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Monoclonal antibodies modelling - predictive analytics

Improved analytics is helping to ensure that the active pharmaceutical ingredient (API) quality attributes of monoclonal antibodies (MAbs) are identified as early as possible, determining both the desirable and undesirable characteristics, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010 (see also How to tackle overcapacity in monoclonal antibody production, Improving monoclonal antibody production - antibody-drug conjugate technology and Modern monoclonal antibody production - focus on quality by design, timelines, cost)

Improving monoclonal antibody production - antibody-drug conjugate technology

Researchers are developing new approaches to improve monoclonal antibody (MAb) production, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010 (see also How to tackle overcapacity in monoclonal antibody production, Monoclonal antibodies modelling - predictive analytics and Modern monoclonal antibody production - focus on quality by design, timelines, cost)

GTC achieves high-level production of TG20, a biobetter anti-CD20 MAb with enhanced antibody-dependent cell-mediated cytotoxicity

GTC Biotherapeutics announced on 1 March 2010 that it has achieved high-level production of TG20; an anti-CD20 monoclonal antibody (MAb). The TG20 MAb, which is produced in the milk of transgenic goats, is being co-developed by GTC and LFB as part of an LFB-GTC joint venture.

Biosimilar epoetin zeta gets positive EMA-CHMP opinion for SC route in renal patients in EU

Hospira announced on 22 February 2010 that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended for approval the administration of Retacrit (epoetin zeta) subcutaneously in the nephrology setting. This provides an alternative option to intravenous (IV) delivery of the drug for the symptomatic treatment of anaemia associated with chronic renal failure. Final approval by the European Commission is expected in the next few months, which will result in marketing authorisation for Retacrit subcutaneous (SC) administration in all EU Member States.

Rituximab gets US FDA approval for chronic lymphocytic leukaemia

The US FDA has approved Roche’s Genentech/Biogen Idec's anti-CD20 monoclonal antibody Rituxan/MabThera (rituximab) plus chemotherapy for people with either previously untreated or previously treated (relapsed or refractory) chronic lymphocytic leukaemia (CLL).

As pointed out by Scrip, MabThera was approved in the EU in 2009 for these same indications. However, US approval was held up by a complete response letter issued by the FDA in November 2009. The companies said then that the agency had not requested any new data to complete its review of these applications, but that they were continuing final labelling discussions.

FDA approves Amgen’s and Johnson & Johnson's the risk evaluation and mitigation strategy (REMS) for erythropoiesis-stimulating agents (ESAs)

Amgen and Johnson & Johnson (J&J) announced on 16 February 2010 that the US FDA approved the companies' risk management strategy for patients with chemotherapy-induced anaemia who are receiving erythropoiesis-stimulating agents (ESAs), including Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), and Johnson & Johnson's Procrit (epoetin alfa).

Aglycosylated IgG mAbs can be engineered to display unique FcγR selectivity that mediate antibody dependent cell-mediated cytotoxicity

Until recently, bacterially derived monoclonal antibodies (mAbs) were unable to recruit innate immune cells and were thus ineffective at raising an attack against tumour cells. However, Mr George Georgiou et al. of the University of Texas, Austin, found that engineered mutations in the Fc domain can improve innate immune cell recognition by mAbs manufactured in bacteria, as published in the Proceedings of the National Academy of Sciences.

The study stems from efforts to make therapeutically useful mAbs in bacteria. A key roadblock is that bacterially manufactured antibodies lack Fc region glycosylation. “Antibodies that are not glycosylated cannot be recognised by immune cells,” said Mr Georgiou. In the article it is described how aglycosylated IgG variants expressed in bacteria that selectively bind FcγRI potentiate tumour cell killing by monocyte-dendritic cells. The authors explain that the N-linked glycan of immunoglobulin G (IgG) is indispensable for the interaction of the Fc domain with Fcγ receptors on effector cells and the clearance of target cells via antibody dependent cell-mediated cytotoxicity (ADCC). E.coli-expressed, aglycosylated Fc domains bind effector FcγRs poorly and cannot elicit ADCC.

US FDA prepares for biosimilars in 2011 budget plan, despite stalled healthcare reform bill

Increasing inspections and creating a regulatory pathway for the approval of biosimilars are among the most important areas of the US FDA's fiscal 2011 budget request, US Department of Health and Human Services (HHS) Secretary Ms Kathleen Sebelius says. In testimony before the House Energy and Commerce Committee on 4 February 2010, Ms Sebelius focused on funds included in the budget request for the FDA's efforts to improve medical product safety, including increased inspections and investment in tools to enhance the safety of increasingly complex drugs and biologics.

FDA accepts Teva’s biosimilar filgrastim BLA, Amgen not

The US FDA has accepted Teva‘s application to sell a biosimilar version of Amgen's Neupogen (filgrastim), although the biotech giant is working to block the move in court.

XM02, a granulocyte colony-stimulating factor (G-CSF), is designed to treat severe neutropenia, a haematological disorder characterised by an abnormally low number of white blood cells. If approved, the drug would be marketed under the name Neutroval by US pharma company Hospira, which in 2009 acquired worldwide rights to the new version in a deal that also saw it gain manufacturing capacity for filgrastim and pegfilgrastim - a long-acting version of the drug marketed by Amgen as Neulasta. The worldwide market for Neulasta and Neupogen currently stands at more than US$2 billion.

Celtic Pharma invests in Cantab, PolyTherics for ‘biosuperiors’

As reported by Genetic Engineering & Biotechnology News on 25 and 26 January 2010, Celtic Pharma Holdings is making an initial £5 million (about $8.1 million) investment in Cantab Biopharmaceuticals, Cambridge, UK. Cantab is wholly owned by the Celtic Pharma Holdings II LP (CP2) fund. The new CP2 funding will be spread over three years and will support the development of the firm’s first clinical-stage so-called ‘biosuperior’ biologic in haematology.