News

Symphogen meets Phase II endpoints
Enlarge image

Clinical TrialsDenmarkPolandSweden

Symphogen meets Phase II endpoints

23.08.2012 - Danish Symphogen has published positive study results with the first recombinant polyclonal antibody therapy ever tested in clinical trials.

Results of an open-label, dose-escalation Phase II study including 61 patients with primary immune thromocytopenia (ITP) suggest that  a single injection of rozrolimupab (SYM001) is safe and boosts platelet counts significantly (Blood). In doses ranging from 75-300µg/kg the recombinantly produced mixture of 25 fully human anti-Rhesus D (RhD)-specific antibodies induced mild adverse effects in up to 20% of the volunteers, mostly headache (20%) and pyrexia (13%). In 8 out of 13 patients (62%), Symphogen’s lead drug induced an increase in platelet counts of at least 20x109/L after 72 hours that persisted for seven days after injection. Median time to response was 59 hours and the median duration of response was 14 days.

Lead investigator Professor Tadeusz Robak, from Lodz University said: “These phase II results suggest an efficacy and safety profile similar to that seen with plasma derived immunoglobulin products. Rozrolimupab can be produced indefinitely and may represent a novel and convenient replacement for blood-derived immunoglobulins with more limited supply.” Kirsten Drejer, Symphogen chief executive officer, added: “The multicenter study included involvement of the regulatory authorities of the USA, Europe and Asia, and we are confident that antibody mixtures represent a viable new class of antibody therapeutics offering well-characterized and potentially more efficacious alternatives to existing treatments.”

Symphogen’s rozrolimupab is the first human recombinant mixture of 25 antibodies which has been clinically tested. The mixture is manufactured simultaneously from a single batch, mimicking the natural diversity of the human antibody response.  Sym001 is being developed as an alternative to existing anti-RhD hyperimmune immunoglobulins for the treatment of Idiopathic Thrombocytopenic Purpura (ITP) and the prevention of Hemolytic Disease of Newborns (HDN). Sym001 is being co-developed with Swedish Biovitrum AB. Idiopathic Thrombocytopenic Purpura is an autoimmune bleeding disorder caused by abnormally low platelet levels, making it difficult for the blood to clot normally. Hemolytic Disease in Newborns is a Rhesus D-negative woman becoming sensitive to RhD during the pregnancy with or delivery of a Rhesus D-positive child. This immune reaction may trigger a maternal antibody response in subsequent RhD-positive pregnancies, causing the breakdown of fetal red blood cells.

http://www.european-biotechnology-news.com/news/news/2012-03/symphogen-meets-phase-ii-endpoints.html

Stock MarketsFranceEU

27.03.2015 Europe is once more proving that it can be a good bet for biotech companies going public. A newly established EU-wide lobbying initiative could help the IPO boom on its way.

FinancingPoland

24.03.2015 Poland has announced the closing of a new venture capital fund at US$42m (€32m). The fund, which is the first of its kind in Poland, is dedicated to the Life Sciences with a strong connection to Central and Eastern Europe.

BioeconomyFranceSwedenGermanyNetherlandsFinland

23.03.2015 A BASF-led consortium aims to decrease bio-based production costs using industrial biotechnology. The Horizon2020 funded consortium is the sixth project of the SPIRE Public Private Partnership and has a budget of €14m.

Stock MarketsFranceSwedenUKNorwayIreland

20.03.2015 There are no signs of inertia creeping into the European biotech industry this spring. A total of eight IPOs are set to go public by the end of the year’s first quarter.

FinancingUKEU

17.03.2015 Pharma giants GlaxoSmithKline (GSK) and Johnson & Johnson (J&J) will be key collaborators in a new global fund for dementia research to address the rising threat posed by dementia and Alzheimer’s disease.

FinancingFranceDenmarkSwedenGermany

19.03.2015 French venture capital firm Seventure Partners has raised a further €25m for its microbiome-focused Health for Life Capital Fund. It now stands at €100m.

EventsFranceEUSwitzerlandUKGermany

12.03.2015 With around 1,400 companies and 2,400 participants, the springtime counterpart of BIO-Europe enjoyed a successful premiere in France this year. The overall mood of the European biotech industry was positive, and the French hosts in particular reported new initiatives.

M&ABelgium

11.03.2015 Belgian cell-based therapeutics developer and CMO MaSTherCell SA has been acquired by US biotech Orgenesis Inc. for €23m.

FinancingGermany

10.03.2015 The Gates Foundation has dipped into its purse to bring infectious diseases vaccines to the poorest countries. German vaccine specialist CureVac is set to receive US$52m for their mRNA platform technology.

Stock MarketsIrelandUK

05.03.2015 The IPO wave in the biotech sector shows no signs of slowing down. An Irish life sciences fund set up by former Elan executives plans to raise €325m with its IPO, whilst Summit Therapeutics has announced its IPO pricing of US$34m on Nasdaq.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • ANALYTIK JENA14.00 EUR0.07%
  • 4SC1.28 EUR0.00%
  • ACTELION112.60 CHF0.00%

FLOP

  • CYTOTOOLS31.45 EUR-0.47%
  • 4SC1.28 EUR0.00%
  • ACTELION112.60 CHF0.00%

TOP

  • CYTOS1.40 CHF311.8%
  • MEDIGENE11.65 EUR174.1%
  • 4SC1.28 EUR64.1%

FLOP

  • MORPHOSYS54.71 EUR-26.8%
  • WILEX2.96 EUR-13.7%
  • BASILEA106.70 CHF-12.7%

TOP

  • SANTHERA92.00 CHF2259.0%
  • WILEX2.96 EUR393.3%
  • FORMYCON23.15 EUR230.7%

FLOP

  • CYTOS1.40 CHF-53.0%
  • MOLOGEN5.68 EUR-49.9%
  • PAION2.35 EUR-29.6%

No liability assumed, Date: 28.03.2015