Immunomedics, Inc. (Nasdaq:IMMU), a
biopharmaceutical company focused on the development of monoclonal
antibody-based products for the targeted treatment of cancer,
autoimmune and other serious diseases, today announced a historical
milestone in the Company's listing at the NASDAQ stock market,
which is going on 30 years strong. Only a small, elite group of
biopharmaceutical companies has this longevity.
After ringing the opening bell at NASDAQ, the Company held its
Research and Development Day for analysts and institutional
investors, highlighting the 3 major pillars that are the value
drivers for the Company: epratuzumab, (anti-CD22 humanized
antibody), from which top-line data from the two Phase III
registration trials in patients with moderate to severe lupus is
expected first quarter 2015 by partner UCB; yttrium-90
(90Y)-labeled clivatuzumab tetraxetan that is being evaluated in a
Phase III trial to treat patients with advanced pancreatic cancer;
and the two antibody-drug conjugates (ADCs) for solid tumor
therapy, IMMU-132 and IMMU-130, which are progressing in Phase II
trials.
"In addition," Company President and Chief Executive Officer,
Cynthia L. Sullivan, emphasized, "we are advancing other product
candidates in earlier-stage clinical trials as well as other novel
technologies in preclinical studies."
Dr. David M. Goldenberg, Chairman and Chief Scientific Officer,
introduced the science underlying the agents in clinical trials,
beginning with new information on the mechanism of action of
epratuzumab, followed by the Company's proprietary linker for
conjugating SN-38 to the two ADCs. Before introducing the clinical
investigators who summarized their experiences with the Company's
most advanced therapeutics, Dr. Goldenberg also described the
scientific efforts to develop a novel and potent T-cell
immunotherapy for solid cancers.
Dr. Michael J. Guarino, medical oncologist at the Christiana
Care Health System, Helen F. Graham Cancer Center, in Newark, DE,
summarized the current status of the clinical trials with IMMU-130,
the Company's ADC targeting CEACAM5 for colorectal cancers therapy,
including two cases where IMMU-130 was able to shrink the patients'
colonic cancer metastases 52% and 66%, respectively. "The second
patient is being treated at our center for almost 9 months,
receiving doses twice weekly during this time, without evidence of
major side effects or any immune reaction to the ADC; the patients
had 4 prior therapies before entering this trial," Dr. Guarino
explained.
An update of 42 patients who had computed tomography (CT) scans
following their therapy with IMMU-132 was presented by Dr.
Alexander N. Starodub, medical oncologist and Director of Clinical
Research at Indiana University Health Goshen Center for Cancer
Care, in Goshen, IN. "The most exciting observation so far," Dr.
Starodub stated, "is that a high percentage of patients with
advanced disease are showing high rates of disease control, with
the most impressive results in triple-negative breast cancer and
small-cell lung cancer patients. These cancers are very difficult
to treat, especially after failing other therapies, so it is
unusual to see 2 of 7 patients with triple-negative breast cancer
and 2 of 4 patients with small-cell lung cancer showing partial
responses by computed tomography, or RECIST criteria." "A 67%
response rate, with one partial response and 9 with stable disease,
also was achieved in advanced colorectal cancer patients," he
added. Dr. Starodub further emphasized that "a time-to-progression
plot of responders shows that many are of long duration, even up to
almost a year in some cases, which is most encouraging in this
population of patients with advanced solid cancers that have
relapsed after multiple prior therapies."
Results of 13 pancreatic cancer patients with CT-assessments
were not included in Dr. Starodub's update but will be presented at
the American Association for Cancer Research (AACR) Special
Conference on Pancreatic Cancer: Innovations in Research and
Treatment on Tuesday, May 20, 2014. Additional Phase II data from
the IMMU-132 trial will be provided at the 2014 Annual Meeting of
American Society of Clinical Oncology (ASCO) on Monday, June 2,
2014, in a Poster Highlights Session.
The final investigator presentation was made by Dr. Allyson J.
Ocean, medical oncologist and Associate Professor of Medicine at
Weill Cornell Medical College, New York Presbyterian Hospital, New
York, NY. Dr. Ocean presented the results of the Phase Ib study of
fractionated 90Y-clivatuzumab tetraxetan in patients with
metastatic pancreatic cancer after receiving at least 2 prior
therapies. Dr. Ocean remarked that "it was a surprise to all of the
investigators that this study in patients having had 2 or more
prior treatments could be completed in 8 months and with so much
enthusiasm." "The trial showed that patients given clivatuzumab
tetraxetan combined with low-dose gemcitabine as a radiosensitizer
had better survival outcome than the control group only given the
radiolabeled antibody without gemcitabine. On a personal note, I
have been impressed with how well my patients tolerate this therapy
and that their severe pain is reduced under this therapy,"
concluded Dr. Ocean.
This study will also be presented at the AACR Special Conference
on Pancreatic Cancer: Innovations in Research and Treatment on
Tuesday, May 20, 2014, and at the 2014 ASCO Annual Meeting on
Sunday, June 1, 2014, also in a Poster Highlights Session.
An archived version of the R&D day webcast is available on
the Company's website until May 22, 2014.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company
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 246 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-4 ranking in the January 2014
Patent Board scorecard in the Biotechnology industry. For
additional information on us, please visit our website at
www.immunomedics.com. The information on our 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, 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
ccheng@immunomedics.com
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