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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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The 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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Facts on Botulism

Botulism is a paralytic illness. It is serious but rare.

In this article:

What is botulism?

Symptoms

Causes

Diagnosis

Treatment

How Chemist Online can help

Advice & Support

What is botulism?
Botulism causes flaccid paralysis of the muscles.

There are three types of botulism:

Food-borne botulism: This is botulism caused by bacteria contaminating food (i.e. food kept in cans, tins, jars and also foods preserved in oil). The contamination is usually due to a fault or improper practice in the canning or preservation process. The onset of symptoms occurs when you digest the food as your body reacts to the spores of the organism Clostridium Botulinum – the bacteria that is at the core of botulism.

Wound botulism: Where the spores of the Clostridium Botulinum organism infects an open wound and then multiplies (massively reproduces within the wound and, to a certain degree, beneath the skin in the wound’s surrounding area). This can often occur to drug users injecting Class A drugs (e.g., heroin) into muscle tissue.

Infant botulism: This is rare, but occurs where an infant (usually before they have reached 12 months) somehow consumes the spores of the Clostridium Botulinum bacteria/organism. Once the child reaches its first birthday, its body will then develop a defence mechanism against the spores.

Symptoms
Symptoms of botulism in adults include:

Muscle paralysis

Dry mouth and throat

Droopy eyelids

Headache, blurred vision and double vision

Speech and breathing difficulties

Weak muscles (resulting in poor grip, for example)

Constipation

Nausea and vomiting

Abdominal pain

Symptoms in botulism in children include:

Constipation

A flat facial expression

Irritability

Lethargy

Floppiness

Breathing problems

Muscle weakness

Weak sucking

Feeble crying

Reduced movement

Swallowing problems

Excessive drooling

Causes
The Clostridium Botulinum bacteria can be found in soil and foods, such as honey and corn.

Diagnosis
If you (or your baby) are suffering from the aforementioned symptoms and think that you may have developed botulism, seek immediate medical treatment. Also call 999 and ask for an ambulance if you suspect that someone you know may be suffering from botulism.

At your local (or nearest) hospital: After taking your medical history, asking you some questions about your symptoms and carrying out a physical examination, you will be asked to undergo either an MRI scan or a CT scan. Based upon the results, a confirmed diagnosis will/may be made. These tests (as well as a possible spinal tap test where a sample of cerebrospinal fluid is taken from your lower back) will also help to rule out other possible health conditions, such as Guillian-Barre Syndrome, mild heart attack or stroke – all of which have similar symptoms to botulism.

You may also be asked to provide a urine or stool sample in order to detect the presence of toxins.

Note: It is important to point out that botulism is an extremely rare condition. In fact, due to the high standards enforced by the Department of Health and other Government bodies when it comes to canning and food preservation methods across the UK (and also in the control of imported food and food stuffs from abroad) the chances of a UK citizen developing food-borne botulism are actually less than zero.

Treatment
Food-borne botulism is usual treated with a series of antitoxin injections which will be carried out immediately and in isolation at your local (or nearest) hospital.

Surgery may be carried out to the affected area where wound botulism occurs.

With infant botulism, your baby will be placed safely in an incubator and treated with botulinum immune globulin medicine.

Al these treatments are proven as being successful in treating botulism.

How Chemist Online can help
Through this website we have a range of treatments available to buy which can help ease the symptoms and associated symptoms of botulism, such as constipation remedies and painkillers for headaches.

www.chemistonline.co.uk

Advice & Support
Core
Tel: 020 7486 0341
Website: www.corecharity.org.uk

The Gut Trust
Helpline: 0114 272 3253
Website: www.theguttrust.org

This information and advice is not intended to replace the advice of your GP or chemist. Chemist Online is also not responsible or liable for any diagnosis made by a user based upon the content of the Chemist Online website. Chemist Online is also not liable for the contents of any external internet sites listed, nor does it endorse any commercial product or service mentioned or advised on any of the sites.

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