Genmab announced that it would make presentations about both HuMax-CD4 and HuMax-CD20 at the 45th annual meeting of American Society of Hematology. The first presentation will be an interim analysis of two ongoing Phase II Humax-CD4 studies to treat cutaneous T-cell lymphoma (CTCL). The two studies encompass both early and late stage CTCL patients, with 11 early stage patients and 13 late stage patients enrolled in total.
Preliminary results indicate a favorable response to Humax-CD4 and it has also been safe and well tolerated in these trials to date. Based on this encouraging preliminary analysis, Genmab has begun enrolling additional patients in both studies and increased the weekly dose from 280 mg to 560 mg for early stage patients and from 280 mg to 980 mg for patients with late stage disease. Treatment of these additional patients will continue for up to 16 weeks. The studies involving the original 24 patients also continue and a number of them have not received their entire course of therapy.
On behalf of Genmab, Dr. Jan van de Winkel, chief scientific officer, will make an oral presentation of new pre-clinical data on Humax-CD20 focused on further research into its novelty and mechanism of action. In previous studies, Humax-CD20 was far more effective than rituximab in eradicating B-cell tumors in SCID mouse models, as well as in depleting B-cells from peripheral blood and lymph nodes in cynomolgus monkeys.
"This preliminary Humax-CD4 data is encouraging and I look forward to the interim analysis as well as the new Humax-CD20 data," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab.