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Zanolimumab data
Additional positive results have been obtained in the Phase II study totreat patients with relapsed or refractory NCTCL. A total of 21 patients wereenrolled in the study and received 980 mg of zanolimumab once weekly for 12weeks. Objective tumor response was obtained in 5 of 21 patients (24%). Threepatients obtained partial responses lasting 43 and 51 days with one patientnot relapsing at 182 days. Two patients obtained a complete responseunconfirmed, 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 asrelated to zanolimumab treatment and included 4 infusion related events. Thepatients with related serious adverse events completely recovered.
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Ofatumumab data
In a pre-clinical study, ofatumumab appeared to be more effective thanrituximab in treating chemotherapy refractory diffuse large B-cell lymphoma(DLBCL). Ofatumumab was significantly more effective in inducing the immunesystem killing mechanism complement dependent cytotoxicity (CDC) in 9 of 10DLBCL tumor samples when compared to rituximab. In addition, the dose ofofatumumab required to kill the patients' tumor cells was lower than thatrequired for rituximab.
In an additional pre-clinical study, B-cells incubated with cholesteroldepleting agents called statins were found to be killed less effectively byCD20 monoclonal antibodies. Importantly, cell lysis of statin-treated B-cellswas consistently higher when using ofatumumab in comparison to rituximab.Statin incubation was shown to induce conformational changes in the CD20target and impaired the binding of ofatumumab and rituximab to the CD20molecule.
Previously reported data illustrating that ofatumumab appears to induceCDC of target cells far more rapidly and effectively than rituximab will alsobe presented at the ASH conference.
Ofatumumab is an investigational, fully human, next generation monoclonalantibody that targets a unique epitope of the CD20 receptor on the surface ofB-cells. This epitope is different to the other anti-CD20 antibodiescurrently available or in development. Ofatumumab is being developed under aco-development and commercialization agreement between Genmab andGlaxoSmithKline.
"We are pleased to present this new information on zanolimumab andofatumumab at the ASH conference," said Lisa N. Drakeman, Ph.D., ChiefExecutive Officer of Genmab. "The response rate in the zanolimumab trial forNCTCL is encouraging and we look forward to investigating zanolimumab incombination with other therapies for NCTCL."
ASH Poster Sessions Poster 628 - Zanolimumab (HuMax-CD4), a Fully HumanMonoclonal Antibody: Efficacy and Safety in Patients with Relapsed orTreatment-Refractory Non-Cutaneous CD4+ T-cell Lymphoma
Poster 536 - Chemotherapy-Refractory Diffuse Large B-Cell Lymphomas(DLBCL) Are Effectively Killed by Ofatumumab-Induced Complement-MediatedCytoxicity
Poster 531 - Statins Impair Antitumor Effects of CD20 mAb by InducingConformational 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 BCells Promoted by Anti-CD20 Monoclonal Antibodies (mAb) Rituximab andOfatumumab Are Rapid, and Ofatumumab Kills Cells More Rapidly and withGreater Efficacy
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