ImmunoGen, Inc. Initiates Phase I Trial of IMGN853 in Ovarian Cancer & Other Solid Tumors Over-Expressing Its Folate Receptor...
11 July 2012 - 8:30PM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a
biotechnology company that develops anticancer therapeutics using
its antibody expertise and Targeted Antibody Payload (TAP)
technology, today announced the start of clinical testing with its
IMGN853 product candidate. The Phase I trial initiated evaluates
the safety, tolerability, pharmacokinetics, pharmacodynamics and
anticancer activity of this TAP compound in patients with ovarian
cancer or other solid tumors that over-express FOLR1 (also known as
folate receptor alpha), including non-small cell lung cancer
(NSCLC). Once the maximum tolerated dose (MTD) of IMGN853 is
established, the activity of the compound will be evaluated in
disease-specific patient cohorts.
“This trial is expected to provide key information needed to
define the registration path for IMGN853,” commented James O’Leary,
MD, Vice President and Chief Medical Officer. “The study protocol
allows for the use of single-patient cohorts for evaluation of the
lower dose levels, which should accelerate the pace of advancement
to higher doses and to the trial’s expansion phase. In the
expansion phase, IMGN853 will be evaluated as a treatment for
specific types of FOLR1-overexpressing tumors. These findings
should enable us to make decisions needed to advance IMGN853 into
later-stage clinical testing.”
About the Phase I Trial Initiated
This multi-center, first-in-human US Phase I trial is designed
to enroll approximately 64 patients with previously treated ovarian
cancer, NSCLC or other epithelial malignancies that over-express
FOLR1. Once the MTD is defined in the dose-escalation part of the
trial, three expansion cohorts will be opened to evaluate the
pharmacodynamics and antitumor activity of IMGN853 at this MTD in
patients with specific types of cancers:
- Epithelial ovarian cancer (EOC) that is
refractory/resistant to platinum;
- EOC that is relapsed/refractory to
conventional treatments;
- Adenocarcinoma NSCLC that is
relapsed/refractory to conventional treatments.
More patients die from lung cancer in the US than from any other
type of cancer: each year, approximately 226,000 patients in the US
are diagnosed with lung cancer and approximately 160,000 die from
the disease.1 About 40% of lung cancers are the adenocarcinoma
subtype of NSCLC.2
Each year, there are approximately 22,000 new cases of ovarian
cancer diagnosed in the US and approximately 15,500 women die from
the disease.1 EOC accounts for approximately 85% to 90% of all
cases of ovarian cancer.3
About IMGN853
The novel agent IMGN853, a TAP compound, contains an ImmunoGen
FOLR1-targeting antibody attached to the Company’s potent
cell-killing agent, DM4. The antibody enables the compound to bind
specifically to cancer cells expressing FOLR1, and the DM4 serves
to kill these cells. The DM4 is attached to the antibody using one
of ImmunoGen’s engineered linkers. The linker in IMGN853 serves not
only to keep the DM4 stably attached to the antibody while the
compound is in the bloodstream, but also – once at the tumor site –
to counteract the multi-drug resistance that can make previously
treated tumors more difficult to kill.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
the Company's expertise in tumor biology, monoclonal antibodies,
potent cancer-cell killing agents and engineered linkers. The
Company's TAP technology uses monoclonal antibodies to deliver one
of ImmunoGen's proprietary cancer-cell killing agents specifically
to tumor cells. There are now numerous TAP compounds in clinical
development with a wealth of clinical data reported. ImmunoGen’s
collaborative partners include Amgen, Bayer HealthCare
Pharmaceuticals, Biotest, Lilly, Novartis, Roche, and Sanofi. The
most advanced compound using ImmunoGen's TAP technology,
trastuzumab emtansine (T-DM1), is in Phase III testing through the
Company's collaboration with Genentech, a member of the Roche
Group. More information about ImmunoGen can be found at
www.immunogen.com.
1American Cancer Society (2012), Cancer Facts & Figures.
2 American Cancer Society (2012), Lung Cancer (Non-Small Cell)
Detailed Guide.
3 American Cancer Society (2012), Ovarian Cancer Detailed
Guide.
This press release includes forward-looking statements. For
these statements, ImmunoGen claims the protection of the safe
harbor for forward-looking statements provided by the Private
Securities Litigation Reform Act of 1995. It should be noted that
there are risks and uncertainties related to the development of
novel anticancer products, including IMGN853, including risks
related to preclinical and clinical studies, their timings and
results. A review of these risks can be found in ImmunoGen’s Annual
Report on Form 10-K for the fiscal year ended June 30, 2011 and
other reports filed with the Securities and Exchange
Commission.
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Sep 2024 to Oct 2024
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Oct 2023 to Oct 2024