Earnings release
Page 1
888C4 Therapeutics C4 Therapeutics Reports Recent Business Highlights and First Quarter 2021 Financial Results May 13 , 2021 - Preclinical Data for CFT7455 , a novel IKZF1 / 3 Degrader , in Non - Hodgkin's Lymphoma Xenograft Models Accepted for Presentation at the International Conference on Malignant Lymphoma ( ICML ) in June - - CFT7455 Phase 1/2 Clinical Trial in Multiple Myeloma and Non - Hodgkin's Lymphomas On Track to Initiate in 1H 2021 - -IND Application Submission for CFT8634 , a BiDACTM Degrader Targeting BRD9 for Synovial Sarcoma and SMARCB1 - deleted Tumors , Planned for 2H 2021 - WATERTOWN , Mass . , May 13 , 2021 ( GLOBE NEWSWIRE ) -- C4 Therapeutics , Inc. ( C4T ) ( Nasdaq : CCCC ) , a biopharmaceutical company pioneering a new class of small - molecule medicines that selectively destroy disease - causing proteins through degradation , today reported business highlights and financial results for the first quarter of 2021 . " C4T continues to build momentum following FDA clearance of our IND application for our lead candidate , CFT7455 , a MonoDACTM protein degrader for the treatment of hematologic malignancies , " said Andrew Hirsch , chief executive officer at C4 Therapeutics . " After presenting compelling preclinical data for CFT7455 in multiple myeloma at AACR , we are excited to share our preclinical work in non - Hodgkin's lymphoma at the upcoming ICML meeting . Our team has also successfully completed site initiation activities to enable patient enrollment in our CFT7455 Phase 1/2 clinical trial and we are on track to begin dosing patients this quarter . In tandem , we continue to invest in our TORPEDO ™ platform and advance our emerging pipeline with the goal of delivering four clinical - stage programs by year - end 2022. This includes submission of our second IND application to the FDA for CFT8634 , a BiDAC protein degrader targeting BRD9 for synovial sarcoma and SMARCB1 - deleted tumors , which is anticipated by year - end 2021. " FIRST QUARTER 2021 AND RECENT HIGHLIGHTS • Presented at the American Association for Cancer Research ( AACR ) Annual Meeting 2021 : In April 2021 , C4T presented preclinical data for CFT7455 , C4T's lead Mono DAC degrader , targeting IKZF1 / 3 for the treatment of hematologic malignancies . The in vitro results presented confirmed that treatment with CFT7455 results in deep , rapid degradation of IKZF1 / 3 proteins , generating apoptotic cell death . In mouse xenograft models of IMID - insensitive multiple myeloma , preclinical data further established CFT7455 as a highly potent , catalytic degrader of IKZF1 / 3 , capable of generating anti - tumor activity as a single agent and in combination with dexamethasone . These results , which support clinical evaluation of CFT7455 in multiple myeloma and other hematologic malignancies , were delivered as a late - breaking oral presentation during the first session of the AACR Annual Meeting 2021 . • Secured IND Clearance for CFT7455 : In January 2021 , the U.S. Food and Drug Administration ( FDA ) cleared C4T's first investigational new drug ( IND ) application for CFT7455 for the treatment of relapsed or refractory multiple myeloma and non - Hodgkin's lymphomas . UPCOMING KEY MILESTONES • Initiate a Phase 1/2 clinical trial for CFT7455 in 1H 2021. The Phase 1/2 clinical trial will be an open - label , two - part dose escalation and expansion study evaluating CFT7455 across multiple hematologic malignancies , including multiple myeloma and various non - Hodgkin's lymphomas , including peripheral T cell lymphoma and mantle cell lymphoma . The trial will primarily assess safety and tolerability , with key secondary objectives to characterize the pharmacokinetic and pharmacodynamic profile and anti - tumor activity of CFT7455 . • Submit an IND application for CFT8634 in 2H 2021. CFT8634 is an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1 - deleted solid tumors . • Advance the BRAF program into IND - enabling studies in 2021. The objective of the BRAF program is to develop an orally bioavailable BiDAC degrader targeting BRAF V600E mutations for the treatment of genetically defined solid tumors , including locally advanced or metastatic melanoma and non - small cell lung cancer ( NSCLC ) . The BRAF program is partnered with Roche . • Advance the RET program into IND - enabling studies in 2021. The objective of the RET program is to develop an orally bioavailable BiDAC degrader targeting genetically altered RET for the treatment of solid tumors , including relapsed or refractory NSCLC and sporadic medullary thyroid cancers that are resistant to RET inhibitors . UPCOMING EVENTS • May 26 , 2021 - C4T will participate in the UBS Global Healthcare Conference