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EX - 99.1 2 d254451dex991.htm EX - 99.1 Igm biosciences ™ Exhibit 99.1 IGM Biosciences Announces Third Quarter 2021 Financial Results and Provides Corporate Update - Plans to Initiate Phase 2 Studies of IGM - 2323 in Diffuse Large B - cell Lymphoma and Follicular Lymphoma – - Data from IGM - 2323 Selected for Oral Presentation at 2021 ASH Annual Meeting - - IGM - 8444 Successfully Completes Phase 1 Monotherapy Dose Escalation - - IGM - 8444 Showed No Clinically Significant Liver Toxicity or Dose Limiting Toxicities Observed to Date - - IGM - 2644 ( CD38 x CD3 ) Expected to Enter Clinical Testing for Multiple Myeloma in 2022 - - IGM Establishes Infectious Diseases and Autoimmunity and Inflammation Business Units – MOUNTAIN VIEW , Calif . , Nov. 4 , 2021 ( GLOBE NEWSWIRE ) 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 third quarter ended September 30 , 2021 and provided an update on recent developments . " IGM continues to validate and expand the IgM platform through the clinical development of IGM - 2323 , our CD20 x CD3 T cell engager IgM antibody for the treatment of B cell proliferative diseases , IGM - 8444 , our Death Receptor 5 ( DR5 ) agonist IgM antibody for the treatment of solid and hematologic cancers , and the establishment of our infectious diseases and autoimmunity and inflammation business units , " said Fred Schwarzer , Chief Executive Officer of IGM Biosciences . " We plan to continue to expand our clinical development efforts , and by the end of 2022 we expect to be actively pursuing the clinical development of four oncology product candidates , led by two Phase 2 clinical studies of IGM - 2323 . " " We are encouraged by the emerging data from the clinical testing of IGM - 2323 in our most fully explored titration dose cohort , 100 mg , where we have seen multiple complete responses in both diffuse large B - cell lymphoma ( DLBCL ) and follicular lymphoma ( FL ) , and we look forward to sharing the initial data from this 100 mg dose cohort at our American Society of Hematology ( ASH ) presentation in December , ” said Chris Takimoto , M.D. , Ph.D. , F.A.C.P. , Chief Medical Officer of IGM Biosciences . " While the number of patients we have treated at 100 mg is relatively small , we believe that the planned Phase 2 expansion studies could potentially provide the basis for accelerated review and approval . As a first step , consistent with the spirit of the U.S. Food and Drug Administration's ( FDA ) Project Optimus , we plan to test doses of 100 mg and 300 mg in two separate randomized ' pick the winner ' Phase 2 studies of 30 patients at each dose level , one in DLBCL and one in FL . We plan to then expand the Phase 2 studies at the optimal dose , while including the prior data from that dose for purposes of potential registration . While our safety profile at 600 mg and 1000 mg is consistent with lower doses and very encouraging , we do not plan to continue to explore doses higher than 300 mg for purposes of greater efficacy in either DLBCL or FL . "