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.

NIH grant for Lpath to advance clinical development of its antibody therapeutics

The National Cancer Institute's Small Business Innovation Research (SBIR) Program has awarded Lpath (OTCBB: LPTN), the category leader in lipidomics-based therapeutics, two Phase 1 grants totaling $0.3 million. This follows a series of other SBIR grants awarded to Lpath totaling $6.9 million, including a $3.0 million Phase 2 bridge grant from the NCI awarded this past June.

21 Oct 2009

Repligen completes patient treatment in its Phase 3 RG1068 clinical trial

Repligen Corporation reported today that it has completed patient treatment in its Phase 3 clinical trial of RG1068, synthetic human secretin, in magnetic resonance imaging (MRI) of the pancreas. The study is designed to assess the sensitivity and specificity of RG1068 in conjunction with MRI for the detection of pancreatic duct abnormalities compared to MRI alone.

20 Oct 2009

SIMPONI treatment results in greater inhibition of structural damage in arthritis patients

Phase 3 data reported for the first time show that once every four week subcutaneous injections of SIMPONI(TM) (golimumab) resulted in significantly greater inhibition of structural damage compared with placebo plus methotrexate in patients with active rheumatoid arthritis (RA) and active psoriatic arthritis (PsA).

20 Oct 2009

ImmunoCellular Therapeutics files a provisional patent application

ImmunoCellular Therapeutics, Ltd., a clinical-stage biotechnology company that is developing immune-based therapies for the treatment of brain and other cancers, announced today that it has filed a provisional patent application at US Patent Office seeking protection of intellectual property relating to novel glycosylated epitopes present in lung cancer, pancreatic cancer and colon cancer that are targeted by the Company’s ICT-109 monoclonal antibody product candidate.

20 Oct 2009

Origene Technologies' acquisition of Marligen Biosciences reinforces its leading position in the bio-medical research industry

OriGene Technologies, Inc. today announced the acquisition of Marligen Biosciences, Inc., a provider of cutting-edge multiplex assays for the Luminex xMAP(R) platform for protein and gene expression profiling assays and testing services, and DNA and RNA purification kits.

20 Oct 2009

Human Genome Sciences and GlaxoSmithKline to present Phase 3 trial results of BENLYSTA

Human Genome Sciences, Inc. and GlaxoSmithKline PLC (GSK) today announced the full presentation of results from BLISS-52, the first of two pivotal Phase 3 trials of BENLYSTA™ (belimumab) in seropositive patients with systemic lupus erythematosus (SLE).

20 Oct 2009

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

New long-term data from two pivotal, Phase 3 clinical trials showed that patients with active rheumatoid arthritis (RA) receiving SIMPONI(TM) (golimumab) every four weeks achieved sustained improvements in signs and symptoms and physical function response through one year. These new data were presented today at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting.

19 Oct 2009

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis.

19 Oct 2009

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Quotient Biodiagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved its biologics license application (BLA) for the first 15 monoclonal antibodies in its proprietary line of transfusion diagnostics. These products are for use by blood donor centers, reference laboratories, and hospitals to type and screen blood.

19 Oct 2009

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

Genentech, Inc., a wholly-owned member of the Roche Group, today announced two-year results from a Phase III study, which showed that people with rheumatoid arthritis (RA) who received either a 4 mg/kg or 8 mg/kg dose of ACTEMRA® (tocilizumab), in combination with methotrexate, had no progression of joint damage, (75 and 83 percent, respectively, as assessed by radiograph) compared with people who received methotrexate alone (66 percent).

19 Oct 2009

Access Pharmaceuticals' update on its European commercial launch of Mugard

ACCESS PHARMACEUTICALS, INC. today provided an update on its European commercial launch of MuGard, an FDA approved treatment for oral mucositis, a debilitating side effect of radiation treatment and chemotherapy.

15 Oct 2009

PIKAMAB obtains U.S. patent rights to develop theragnostic product

PIKAMAB, a stratified medicine biopharmaceutical company, announced today that it has secured exclusive rights to two issued U.S. patents from Hospital for Special Surgery, New York. PIKAMAB is developing Lupus TherasightTM, a novel theragnostic product that will eventually help guide the drug development process and patient treatment protocols in the areas of lupus and lupus nephritis.

15 Oct 2009

Progenics Pharmaceuticals and Wyeth Pharmaceuticals sign license agreement

Progenics Pharmaceuticals, Inc. today announced that it has entered into an agreement with Wyeth Pharmaceuticals, a division of Wyeth under which Progenics is regaining all worldwide rights to the RELISTOR® franchise from Wyeth Pharmaceuticals, which Progenics had previously licensed to Wyeth Pharmaceuticals.

14 Oct 2009

Study: Animals are not essential for human cancer research

A recently released paper published in the journal Alternatives to Laboratory Animals (ATLA 37, 399-416), presents a serious challenge to long-standing claims that animals are an important part of human cancer research.

14 Oct 2009

AVANIR Pharmaceuticals announces results of Zenvia double-blind Phase III STAR trial

AVANIR Pharmaceuticals, Inc. today announced detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ (dextromethorphan/quinidine) compared to placebo in the treatment of pseudobulbar affect (PBA) in patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS).

14 Oct 2009

Sanofi-aventis collaborates with Merrimack Pharmaceuticals for rights to human monoclonal antibody MM-121

Dyax Corp. announced today new developments involving drug candidates identified using the Company’s proprietary phage display technology as a result of two deals recently announced by sanofi-aventis.

13 Oct 2009

Johnson & Johnson announces financial results for the third quarter of 2009

Johnson & Johnson today announced sales of $15.1 billion for the third quarter of 2009, a decrease of 5.3% as compared to the third quarter of 2008. Operational results declined 2.8% and the negative impact of currency was 2.5%. Domestic sales declined 8.1%, while international sales declined 2.5%, reflecting operational growth of 2.4% and a negative currency impact of 4.9%.

13 Oct 2009

Compugen, Bayer Schering Pharma sign collaboration agreement for tumor research

Compugen Ltd. announced today that they have signed a collaboration agreement with Bayer Schering Pharma AG, Germany covering the further evaluation of a Compugen discovered tumor target and its splice variants.

13 Oct 2009

Selexis and Irvine Scientificti to jointly present results of recent collaborative effort

Selexis SA and Irvine Scientific Inc. announced today plans to jointly present results of a recent collaborative effort combining the Selexis SURE Cell Line Development Programs(TM) and the Irvine IS CHO Culture System, demonstrating the rapid production of gram quantities of monoclonal antibodies from stable CHO production cell lines.

12 Oct 2009

World’s first engineered T cell receptor trial opens with new cellular therapy for HIV

Researchers at Adaptimmune Limited and the University of Pennsylvania School of Medicine, have announced the approval of an Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) and opening for enrolment of the first ever study using patients’ cells carrying an engineered T cell receptor to treat HIV (SL9 HA-GAG-TCR). The trial may have important implications in the development of new treatments for HIV potentially slowing – or even preventing – the onset of AIDS.

11 Oct 2009

Monoclonal Antibody News and Research

Further Reading

NIH grant for Lpath to advance clinical development of its antibody therapeutics

Repligen completes patient treatment in its Phase 3 RG1068 clinical trial

SIMPONI treatment results in greater inhibition of structural damage in arthritis patients

ImmunoCellular Therapeutics files a provisional patent application

Origene Technologies' acquisition of Marligen Biosciences reinforces its leading position in the bio-medical research industry

Human Genome Sciences and GlaxoSmithKline to present Phase 3 trial results of BENLYSTA

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Genentech reports results of ACTEMRA Phase III study for rheumatoid arthritis

Access Pharmaceuticals' update on its European commercial launch of Mugard

PIKAMAB obtains U.S. patent rights to develop theragnostic product

Progenics Pharmaceuticals and Wyeth Pharmaceuticals sign license agreement

Study: Animals are not essential for human cancer research

AVANIR Pharmaceuticals announces results of Zenvia double-blind Phase III STAR trial

Sanofi-aventis collaborates with Merrimack Pharmaceuticals for rights to human monoclonal antibody MM-121

Johnson & Johnson announces financial results for the third quarter of 2009

Compugen, Bayer Schering Pharma sign collaboration agreement for tumor research

Selexis and Irvine Scientificti to jointly present results of recent collaborative effort

World’s first engineered T cell receptor trial opens with new cellular therapy for HIV

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