ImmunoGen, Inc. Announces First Clinical Findings with Refined Dosing Strategy for IMGN853
April 08 2014 - 3:15PM
Business Wire
- Initial Findings Show New Dosing
Approach for IMGN853 Achieves Objective
- Data Presented at American Association
for Cancer Research Annual Meeting
ImmunoGen, Inc. (NASDAQ: IMGN), a biotechnology company that
develops novel anticancer therapeutics using its antibody-drug
conjugate (ADC) technology, today announced the first findings from
Company research aimed at optimizing the dosing of its IMGN853
product candidate. The data were presented at the American
Association for Cancer Research (AACR) Annual Meeting in San Diego,
CA.
Based on findings in the first patients to receive IMGN853,
ImmunoGen identified that clinical activity is seen with the
compound starting at doses of 3.3 mg/kg and its dose-limiting
toxicity is the reversible ocular side effects (blurred vision and
keratitis) reported with ADCs in development by several companies.
These side effects occurred at IMGN853 doses of 5 mg/kg and
above, with dose based on patient total body weight (TBW).
As presented today, modeling research conducted by ImmunoGen
predicted that dosing IMGN853 using adjusted ideal body weight
(ADJ) rather than TBW should reduce the variability among patients
in the concentration of IMGN853 in their blood, as ADJ would better
match the dose administered to patient blood volume. Reducing this
variability should enable IMGN853 to be well tolerated in more
patients at dose levels greater than 3.3 mg/kg. Based on these
insights, dosing in the ongoing IMGN853 Phase 1 trial was changed
to ADJ several months ago, and the first findings were reported
today.
The clinical findings to date validate the prediction: none (0
of 6) of the patients treated with IMGN853 at 5 mg/kg ADJ have had
ocular side effects of any grade. This compares with 4 of 10
patients treated at 5 mg/kg TBW. IMGN853 dose escalation above 5
mg/kg ADJ is ongoing.
“ImmunoGen is committed to successfully developing novel drugs
that make a difference for people with cancer,” said Dr. Charles
Morris, ImmunoGen Executive Vice President and
Chief Development Officer. “Key to drug development is
establishing the dosing strategy that provides the greatest
efficacy with the least toxicity for each compound, and we believe
the findings reported today reflect a strong path forward for
IMGN853. We look forward to sharing additional IMGN853 clinical
data in the months ahead.”
ImmunoGen also identified that dosing IMGN853 with a modified
weekly schedule – weekly for three weeks every four weeks – should
maximize tumor exposure to the compound while keeping IMGN853 blood
levels in well-tolerated ranges. This dosing schedule, also using
ADJ, has been added to the IMGN853 Phase 1 trial, but patient
enrollment started too recently for findings to be available by
AACR.
IMGN853 is in Phase I clinical testing for the treatment of
folate receptor α (FRα)-positive cancers. The Company is currently
establishing the maximum tolerated dose (MTD) of IMGN853 when
administered once every three weeks using ADJ. Once this MTD is
established, IMGN853 will be evaluated at that dose specifically in
patients with platinum-resistant ovarian cancer and in patients
with relapsed endometrial cancer. The Company is now also
establishing its MTD with the modified weekly schedule.
About IMGN853
IMGN853, an ADC, is a potential new treatment for ovarian,
endometrial, lung and other cancers that highly express FRα. It
comprises an ImmunoGen FRα-targeting antibody attached to the
Company's potent cancer cell-killing agent, DM4. The antibody
serves to target the compound specifically to cancer cells
expressing FRα, and the DM4 serves to kill these cells.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The
Company’s ADC technology uses tumor-targeting antibodies to deliver
an ImmunoGen cell-killing agent specifically to cancer cells; the
Company has also developed antibodies with anticancer activity of
their own. The first product approved with ImmunoGen’s ADC
technology is Roche’s Kadcyla®. ImmunoGen has three wholly owned
product candidates in clinical testing, with seven additional
compounds in the clinic through the Company’s partnerships with
Amgen, Bayer HealthCare, Biotest and Sanofi. More information about
ImmunoGen can be found at www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, Inc., a member
of the Roche Group.
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. A review of these
risks can be found in ImmunoGen's Annual Report on Form 10-K for
the fiscal year ended June 30, 2013 and other reports filed with
the Securities and Exchange Commission.
For Investors:ImmunoGen, Inc.Carol Hausner, 781-895-0600orFor
Media:Pure Communications, Inc.Dan Budwick, 973-271-6085
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