is also evaluating the potential of isatuximab to treat other hematological malignancies and solid tumors.

Sacituzumab govitecan
Sacituzumab govitecan is a novel, first-in-class antibody drug conjugate (ADC) that combines the humanized IgG1 antibody targeting the TROP-2 antigen with SN-38, the metabolic activity of the chemotherapeutic drug irinotecan (a topoisomerase I inhibitor). It is currently being developed for the treatment of metastatic triple negative breast cancer (mTNBC). TNBC is a type of breast cancer with very limited treatment options. TROP-2 is a cell surface glycoprotein that is expressed in more than 90% of TNBC.

Developed by Immunomedics, Sacituzumab govitecan was submitted to the FDA in May 2018 for accelerated approval for mTNBC patients who have previously received at least 2 therapies for metastatic disease. However, it was rejected by the FDA in January 2019 because of manufacturing-related issues and no new clinical or preclinical data was required. At the beginning of December 2019, the company re-submitted BLA to the FDA. The last updated Phase II clinical data of the month showed that the total response rate of mTNBC treated by the drug was 34% and the median response duration was 9 months. Currently, the company is conducting a confirmatory phase III study. If approved, the drug will be the first ADC to treat mTNBC.

Tafasitamab
Tafasitamab is a novel humanized Fc domain-targeted CD19-optimized immune-enhancing IgG1 monoclonal antibody developed for the treatment of two types of B-cell malignancies: diffuse large B-cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL). CD19 is a clear biomarker for a variety of B-cell malignancies. The drug’s Fc domain has been optimized to improve its affinity for activated FcγRIIIa on effector cells, significantly enhance antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP), thereby improving the key mechanism of tumor cell killing. In preclinical model studies, tafasitamab has been shown to induce direct apoptosis of cancer cells by binding to CD19.

The drug was developed by MorphoSys. At the end of last month, the company announced that it had completed its BLA submission and approved the application of tafasitamab in combination with lenalidomide in the treatment of patients with relapsed or refractory DLBCL. In the United States and the European Union, the drug has been granted orphan drug status for the treatment of DLBCL, and in the United States has also been granted fast-track status and breakthrough drug status for DLBCL. In a phase III clinical study, the total response rate of the drug combined with lenalidomide reached 60%, the complete response rate reached 43%, and the median progression-free survival was 12.1 months. Remissions are persistent with a median duration of 21.7 months. If approved, the drug will pose serious challenges to two CAR-T cell therapies on the market for relapsed or refractory DLBCL, including Novartis’ Kymriah and Gilead’s Yescarta.

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Basic ways of high-pressure boiler steel pipe derusting

The basic ways of high-pressure boiler steel pipe derusting:

 1  cleaning: use solvent, emulsion high-pressure boiler steel pipe surface cleaning, to remove oil, grease, dirt, lubricants, and similar organic matter, but it cannot remove high-pressure boiler steel pipe surface rust, scale, welding flux, etc., therefore in the production of anti-corrosion only as a supplementary means.

[2] tool cleaning: mainly USES steel wire brush and other tools of high-pressure boiler steel pipe surface grinding, can remove loose or cock scale, rust, slag, etc. Hand tools can achieve derusting Sa2 level, power tool cleaning can reach grade Sa3, if a high-pressure boiler steel pipe firmly adhered on the surface of iron oxide, tool cleaning effect is not ideal, anchor pattern depth of anticorrosion construction requirements

[3] pickling: generally do with two methods of chemical and electrolytic pickling process, pipeline corrosion protection using chemical pickling, can remove scale, rust, old coating, sometimes can be used as sandblasting derusting after reprocessing. Chemical cleaning while can make the surface reaches a certain cleanness and roughness, but the anchor lines shallow, and easy to damage to the environment.

[4] shot derusting spray (cast) : shot derusting spray (cast) is driven by high-power motor spray (cast) shoot high-speed rotating blades, make steel grit, steel shot, segment, minerals and other abrasive wire under the action of centrifugal force on steel pipe surface spray (cast) processing, not only can thoroughly remove rust, oxides and dirt, and high-pressure boiler steel pipe under the action of abrasive violent impact and friction, also can achieve the required uniform roughness.

After shot derusting spray (left), not only can enlarge the physical adsorption on the surface of the pipe, and can enhance anti-corrosion layer and mechanical adhesion on the surface of the pipe. Therefore, shot derusting spray (cast) is an ideal cleaning pipeline corrosion protection method. In general, shot peening (sand) is mainly used for high pressure boiler steel pipe derusting surface treatment, shot (sand) is mainly used for pipe derusting outside surface treatment. Using spray (cast) shot derusting several problems should be paid attention to.

With the development of the current our country economy, long distance oil and gas pipeline is an important means of energy security, in the process of oil (gas) pipeline anticorrosion construction, high pressure boiler tube surface derusting also led to the life they use factor. To ensure the quality of the anticorrosive coating, on the basis of the same equipment, improve the technological level, reduce the production cost.

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Why Should You Invest in Earthcon’s Casa Royale Project?

Generally people are confused when it comes to investment of any sorts, and especially if it is related to property. There lingers a dilemma, which is pretty much understandable, when it comes to weigh the options: invest in a plot of land, or buy an apartment. The world is not perfect and there lie the pros and cons of both forms of investment. There are controversies stating that buying a plot of land gives more flexibility to the owner, but on the other hand, apartments are more secure and easy to buy as compared to plots. Here is where Earthcon comes in.

Contact us and make an appointment. Together we will sit and discuss the best possible investment for you. Our professional at Casa Royal, Residential Property in Noida Extension will talk you through the whole procedure. Also, feel free to bring any of your personal advisors. The terms and conditions are clearly stated, and you may take your time going through the papers, before giving a final answer. Here are a few pointers that are to be considered before investing your money.

Flexibility of Construction and Enhancement

While buying a plot you gets the sole power to customize the building, however you may desire. However, in case of an apartment, the scope of customization gets pretty limited. Some features can be modified to suit the needs, but most cannot. If you intend buy an apartment, notify us beforehand, and after receiving the down payment we will tweak the apartment according to your tastes.

Appreciation of Value

In today’s world of ever rising inflation, the cost of living is rising by the day. As such, to procure a land just for the sake of investment and not actually having any plans for future constructions is a waste. Investing in an apartment gives you an extra benefit of renting it, thereby adding an extra benefit to your investment. Our apartments are in the developing stage and still have the potential to grab and produce, the requirements of the present generation hence, making it a worthwhile investment.

Financial Assistance

It’s a lot easier to get a loan for an apartment. Several banks provide a variety of loans to choose from. On the other hand, when applying for a loan for a plot of land, the buyer has to be financially sound, in order to get a loan, because banks do not offer loans on plots, so easily. The process takes a lot of time and is very tedious, and also, in order to get the tax benefits, the construction has to be completed on the land.

Security

It goes without saying that an apartment complex is more safe and secure than an empty plot of land. The plot is susceptible to vandalism, whereas the apartment is under security supervision. As for Earthcon, our two-tier security is unreachable.

Coming up within reach of three major urban settlements in the NCR, the Casa Royale Project is a sprawling piece of example how real estate development has reached new heights. Spanning an area of 11.14 acres, this project by Earthcon Universal is al poised to take the challenge of affordable housing in congested Indian urban centers head on, especially in the NCR.

According to a survey of 2011-12, the NCR was responsible about 7.5 percent of India’s total GDP, or roughly $128.9 billion. This major economic powerhouse has seen developmental activities at a breakneck pace, gradually incorporating more districts and smaller urban conglomerates, into one big, and unified urban centre. This rapid rate of development has seen its limitations: shortage of affordable housing for all. The Residential Property in Noida Extension by Earthcon Universal has sought to answer that bulging problem.

Major Advantages Offered by Casa Royale Project:

As is the case with any urban settlement in India, the city centers lack affordable lands where individuals can build their houses upon. Major housing projects address this crisis, both in terms of monetary part, as well as the time investments. Any single building meant for one family would take into account all the cost of buying up the plot, preparation of necessary documents, registering it, obtaining permission from various state and federal agencies, and on top of that constructing the house itself. Compare this with any housing project such as the one mentioned here and you will notice the difference.

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