Ablynx initiates a phase I study for the ALX-0651 nanobody targeting a GPCR

01-Jul-2011 - Belgium

Ablynx 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.

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Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous

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Topic world Antibodies

Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous