Date: 2014-05-05
Type of information: Initiation of preclinical development
phase: 1b-2a
Announcement: initiation of the study
Company: Covagen (Switzerland)
Product: COVA322
Action
mechanism: COVA322 is a bispecific anti-TNF/IL-17A FynomAb that is being developed for the treatment of inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, psoriasis and ankylosing spondylitis. This Fynomab acts by simultaneously inhibiting both TNF and IL-17ABi- and trispecific FynomAbs are generated by genetically fusing human Fynomer binding proteins to antibodies, resulting in therapeutics with novel modes of action and enhanced efficacy in the treatment of inflammatory diseases and cancer. Fynomers are small binding proteins derived from the human Fyn SH3 domain. They can be engineered to bind to target molecules with the same affinity and specificity as antibodies. Genetic fusion of Fynomers to an antibody of choice allows the straightforward production of multispecific FynomAbs.The ability to fuse Fynomers to multiple sites on an antibody allows to create FynomAbs with tailored architectures to maximize efficacy. terminal and/or C-terminal ends of antibodies to create bi- and trispecific FynomAbs with different architectures.
Disease: psoriasis
Therapeutic area: Autoimmune diseases - Dermatological diseases
Country: Germany
Trial
details: The primary aim of the Phase Ib/IIa trial is to evaluate the safety, tolerability and pharmacokinetics of a single ascending dose of COVA322. The randomized, double-blind, placebo-controlled, multi-center study will be conducted in Germany in 39 patients with psoriasis. Secondary endpoints include readouts on psoriatic skin lesions as well as biological responses measured in skin biopsies.
Latest
news: * On May 5, 2014, Covagen announced it has initiated a Phase Ib/IIa study with COVA322, a bispecific TNF/IL-17A inhibitor. COVA322 is Covagen\'s lead bispecific FynomAb® developed for treatment of patients with rheumatoid arthritis, psoriatic arthritis and other inflammatory diseases. The trial will enroll 39 patients with psoriasis and evaluate safety as well as biological activity of COVA322. Enrollment in the trial and dosing of COVA322 has begun for the first cohort of patients. The FynomAb COVA322 consists of a fully human, clinically validated anti-TNF antibody and anti-IL-17A Fynomers genetically fused to C-terminal light-chains of the antibody. COVA322 has a unique mode of action as it inhibits with picomolar potency TNF as well as IL-17A. COVA322 has excellent, antibody-like drug properties and has been produced under GMP conditions using standard antibody production technology. With COVA322, Covagen has moved its first proprietary FynomAb into the clinic. The company expects to have top-line data in the first quarter of 2015.
