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.

Advaxis publishes research article on Her2 antigen for Listeria vaccine

Scientists at Advaxis, Inc.,the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, recently had their research using ADXS31-164, a live Listeria vaccine that targets Her2, published in a leading peer reviewed journal (Shahabi, et al 2010 Cancer Gene Therapy epublished ahead of print).

13 Sep 2010

John Theurer Cancer Center plays major role in FDA's fast tracking of ipilimumab for metastatic melanoma

Researchers from the John Theurer Cancer Center at Hackensack University Medical Center played an important role in a study that led to the Food & Drug Administration's (FDA) recent fast tracking of ipilimumab, a promising treatment for metastatic melanoma. The FDA based its decision largely on the results of a pivotal study published in the New England Journal of Medicine on August 19, 2010 – the same day the agency accepted Bristol-Myers Squibb's application for the drug's approval and granted the application priority review status.

10 Sep 2010

$GSK, Genmab commence ofatumumab Phase III study in rituximab refractory patients with indolent B-NHL$

GSK, Genmab commence ofatumumab Phase III study in rituximab refractory patients with indolent B-NHL

GlaxoSmithKline and Genmab A/S announced today the start of a Phase III study in patients with indolent B-cell non-Hodgkin's lymphoma (B-NHL) who did not respond to or progressed during, or within 6 months of a rituximab containing regimen.

9 Sep 2010

Progenics commences Phase 3 trial of oral methylnaltrexone for opioid-induced constipation

Progenics Pharmaceuticals, Inc. today announced the initiation of an international 700-patient, phase 3 trial of oral methylnaltrexone in patients with chronic, non-cancer pain who are experiencing constipation as a result of their opioid-pain management regimens. The goal of the study is to evaluate the safety and efficacy of oral methylnaltrexone to treat opioid-induced constipation (OIC) in this patient setting.

8 Sep 2010

Vela Laboratories renews GMP certificate for analytical and Quality Control laboratories

Vela Laboratories, a provider of analytical services to the global biopharmaceutical industry, today announced the renewal of the GMP certificate for its analytical and Quality Control laboratories until 2013.

8 Sep 2010

Positive results from YM BioSciences' CYT997 Phase I study for vascular disruption in tumors

YM BioSciences Inc., today announced the publication of Phase I results demonstrating that CYT997, a novel vascular disrupting agent (VDA), was well tolerated at doses that were associated with pharmacodynamic evidence of vascular disruption in tumors. The article entitled "Phase I trial of CYT997, a novel cytotoxic and vascular-disrupting agent," was published in the premier cancer journal, the British Journal of Cancer.

8 Sep 2010

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

Emergent BioSolutions Inc. announced today that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject. Emergent's fully human monoclonal antibody product candidate is being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

8 Sep 2010

Alzheimer's disease drug market to increase from $4.3 billion to $13.3 billion in 2019: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, owing to the emergence of new agents that have the potential to affect disease progression, the Alzheimer's disease drug market will more than triple, from $4.3 billion in 2009 to $13.3 billion in 2019 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

8 Sep 2010

Bristol-Myers Squibb signs definitive agreement to acquire ZymoGenetics

Bristol-Myers Squibb Company and ZymoGenetics, Inc. announced today that the companies have signed a definitive agreement providing for the acquisition of ZymoGenetics by Bristol-Myers Squibb, for $9.75 per share in cash.

8 Sep 2010

TenX Biopharma recommences enrollment in suspended Phase III trial for cutaneous T-cell lymphoma

TenX Biopharma, Inc. announced today that it has re-initiated enrollment in the pivotal Phase III clinical trial assessing zanolimumab treatment for cutaneous T-cell lymphoma (CTCL) patients (ClinicalTrials.gov identifier: NCT00127881). The trial enrollment was suspended in October 2008 while Genmab was seeking a out-license agreement to further develop the compound. TenX Biopharma acquired global rights to zanolimumab in February, 2010 from Genmab.

7 Sep 2010

ImmunoCellular Therapeutics updates accomplishments in Letter to Shareholders

As the summer comes to a close, I wanted to update you on the Company's accomplishments this year, which set the stage for an exciting fall. The first eight months of the year have been very successful, with the Company attaining many of its goals, despite a very difficult economic environment, which has created challenges for many small biotechnology companies. Today, IMUC is in its best financial position ever and well positioned to validate the success it achieved in a Phase I trial for ICT-107, its dendritic cell-based cancer vaccine product candidate.

3 Sep 2010

Seattle Genetics achieves milestone on Agensys' initiation of AGS-16M8F ADC phase I trial for cancer

Seattle Genetics, Inc. announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc. The milestone was triggered by Agensys' initiation of a phase I trial for AGS-16M8F, an ADC for the treatment of cancer utilizing Seattle Genetics' technology.

3 Sep 2010

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing.

2 Sep 2010

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that its lead clinical candidate STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis, a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung.

31 Aug 2010

Roche's MabThera continues to dwarf recently launched monoclonal antibodies: Report

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia, 41 percent of surveyed European hematologist-oncologists say that the favorable efficacy profile of Roche's MabThera (rituximab) is the most significant driver of their use of this brand, while 26 percent say MabThera's favorable risk-benefit profile is the most significant driver.

31 Aug 2010

Immunomedics 2010 fourth quarter revenue decreases to $0.7 million

Immunomedics, Inc., a biopharmaceutical company primarily focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported financial results for the fourth quarter and fiscal year ended June 30, 2010.

27 Aug 2010

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

The recombinant anti-CD20 monoclonal antibody produced by LFB Biotechnologies received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the FDA Office of Orphan Products Development was granted on August 6th, 2010.

26 Aug 2010

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

ZymoGenetics, Inc. today announced enrollment has been completed in the Phase 2b clinical trial with PEG-Interferon lambda and ribavirin in chronic hepatitis C virus (HCV) infection.

25 Aug 2010

CMC Biologics completes new, disposable manufacturing facility at Seattle

CMC Biologics, a Contract Manufacturing Organization with manufacturing sites in Europe and the USA, today announced the completion of a new state-of-the-art disposable manufacturing facility at its Seattle, WA site. The addition comes as part of a staged major expansion plan, which will add significant production capacity to its existing facility to accommodate a growing demand for cGMP manufacture of biopharmaceuticals.

25 Aug 2010

Monoclonal Antibody News and Research

Further Reading

Advaxis publishes research article on Her2 antigen for Listeria vaccine

John Theurer Cancer Center plays major role in FDA's fast tracking of ipilimumab for metastatic melanoma

GSK, Genmab commence ofatumumab Phase III study in rituximab refractory patients with indolent B-NHL

Progenics commences Phase 3 trial of oral methylnaltrexone for opioid-induced constipation

Vela Laboratories renews GMP certificate for analytical and Quality Control laboratories

Positive results from YM BioSciences' CYT997 Phase I study for vascular disruption in tumors

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

Alzheimer's disease drug market to increase from $4.3 billion to $13.3 billion in 2019: Report

Bristol-Myers Squibb signs definitive agreement to acquire ZymoGenetics

TenX Biopharma recommences enrollment in suspended Phase III trial for cutaneous T-cell lymphoma

ImmunoCellular Therapeutics updates accomplishments in Letter to Shareholders

Seattle Genetics achieves milestone on Agensys' initiation of AGS-16M8F ADC phase I trial for cancer

Agensys commences AGS-16M8F ADC Phase I clinical trial for renal cancer

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Roche's MabThera continues to dwarf recently launched monoclonal antibodies: Report

Immunomedics 2010 fourth quarter revenue decreases to $0.7 million

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

FDA grants LFB's recombinant anti-CD20 monoclonal antibody orphan drug status for CLL

ZymoGenetics completes enrollment in Phase 2b PEG-IFN lambda clinical trial

CMC Biologics completes new, disposable manufacturing facility at Seattle

Antibodies eBook

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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