Ablynx Initiates a Phase I Study for Alx-0651, The First Nanobody in Clinical Development Targeting a GPCR

GHENT, BELGIUM--(Marketwire - June 29, 2011) -

GHENT, Belgium, 29 June 2011 - Ablynx [Euronext Brussels: ABLX] today announced that it has initiated a Phase I clinical trial in healthy volunteers with ALX- 0651, an anti-CXCR4 Nanobody, for use in stem cell mobilisation. ALX-0651 is the first Nanobody in clinical trials targeting a GPCR, a target class that has proven to be difficult to address with conventional antibodies. It is the second Nanobody that has entered clinical development this year, which brings the total number of Nanobodies in the clinic to seven.

CXCR4 plays a key regulatory role in hematopoietic stem cell trafficking. Blocking CXCR4 effectively releases the hematopoietic stem cells from the bone marrow and allows them to be mobilised to the peripheral blood for collection and subsequent transplantation in patients.

Hematopoietic stem cell transplantation is used to reconstitute the bone marrow and repopulate the blood and immune system in patients whose immune system has been depleted of stem cells as a result of high-dose chemotherapy. It has become a widely used procedure in patients with multiple myeloma and non- Hodgkin's lymphoma.

The Phase I study will evaluate the safety and tolerability of ALX- 0651. The study will investigate the PK/PD and immunogenicity profile of the Nanobody and will establish one or more biologically effective dose levels and/or the maximum tolerated dose.

The study is expected to recruit between 70 and 120 healthy volunteers and will include a single-blinded, placebo-controlled single ascending dose phase with six to seven dose levels, followed either by an open-label extension phase or a multiple dose phase.

Dr Edwin Moses, CEO and Chairman of Ablynx, commented: "We are delighted to see our first Nanobody that targets a GPCR progressing into the clinic. GPCRs form part of an important drug target class that is difficult to address with conventional antibodies but the unique characteristics of our Nanobodies have allowed us to generate active lead Nanobody candidates for a number of different GPCRs. We are looking forward to seeing the outcome of this first clinical study during the course of 2012. There are now seven Nanobodies in clinical development and we are on track internally to initiate a third Phase I study this year before the end of 2011."

For more information, please contact Ablynx: Dr Edwin Moses Chairman and CEO t: +32 (0)9 262 00 07 m: +44 (0)7771 954 193 / +32 (0)473 39 50 68 e: edwin.moses@ablynx.com

Marieke Vermeersch Investor Relations Manager t: +32 (0)9 262 00 82 m: +32 (0)479 49 06 03 e: marieke.vermeersch@ablynx.com

Complete version of the press release: http://hugin.info/137912/R/1527019/462724.pdf

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Source: Ablynx via Thomson Reuters ONE

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