Ablynx announced that it is now eligible for a milestone payment of $3 million as a result of the initiation by Pfizer of a new Phase I clinical study in healthy volunteers for a second Nanobody (PF-05230905) targeting tumour necrosis factor alpha (TNF-alpha)
GHENT, Belgium | November 9, 2010 | Ablynx [Euronext Brussels: ABLX] today announced that it is now eligible for a milestone payment of $3 million as a result of the initiation by Pfizer of a new Phase I clinical study in healthy volunteers for a second Nanobody (PF-05230905) targeting tumour necrosis factor alpha (TNF-alpha).
Pfizer’s lead anti-TNF-alpha Nanobody, ATN-103, is currently in a Phase II study in patients with rheumatoid arthritis (RA). Pfizer has completed recruitment for the Phase II study.
Ablynx entered into an exclusive research collaboration and license agreement in November 2006 with Wyeth, which was acquired by Pfizer. As part of the agreement, Pfizer now owns the exclusive worldwide development and commercialisation rights to the anti-TNF-alpha Nanobody programme. This deal has a potential value to Ablynx of $212.5 million in up-fronts and milestone payments. Ablynx will now have earned a total of $10 million in milestone payments from Pfizer. In addition, Ablynx is eligible to receive royalties on product sales.
Dr Edwin Moses, CEO and Chairman of Ablynx commented: “Pfizer’s decision to advance a second anti-TNF-alpha Nanobody into the clinic underscores the importance and potential of this programme. We are very pleased with the progress made in this TNF-alpha partnership, and we continue to work with Pfizer to discover additional anti-TNF-alpha Nanobodies which could have important therapeutic applications. Pfizer is well placed to maximize the value of these Nanobody programmes based on their proven success in the TNF-alpha field and their significant biologics expertise. We would anticipate the study to be completed by the second quarter of 2011. There are now five Nanobodies in clinical development.”
About Ablynx [Euronext Brussels: ABLX] – http://www.ablynx.com
Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company currently has over 240 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007 and raised €50 million through an SPO in March 2010.
Ablynx is developing a portfolio of Nanobody-based therapeutics in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Ablynx now has over 25 programmes in its therapeutic pipeline and there are five Nanobodies in clinical development. So far, Nanobodies have been successfully generated against more than 220 different protein targets including several complex targets such as chemokines, GPCRs, ion channels and viruses, which are typically very difficult to address with conventional monoclonal antibodies. Efficacy data have been obtained in 35 in vivo models for Nanobodies against a range of different targets.
Ablynx has an extensive patent position in the field of Nanobodies for healthcare applications. It has exclusive and worldwide rights to more than 130 families of granted patents and pending patent applications, including the Hamers patents covering the basic structure, composition, preparation and uses of Nanobodies. Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono and Pfizer. Ablynx is building a diverse and broad portfolio of therapeutic Nanobodies through these collaborations as well as through its own internal discovery programmes.
The Company’s lead programme ALX-0081, an intravenously administered novel anti-thrombotic, entered a Phase II study in patients undergoing percutaneous coronary intervention (PCI) in September 2009. Ablynx demonstrated proof-of-concept by biomarker for ALX-0081 in December 2009. ALX-0681, a subcutaneous administration of the anti-von Willebrand factor (vWF) Nanobody and ALX-0081 will enter into a Phase II study in TTP patients during Q3 2011.
In September 2009, Ablynx’s partner Pfizer entered a Phase II study in RA patients, with an anti-TNF-alpha Nanobody, ATN-103. ATN-103 is administered via subcutaneous injection every 4 and 8 weeks. In November 2010, Pfizer initiated a Phase I clinical trial with a second anti-TNF-alpha Nanobody, PF-05230905.
ALX-0061, an anti-IL6R Nanobody is in preclinical development for the treatment of autoimmune and inflammatory diseases. Ablynx is on track to initiate a Phase I/II single and multiple dose study in patients with active RA during the first quarter of 2011.
In February 2010, Ablynx announced that it had reached its criteria for initiating the preclinical development of ALX-0651, a Nanobody against CXCR4, and will progress this programme towards the clinic. CXCR4 plays an important role in cell mobility, tumor growth and metastasis. In March 2010, Ablynx advanced an anti-RSV Nanobody, ALX-0171, into preclinical development. ALX-0171 will be developed for the treatment of respiratory syncytial virus (RSV) infections, delivered through inhalation and has the potential to be effective both in the prevention of infection as well as in treatment once infection has occurred.
Nanobody® is a registered trademark of Ablynx NV.
SOURCE: Ablynx NV.
Post Views: 46
Ablynx announced that it is now eligible for a milestone payment of $3 million as a result of the initiation by Pfizer of a new Phase I clinical study in healthy volunteers for a second Nanobody (PF-05230905) targeting tumour necrosis factor alpha (TNF-alpha)
GHENT, Belgium | November 9, 2010 | Ablynx [Euronext Brussels: ABLX] today announced that it is now eligible for a milestone payment of $3 million as a result of the initiation by Pfizer of a new Phase I clinical study in healthy volunteers for a second Nanobody (PF-05230905) targeting tumour necrosis factor alpha (TNF-alpha).
Pfizer’s lead anti-TNF-alpha Nanobody, ATN-103, is currently in a Phase II study in patients with rheumatoid arthritis (RA). Pfizer has completed recruitment for the Phase II study.
Ablynx entered into an exclusive research collaboration and license agreement in November 2006 with Wyeth, which was acquired by Pfizer. As part of the agreement, Pfizer now owns the exclusive worldwide development and commercialisation rights to the anti-TNF-alpha Nanobody programme. This deal has a potential value to Ablynx of $212.5 million in up-fronts and milestone payments. Ablynx will now have earned a total of $10 million in milestone payments from Pfizer. In addition, Ablynx is eligible to receive royalties on product sales.
Dr Edwin Moses, CEO and Chairman of Ablynx commented: “Pfizer’s decision to advance a second anti-TNF-alpha Nanobody into the clinic underscores the importance and potential of this programme. We are very pleased with the progress made in this TNF-alpha partnership, and we continue to work with Pfizer to discover additional anti-TNF-alpha Nanobodies which could have important therapeutic applications. Pfizer is well placed to maximize the value of these Nanobody programmes based on their proven success in the TNF-alpha field and their significant biologics expertise. We would anticipate the study to be completed by the second quarter of 2011. There are now five Nanobodies in clinical development.”
About Ablynx [Euronext Brussels: ABLX] – http://www.ablynx.com
Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company currently has over 240 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007 and raised €50 million through an SPO in March 2010.
Ablynx is developing a portfolio of Nanobody-based therapeutics in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Ablynx now has over 25 programmes in its therapeutic pipeline and there are five Nanobodies in clinical development. So far, Nanobodies have been successfully generated against more than 220 different protein targets including several complex targets such as chemokines, GPCRs, ion channels and viruses, which are typically very difficult to address with conventional monoclonal antibodies. Efficacy data have been obtained in 35 in vivo models for Nanobodies against a range of different targets.
Ablynx has an extensive patent position in the field of Nanobodies for healthcare applications. It has exclusive and worldwide rights to more than 130 families of granted patents and pending patent applications, including the Hamers patents covering the basic structure, composition, preparation and uses of Nanobodies. Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono and Pfizer. Ablynx is building a diverse and broad portfolio of therapeutic Nanobodies through these collaborations as well as through its own internal discovery programmes.
The Company’s lead programme ALX-0081, an intravenously administered novel anti-thrombotic, entered a Phase II study in patients undergoing percutaneous coronary intervention (PCI) in September 2009. Ablynx demonstrated proof-of-concept by biomarker for ALX-0081 in December 2009. ALX-0681, a subcutaneous administration of the anti-von Willebrand factor (vWF) Nanobody and ALX-0081 will enter into a Phase II study in TTP patients during Q3 2011.
In September 2009, Ablynx’s partner Pfizer entered a Phase II study in RA patients, with an anti-TNF-alpha Nanobody, ATN-103. ATN-103 is administered via subcutaneous injection every 4 and 8 weeks. In November 2010, Pfizer initiated a Phase I clinical trial with a second anti-TNF-alpha Nanobody, PF-05230905.
ALX-0061, an anti-IL6R Nanobody is in preclinical development for the treatment of autoimmune and inflammatory diseases. Ablynx is on track to initiate a Phase I/II single and multiple dose study in patients with active RA during the first quarter of 2011.
In February 2010, Ablynx announced that it had reached its criteria for initiating the preclinical development of ALX-0651, a Nanobody against CXCR4, and will progress this programme towards the clinic. CXCR4 plays an important role in cell mobility, tumor growth and metastasis. In March 2010, Ablynx advanced an anti-RSV Nanobody, ALX-0171, into preclinical development. ALX-0171 will be developed for the treatment of respiratory syncytial virus (RSV) infections, delivered through inhalation and has the potential to be effective both in the prevention of infection as well as in treatment once infection has occurred.
Nanobody® is a registered trademark of Ablynx NV.
SOURCE: Ablynx NV.
Post Views: 46
