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.

Repligen receives USPTO Notice of Allowance for patent covering a recombinant form of Protein A

Repligen Corporation announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering a recombinant form of Protein A which is identical in structure to the commercial form of Protein A from Staphylococcus aureus which is used in the production of many of the world's approved monoclonal antibodies. The patent, which will remain in force until 2028, covers a new Repligen proprietary product which is now available in commercial quantities.

4 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 Feb 2010

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

ZymoGenetics, Inc., today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.

2 Feb 2010

New therapeutic made from tobacco plants shown to arrest West Nile virus infection

A new therapeutic made from tobacco plants has been shown to arrest West Nile virus infection, according to a new study by Arizona State University scientist Qiang Chen and his colleagues.

2 Feb 2010

SDI selected for third consecutive time as key monoclonal antibody provider

SDI (Strategic Diagnostics Inc.), a leading provider of biotechnology-based products and services for a broad range of life science, food safety, and industrial applications, today announced it has been selected again by Science Applications International Corporation - Frederick (SAIC-F) to develop monoclonal antibodies for the National Cancer Institute’s “Clinical Proteomic Technologies for Cancer” initiative (CPTC: http://proteomics.cancer.gov).

2 Feb 2010

YM BioSciences-Cytopia merger complete

YM BioSciences Inc., announced that the merger of Cytopia Limited, the Australian biopharmaceutical company, into YM under a Scheme of Arrangement, has been concluded.

1 Feb 2010

Abbott signs licensing agreement with Pierre Fabre SA to develop and commercialize cancer antibody h224G11

Abbott announced today an exclusive worldwide licensing agreement with Pierre Fabre SA to develop and commercialize h224G11, a pre-clinical monoclonal antibody identified at the Centre d'Immunologie Pierre Fabre (CIPF) in France and targeting the cMet receptor for the treatment of cancer.

1 Feb 2010

Clinical results of MedImmune's pivotal trial for motavizumab published

MedImmune today announced that clinical results of its pivotal multinational, randomized, double-masked trial for motavizumab have been published in the current issue of the peer-reviewed publication, Pediatrics: Official Journal of the American Academy of Pediatrics.

30 Jan 2010

Global market for oncology drugs is forecast to reach $80 billion by 2050

New Medicine's Oncology KnowledgeBASE (nm/OK) residing at http://nmok.net became available on the Internet 10 years ago and, since then, the oncology field has evolved into one of the most challenging, complex and promising drug development sectors, both in terms of its potential contribution to medicine and to its market opportunities.

29 Jan 2010

Repligen announces five-year supply agreement for recombinant Protein A with GE Healthcare Bio-Sciences

Repligen Corporation announced today that it has extended its longstanding relationship with GE Healthcare Bio-Sciences AB by entering into a five-year supply agreement for recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies, a highly successful class of biopharmaceutical. Repligen is the world's leading supplier of recombinant Protein A and has manufactured recombinant Protein A for GE Healthcare for more than 10 years.

28 Jan 2010

MBL generates human monoclonal antibodies against pandemic A type influenza virus

Medical & Biological Laboratories Co., Ltd. (MBL), with the collaboration of Osaka University, has successfully generated several fully human monoclonal antibodies against pandemic A (H1N1 and H3N2) type influenza virus by utilizing blood samples from volunteers who were inoculated with influenza vaccine.

27 Jan 2010

Neoprobe completes license amendment with The Dow Chemical

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, announced today that it has completed a license amendment with The Dow Chemical Company for a variety of antibodies used in its proprietary surgical oncology system called radioimmunoguided surgery or RIGS®.

27 Jan 2010

YM BioSciences' nimotuzumab Phase II trials: FDA advises patient enrollment

YM BioSciences Inc., announced that the FDA has advised the Company that it may now enroll patients at US clinical sites into two ongoing randomized, double-blind Phase II trials of its lead product, nimotuzumab. One of the two trials is in non-small-cell lung cancer (NSCLC) patients who are ineligible for curative treatment and being treated palliatively and the other in patients with brain metastases from NSCLC. Current NSCLC palliative treatment and treatment for brain metastases is radiation alone.

27 Jan 2010

Erbitux improves survival of mCRC patients with KRAS wild-type tumors

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Erbitux® (cetuximab) provided an improvement in overall survival (OS) when added to the standard 1st-line FOLFIRI chemotherapy regimen for metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors in the CRYSTAL study.

24 Jan 2010

Amgen announces results of two Phase 3 studies evaluating Vectibix for mCRC

Amgen today announced that detailed results from two pivotal Phase 3 studies evaluating Vectibix® (panitumumab) in combination with chemotherapy for the first and second-line treatment of metastatic colorectal cancer (mCRC) (the PRIME '203' and '181' trials, respectively) will be presented at the 2010 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in Orlando, Florida from Jan. 22-24, 2010.

21 Jan 2010

IMUC’s ICT-107 vaccine product candidate targets cancer stem cells

ImmunoCellular Therapeutics today announced the results of a study in which it was shown that certain specific antigens are highly expressed on cancer stem cells (CSCs). This suggests that IMUC’s lead cancer vaccine product candidate ICT-107, which targets those antigens, may effectively target not only the cells that make up the bulk of certain cancerous tumors, but also the CSCs that are widely believed to give rise to them and cause their recurrence.

21 Jan 2010

Kolltan Pharmaceuticals raises $10M for advancing its therapeutic development pipeline

Kolltan Pharmaceuticals, Inc., a next-generation oncology therapeutics company, announced today that it has raised $10 million in investments and related payments from an affiliate of Celtic Therapeutics Holdings L.P. (“Celtic Therapeutics”) and Tichenor Ventures, LLC.

20 Jan 2010

Fc engineering enhances antibody half-life

A Nature Biotechnology article published online January 17 reveals that Xencor Inc.’s proprietary Fc engineering extends the half-life of antibodies while maintaining their potency and extending duration of action. These results, published in an article entitled, “Enhanced antibody half-life improves in vivo activity” demonstrate the potential of Fc engineering to impact the flexibility of route, schedule and dose for nearly any antibody.

20 Jan 2010

Access Pharmaceuticals provides update on its Cobalamin insulin development program

ACCESS PHARMACEUTICALS, INC. provided an update today on its Cobalamin™ oral drug delivery product development programs. The proprietary Cobalamin™ technology utilizes the body's natural vitamin B12 oral uptake mechanism to facilitate oral absorption of pharmaceuticals by a "Trojan horse" mechanism.

20 Jan 2010

CytoDyn commences enrollment in Cytolin clinical trial

Following approval of the Institutional Review Board, CytoDyn, Inc. has discharged its duty to register a clinical trial of Cytolin®, the Company’s lead product, with the government’s website at www.clinicaltrials.gov, ID NCT01048372. The public has online access to this federal database, which describes the key elements of clinical trials and their status.

19 Jan 2010