The Development of the First Nanobody Drug

In February 2017, Ablynx filed an application for the listing of the nanobody Caplacizumab with the EMA of the European Medicines Agency, which is the first application for the market for nanobody drugs in the world and is of great significance.

As an absolute authority in the field of antibody development, the company has applied for more than 500 patents in the field of Nanobody, and the company has a wide range of nanobody development pipelines around various diseases. Currently, the Nanobody Targeting vWF is Caplacizumab (ALX-0081). ) is one of the most rapidly progressing products in the pipeline for R&D. It entered clinical research in 2007 for the treatment of thrombocytopenic purpura (aTTP), which can reduce disease morbidity and mortality. The EMA/FDA grants the drug orphan drug status.

In response to Caplacizumab, the company's Phase II clinical study TITAN was the core data for this listing application. Clinical data showed a very good clinical benefit. Caplacizumab (a bivalent anti-vWF Nanobody that can prevent the interaction of ULvWF with platelets, immediate impact Platelet aggregation and microclot formation that can lead to severe thrombocytopenia, tissue ischemia, and organ dysfunction. This role protects the patient from disease symptoms during the etiological process.)

a. Can accelerate the recovery of platelet levels and reduce the incidence of cyanosis

b. Can significantly reduce the number of severe thrombotic events

c. Drugs fill the blank of clinical use of thrombocytopenic purpura

In October 2017, Ablynx announced the positive results of the Phase 3 clinical trial HERCULES, reaching the primary endpoint. The data show that the drug can reduce the recurrence rate of aTTP by 67%, and the results support drug safety. Experts said that if capaccizumab is approved, it will become the first choice for the treatment of aTTP disease, and it is expected to be listed in the European Union in the first half of 2018 and will be promoted to the United States next year.

In March 2017, Ablynx and its partner German pharmaceutical giant Merck KGaA announced the bispecific anti-IL-17A/F Nanobody at the 2017 American Academy of Dermatology (AAD) annual meeting in Orlando, USA. M1095;ALX-0761) New data from a phase Ib clinical study of the treatment of moderate-to-severe chronic plaque psoriasis.

Among them, ALX-0761/M1095 (40 kD) is a trivalent bispecific Nanobody that blocks both IL-17A and IL-17F and binds human serum albumin to reduce the half-life in serum in vivo. Th17 cells and IL-17 are associated with a variety of human inflammatory and autoimmune diseases such as psoriasis, rheumatoid arthritis (RA) and multiple sclerosis (MS).

In this multicenter, randomized, double-blind, placebo-controlled study, clinical data from 41 patients with moderate-to-severe chronic plaque psoriasis showed disease activity in all doses of M1095 patients were both reduced, while the static doctor overall score (sPGA) was improved, compared with 0% of patients in the placebo group. Specifically, on the 85th day of treatment, 100% of patients in the M1095240mg treatment group had a 75% reduction in disease activity (PASI75), skin plaque removal or total elimination (PASI 90), and the highest dose group had 56%. The patient achieved complete removal of skin plaque (PASI 100). In addition, clinical effects of rapid onset were observed after the first dose and continued until the end of the study on Day 85.

The test results show that M1095 has good safety and tolerability, no treatment-related adverse events have been reported, and there is no dose-dependent increase in the frequency and severity of adverse events.

Author Bio

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