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.

Positive Phase 2 study results of CDX-011 reported by Celldex Therapeutics

Celldex Therapeutics, Inc. today announced the results of a positive Phase 2 study of CDX-011 (formerly CR011-vcMMAE), in patients with heavily pre-treated, locally advanced or metastatic breast cancers.

13 Dec 2009

Phase 1 clinical trial of iCo-007 demonstrates positive safety profile

iCo Therapeutics Inc. - iCo Therapeutics ("iCo") is pleased to announce that its Phase 1 clinical trial of iCo-007, having enrolled all patients in four cohorts of increasing concentration (110ug, 350ug, 700ug, 1000ug), has to date demonstrated a positive safety profile.

12 Dec 2009

Zevalin clinical data presented at 2009 ASH meeting

Spectrum Pharmaceuticals, Inc., a commercial stage biotechnology company with a primary focus in oncology, today announced that clinical data on ZEVALIN (ibritumomab tiuxetan) was presented at the 51st Annual Meeting of the American Society of Hematology (ASH), which was held December 5-8, 2009 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

11 Dec 2009

Genentech terminates dacetuzumab collaboration agreement with Seattle Genetics

Seattle Genetics, Inc. today reported that it has been notified by Genentech, a wholly owned member of the Roche Group, that Genentech has elected to terminate the companies’ collaboration agreement for dacetuzumab (SGN-40). Dacetuzumab is a monoclonal antibody targeting CD40 that has been investigated in clinical trials for non-Hodgkin lymphoma and multiple myeloma.

11 Dec 2009

Update on proposed transaction that will lead to the merger of Cytopia into YM BioSciences provided

YM BioSciences Inc., a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today provided an update on the proposed transaction which would result in the merger of Cytopia Ltd. into YM, details of which were announced on October 5, 2009.

11 Dec 2009

Genentech and Biogen Idec report positive outcome from ocrelizumab-MTX combination study in RA

Genentech, Inc. a wholly owned member of the Roche Group, and Biogen Idec announced today a Phase III study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by American College of Rheumatology or ACR20 response) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks.

11 Dec 2009

YM BioSciences announces results of collaborative antibody development program

YM BioSciences Inc., today announced the first results of a collaborative program between YM and the National Research Council of Canada's Biotechnology Research Institute (NRC-BRI). Utilizing YM's IntelliMab(TM) technology, the program is designed to generate novel antibodies that target cell surface receptors associated with cancer, uniquely optimized to produce efficacy with reduced toxicities.

10 Dec 2009

Eli Lilly provides financial guidance for 2010

At its annual meeting today with the investment community, Eli Lilly and Company highlighted how its innovation-based strategy will enable it to better serve patients and compete effectively in a challenging health care environment. The company also detailed the progress being made in its labs and across its five new business units on an expanding pipeline of innovative molecules and marketed medicines, and provided investors with the company's financial guidance for 2010.

10 Dec 2009

Additional data from ALS patients enrolled in confirmatory Phase III STAR trial announced

AVANIR Pharmaceuticals, Inc. today announced additional data from the subset of patients with amyotrophic lateral sclerosis (ALS) enrolled in the confirmatory Phase III STAR trial.

9 Dec 2009

Phase 3 clinical trial results of RG1068 to be discussed

Repligen Corporation announced today that the Company President and Chief Executive Officer, Walter C. Herlihy, Ph.D., will host a conference call and webcast on Wednesday, December 9th, 2009 at 8:30 a.m. EST, to discuss results of its Phase 3 clinical trial of RG1068 in MRI imaging of the pancreas.

9 Dec 2009

Mozobil with chemotherapy may have a therapeutic impact on leukemic cells, reveals study

Genzyme Corporation announced today that a Phase 1/2 trial provided early clinical data suggesting that Mozobil (plerixafor injection) in combination with chemotherapy may offer a therapeutic impact on leukemic cells protected in bone marrow.

9 Dec 2009

GSK updates long-term survival data of BEXXAR Therapeutic Regimen for Non-Hodgkin's lymphoma

GlaxoSmithKline announced today updated long-term survival data from two Phase II studies of BEXXAR® (tositumomab and iodine I-131 tositumomab) used in either patients with previously untreated cancer of the immune system (follicular lymphoma) or in patients with cancer of the lymphocytes (non-Hodgkin's lymphoma, NHL) that no longer responded to rituximab.

9 Dec 2009

BARDA cancels PharmAthene's RFP for Recombinant Protective Antigen Anthrax Vaccine

PharmAthene, Inc. a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced today that the Department of Health and Human Services Biomedical Research and Development Authority (BARDA) has canceled its request for proposal (RFP) for Recombinant Protective Antigen Anthrax Vaccine for the Strategic National Stockpile (RFP BARDA 08-15).

8 Dec 2009

Neovacs announces initiation of a Phase IIa clinical study of TNFα Kinoid immunotherapy

Neovacs, a biotechnology company developing proprietary immunotherapies for autoimmune and chronic diseases, today announced the initiation of a Phase IIa clinical study of its TNFα Kinoid immunotherapy in rheumatoid arthritis patients who have ceased to respond to an anti-TNFα monoclonal antibody and who test positive for anti-drug antibodies (ADAs).

8 Dec 2009

ImmunoGen's SAR3419 holds hope for B-cell non-Hodgkin’s lymphoma

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of encouraging initial clinical findings with SAR3419 at the American Society of Hematology (ASH) 51st Annual Meeting and Exposition. Among the findings reported were responses to SAR3419 – administered as a single agent – among patients with B-cell non-Hodgkin's lymphoma that is refractory to treatment with rituximab (Rituxan®).

8 Dec 2009

Novo Nordisk in-licenses intellectual property rights to IL-21 antibodies

Novo Nordisk A/S and ZymoGenetics, Inc. today announced an agreement where Novo Nordisk in-licenses a fully-human anti-IL21 monoclonal antibody (IL-21 mAb) developed by ZymoGenetics, as well as broad intellectual property rights covering IL-21 mAb and the development of other IL-21 antibodies.

From Novo Nordisk 8 Dec 2009

Potentially promising data from Phase I/II study of elotuzumab presented at ASH 2009

Facet Biotech Corporation and Bristol-Myers Squibb Company announced that potentially promising data from a Phase I/II study of elotuzumab, an investigational humanized antibody being studied for the treatment of relapsed multiple myeloma (MM), were presented today at the American Society of Hematology (ASH) 2009 Annual Meeting in New Orleans.

8 Dec 2009

CAM314 randomized Phase 3 clinical trial results released

Genzyme Corporation announced data from its CAM314 randomized Phase 3 clinical trial comparing Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) (FluCAM) to Fludara alone in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) demonstrated that the FluCAM regimen significantly reduced the risk of disease progression or death compared to single-agent Fludara.

8 Dec 2009

Data from two phase Ib clinical trials of dacetuzumab for DLBCL reported

Seattle Genetics, Inc. today reported data from two phase Ib clinical trials of dacetuzumab, one in combination with Rituxan® (rituximab) and Gemzar® (gemcitabine) for diffuse large B-cell lymphoma (DLBCL), and the other in combination with Revlimid® (lenalidomide) for multiple myeloma.

8 Dec 2009

PharmAthene presents Protexia clinical trial results at PHEMCE conference

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, today announced Phase I clinical trial results for Protexia, a pegylated recombinant version of human butyrylcholinesterase (rBChE), which has been shown to be effective in animal models in preventing toxicity from exposure to chemical nerve agents.

7 Dec 2009

Monoclonal Antibody News and Research

Further Reading

Positive Phase 2 study results of CDX-011 reported by Celldex Therapeutics

Phase 1 clinical trial of iCo-007 demonstrates positive safety profile

Zevalin clinical data presented at 2009 ASH meeting

Genentech terminates dacetuzumab collaboration agreement with Seattle Genetics

Update on proposed transaction that will lead to the merger of Cytopia into YM BioSciences provided

Genentech and Biogen Idec report positive outcome from ocrelizumab-MTX combination study in RA

YM BioSciences announces results of collaborative antibody development program

Eli Lilly provides financial guidance for 2010

Additional data from ALS patients enrolled in confirmatory Phase III STAR trial announced

Phase 3 clinical trial results of RG1068 to be discussed

Mozobil with chemotherapy may have a therapeutic impact on leukemic cells, reveals study

GSK updates long-term survival data of BEXXAR Therapeutic Regimen for Non-Hodgkin's lymphoma

BARDA cancels PharmAthene's RFP for Recombinant Protective Antigen Anthrax Vaccine

Neovacs announces initiation of a Phase IIa clinical study of TNFα Kinoid immunotherapy

ImmunoGen's SAR3419 holds hope for B-cell non-Hodgkin’s lymphoma

Novo Nordisk in-licenses intellectual property rights to IL-21 antibodies

Potentially promising data from Phase I/II study of elotuzumab presented at ASH 2009

CAM314 randomized Phase 3 clinical trial results released

Data from two phase Ib clinical trials of dacetuzumab for DLBCL reported

PharmAthene presents Protexia clinical trial results at PHEMCE conference

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