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.

Scientists develop monoclonal antibodies that may lead to new, innovative treatments for cancer patients

Using monoclonal antibodies to fight cancer is a complex, yet promising area of study. At Memorial Sloan Kettering Cancer Center, physician-scientists have focused their attention on expanding the current therapeutic antibody repertoire, and believe a newly developed platform will do just that - ultimately leading to new and innovative treatments for cancer patients with a broad range of malignancies.

29 Jan 2014

Bristol-Myers Squibb fourth quarter 2013 revenues increase 6% to $4.4 billion

Bristol-Myers Squibb Company today reported results for the fourth quarter and full year of 2013. The fourth quarter was highlighted by the company's announcement to sell its diabetes business as part of the continued evolution of its successful BioPharma strategy to a specialty care model. The company achieved important regulatory milestones in the quarter for Eliquis in the U.S., daclatasvir/asunaprevir in Japan, daclatasvir in Europe and Farxiga in the U.S. In addition, the company provided financial guidance for 2014.

24 Jan 2014

Kolltan Pharmaceuticals announces treatment of first cancer patient with KTN3379

Kolltan Pharmaceuticals, a privately held biopharmaceutical company, today announced treatment of the first cancer patient with Kolltan's lead drug candidate, KTN3379, as part of a Phase 1 clinical study evaluating safety, preliminary evidence of antitumor activity, and pharmacokinetics. KTN3379 is a human monoclonal antibody that blocks the activity of ErbB3, a member of the ErbB family of receptor tyrosine kinases.

21 Jan 2014

$Japanese MHLW approves ADCETRIS for relapsed or refractory CD30-positive HL and ALCL$

Japanese MHLW approves ADCETRIS for relapsed or refractory CD30-positive HL and ALCL

Seattle Genetics, Inc. today announced that its collaborator, Takeda Pharmaceutical Company Limited, has received approval of ADCETRIS (brentuximab vedotin) from the Japanese Ministry of Health, Labour and Welfare for the treatment of patients with CD30-positive relapsed or refractory Hodgkin lymphoma and anaplastic large cell lymphoma.

18 Jan 2014

Biothera enhances innate immune responses to Imprime PGG drug candidate

Biothera has enhanced innate immune responses to its cancer immunotherapy drug candidate Imprime PGG in subjects regardless of biomarker status, demonstrating the opportunity to treat a larger patient population. The in vitro research will be presented today at the Cambridge Healthtech Institute's Antibody-Drug Conjugates/Engineering Targeted Therapeutics conference in Palm Springs, CA.

16 Jan 2014

CytoDyn receives FDA approval to start Phase 2b study of PRO 140 for treatment of HIV-1

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today the Company has received approval from the United States Food and Drug Administration (FDA) to commence patient screening of a Phase 2b study of PRO 140, a monoclonal CCR5 antibody, for the treatment of patients with Human Immunodeficiency Virus Type 1.

8 Jan 2014

Biothera reports positive results from Phase 2 clinical trial of Imprime PGG in NSCLC patients

Biothera today reported positive results from its proof of concept Phase 2 clinical trial in 90 patients with advanced non-small cell lung cancer (NSCLC) at the American Association for Cancer Research and the International Association for the Study of Lung Cancer joint conference on the Molecular Origins of Lung Cancer in San Diego.

8 Jan 2014

Memorial Sloan-Kettering to use Sutro's cell-free protein synthesis technology to produce bispecific antibodies

Sutro Biopharma, a biopharmaceutical company developing a new generation of protein therapeutics, including next-generation antibody drug conjugates and bispecific antibodies, today announced that it has entered into a collaboration agreement with Memorial Sloan-Kettering Cancer Center to use Sutro's proprietary cell-free protein synthesis technology to produce bispecific antibodies that were discovered by Memorial Sloan-Kettering for the treatment of neuroblastoma in children.

7 Jan 2014

Study suggests that ROR1 could be an important therapeutic target for patients with CLL

Researchers at the University of California, San Diego School of Medicine report that an oncogene dubbed ROR1, found on chronic lymphocytic leukemia (CLL) B cells but not normal adult tissues, acts as an accelerant when combined with another oncogene, resulting in a faster-developing, more aggressive form of CLL in mice.

3 Jan 2014

Amgen announces romosozumab Phase 2 trial results in postmenopausal women with low BMD

Amgen and UCB (Euronext Brussels:UCB) today announced results from a Phase 2 trial evaluating romosozumab (AMG 785/CDP7851) in postmenopausal women with low bone mineral density (BMD).

2 Jan 2014

Genzyme gets FDA Complete Response Letter for Lemtrada sBLA

Genzyme, a Sanofi company, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

30 Dec 2013

FDA extends PDUFA Priority Review action date for UC indication of Takeda's vedolizumab

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States Food & Drug Administration has extended the Prescription Drug User Fee Act Priority Review action date for the ulcerative colitis indication of Takeda's investigational biologic, vedolizumab.

24 Dec 2013

Reflux disease diagnosis: an interview with Professor Peter Dettmar, Managing Director of RD Biomed Limited

Generally speaking, reflux has been a major chronic issue for probably the last 40 or 50 years. When you look at the global population, depending on which country we're talking about, around 20% to 40% of individuals have reflux disease within their populations.

23 Dec 2013

European Commission approves update of Erbitux to treat patients with RAS wild-type mCRC

Merck Serono, the biopharmaceutical division of Merck, today announced that the European Commission has approved the Type II variation to amend the Erbitux(cetuximab) product information, updating the indication for Erbitux to the treatment of patients with RAS wild-type metastatic colorectal cancer (mCRC).

23 Dec 2013

Amgen reports that Phase 3 DESCARTES study for high cholesterol meets primary endpoint

Amgen today announced that the Phase 3 DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) study evaluating the long-term 52-week safety and efficacy of evolocumab for the treatment of high cholesterol met its primary endpoint of percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 52.

20 Dec 2013

FibroGen starts patient enrollment in FG-3019 Phase 2 study for idiopathic pulmonary fibrosis treatment

FibroGen, Inc., announced today that patient enrollment has started in a new Phase 2 clinical study of FG-3019 in patients who suffer from idiopathic pulmonary fibrosis.

20 Dec 2013

Takeda to acquire exclusive license to develop Natrogen's Natura-alpha compound

Takeda Pharmaceutical Company Limited and Natrogen Therapeutics International, Inc. jointly announced today an agreement whereby Takeda will acquire an exclusive license to develop Natrogen's Natura-alpha compound as well as an option to acquire Natrogen. Natura-alpha is a synthetic small molecule oral compound that is believed to inhibit pro-inflammatory cytokine expression, which may help to reduce gastrointestinal inflammation. Natura-alpha is currently in Phase 2 development for the treatment of ulcerative colitis.

20 Dec 2013

Australian Therapeutic Goods Administration approves Genzyme's Lemtrada for multiple sclerosis

Genzyme, a Sanofi company, announced today that the Australian Therapeutic Goods Administration has approved Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

19 Dec 2013

Sorrento Therapeutics acquires Concortis Biosystems

Sorrento Therapeutics, Inc. announced today that it has completed its acquisition of Concortis Biosystems, Corp., providing Sorrento with a comprehensive technology platform to create a new generation of homogenous antibody drug conjugates with site-specific toxin conjugation and consistent drug-antibody ratios. With the close of the deal, Sorrento has issued an aggregate of 1,331,978 shares of its common stock to the Concortis shareholders. Based on the closing share price on December 18, 2013, the transaction is valued at $11.3 million.

19 Dec 2013

Sanofi and Regeneron Pharmaceuticals team up with ACC to enhance clinical research with alirocumab

Sanofi and Regeneron Pharmaceuticals, Inc. today announced an innovative collaboration with the American College of Cardiology focused on enhancing clinical research with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is known to contribute to circulating low-density lipoprotein cholesterol (LDL-C) levels. Alirocumab is being co-developed by Sanofi and Regeneron.

19 Dec 2013

Monoclonal Antibody News and Research

Further Reading

Scientists develop monoclonal antibodies that may lead to new, innovative treatments for cancer patients

Bristol-Myers Squibb fourth quarter 2013 revenues increase 6% to $4.4 billion

Kolltan Pharmaceuticals announces treatment of first cancer patient with KTN3379

Japanese MHLW approves ADCETRIS for relapsed or refractory CD30-positive HL and ALCL

Biothera enhances innate immune responses to Imprime PGG drug candidate

CytoDyn receives FDA approval to start Phase 2b study of PRO 140 for treatment of HIV-1

Biothera reports positive results from Phase 2 clinical trial of Imprime PGG in NSCLC patients

Memorial Sloan-Kettering to use Sutro's cell-free protein synthesis technology to produce bispecific antibodies

Study suggests that ROR1 could be an important therapeutic target for patients with CLL

Amgen announces romosozumab Phase 2 trial results in postmenopausal women with low BMD

Genzyme gets FDA Complete Response Letter for Lemtrada sBLA

FDA extends PDUFA Priority Review action date for UC indication of Takeda's vedolizumab

Reflux disease diagnosis: an interview with Professor Peter Dettmar, Managing Director of RD Biomed Limited

European Commission approves update of Erbitux to treat patients with RAS wild-type mCRC

Amgen reports that Phase 3 DESCARTES study for high cholesterol meets primary endpoint

FibroGen starts patient enrollment in FG-3019 Phase 2 study for idiopathic pulmonary fibrosis treatment

Takeda to acquire exclusive license to develop Natrogen's Natura-alpha compound

Australian Therapeutic Goods Administration approves Genzyme's Lemtrada for multiple sclerosis

Sorrento Therapeutics acquires Concortis Biosystems

Sanofi and Regeneron Pharmaceuticals team up with ACC to enhance clinical research with alirocumab

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