Genmab to Present Zanolimumab and Ofatumumab Data at ASH
COPENHAGEN, November 9 /PRNewswire/ --
- Summary: Genmab Will Present Phase II Non-Cutaneous T-cell Lymphoma Zanolimumab Data and Pre-Clinical Ofatumumab Data on at the 2007 Annual Meeting of the American Society of Hematology in December.
Genmab A/S (OMX: GEN) announced today it will present clinical data from the zanolimumab (HuMax-CD4(R)) Phase II study in non-cutaneous T-cell lymphoma (NCTCL) and pre-clinical data on ofatumumab's (HuMax-CD20(R)) mechanisms of action in poster sessions at the 2007 Annual Meeting of the American Society of Hematology December 8-11 in Atlanta, Georgia, USA.
Zanolimumab data
Additional positive results have been obtained in the Phase II study to treat patients with relapsed or refractory NCTCL. A total of 21 patients were enrolled in the study and received 980 mg of zanolimumab once weekly for 12 weeks. Objective tumor response was obtained in 5 of 21 patients (24%). Three patients obtained partial responses lasting 43 and 51 days with one patient not relapsing at 182 days. Two patients obtained a complete response unconfirmed, one lasting 46 days and one showing no relapse after 252 days. During the study period, a total of 6 serious adverse events were assessed as related to zanolimumab treatment and included 4 infusion related events. The patients with related serious adverse events completely recovered.
Ofatumumab data
In a pre-clinical study, ofatumumab appeared to be more effective than rituximab in treating chemotherapy refractory diffuse large B-cell lymphoma (DLBCL). Ofatumumab was significantly more effective in inducing the immune system killing mechanism complement dependent cytotoxicity (CDC) in 9 of 10 DLBCL tumor samples when compared to rituximab. In addition, the dose of ofatumumab required to kill the patients' tumor cells was lower than that required for rituximab.
In an additional pre-clinical study, B-cells incubated with cholesterol depleting agents called statins were found to be killed less effectively by CD20 monoclonal antibodies. Importantly, cell lysis of statin-treated B-cells was consistently higher when using ofatumumab in comparison to rituximab. Statin incubation was shown to induce conformational changes in the CD20 target and impaired the binding of ofatumumab and rituximab to the CD20 molecule.
Previously reported data illustrating that ofatumumab appears to induce CDC of target cells far more rapidly and effectively than rituximab will also be presented at the ASH conference.
Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. This epitope is different to the other anti-CD20 antibodies currently available or in development. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
"We are pleased to present this new information on zanolimumab and ofatumumab at the ASH conference," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "The response rate in the zanolimumab trial for NCTCL is encouraging and we look forward to investigating zanolimumab in combination with other therapies for NCTCL."
ASH Poster Sessions Poster 628 - Zanolimumab (HuMax-CD4), a Fully Human Monoclonal Antibody: Efficacy and Safety in Patients with Relapsed or Treatment-Refractory Non-Cutaneous CD4+ T-cell Lymphoma
Poster 536 - Chemotherapy-Refractory Diffuse Large B-Cell Lymphomas (DLBCL) Are Effectively Killed by Ofatumumab-Induced Complement-Mediated Cytoxicity
Poster 531 - Statins Impair Antitumor Effects of CD20 mAb by Inducing Conformational Changes of CD20
Poster 1499 - Spinning Disk Confocal Fluorescent Microscopy (SDCFM) Analyses of Complement Activation Promoted by Anti-CD20 Monoclonal Antibodies (mAbs) Rituximab and Ofatumumab
Poster 1506 - Complement Activation and Complement-Mediated Killing of B Cells Promoted by Anti-CD20 Monoclonal Antibodies (mAb) Rituximab and Ofatumumab Are Rapid, and Ofatumumab Kills Cells More Rapidly and with Greater Efficacy |
