Monoclonal Antibody News and Research

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Monoclonal antibodies (MAbs) are produced from a single B cell clone and can bind to a single type of antigen binding site. MAbs are homogenous antibodies that cannot form lattices with monomeric proteins as they can bind to only a single epitope on the antigen. Developed in the 1970s, MAbs can be produced against any given substance. Thus they can be used to detect and purify any substance of interest. This has made MAbs a powerful tool of molecular biology, biochemistry, and medicine.

Roche's cobas KRAS Mutation Test for colorectal cancer now available in Europe

Roche announced today that the cobas KRAS Mutation Test is now commercially available in Europe for use in colorectal cancer.

22 Jul 2011

UK regulators approve Europe's first clinical trial of plant-derived antibody for HIV

UK regulators have approved Europe's first clinical trial of a monoclonal antibody produced from genetically modified plants. This landmark decision sets the stage for the testing, in humans, of an anti-HIV product made from genetically modified tobacco plants. It will open the door for trials of additional plant-derived medicines treating a range of diseases.

22 Jul 2011

Quest receives U.S. patent allowance for cancer combination therapy

Quest PharmaTech Inc., a pharmaceutical company developing and commercializing products for the treatment of cancer, today announced that it has received notice of allowance for U.S. Patent Application 10/831,886 entitled: "Combination Therapy for Treating Disease".

22 Jul 2011

Australian anti-cancer company completes $2.6 million placement

Australian monoclonal antibody company, Immune System Therapeutics Limited (IST), today said it completed a private placement to raise $2 million from new and existing private and institutional investors in Australia. Investors have agreed to purchase 5,200,000 shares in the company at a price of $0.50 cents per share resulting in gross proceeds of $2.6 million.

21 Jul 2011

Clinical study of anti-HIV antibody made from genetically modified tobacco plants

Pharmaceuticals can be produced by plants. Antibodies that have been produced in tobacco plants will now for the first time be tested in a clinical study.

21 Jul 2011

Possible new drug targets for treating diffuse large B-cell lymphoma

Researchers at the University of Maryland School of Medicine have discovered a novel interaction between two proteins involved in regulating cell growth that could provide possible new drug targets for treating diffuse large B-cell lymphoma, the most common type of non-Hodgkin's lymphoma.

20 Jul 2011

FDA ODAC recommends approval of Seattle Genetics' ADCETRIS for Hodgkin lymphoma after ASCT

Seattle Genetics, Inc. today announced that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration (FDA) voted 10-0 to recommend that the FDA grant accelerated approval of ADCETRIS™ (brentuximab vedotin) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant (ASCT).

15 Jul 2011

EC grants marketing authorization for Amgen's XGEVA to prevent skeletal-related events

Amgen today announced that the European Commission (EC) has granted marketing authorization for XGEVA (denosumab) for the prevention of skeletal-related events (SREs) in adults with bone metastases from solid tumors.

15 Jul 2011

CLEOPATRA Phase III study on HER2-positive mBC meets primary endpoint

Genentech, a member of the Roche Group, today announced that CLEOPATRA, a pivotal Phase III study, met its primary endpoint.

15 Jul 2011

PharmAthene demonstrates 36 month stability of rPA anthrax vaccine program candidate

PharmAthene, Inc. announced today that it has achieved an important program milestone in its recombinant protective antigen (rPA) anthrax vaccine program and demonstrated 36 month stability of its rPA drug product candidate previously produced at Avecia Biologics Laboratories in the United Kingdom. The stability data were prepared utilizing a variety of analytical methods and a well characterized mouse challenge potency assay.

14 Jul 2011

Positive results from sarilumab Phase 2b trial on RA, ankylosing spondylitis

Sanofi and Regeneron Pharmaceuticals, Inc. announced results from Phase 2b trials in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) with sarilumab, a novel, high-affinity, subcutaneously administered, fully-human antibody targeting the interleukin-6 receptor.

13 Jul 2011

iBio successfully produces human plasma proteins using proprietary technology

iBio, Inc. today announced successful production of human plasma proteins using its proprietary iBioLaunch technology. Human alpha 1-antitrypsin and human C1 esterase inhibitor were successfully produced at high yield in green plants via the Company's proprietary iBioLaunch technology. Both of these proteins are important therapeutic products, but until now they have been made from human blood.

11 Jul 2011

Positive top-line results from alemtuzumab Phase 3 trial on multiple sclerosis

Sanofi and its subsidiary Genzyme announced today positive top-line results from CARE-MS I, the first of two randomized, Phase 3 clinical trials comparing the investigational drug alemtuzumab to the approved multiple sclerosis therapy Rebif in patients with relapsing-remitting multiple sclerosis.

11 Jul 2011

LFB receives U.S. patent titled 'Monoclonal Antibodies with Enhanced ADCC Function'

LFB announced today that it has been recently issued U.S. Patent 7,931,895 titled "Monoclonal Antibodies with Enhanced ADCC Function" on April 26, 2011, by the U.S. Patent and Trademark Office.

8 Jul 2011

Macrogenics' Protege Phase 3 clinical study of teplizumab in type 1 diabetes published in The Lancet

MacroGenics, Inc., a privately held biotechnology company that develops immunotherapeutics to treat autoimmune disorders, cancer and infectious diseases, announced the publication in The Lancet of results from Protege, a Phase 3 clinical study of teplizumab in type 1 diabetes.

29 Jun 2011

DSM introduces Kremer Method for rapid, cost effective production of biopharmaceuticals

Royal DSM, the global Life Sciences and Materials Sciences company, today announced the introduction of the Kremer Method, an innovative proprietary technology developed by DSM scientists which improves downstream processing of monoclonal antibodies (mAbs) for faster and more cost effective production of biopharmaceuticals

28 Jun 2011

Scientists discover origin of Barrett's esophagus

Dr Frank McKeon, Senior Group Leader of the Stem Cell and Developmental Biology at A*STAR's Genome Institute of Singapore, and Principal Investigator Dr Wa Xian at A*STAR's Institute of Medical Biology, together with their counterparts from the Harvard Medical School, the Brigham and Women's Hospital in Boston, and the National University of Singapore, have made the striking finding that Barrett's esophagus work, published online in the journal Cell on 24 June 2011, is essential to developing therapeutics for esophageal cancer.

28 Jun 2011

Amgen files sBLA for XGEVA with FDA to treat castrate-resistant prostate cancer

Amgen today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

28 Jun 2011

Polymedco launches BTA stat test for detection of recurrent bladder cancer

Polymedco, Inc. is pleased to announce the direct availability of the BTA stat® test from our sales force – The BTA stat® test is a point of care technology for the early detection of recurrent bladder cancer. This method uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine.

27 Jun 2011

EMA acceptance of brentuximab vedotin MAA triggers $5M milestone payment to Seattle Genetics

Seattle Genetics, Inc., today announced that it will receive a $5 million milestone payment under its brentuximab vedotin (ADCETRIS) collaboration with Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

27 Jun 2011

Monoclonal Antibody News and Research

Further Reading

Roche's cobas KRAS Mutation Test for colorectal cancer now available in Europe

UK regulators approve Europe's first clinical trial of plant-derived antibody for HIV

Quest receives U.S. patent allowance for cancer combination therapy

Australian anti-cancer company completes $2.6 million placement

Clinical study of anti-HIV antibody made from genetically modified tobacco plants

Possible new drug targets for treating diffuse large B-cell lymphoma

FDA ODAC recommends approval of Seattle Genetics' ADCETRIS for Hodgkin lymphoma after ASCT

EC grants marketing authorization for Amgen's XGEVA to prevent skeletal-related events

CLEOPATRA Phase III study on HER2-positive mBC meets primary endpoint

PharmAthene demonstrates 36 month stability of rPA anthrax vaccine program candidate

Positive results from sarilumab Phase 2b trial on RA, ankylosing spondylitis

iBio successfully produces human plasma proteins using proprietary technology

Positive top-line results from alemtuzumab Phase 3 trial on multiple sclerosis

LFB receives U.S. patent titled 'Monoclonal Antibodies with Enhanced ADCC Function'

Macrogenics' Protege Phase 3 clinical study of teplizumab in type 1 diabetes published in The Lancet

DSM introduces Kremer Method for rapid, cost effective production of biopharmaceuticals

Scientists discover origin of Barrett's esophagus

Amgen files sBLA for XGEVA with FDA to treat castrate-resistant prostate cancer

Polymedco launches BTA stat test for detection of recurrent bladder cancer

EMA acceptance of brentuximab vedotin MAA triggers $5M milestone payment to Seattle Genetics

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