Immunomedics Reports Results With IMMU-132 in Patients With Pancreatic Cancer

Immunomedics Reports Results With IMMU-132 in Patients With Pancreatic Cancer

NEW ORLEANS, May 20, 2014 (GLOBE NEWSWIRE) -- Immunomedics, Inc.,
(Nasdaq:IMMU) today reported a stabilization of disease, as measured by
computed tomography (CT) according to RECIST criteria, in pancreatic cancer
patients with advanced disease and who failed 1-5 prior therapies. In a group
of 13 CT-assessable patients receiving repeated doses of the Company's
investigational antibody-drug conjugate (ADC), IMMU-132, a median
time-to-progression of 12.7 weeks was reported (range 4.3-21.4 weeks), which
is better than the median 8.0 weeks (range 4-36 weeks) estimated from their
last prior therapy.

Results from the ongoing Phase I/II study were presented at the American
Association for Cancer Research Special Conference on Pancreatic Cancer:
Innovations in Research and Treatment by Vincent J. Picozzi Jr., M.D.,
Director of the Pancreas Center of Excellence at the Virginia Mason Medical
Center's Digestive Disease Institute, Seattle, WA.

It is known that in such advanced, highly malignant cancers, responses and
outcome are poorer with each successive treatment. "This is why we are
encouraged that this group of heavily pretreated, advanced pancreatic cancer
patients showed a longer period of disease control compared with their most
recent therapy before entering this trial," Dr. Picozzi stated.

A total of 15 advanced PDC patients who relapsed after a median of 2 prior
therapies (range 1-5) have been enrolled in the multicenter trial. One patient
was not evaluated due to clinical progression, while another patient's CT
assessment is pending. Patients were administered IMMU-132 on days 1 and 8 in
repeated 21-day cycles for up to 8 cycles. IMMU-132 consists of the Company's
proprietary anti-TROP-2 humanized antibody conjugated with a high number of
SN-38 drug molecules by a site-specific linker technology. Preclinical studies
have indicated that a significantly higher amount of SN-38, the active
metabolite of irinotecan, is delivered to human cancers growing in mice than
when high doses of the parent compound, irinotecan, is given.

IMMU-132 was well tolerated by patients, with 2 patients having received more
than 10 doses. Furthermore, despite multiple administrations, none of the
patients developed an antibody response to IMMU-132 or SN-38 to-date. The
major toxicities are similar to irinotecan, such as neutropenia and diarrhea,
but less severe.

"We are encouraged with these early clinical results from IMMU-132 in patients
with advanced pancreatic cancer," said Cynthia L. Sullivan, President and
Chief Executive Officer. "For future clinical development of this ADC in this
indication, we plan to evaluate it in combination with other drugs used
earlier in this disease, since these results suggest that IMMU-132 is active
in pancreatic cancer," Ms. Sullivan added.

The Company will present current Phase I and II results with IMMU-132 in
diverse advanced solid cancers at the forthcoming American Society of Clinical
Oncology annual meeting, including encouraging partial responses by RECIST
criteria in patients with colorectal, triple-negative breast, small-cell and
non-small cell lung, and esophageal cancers.

This study in pancreatic cancer patients 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.

About IMMU-132

IMMU-132 is composed of hRS7, a humanized antibody that binds to the
trophoblast cell-surface antigen (TROP-2), also known as the epithelial
glycoprotein-1 antigen (EGP-1). TROP-2 is expressed by many human tumors, such
as cancers of the breast, cervix, colon and rectum, kidney, liver, lung,
ovary, pancreas, and prostate, but with only limited expression in normal
human tissues. The antibody, hRS7, internalizes into cancer cells following
binding to TROP-2, making it a suitable candidate for the delivery of
cytotoxic drugs.

SN-38 is the active metabolite of irinotecan, which is a standard therapy for
patients with metastatic colorectal cancer, but has major gastrointestinal and
hematologic toxicity. By attaching SN-38 to tumor-targeting antibodies,
delivery of SN-38 to the tumor may be increased several-fold while mitigating
systemic toxicity. Preclinical studies have indicated that IMMU-132 delivers
120-times the amount of SN-38 to a human pancreatic tumor xenograft than when
irinotecan is given. In various animal models of human cancers, IMMU-132
significantly improved survival and tumor regression.

About Immunomedics

Immunomedics 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 nine clinical-stage product
candidates. Immunomedics has an ongoing collaboration with UCB, S.A. (UCB),
who has worldwide rights in non-cancer indications to Immunomedics' Phase III
product candidate, epratuzumab. UCB expects Phase III data in systemic lupus
erythematosus (SLE) in the first quarter of 2015. Immunomedics is exploring
epratuzumab in oncology in collaboration with outside cancer study groups.
Immunomedics' most advanced wholly owned candidate is ^90Y-clivatuzumab
tetraxetan, which is in an ongoing Phase III registration trial in patients
with pancreatic cancer. Immunomedics' portfolio of wholly owned product
candidates also includes antibody-drug conjugates (ADCs) that are designed to
deliver a specific payload of a chemotherapeutic directly to the tumor while
reducing overall toxicity effects that typically occur when these
chemotherapeutic agents are dosed alone. Immunomedics' most advanced ADCs are
IMMU-132 and IMMU-130, which are in Phase I/II trials for a number of solid
tumors and metastatic colorectal cancer (mCRC), respectively. 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 pre-clinical development. These include bispecific antibodies
which have application as T-cell redirecting immunotherapies targeting cancers
and infectious diseases as well as next-generation therapies in cancer and
autoimmune disease. Immunomedics creates these bispecific antibodies using its
patented DOCK-AND-LOCK™ (DNL™) protein conjugation technology. The Company
believes that its portfolio of intellectual property, which includes
approximately 248 active patents in the United States and more than 400
foreign patents, protects its product candidates and
technologies.Immunomedics' strength in intellectual property has resulted in
the top-4 ranking in the January 2014 Patent Board scorecard in the
Biotechnology industry. 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, outcomes, timing or associated costs),
out-licensing arrangements (including the timing and amount of contingent
payments), 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, new product development (including clinical trials outcome and regulatory
requirements/actions), our dependence on UCB for the further development of
epratuzumab for non-cancer indications, risks associated with the outcome of
pending litigation, competitive risks to marketed products and availability of
required financing and other sources of funds on acceptable terms, if at all,
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.

CONTACT: For More Information:
         Dr. Chau Cheng
         Senior Director, Investor Relations & Grant Management
         (973) 605-8200, extension 123
         ccheng@immunomedics.com
 
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