Immunomedics, Inc. IMMU, a
biopharmaceutical company primarily focused on the development of monoclonal
antibody-based products for the targeted treatment of cancer, autoimmune and
other serious diseases, today announced that its newest antibody-drug
conjugate (ADC), IMMU-132, has produced durable partial responses in three
different cancer types in early phase of clinical evaluation.
Results from the multicenter, dose-escalation Phase I trial were presented by
Dr. Alexander N. Starodub of the Indiana University Health Goshen Center for
Cancer Care, Goshen, IN, at the AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics in Boston, Massachusetts.
In addition to the 3 partial responses observed by computed tomography (CT)
using RECIST criteria, 15 patients also reported stable disease as their best
response for an overall disease control rate of 86% in 21 patients with at
least 1 CT assessment reported at the Conference. In terms of CT-confirmed
tumor shrinkage, about half of the patients showed this result.
"We, as well as our clinical investigators, are very encouraged by these early
promising results with IMMU-132 in this refractory, advanced cancer patient
population with difficult-to-treat tumors that failed multiple prior
therapies," commented Cynthia L. Sullivan, President and Chief Executive
Officer of Immunomedics. "This is the first time these results have been
presented at a scientific meeting after peer-review of the submitted abstract.
The study has now transitioned to Phase II for additional safety and efficacy
data in patients with certain tumor types using doses that were found active
and tolerable in Phase I," Ms. Sullivan added.
At the time of reporting, a total of 25 patients with 12 different types of
epithelial cancers have been enrolled into the Phase I trial. These patients
had failed a median of 3 (range 1-6) prior standard therapies for their tumor
types and were enrolled with disease progression. IMMU-132 was administered
weekly for 2 consecutive weeks, followed by one week off, in 3-week cycles.
Treatments may continue for up to 8 cycles until unacceptable toxicity or
progression of disease. Currently, 10 patients are continuing treatments.
The major side-effects of IMMU-132 are neutropenia and controllable diarrhea,
consistent with the toxicity experienced with irinotecan, the parent drug of
SN-38, despite this agent releasing about 20-fold more SN-38 than when
irinotecan is given.
This study was supported in part by Award Number R43CA171388 from the National
Cancer Institute. The content is solely the responsibility of the Company and
does not necessarily represent the official views of the National Cancer
Institute or the National Institutes of Health.
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