Apeiron Licenses Phase II/III Anticancer Ab-IL2 Fusion Protein from Merck KGaA

Apeiron Biologics has acquired rights to develop and commercialize Merck KGaA’s Phase II-stage immunocytokine anticancer candidate, Hu14.18-IL2. The firm says the antibody-based fusion protein has met drug development checkpoints in a Phase II pediatric neuroblastoma study that should allow it to proceed to Phase III. It aims to continue development in the pediatric neuroblastoma indication and evaluate the potential to develop the candidate for other cancer indications including melanoma.

Hu14.18-IL2 comprises the hu14.18 mAb linked to interleukin 2. The fusion protein is designed to bind to the GD2 antigen expressed by neuroectodermal origin tumors such as neuroblastoma and melanoma as well as by renal cell and small-cell lung cancers. It is expected both to stimulate immune system NK and T-cell activity against the tumor and trigger tumor cell killing by antibody-dependent cellular cytotoicity and complement-dependent cytotoxicity mechanisms.

Apeiron says acquisition of the Hu14.18-IL2 from Merck is in line with its strategy to broaden its clinical development pipeline. In November 2010 the firm announced an agreement with Polymun Scientific under which Apeiron acquired exclusive rights to recombinant human super oxide dismutase (SOD), a naturally occurring enzyme which has been under development as a potential treatment for various inflammatory conditions and which had shown signs of efficacy in first clinical trials.

The week prior to reporting on its Polymun deal, Apeiron announced a announced a collaboration with Evotec. The agreement initially focusses on identifying small molecule modulators of DREAM (downstream regulatory element antagonistic modulator), a target involved in the perception of various pain mechanisms.

Apeiron’s R&D is also focused on an immunotherapeutic anticancer technology that aims to modulate the immuno-reactivity of T cells by targeting the E3 ubiquitin ligase Cbl-b, which it notes is a promising target for cancer and autoimmune indicatons. The firm is currently collaborating with researchers at the University of Innsbruck on an siRNA-based approach to the transient silencing of of Cbl-b in lymphocytes ex vivo. It is also working to identify low molecular weight compounds that selectively interfere with Cbl-b.

Until the start of 2010, Apeiron’s lead project was the recombinant human soluble angiotensin converting enzyme 2 candidate, APN01, which it took through to the end of Phase I trials. In January 2010 the firm outlicensed the candidate to GlaxoSmithKline, in a deal potentially worth €230 million. It says GSK is initially focusing on further clinical development of APN01 for the treatment of acute respiratory distress syndrome.