Tag: antibody
Company News: Humabs BioMed Reports Clinical Milestone in MedImmune Partnership
– MedImmune Starts Phase I Clinical Trial to Investigate an Antibody Developed Under a Collaboration with Humabs for the Treatment of Influenza A –
Humabs BioMed SA, a leading Swiss antibody therapeutics company, today announced that a novel antibody developed through its proprietary Cellclone technology will be investigated for the treatment of influenza A in a Phase I trial being conducted by MedImmune, the global biologics research and development arm of AstraZeneca.
The investigational antibody, which has broad influenza-neutralizing properties, was isolated by Humabs from human memory B cells and further optimized for higher potency by MedImmune. The resulting antibody, MEDI8852, is exclusively licensed to MedImmune. The Phase I trial (NCT02350751) is designed to evaluate the safety and pharmacokinetics of MEDI8852 in healthy adults.
MEDI8852 binds to a novel site in the hemagglutinin stem region that is shared in viruses from all 18 Influenza A subtypes. This region is highly conserved and is considered to be the “Achilles’ heel” of the virus.
Humabs discovers and develops antibodies directly derived from individuals whose immune systems have successfully responded to major diseases. While the concept of isolating antibodies directly from recovered patients is not new, Humabs has developed a unique, comprehensive scheme for screening and selecting naturally occurring antibodies. Its proprietary technology platforms use immortalized donor B cells or cultured plasma cells with unmatched, stable secretion rates. This allows Humabs to perform sophisticated functional screens to rapidly discover antibodies able to opsonize or kill bacteria, block viral entry, or eliminate virus-infected and cancer cells. Instead of looking for binders to predefined targets, the Humabs functional approach is target-agnostic. Within weeks, it leads to ultra-potent antibodies, which can subsequently be developed for therapeutic, diagnostic, or research purposes, including the identification of novel targets or vaccines.
Company News: Micromet Presents Promising New Data on Anti-Cancer BiTE® Antibody Blinatumomab
Micromet has presented promising new data from two clinical trials with its lead BiTE® antibody, blinatumomab, at the 53rd American Society of Hematology (ASH) Annual Meeting in San Diego, CA. Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells. The compound is being developed for the treatment of leukemia and B cell lymhoma.
The data show that Micromet’s blinatumomab more than doubled the complete remission rate produced by current standard therapies used to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).
In a phase 2 single-arm dose-ranging trial, 68% of evaluable patients (17/25) across all tested doses and schedules achieved a complete response (CR) or complete response with partial hematologic recovery (CRh*) following treatment with blinatumomab. Of the 12 evaluable patients who received the selected dose and schedule 75% (9 of 12) achieved a CR or CRh*. Notably, all responders also achieved a molecular response, or in other words, had no evidence of remaining leukemic cells detectable in the blood or bone marrow.
A first interim analysis of the time impact of blinatumomab treatment was conducted for the initial 18 patients enrolled to the trial. The median survival had not been reached, with a median follow-up period of 9.7 months. With combination chemotherapy, median survival typically ranges from 3 – 6 months1-5. 12 of the initial 18 patients had a CR or CRh* with a median duration of response of 7.1 months. Based on the results of this study, the Company initiated a global phase 2 study in this patient population in November 2011.
Moreover, new findings from a phase 1 trial presented at the meeting demonstrate Micromet’s blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL).
Data focused on a cohort of 13 patients with DLBCL, of which 11 received the target dose and were evaluable for response. Of these 11 patients, 6 (55%) achieved an objective response following treatment with blinatumomab. 4 of 11 patients (38%) achieved a complete response. Patients were treated with a single course of blinatumomab induction therapy for up to eight weeks. As of October 2011, 5 of 6 patients had ongoing responses for up to 16.6 months. The median duration of response had not been reached with a median observation time of 7.1 months.
All patients enrolled in this study had received prior rituximab-containing regimens. Most had received three or more prior lines of therapy, including 8 of 13 patients with prior autologous stem cell transplant.