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EX - 99.1 2 d940389dex991.htm EX - 99.1 igm biosciences ™ IGM Biosciences Announces First Quarter 2021 Financial Results and Provides Corporate Update - Recommended Phase 2 Dose of IGM - 2323 Expected in 2021 - - Initial Data from Phase 1 Trial of IGM - 8444 in Solid Cancers Expected in 2021 – - IND Filing for IGM - 7354 Planned in 2021 - MOUNTAIN VIEW , Calif . , May 6 , 2021 – IGM Biosciences , Inc. ( Nasdaq : IGMS ) , a clinical - stage biotechnology company focused on creating and developing engineered IgM antibodies , today announced its financial results for the first quarter ended March 31 , 2021 and provided an update on recent developments . Pipeline Updates IGM - 2323 Exhibit 99.1 " We are very pleased with the progress we made in the first quarter towards achieving our clinical and pipeline goals for 2021 , " said Fred Schwarzer , Chief Executive Officer of IGM Biosciences . " We look forward to announcing a recommended Phase 2 dose for IGM - 2323 , presenting initial data from the dose escalation portion of the Phase 1 trial of IGM - 8444 and filing an IND for IGM - 7354 during 2021. " IGM - 8444 Recommended Phase 2 dose expected in 2021. IGM continues to advance the clinical development of IGM - 2323 , the Company's IgM - based CD20 x CD3 bispecific antibody , for the treatment of non - Hodgkin's lymphoma ( NHL ) and potentially other CD20 - expressing hematologic malignancies , including chronic lymphocytic leukemia ( CLL ) . IGM has cleared the titration dose cohorts of 50/100 mgs , 50/300 mgs and 50/600 mgs in the ongoing Phase 1 clinical trial of IGM - 2323 , and is currently enrolling patients in what is expected to be its top titration dose cohort , 50/1000 mgs . IGM is also currently enrolling patients in the expansion dose cohorts of 50/100 mgs , 50/300 mgs and 50/600 mgs . IGM expects to complete enrollment in the dose escalation portion of the Phase 1 clinical trial and select a recommended Phase 2 dose in 2021 . Phase 1 data expected in the second half of 2021. IGM also continues to advance the clinical development of IGM - 8444 , the Company's IgM Death Receptor 5 ( DR5 ) agonist , for the treatment of a potentially broad range of solid tumors and hematologic malignancies . IGM has cleared its second dose escalation dose cohort , 1 mg / kg , in the ongoing Phase 1 trial , and is currently dosing patients in its third dose escalation cohort , 3 mg / kg , with every two week dosing . IGM has also begun dosing patients in its first combination with FOLFIRI dose cohort and its first weekly dosing cohort . IGM expects to report initial data from the dose escalation portion of the Phase 1 trial in the second half of 2021 . Clinical testing of birinapant in combination with IGM - 8444 expected to begin this year . As previously announced , during the first quarter of 2021 , IGM entered into an exclusive license agreement with Medivir AB , by which IGM received global , exclusive development and commercialization rights for birinapant . IGM remains on track to begin clinical testing of birinapant in combination with IGM - 8444 this year .