Natte krant schreef op 1 februari 2016 14:54:
Een KaBeeCeetje:
first bi-specific nanobody into clinical development
Ablynx announced that Boehringer Ingelheim has administered the first dose in a Phase I dose escalation study with the half-life extended bi-specific anti-VEGF/Ang2 Nanobody in adult patients with advanced solid tumors, triggering a € 8m milestone payment to Ablynx.
The aim of the study is to evaluate the safety profile and dosing schedule for this Nanobody. The anti-VEGF/Ang2 Nanobody was discovered and developed as part of the Strategic Alliance between both parties, signed in September 2007. This Nanobody blocks both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang2), important proteins which are involved in the formation of new blood vessels from pre-existing vessels (angiogenesis), a vital mechanism in the growth of tumours.
Recall that in September 2007, Ablynx and Boehringer Ingelheim entered into a strategic alliance on the discovery, development and commercialisation of Nanobody therapeutics across a range of diseases, including oncology, immunology, respiratory and vascular diseases. The agreement allows for potential milestone payments of up to € 125m plus royalties to Ablynx for each Nanobody which reaches the market. Boehringer Ingelheim is exclusively responsible for the development, manufacturing and commercialisation of any products resulting from the collaboration. Ablynx retains certain co-promotion rights in Europe. To date, Ablynx has earned >€ 75 m in cash from this strategic alliance and in addition to the anti-VEGF/Ang2 Nanobody there are a number of other programmes advancing through pre-clinical development, all fully funded by Boehringer Ingelheim.
Conclusion
Positive that the first bi-specific Nanobody, as part of Ablynx’ collaboration with Boehringer Ingelheim, has entered clinical development. The formatting flexibility and ability to link different Nanobodies together to bind to different proteins and/or epitopes is a key feature of Ablynx’ technology and is of particular interest in cancer drug development.
Our investment case stands: First-in-class and best-in-class opportunities are targeted in areas where the Nanobodies can provide therapeutic advantages. With one phase III (anti-vWF), two phase II (anti- IL6R, anti-RSV) and numerous earlier-stage assets, the pipeline is diversified, with several shots on goal for value creation. The end-September cash position stood at € 268m. For FY15, cash burn is guided at ~€ 70m. We stick to our Buy rating and € 18 Target Price. As in the coming year, several options for stock revaluation will materialize. In 1H16, the phase IIa anti-RSV trial in infants will read out while data from the phase 2b rheuma study with anti-IL6R is due in 2H16. In addition, progress on the phase III asset Caplacizumab and the Merck immune-oncology pipeline should further unlock the potential of the Nanobody platform.