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GA101 succeeds in Phase III

17.05.2013 - Roche’s glyco-optimised anti-CD20 antibody obinutuzumab (GA101) significantly reduced the risk of disease in patients with leukaemia (CCL).

According to the first results from Roche/Genentech’s Phase III-CLL11, GA101 plus chlorambucil therapy more than doubled progression-free survival (PFS) of treatment-native chronic lymphocytic leukaemia  (CCL) patients (23 months compared to 10.9 months, HR=0.14, 95% CI 0.09-0.21, p <.0001) compared to the chemotherapeutic chlorambucil alone. The combination therapy with chlorambucil demonstrated a significant 86% reduction in the risk of disease progression, relapse or death. Full data will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago on 4th June.  

In the third arm of the trial including 192 patients, Roche compares the efficacy of the type-II-anti-CD20 antibody GA101 versus its type-I-anti-CD20 blockbuster MabThera (rituximab) both in combination with chlorambucil. According to Roche GlycArt’s head, Pablo Umaña, GA101 has been glyco-optimised to show improved antibody-dependent cellular cytotoxicity and direct cytotoxicity. Roche said that at this time, no formal comparison between the GA101 and MabThera/Rituxan arms can be made as the number of PFS events required for that formal analysis has not yet been reached. However the company has filed for market authorisation in the US and the EU based on the CLL11 study.  

CLL is one of the most common forms of blood cancer and each year it causes approximately 75,000 deaths across the globe. The CLL11 study included elderly people with previously untreated CLL who were often not able to tolerate existing aggressive treatment options. According to Roche, no new safety signals were detected for either GA101 or MabThera/Rituxan. The most common severe adverse events for GA101 were infusion-related reactions (IRRs) and low cell counts of neutrophile (neutropenia).

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-02/rituxan-successor-succeeds-in-phase-iii.html

Industry reportGermany

27.04.2016 More revenue, more jobs, more financing, more R&D expenditure – all signs point towards sustainable growth in the German biotech sector. These are the results of the most recent company survey 2016, published by biotechnologie.de. The report was once again conducted alongside the biotech standards defined by the organisation for economic cooperation and development (OECD).

Clinical ResearchFrancePortugal

21.04.2016 An expert panel’s final report on the fatal drug trial earlier this year in France states that the death of one of the participants was most likely caused by the drug’s toxicity and not by any violation of the rules.

Immuno-oncologyNetherlandsBelgium

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RegulatorySwitzerlandEU

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Immuno-oncologyUK

19.04.2016 British drug developer Heptares Therapeutics and mAb maker Kymab Ltd have partnered up in yet another immuno-oncology collaboration. The companies plan to discover antibody meds targeting a superfamily of receptors.

FinancingSwitzerlandFranceEUGermanyDenmark

15.04.2016 Not every company is put off by the current stock market climate. Swiss biopharma company GeNeuro has gone public at Euronext Paris, raising €33m in the process. Others, meanwhile, have to find different ways to raise money.

Event ReviewSwitzerlandBelgiumEU

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FinancingGermanyNetherlandsEU

12.04.2016 German-Dutch life science investment specialist Forbion Capital Partners has raised more than €180m for its venture capital fund Forbion Capital Fund III. Once more the money will primarily go to European start-ups.

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08.04.2016 Do you win by being innovative?, was the question asked at this year’s DIA Euromeeting in Hamburg. In a relaxed and cooperative atmosphere, regulators, physicians and patients had ample opportunity to interact with the healthcare industry.

M&AIrelandEU

07.04.2016 Pfizer and Allergan have called off their merger, cancelling plans to relocate the US pharma giant to Ireland to avoid US taxation. The US government has put a spoke in Pfizer’s wheels - an unfair move, Allergan says.

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