Immunomedics Presents Preclinical Study That Demonstrates Increased SN-38 Delivery With Labetuzumab Govitecan (IMMU-130) Comp...
April 04 2017 - 1:00PM
Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics”
or “the Company”) today reported that labetuzumab govitecan
(IMMU-130), the Company’s second investigational agent from its
award-winning antibody-drug conjugate (ADC) platform, delivers a
greater than 300-fold more SN-38 to CEA-producing tumors compared
to irinotecan, while also reducing levels of potentially harmful
SN-38 and glucuronidated SN-38 (SN-38G) in normal tissues.
Commenting on these preclinical results, which
were presented at the 2017 American Association for Cancer Research
(AACR) Annual Meeting, Cynthia L. Sullivan, President and Chief
Executive Officer stated, “These observations are consistent with
our preclinical data showing improved efficacy and safety of
IMMU-130 in colorectal cancer.”
Labetuzumab govitecan is an investigational ADC
in clinical development as a monotherapy for patients with
metastatic colorectal cancer. It is composed of a humanized
anti-CEACAM5 antibody conjugated via the Company’s proprietary
linker to SN-38, a topoisomerase-I inhibitor and the active form of
irinotecan. SN-38 is a highly toxic therapeutic, but its delivery
by irinotecan is hampered by a lack of selectivity and poor
bioavailability.
The goal of this preclinical study was to
investigate the potential advantage of labetuzumab govitecan versus
irinotecan for SN-38 delivery in animal models. Mice bearing human
colonic cancer cells were treated with irinotecan at the maximum
tolerated dose of approximately 900 µg (SN-38 equivalents of ~500
µg) or 1 mg of labetuzumab govitecan (16 µg SN-38 equivalents).
Despite a lower SN-38 equivalents dose, area
under the curve analysis found labetuzumab govitecan provided a
sustained level of SN-38 in the tumor. Specifically, SN-38 levels
were ~10- to 17-fold higher in the tumors of labetuzumab
govitecan-dosed versus irinotecan-dosed animals. Since the
irinotecan group received nearly 30-fold more SN-38 equivalents,
the delivery advantage for labetuzumab govitecan could be more than
300-fold. In addition, levels of SN-38 and SN-38G were appreciably
lower in the liver and small intestinal contents, which is a likely
explanation for the lower incidence of severe diarrhea reported in
patients given labetuzumab govitecan. Importantly, SN-38 released
within the tumor will be in its fully active form.
“By enhancing the bioavailability of SN-38 in
the tumors while simultaneously lowering its amount in serum and
tissues, we believe IMMU-130 has an improved therapeutic window
over irinotecan,” concluded Ms. Sullivan.
About ImmunomedicsImmunomedics
(the “Company”) is a clinical-stage biopharmaceutical company
developing monoclonal antibody-based products for the targeted
treatment of cancer, autoimmune disorders and other serious
diseases. Immunomedics’ advanced proprietary technologies allow the
Company to create humanized antibodies that can be used either
alone in unlabeled or “naked” form, or conjugated with radioactive
isotopes, chemotherapeutics, cytokines or toxins. Using these
technologies, Immunomedics has built a pipeline of eight
clinical-stage product candidates. Immunomedics’ portfolio of
investigational products includes antibody-drug conjugates (ADCs)
that are designed to deliver a specific payload of a
chemotherapeutic directly to the tumor while reducing overall
toxicities that are usually found with conventional administration
of these chemotherapeutic agents. Immunomedics’ most advanced ADCs
are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan
(IMMU-130), which are in Phase 2 trials for a number of solid
tumors and metastatic colorectal cancer, respectively. IMMU-132 has
received Breakthrough Therapy Designation from the FDA for the
treatment of patients with triple-negative breast cancer who have
failed at least two prior therapies for metastatic disease.
Immunomedics has a research collaboration with Bayer to study
epratuzumab as a thorium-227-labeled antibody. Immunomedics has
other ongoing collaborations in oncology with independent cancer
study groups. The IntreALL Inter-European study group is conducting
a large, randomized Phase 3 trial combining epratuzumab with
chemotherapy in children with relapsed acute lymphoblastic leukemia
at clinical sites in Australia, Europe, and Israel. Immunomedics
also has a number of other product candidates that target solid
tumors and hematologic malignancies, as well as other diseases, in
various stages of clinical and preclinical development. These
include combination therapies involving its antibody-drug
conjugates, bispecific antibodies targeting cancers and infectious
diseases as T-cell redirecting immunotherapies, as well as
bispecific antibodies for next-generation cancer and autoimmune
disease therapies, created using its patented DOCK-AND-LOCK®
protein conjugation technology. The Company believes that its
portfolio of intellectual property, which includes approximately
310 active patents in the United States and more than 400 foreign
patents, protects its product candidates and technologies. For
additional information on the Company, please visit its website at
www.immunomedics.com. The information on its website does not,
however, form a part of this press release.
This release, in addition to historical
information, may contain forward-looking statements made pursuant
to the Private Securities Litigation Reform Act of 1995. Such
statements, including statements regarding clinical trials
(including the funding therefor, anticipated patient enrollment,
trial outcomes, timing or associated costs), regulatory
applications and related timelines, out-licensing arrangements
(including the timing and amount of contingent payments under the
licensing and development agreement with Seattle Genetics),
forecasts of future operating results, potential collaborations,
and capital raising activities, involve significant risks and
uncertainties and actual results could differ materially from those
expressed or implied herein. Factors that could cause such
differences include, but are not limited to, the
Company’s dependence on business collaborations or
availability of required financing from capital markets, or other
sources on acceptable terms, if at all, in order to further develop
our products and finance our operations, new product development
(including clinical trials outcome and regulatory
requirements/actions), the risk that we or any of our collaborators
may be unable to secure regulatory approval of and market our drug
candidates, risks associated with the outcome of pending litigation
and competitive risks to marketed products, and the Company’s
ability to repay its outstanding indebtedness, if and when
required, as well as the risks discussed in the Company’s filings
with the Securities and Exchange Commission. The Company is
not under any obligation, and the Company expressly disclaims any
obligation, to update or alter any forward-looking statements,
whether as a result of new information, future events or
otherwise.
For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary
(973) 605-8200, extension 123
ccheng@immunomedics.com
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