Immunomedics Announces Initiation of Phase III Clinical Trial of Clivatuzumab Tetraxetan in Patients With Pancreatic Cancer

Immunomedics Announces Initiation of Phase III Clinical Trial of Clivatuzumab
Tetraxetan in Patients With Pancreatic Cancer

MORRIS PLAINS, N.J., Jan. 9, 2014 (GLOBE NEWSWIRE) -- Immunomedics, Inc.
(Nasdaq: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 first
patient dosing in the Company's Phase III registration study of its pancreatic
cancer drug, yttrium-90 (^90Y)-clivatuzumab tetraxetan.

The PANcreatic Cancer RadioImmunotherapy Trial-1 (PANCRIT-1) is a
double-blind, randomized study aimed to evaluate the safety and efficacy of
^90Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best
supportive care in patients with metastatic pancreatic cancer who have
received at least two prior therapies, one of which must have been a
gemcitabine-containing regimen. The primary endpoint of this study is overall
survival (OS).

In a recently completed Phase Ib clinical trial in the same patient population
with relapsed pancreatic cancer, the combination of ^90Y-clivatuzumab
tetraxetan and low-dose gemcitabine produced a median OS of 4.0 months (6 of
27 subjects were alive 9 months after first dose) with a manageable safety
profile. That was statistically significant (p = 0.021) compared to the median
OS of 2.8 months when patients were treated with ^90Y-clivatuzumab tetraxetan
alone. Additionally, there were 2 partial responders in the combination arm.
More importantly, the rapid enrollment of the Phase Ib study demonstrated an
unmet medical need for treatment options for patients in this late-stage

"This is a major milestone for the Company and for the clinical development of
^90Y-clivatuzumab tetraxetan," remarked Cynthia L. Sullivan, President and
Chief Executive Officer. "If the results from the Phase Ib study are confirmed
by the PANCRIT-1 trial, clivatuzumab tetraxetan could become the first
antibody-directed radiation therapy approved to treat patients with solid
tumors. We plan to complete patient accrual in the first half of 2015," Ms.
Sullivan added.


The PANCRIT-1 trial was designed to enroll approximately 440 patients with
metastatic pancreatic cancer. A majority of these patients will be recruited
at clinical trial sites across the U.S., with additional sites in Canada,
Europe and Israel participating. Eligible patients will be randomized 2 to 1
to the treatment arm of 3 doses of ^90Y-clivatuzumab tetraxetan plus 4 doses
of gemcitabine at 200 mg/m^2 per cycle or placebo plus low-dose gemcitabine.
All patients will receive best supportive care. Treatments are administered
during the initial 4 weeks of each 7-week cycle, and may be repeated up to a
maximum of 6 cycles.

About Clivatuzumab Tetraxetan

Clivatuzumab tetraxetan contains a humanized, highly specific antibody that
targets a mucin antigen found on pancreatic cancer cells, and is conjugated to
a linker that facilitates complexing with radiometals. This mucin has been
found by tissue staining to be present on about 85% of pancreatic cancers but
is not found on normal pancreas or tissue from patients with pancreatitis.
When the antibody-linker complex is radiolabeled with yttrium-90, this enables
delivery of high intensity, deep penetrating radiation directly to the
pancreatic tumor cells and the addition of gemcitabine acts as a
radiosensitizer to increase the anti-tumor activity. ^90Y-clivatuzumab
tetraxetan has received Orphan Drug designation in both the U.S. and Europe,
and fast track designation in the U.S. for the treatment of patients with
pancreatic cancer.

In earlier clinical trials, ^90Y-clivatuzumab tetraxetan has produced
encouraging results in combination with gemcitabine in newly-diagnosed
pancreatic cancer patients or alone in the relapsed population.^1,2

About Pancreatic Cancer

According to the American Cancer Society, an estimated 45,220 Americans were
diagnosed with pancreatic cancer in 2013, making it the 10th most common
cancer diagnosis among men and the 9th most common among women in the U.S. It
is, however, the fourth leading cause of cancer death among both men and women
nationwide, with approximately 38,460 deaths expected, or about 7% of all
cancer deaths.

Currently, only 2 percent of patients diagnosed with pancreatic cancer are
alive 5 years later. Gemcitabine alone or in combination with Tarceva or
Abraxane are the only FDA-approved front-line treatments for patients with
late-stage pancreatic cancer. There are no FDA-approved therapies for patients
that relapse and there are few treatment options available.


1.Ocean A.J., Pennington K.L., Guarino M.J. et al. Fractionated
    radioimmunotherapy with ^90Y-clivatuzumab tetraxetan and low-dose
    gemcitabine is active in advanced pancreatic cancer: A Phase I trial.
    Cancer. 2012 Nov 15;118(22):5497-506. doi: 10.1002/cncr.27592. Epub 2012
    May 8.
2.Gulec S.A., Cohen S.J., Pennington K.L. et al. Treatment of advanced
    pancreatic carcinoma with ^90Y-clivatuzumab tetraxetan: a Phase I
    single-dose escalation trial. Clin Cancer Res. 2011 Jun
    15;17(12):4091-100. doi: 10.1158/1078-0432.CCR-10-2579. Epub 2011 Apr 28.

About Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company primarily focused
on the development of monoclonal antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases. We have developed
a number of advanced proprietary technologies that allow us to create
humanized antibodies that can be used either alone in unlabeled or "naked"
form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or
toxins, in each case to create highly targeted agents.Using these
technologies, we have built a pipeline of therapeutic product candidates that
utilize several different mechanisms of action.Our lead product candidate,
epratuzumab, is currently in two Phase III clinical trials in lupus. In
oncology, clivatuzumab tetraxetan labeled with a radioisotope is in a Phase
III pivotal trial in advanced pancreatic cancer patients. Other solid tumor
therapeutics in Phase II clinical development include 2 antibody-drug
conjugates, IMMU-132 (anti-TROP-2-SN-38) and IMMU-130 (anti-CEACAM5-SN-38).We
also have a majority ownership in IBC Pharmaceuticals, Inc., which is
developing a novel DOCK-AND-LOCK™ (DNL™) method with us for making fusion
proteins and multifunctional antibodies. DNL™ is being used particularly to
make bispecific antibodies targeting cancers and infectious diseases as a
T-cell redirecting immunotherapy, as well as bispecific antibodies for
next-generation cancer and autoimmune disease therapies. We believe that our
portfolio of intellectual property, which includes approximately 242 active
patents in the United States and more than 400 foreign patents, protects our
product candidates and technologies.Our strength in intellectual property has
resulted in the top-10 ranking in the 2012 IEEE Spectrum Patent Power
Scorecards in the Biotechnology and Pharmaceuticals category. For additional
information on us, please visit our website at The
information on our website does not, however, form a part of this press

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, 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, risks associated with any cash payment that the Company might
receive in connection with a sublicense involving a third party and UCB, which
is not within the Company's control, 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,
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: Dr. Chau Cheng
         Senior Director, Investor Relations & Grant Management
         (973) 605-8200, extension 123
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