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.

FDA clears Diagnostic HYBRIDS' D3 FastPoint L-DFA Respiratory Virus Identification Kit

Diagnostic HYBRIDS, a leading developer of IVD fluorescent staining kits and cell culture products, today announced the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPointTM L-DFATM Respiratory Virus Identification Kit, which allows the individual detection of influenza A, influenza B, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), adenovirus and parainfluenza viruses from a patient’s specimen in under 30 minutes.

15 Sep 2009

Celldex commences dosing patients in Phase 1/2 study of its CDX-1401 vaccine candidate

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been dosed in a Phase 1/2 study of its vaccine candidate, CDX-1401, in patients with malignant solid tumors that express NY-ESO-1. CDX-1401 is a fully human monoclonal antibody designed to selectively deliver the NY-ESO-1 antigen to dendritic cells to generate a robust immune response against cancer cells expressing NY-ESO-1.

14 Sep 2009

Phase IIa trial results of panobacumab released

Kenta Biotech has presented positive Phase IIa results of its lead drug candidate, panobacumab (KBPA101), showing it is safe and well tolerated in patients with hospital-acquired pneumonia caused by Pseudomonas aeruginosa. The compound, a fully human IgM monoclonal antibody, has the potential to reduce mortality rates.

14 Sep 2009

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Genzyme Corporation reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.

14 Sep 2009

Accupac to manufacture Access Pharmaceuticals' MuGard

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP) has entered into an agreement with a leading commercial manufacturer to produce its FDA-approved MuGard for North American distribution. One or more U.S. market seeding studies could begin as early as Q4 2009, the company says.

11 Sep 2009

Abstracts on Merck Serono oncology treatments to be presented at ECCO and ESMO

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, continues to drive the global effort to ensure patients receive personalized cancer therapies. A total of 17 abstracts concerning Merck Serono oncology treatments will be presented at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO), to be held in Berlin from 20-24 September 2009.

11 Sep 2009

Update on Prolindac clinical development plan provided by Access Pharmaceuticals

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), provided an update today on the Company's clinical development plan for ProLindac, a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies.

11 Sep 2009

Amylin and Biocon collaborate to develop a peptide therapeutic for treating diabetes

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Biocon, Limited (NSE: BIOCON) announced today that they have entered into an exclusive agreement to jointly develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes. Amylin and Biocon will collaborate to develop the therapeutic potential of the compound and share development costs. Research will center on Amylin's "phybrid" technology.

11 Sep 2009

New treatment strategies for multiple sclerosis

The drawback in the new immunotherapies in multiple sclerosis (MS) includMe severe infections that can be fatal. For example, treatment with natalizumab, which reduces the immune surveillance of the brain, can lead to the development of progressive multifocal leukoencephalopathy (PML), a typically fatal form of viral encephalitis.

10 Sep 2009

arGEN-X BV announces first closing of its Series A equity financing round

arGEN-X BV, a biopharmaceutical company focused on the discovery and development of human antibodies using its proprietary SIMPLE Antibody platform, today announced the successful first closing of its Series A equity financing round. The Company raised EUR 9.5million (~ USD 13.6 million) from a syndicate of leading life science investors. The financing round is one of the largest of its kind in the last 12 months.

10 Sep 2009

Therapeutic principles of monoclonal antibodies

Professor Joachim R. Kalden, Member of the Department for Molecular Immunology, Nikolaus-Fiebiger-Zentrum, University Medical School Erlangen-Nuremberg, presents therapeutic principles based on monoclonal antibodies.

10 Sep 2009

Roche Group and ImmunoCellular Therapeutics sign research agreement regarding ICT-69 antibody

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC), a clinical-stage biotechnology company that is developing immune based therapies for the treatment of brain and other cancers, announced today that it has entered into a research and license option agreement regarding its ICT-69 antibody with Roche Group (SWX: ROG.VX; RO.S, OTCQX: RHHBY), one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics.

10 Sep 2009

Bayer submits an IND for its MN-IC antibody-drug conjugate to the FDA

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration with Bayer Schering Pharma AG, Germany. The milestone was triggered by Bayer’s submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for MN-IC, an ADC for solid tumors.

9 Sep 2009

Patient enrollment completed in Phase II clinical trial of bavituximab

Peregrine Pharmaceuticals, Inc. today reported completion of patient enrollment in its Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel in advanced breast cancer patients.

9 Sep 2009

Laureate Pharma and Neoprobe sign manufacturing agreement

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology surgical and diagnostic products, and Laureate Pharma, Inc., a full-service biopharmaceutical development and protein production company, today announced that they have entered into a Biopharmaceutical Development and Manufacturing Agreement.

9 Sep 2009

Axel Ullrich receives the 2009 Dr. Paul Janssen Award for Biomedical Research

Johnson & Johnson today honored the career achievements of Axel Ullrich, Ph.D., with the 2009 Dr. Paul Janssen Award for Biomedical Research. Dr. Ullrich received this award for his scientific discoveries that led to innovative new drugs including Herceptin((R)) (trastuzumab)*, a personalized medicine therapy, which was the first to target a specific type of breast cancer.

8 Sep 2009

Rapid detection and profiling of cancer cells in fine-needle aspirates

Using a new type of paramagnetic nanoparticle and a nuclear magnetic resonance (NMR) system built into a microfluidic device, a team of investigators at the Massachusetts General Hospital and Harvard Medical School has created an assay system capable of detecting as few as two cancer cells in 1 microliter of biological fluid. In addition, the new assay requires little sample processing and produces results in less than 15 minutes.

7 Sep 2009

New protein fragments identified for anthrax vaccine development

Researchers at Albert Einstein College of Medicine of Yeshiva University have identified two small protein fragments that could be developed into an anthrax vaccine that may cause fewer side effects than the current vaccine.

4 Sep 2009

Novel SLE Responder Index as the primary endpoint in two Phase 3 clinical trials

Human Genome Sciences, Inc. today announced publication by the journal Arthritis Care & Research of an article describing the development and use of a novel evidence-based systemic lupus erythematosus (SLE) Responder Index selected as the primary endpoint of two pivotal Phase 3 clinical trials of BENLYSTA (belimumab) in serologically active patients with SLE.

4 Sep 2009

rPA anthrax vaccine and its Valortim anthrax anti-toxin program data presented

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that data from the Company's third generation recombinant protective antigen (rPA) anthrax vaccine program and its Valortim((R)) anthrax anti-toxin program were presented at the Bacillus - ACT 2009 meeting, August 30 - September 3, 2009, organized by the American Society for Microbiology.

4 Sep 2009

Monoclonal Antibody News and Research

Further Reading

FDA clears Diagnostic HYBRIDS' D3 FastPoint L-DFA Respiratory Virus Identification Kit

Celldex commences dosing patients in Phase 1/2 study of its CDX-1401 vaccine candidate

Phase IIa trial results of panobacumab released

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Accupac to manufacture Access Pharmaceuticals' MuGard

Abstracts on Merck Serono oncology treatments to be presented at ECCO and ESMO

Update on Prolindac clinical development plan provided by Access Pharmaceuticals

Amylin and Biocon collaborate to develop a peptide therapeutic for treating diabetes

New treatment strategies for multiple sclerosis

arGEN-X BV announces first closing of its Series A equity financing round

Therapeutic principles of monoclonal antibodies

Roche Group and ImmunoCellular Therapeutics sign research agreement regarding ICT-69 antibody

Bayer submits an IND for its MN-IC antibody-drug conjugate to the FDA

Patient enrollment completed in Phase II clinical trial of bavituximab

Laureate Pharma and Neoprobe sign manufacturing agreement

Axel Ullrich receives the 2009 Dr. Paul Janssen Award for Biomedical Research

Rapid detection and profiling of cancer cells in fine-needle aspirates

New protein fragments identified for anthrax vaccine development

Novel SLE Responder Index as the primary endpoint in two Phase 3 clinical trials

rPA anthrax vaccine and its Valortim anthrax anti-toxin program data presented

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