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April 8, 2014
16:25 EDTIMGNInitial findings show new dosing approach for IMGN853 achieves objective
ImmunoGen announced the first findings from company research aimed at optimizing the dosing of its IMGN853 product candidate. 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, or TBW. As presented, modeling research conducted by ImmunoGen predicted that dosing IMGN853 using adjusted ideal body weight, or 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 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.
News For IMGN From The Last 14 Days
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May 21, 2015
08:39 EDTIMGNNovartis initiates Phase 1 PCA062, triggering milestone payment to ImmunoGen
In a regulatory filing, ImmunoGen disclosed Novartis (NVS) Institutes for BioMedical Research notified ImmunoGen (IMGN) that Novartis had initiated Phase I, first-in-human clinical testing of a product candidate, PCA062, utilizing antibody-drug conjugate technology. Pursuant to the license taken under our 2010 Multi-Target Agreement, this start of clinical testing triggers a $5M milestone payment to ImmunoGen.
May 14, 2015
07:40 EDTIMGNImmunoGen data 'impressive,' says Oppenheimer
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May 13, 2015
17:41 EDTIMGNImmunoGen to present mirvetuximab data at 2015 ASCO meeting
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