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ImmunoGen Says Initial Research Shows New Dosing Approach for IMGN853 Achieves Objective

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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.

Posted-In: News FDA

 

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