Key Developments For Immunomedics, Inc.
Immunomedics, Inc. (IMMU.O) (Consolidated Issue listed on NASDAQ Global Market)
Immunomedics, Inc. Announces Further Topline Results for Epratuzumab Phase IIb Study in Systemic Lupus Erythematosus
Immunomedics, Inc. announced further topline results for UCB's new SLE drug candidate epratuzumab. UCB's Phase IIb dose and regimen-ranging 12-week study compared epratuzumab to placebo in patients with SLE (also commonly known as lupus). In this study all epratuzumab doses, which ranged from 200 mg to 3600 mg cumulative dose administered during one 12-week treatment cycle, had numerically superior response rates compared to placebo at week 12. The primary objective was to assess the dose response and the dose frequency for epratuzumab. The primary endpoint of the study was responder rate based on a combined index of clinical disease activity at week 12. Achievement of response was measured both by disease improvement and no disease worsening, via several indices of SLE disease activity primarily emphasizing BILAG, as well as no increase or addition of background concomitant medications compared to baseline. Notably, the response rate for the group receiving 600 mg of epratuzumab per week for 4 weeks was 46%, or 25% points higher than the placebo rate of 21%. A total of 227 patients were randomized in this multicenter, double-blind, placebo controlled study, the majority of whom were female (94%), with a mean age of 38 years. 70% of patients had severely active disease in multiple organ systems. Epratuzumab was well tolerated, with a similar incidence of serious adverse events and infusion reactions compared to placebo.
UCB Group And Immunomedics, Inc. Announce Positive Results for Epratuzumab Phase IIb Study in Systemic Lupus Erythematosus (SLE)
UCB Group and Immunomedics, Inc. announced top-line results from UCB's phase IIb clinical study comparing epratuzumab to placebo in patients with systemic lupus erythematosus (SLE, also commonly known as lupus). The data from the 12-week dose and regimen-ranging study demonstrated clinical meaningful treatment effect of epratuzumab over placebo in SLE patients. The 227 patients in this study had moderately (30%) to severely (70%) active disease in multiple organ systems. The primary efficacy measure was a combined index endpoint, which included several indices of SLE disease activity, primarily emphasizing BILAG-measured improvement. Treatment advantage of epratuzumab over placebo reached 24.9% at week 12.
Immunomedics, Inc. Announces FDA Allowance of Investigational New Drug Application for Milatuzumab-Doxorubicin Conjugate
Immunomedics, Inc. announced the allowance of an investigational new drug (IND) application filed with the U.S. Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial of the doxorubicin conjugate of milatuzumab for the treatment of patients with multiple myeloma. This product candidate is the Company's antibody-drug conjugate to enter human studies. The primary objective of the study is to evaluate the safety and tolerability of the antibody drug conjugate in patients with recurrent or refractory multiple myeloma. Preliminary information on efficacy, pharmacokinetics, and immunogenicity will also be obtained.
Immunomedics, Inc. Announces U.S. Patents Awarded for Bispecific Antibody Technologies
Immunomedics, Inc. announced that it was awarded US patent 7,560,110.
Immunomedics, Inc. Updates On Phase II Results With Radiolabeled Epratuzumab In Non-Hodgkin's Lymphoma
Immunomedics, Inc. announced that epratuzumab labeled with the potent radioisotope, yttrium-90 (Y-90), when given in small fractionated doses to patients with non-Hodgkin's lymphoma (NHL), achieved high rates of durable responses at total Y-90 doses exceeding the 32-mCi limit approved for a single dose of ibritumomab tiuxetan. The goal of the study is to determine the safety, optimal dosing and preliminary efficacy of Y-90-labeled epratuzumab (yttrium-90 epratuzumab tetraxetan) for NHL. 64 adult patients who had failed one or more therapies, including rituximab, had been enrolled to receive 2 or 3 weekly infusions of Y-90 labeled epratuzumab. The starting Y-90 dose was 5.0 mCi/m(2), 2.5 mCi/m(2) for patients with prior bone marrow involvement, with increments of 2.5 mCi/m(2) or 5.0 mCi/m(2). For 17 patients with prior bone marrow transplant, grade 3 to 4 hematologic toxicity limited dose escalation to a total dose of 10 mCi/m(2). For other patients, the treatment was manageable up to 45 mCi/m(2) (15 mCi/m(2) for 3 weeks) total dose. The overall objective response rate (partial and complete responses) in 62 evaluable patients was 64%, with 49% of patients having a complete response. Both the objective and complete response rates appear to correlate with cumulative doses. In 16 patients unresponsive to last therapy, 75% responded to Y-90 epratuzumab tetraxetan with 56% complete responses. Responses were seen across all different types of NHL.
