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.

BioLineRx's BL-9020 antibody holds promise in treating Type 1 diabetes

Type 1 diabetes, which usually appears in children and adolescents, affects over 30 million people worldwide. Resulting from an auto-immune reaction that destroys the pancreatic beta cells that produce insulin, the disease leads to pathologically high levels of sugar in the blood and urine, resulting in high rates of morbidity and mortality. The current treatment for Type 1 diabetes is lifetime administration of insulin by injection.

8 Jun 2015

Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

Janssen Research & Development, LLC has initiated the rolling submission of its Biologic License Application (BLA) for daratumumab to the U.S. Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD.

7 Jun 2015

New strategy involving three-pronged approach may keep lung cancer aside

Lung cancer is the leading cause of cancer death worldwide, responsible for some 1.59 million deaths a year. That figure is due, in part, to the fact that lung cancer often returns after what seems at first to be successful treatment. However, the recurring cancer is often resistant to the chemotherapy and other drugs that originally drove it into remission.

4 Jun 2015

Celltrion receives approval for infliximab biosimilar antibody from Brazil's ANVISA

Hospira, Inc., a global leader in biosimilars, today announced that its partner, Celltrion – a global biopharmaceutical company – has received approval from ANVISA – the National Health Surveillance Agency in Brazil – for Remsima (infliximab), the first biosimilar monoclonal antibody approved for use in Brazil.

2 Jun 2015

MorphoSys' MOR202 proprietary drug candidate meets primary endpoints in multiple myeloma patients

MorphoSys AG today published first safety and efficacy data on its proprietary drug candidate MOR202. The data are from a phase 1/2a study in 42 heavily pretreated patients with relapsed/refractory multiple myeloma.

2 Jun 2015

Elusys’ Anthim BLA to treat inhalational anthrax accepted for review by the FDA

Elusys Therapeutics, Inc. today announced the U.S. Food and Drug Administration has accepted for filing and review its Biologics License Application for Anthim® (obiltoxaximab) for the treatment and prevention of inhalational anthrax, a top bioterror threat which was submitted on March 20, 2015. Anthim is a candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness.

2 Jun 2015

MedImmune, AstraZeneca present encouraging results from new combination-focused immuno-oncology portfolio at ASCO 2015

AstraZeneca and MedImmune, the company’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015.

2 Jun 2015

Pharmacyclics's Phase III RESONATE™ trial shows adherence to 420mg dose of IMBRUVICA improves outcomes in CLL patients

Pharmacyclics LLC today highlighted results from a sub-analysis of the Phase III RESONATE™ (PCYC-1112) trial, which found that previously-treated patients with chronic lymphocytic leukemia (CLL) who adhered to the recommended 420 mg dose of IMBRUVICA® (ibrutinib) experienced improved progression-free survival (PFS; the primary endpoint) as assessed by an Independent Review Committee (IRC), compared to patients who took lower doses or missed doses, regardless of high-risk genetic factors.

1 Jun 2015

Halozyme announces positive Phase 2 results of PEGPH20 drug for treating metastatic pancreatic cancer patients

Halozyme Therapeutics, Inc., a biotechnology company developing novel oncology and drug-delivery therapies, today announced interim findings from the ongoing phase 2 clinical study of its investigational new drug PEGPH20 for the potential treatment of patients with metastatic pancreatic cancer.

1 Jun 2015

Amgen and Merck expand collaboration for Talimogene laherparepvec-KEYTRUDA combination study

Amgen and Merck, known as MSD outside the U.S. and Canada, today announced an expanded collaboration to evaluate the efficacy and safety of talimogene laherparepvec, Amgen's investigational oncolytic immunotherapy, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in a Phase 1, open-label trial of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

1 Jun 2015

Daratumumab achieves 29.2% overall response rate in heavily pre-treated patients with multiple myeloma

Data from the international, multi-center, open-label, two-part, single-arm Phase 2 MMY2002 (SIRIUS) trial show treatment with single-agent daratumumab – an investigational, human anti-CD38 monoclonal antibody – achieved an overall response rate (ORR) of 29.2 percent (95% CI, 20.8-38.9), as assessed by an independent review committee, in heavily pre-treated patients with multiple myeloma.

30 May 2015

Inhibitors BGB324 and BGB10C9 show promise in multiple murine models of pancreatic cancer

BerGenBio AS, an oncology biopharmaceutical company, today announces that an abstract on the latest data on BGB324, the Company's first-in-class, selective small molecule inhibitor of the Axl receptor tyrosine kinase, and BGB10C9, an Axl function-blocking monoclonal antibody in pre-clinical development at BerGenBio, has been published in conjunction with the 2015 American Society of Clinical Oncology Annual Meeting in Chicago, May 29 - June 2, 2015.

30 May 2015

Global market for asthma treatment expected to reach $21.7 billion by 2020

Despite generic erosion facing several of the leading asthma brands, such as Advair (fluticasone propionate/salmeterol xinafoate), Symbicort (budesonide/formoterol fumarate) and Xolair (omalizumab), the global market for asthma treatment is set to witness moderate growth by the end of the decade.

29 May 2015

Monoclonal antibody nivolumab improves survival rates of melanoma patients

The monoclonal antibody nivolumab has shown promise as a therapeutic agent, particularly by improving the survival rates of melanoma patients. Jeffrey S. Weber, M.D., Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt Cancer Center will be presenting data from a retrospective analysis of the safety of nivolumab in 4 ongoing phase I-III studies in melanoma patients at the 2015 American Society of Clinical Oncology Annual Meeting in Chicago.

29 May 2015

MEDI4736 and tremelimumab combination shows acceptable safety, potential efficacy in NSCLC patients

Advanced non-small cell lung cancer (NSCLC) patients have few effective treatment options and low 5-year survival rates. The checkpoint inhibitors MEDI4736 and tremelimumab have both demonstrated acceptable safety and potential efficacy when used as single-agents in several different types of cancer.

29 May 2015

iCo Therapeutics reports financial results for first quarter 2015

iCo Therapeutics, today reported financial results for the quarter ended March 31, 2015. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS").

29 May 2015

New genetic models allow for comprehensive analysis of drivers for osteosarcoma

New models developed at the Masonic Cancer Center, University of Minnesota reveal the genes and pathways that, when altered, can cause osteosarcoma. The information could be used to better target treatments for the often-deadly type of cancer.

27 May 2015

Researchers identify six mRNA isoforms that could be used to diagnose early-stage ovarian cancer

Ovarian cancer is notoriously difficult to diagnose and treat, making it an especially fatal disease. Researchers at University of California, San Diego School of Medicine and Moores Cancer Center have now identified six mRNA isoforms (bits of genetic material) produced by ovarian cancer cells but not normal cells, opening up the possibility that they could be used to diagnose early-stage ovarian cancer.

26 May 2015

SARIL-RA-TARGET trial: Sarilumab meets co-primary efficacy endpoints in RA patients

Regeneron Pharmaceuticals, Inc. and Sanofi announced today that a Phase 3 study of sarilumab, an investigational, fully human IL-6 receptor antibody, met its co-primary efficacy endpoints of a greater improvement in signs and symptoms of rheumatoid arthritis (RA) at 24 weeks and physical function at 12 weeks, compared to placebo.

21 May 2015

Merus and Selexis receive a € 2.1 million grant for single cell line manufacturing of a bispecific antibody combination to treat colorectal cancer

Merus and Selexis will combine their unique and proprietary Oligoclonics® and SUREtechnology™ platforms respectively to develop a product combining two bispecific full length IgG antibodies that simultaneously targets and potently inhibits three receptor tyrosine kinases...

20 May 2015

Monoclonal Antibody News and Research

Further Reading

BioLineRx's BL-9020 antibody holds promise in treating Type 1 diabetes

Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

New strategy involving three-pronged approach may keep lung cancer aside

Celltrion receives approval for infliximab biosimilar antibody from Brazil's ANVISA

MorphoSys' MOR202 proprietary drug candidate meets primary endpoints in multiple myeloma patients

Elusys’ Anthim BLA to treat inhalational anthrax accepted for review by the FDA

MedImmune, AstraZeneca present encouraging results from new combination-focused immuno-oncology portfolio at ASCO 2015

Pharmacyclics's Phase III RESONATE™ trial shows adherence to 420mg dose of IMBRUVICA improves outcomes in CLL patients

Halozyme announces positive Phase 2 results of PEGPH20 drug for treating metastatic pancreatic cancer patients

Amgen and Merck expand collaboration for Talimogene laherparepvec-KEYTRUDA combination study

Daratumumab achieves 29.2% overall response rate in heavily pre-treated patients with multiple myeloma

Inhibitors BGB324 and BGB10C9 show promise in multiple murine models of pancreatic cancer

Global market for asthma treatment expected to reach $21.7 billion by 2020

Monoclonal antibody nivolumab improves survival rates of melanoma patients

MEDI4736 and tremelimumab combination shows acceptable safety, potential efficacy in NSCLC patients

iCo Therapeutics reports financial results for first quarter 2015

New genetic models allow for comprehensive analysis of drivers for osteosarcoma

Researchers identify six mRNA isoforms that could be used to diagnose early-stage ovarian cancer

SARIL-RA-TARGET trial: Sarilumab meets co-primary efficacy endpoints in RA patients

Merus and Selexis receive a € 2.1 million grant for single cell line manufacturing of a bispecific antibody combination to treat colorectal cancer

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