20 November 2019 - - US-based clinical stage development company Anelixis Therapeutics Inc. has closed a financing led by Biotechnology Value Fund, L.P. and other affiliates of BVF Partners L.P., a San Francisco-based private investment firm which invests exclusively in biotechnology companies, the company said.
Additional financial terms were not disclosed.
Anelixis is developing its lead anti-CD40L antibody, AT-1501, as a potential treatment to slow the progression of ALS, for prevention of allograft rejection after organ and cellular transplantation, and as a therapy for autoimmune diseases that impair kidney function.
Anelixis also announced completion of a Phase 1 safety and pharmacokinetic study of AT-1501, involving both healthy volunteers and participants with ALS.
AT-1501 was well tolerated at all doses tested and the pharmacokinetic properties of AT-1501 were as predicted for an IgG1 antibody. Anelixis expects that these results will enable further clinical studies in ALS and multiple other indications. Details of the study will be presented at an upcoming scientific meeting.
In connection with the financing, Arman Gupta, Principal at BVF, was named to the Anelixis board of directors.
There is a significant body of preclinical and clinical evidence for blocking activation of the CD40/CD40L pathway to induce allograft tolerance, decrease immune mediated toxicities to multiple cell types and organs in the context of autoimmune diseases, and reduce neuroinflammation in neurodegenerative diseases. AT-1501 was designed to mitigate the safety issues observed with previous anti-CD40/CD40L antibodies.
AT-1501 has received orphan drug designation from the US Food and Drug Administration as a potential treatment in slowing the progression of ALS.
AT-1501 is an engineered, humanised anti CD40L antibody that lacks FC effector function and blocks costimulatory signaling between lymphocytes and antigen presenting cells.
Blocking CD40L signaling in preclinical models of organ transplant induces long term tolerance in multiple species and ameliorates disease progression in preclinical models of autoimmunity and preclinical models of neurodegeneration including ALS.
Since its founding in 2015, Anelixis Therapeutics has optimized and validated a cGMP manufacturing process for AT-1501, confirmed exceptional activity in preclinical disease models, demonstrated safety and tolerability in multiple animal species, and has completed phase 1 studies in healthy volunteers and adults with ALS.
Anelixis Therapeutics, Inc. is a clinical stage, privately held biotechnology company developing treatments for patients with neurodegenerative disease, people requiring an organ or cell based transplant, as well as people with an autoimmune disease.