ImmunoGen, Inc. 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.
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