MilliporeSigma to speed up production of Acticor’s antibody against stroke

07-Dec-2016 - Last updated on 07-Dec-2016 at 16:26 GMT

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Acticor Biotech has made a deal with Merck KGaA’s CMO MilliporeSigma to use its Provantage End-to-End services to make its anti-thrombotic antibody fragment ACT-017 for stroke.

Acticor, a privately listed biotech spun out from the French National Institute of Health and Medical Research (INSERM) in Paris, is developing a humanised antibody fragment (Fab) as a primary treatment to break down clots and restore circulation in acute stroke.

The partnership will see Darmstadt, Germany-based MilliporeSigma manufacture the preclinical Fab to progress the candidate through clinical trials.

MilliporeSigma CEO Udit Batra said in a statement "We look forward to executing full process development for the antibody fragment, which will help accelerate this important new molecule through the pipeline to patients in need."

Manufacturing Fabs

The MilliporeSigma Provantage End-to-End services facility for biopharmaceuticals is based in Martillac, France.

The plant has three upstream suites in total, including a Mobius 2000L single-use bioreactor.

The Provantage service package consists of cGMP clinical supply solutions, templates for scaling of clinical development, biopharma process development, tech transfer services and commercial facility design.

CEO of Acticor–Gilles Avenard–announced in a statement that the firm “now [has] access to a comprehensive set of development and manufacturing services.”

In a video statement, Avenard added on the choice to transfer from another cell provider: “in one step, MilliporeSigma was able to produce the master cell bank, expand the clone and start the process scale up.”

The firm has previously recruited Catalent’s GPEx mammalian cell line services to product the Fab candidate ACT-017, signing a deal back in March this year.

acticor_mobius_milliporesigma_act-017_manufacture — Mobius bioreactor equipment in MilliporeSigma’s facility (PRNewsFoto/MilliporeSigma)

Acute Stroke

Founded in 2013, Acticor has been working on antibody fragments called Fabs to stop platelet aggregation and associated tissue damage caused by thrombi in acute ischemic strokes.

ACT-017 targets the GPV1 transmembrane protein on platelets, causing clots to break up and restore oxygenated blood flow to affected tissues in stroke.

Last month, Acticor also announced it had struck a deal with Milan based Mediolanum farmaceutici to co-develop ACT-017.

If successful, the marketing rights for the drug within Europe will therefore go to Mediolanum, and in exchange Acticor received an undisclosed lump sum.