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.

Solvanix set up to commercialise novel antibody-stabilisation technology

The Garvan Institute of Medical Research announces the launch of spin-off company Solvanix Pty Ltd, set up to commercialise a novel technology that will improve the stability of therapeutic monoclonal antibodies.

17 Jan 2015

3SBio, PharmAbcine sign licensing agreement to develop and market DIG-KT

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced it has entered into an exclusive licensing deal with PharmAbcine Inc. for the development, manufacturing and marketing of DIG-KT, a bi-specific monoclonal antibody ("mAb") targeting both VEGFR2/KDR and Tie-2 pathways for cancer in the territory of Greater China (including mainland China, Taiwan, Hong Kong and Macau) and Korea.

14 Jan 2015

EMA accepts Praluent (alirocumab) MAA for review

Regeneron and Sanofi today announced that the European Medicines Agency has accepted for review the Marketing Authorization Application for Praluent (alirocumab). Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia.

12 Jan 2015

Two new ODYSSEY trials meet primary efficacy endpoints

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that two new ODYSSEY trials, which are the first Phase 3 trials to assess alirocumab administered every four weeks, met their primary efficacy endpoints.

9 Jan 2015

Top cancer research and clinical developments at Dana-Farber Cancer Institute in 2014

Immunotherapy, genomic profiling, and investigating game-changing drug therapies topped the list of most important cancer research and clinical developments at Dana-Farber Cancer Institute in 2014.

1 Jan 2015

Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that enrollment has initiated and the first patient was dosed in a Phase 1b clinical trial of SYN-004, an investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

31 Dec 2014

High speed, high resolution glycan mapping now achievable for mAb characterization

The full characterization of biotherapeutics is required by regulatory authorities as properties such as safety, efficacy and the serum half-life of therapeutic proteins can be affected by differences in their glycosylation pattern. Recombinant monoclonal antibody therapeutics (mAbs) represent the largest group of therapeutic proteins the analysis of the glycan pattern is therefore an essential part of the mAb characterization process.

19 Dec 2014

CMC Biologics, OncoSynergy partner to develop novel potential treatment for Ebola

CMC Biologics and OncoSynergy have entered into an agreement for process development and GMP manufacture of OS2966 – a novel potential treatment for Ebola. The investigational drug candidate, designed to inhibit a major cellular adhesion receptor (CD29) that is fundamental for progression of aggressive and resistant cancer tumors, was granted orphan drug designation by the U.S. FDA earlier this year in the treatment of glioblastoma.

16 Dec 2014

Curie-Cancer, GamaMabs Pharma extend partnership to develop 3C23K drug for gynecological cancers

Curie-Cancer, the body responsible for developing Institut Curie’s industry partnership activities, and GamaMabs Pharma, a company specialized in the development of monoclonal antibodies for cancer, today announce the extension of their partnership to develop the 3C23K antibody for the treatment of gynecological cancers.

16 Dec 2014

PD-L1 expression tied to favourable prognosis in SCLC

Programmed death-ligand 1 is expressed by around 70% of small-cell lung cancers and is associated with favourable patient outcomes, Japanese researchers report.

10 Dec 2014

Targeted therapy with radiopharmaceuticals has great potential for cancer treatment

Cancer therapy can be much more effective using a new way to customize nuclear medicine treatment, researchers say in the December 2014 issue of The Journal of Nuclear Medicine. The process could also be useful for other diseases that could benefit from targeted radiation.

10 Dec 2014

$Vaccinex completes VX15/2503 Phase 1 clinical trial in patients with advanced, refractory solid tumors$

Vaccinex completes VX15/2503 Phase 1 clinical trial in patients with advanced, refractory solid tumors

Vaccinex, Inc. today announced the successful completion of a multicenter Phase 1, multiple ascending dose clinical trial of VX15/2503 anti-Semaphorin 4D (SEMA4D) antibody in 42 adult patients with advanced, refractory solid tumors.

9 Dec 2014

Zydus Cadila becomes world's first company to launch biosimilar of Adalimumab

After more than a decade-long wait, the revolutionary therapy that provided a new lease of life to millions of patients suffering from rheumatoid arthritis and other auto immune disorders globally will now be accessible to patients in India. Zydus Cadila becomes the first company anywhere in the world to launch the biosimilar of Adalimumab - the world's largest selling therapy.

9 Dec 2014

Cornerstone Pharmaceuticals initiates CPI-613 Phase I trial in patients with B-cell NHL

Cornerstone Pharmaceuticals, Inc., a clinical stage company and leader in the growing field of cancer metabolism-based therapeutics, today announced the initiation of a Phase I clinical trial assessing the safety and efficacy of escalating doses of CPI-613, in combination with bendamustine and rituximab, in patients with relapsed or refractory B-cell Non-Hodgkin lymphoma (NHL).

8 Dec 2014

Pembrolizumab shows promising results in patients with classical Hodgkin Lymphoma

Merck, known as MSD outside of Canada and the United States, announced today early study findings demonstrating that patients treated with pembrolizumab, the company's investigational anti-PD-1 cancer therapy, achieved an overall response rate of 66 percent, as assessed by International Harmonization Project response criteria (n=19/29: 95% CI, 46-82).

7 Dec 2014

Novel treatments show promising results in patients with different hematologic disorders

In recent years, a number of scientific breakthroughs have led to the development of drugs that unleash the power of the immune system to recognize and attack cancer. Studies presented today at the 56th Annual Meeting of the American Society of Hematology highlight the enormous potential these novel treatments have for patients with a variety of hematologic disorders.

7 Dec 2014

Novel treatments show safe responses in patients with relapsed, treatment-resistant blood cancers

Novel treatments that harness the body's own immune cells to attack cancer cells demonstrate safe and durable responses in patients with relapsed and treatment-resistant blood cancers, according to data presented today at the 56th American Society of Hematology Annual Meeting and Exposition.

7 Dec 2014

Phenotyping human diseases in mice: an interview with Professor Carola Vinuesa

One of the main obstacles to finding effective therapies for human diseases has been our limited understanding of disease pathogenesis: we lack detailed knowledge of the cellular and molecular mechanisms that lead to the development of disease.

30 Nov 2014

Study provides proof of concept for developing antibodies against human pathogens

Scientists investigating the potentially deadly hantavirus have used a novel approach to developing protective antibodies against it. Their work, published in today's online edition of Science Translational Medicine, provides proof of concept for producing antibodies against a broad range of human pathogens.

28 Nov 2014

3SBio enters into exclusive license agreement with PharmAbcine for Tanibirumab

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced it has entered into an exclusive license with PharmAbcine, Inc. for the development, manufacturing and marketing of Tanibirumab, an anti-VEGFR2/KDR antibody for cancer in the territory of Greater China (including Mainland China, Taiwan, Hong Kong and Macau) and several emerging countries, including Thailand, Brazil and Russia.

18 Nov 2014

Monoclonal Antibody News and Research

Further Reading

Solvanix set up to commercialise novel antibody-stabilisation technology

3SBio, PharmAbcine sign licensing agreement to develop and market DIG-KT

EMA accepts Praluent (alirocumab) MAA for review

Two new ODYSSEY trials meet primary efficacy endpoints

Top cancer research and clinical developments at Dana-Farber Cancer Institute in 2014

Synthetic Biologics doses first patient in SYN-004 Phase 1b trial to prevent C. difficile infection

High speed, high resolution glycan mapping now achievable for mAb characterization

CMC Biologics, OncoSynergy partner to develop novel potential treatment for Ebola

Curie-Cancer, GamaMabs Pharma extend partnership to develop 3C23K drug for gynecological cancers

PD-L1 expression tied to favourable prognosis in SCLC

Targeted therapy with radiopharmaceuticals has great potential for cancer treatment

Vaccinex completes VX15/2503 Phase 1 clinical trial in patients with advanced, refractory solid tumors

Zydus Cadila becomes world's first company to launch biosimilar of Adalimumab

Cornerstone Pharmaceuticals initiates CPI-613 Phase I trial in patients with B-cell NHL

Pembrolizumab shows promising results in patients with classical Hodgkin Lymphoma

Novel treatments show promising results in patients with different hematologic disorders

Novel treatments show safe responses in patients with relapsed, treatment-resistant blood cancers

Phenotyping human diseases in mice: an interview with Professor Carola Vinuesa

Study provides proof of concept for developing antibodies against human pathogens

3SBio enters into exclusive license agreement with PharmAbcine for Tanibirumab

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