sendegobresib (CFT8634) / C4 Therap - LARVOL DELTA

CFT8634-1101: A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors (clinicaltrials.gov) - P1 | N=49 | Terminated | Sponsor: C4 Therapeutics, Inc. | Phase classification: P1/2 ➔ P1

Metastases • Phase classification • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • SMARCB1

CFT8634, a BRD9 BiDAC™ degrader, is active in a subset of multiple myeloma cell line models and synergistic when combined with pomalidomide or dexamethasone (AACR 2024) - "CFT8634 demonstrates synergy with dexamethasone in the RPMI-8226 in vivo xenograft model. This combination leads to tumor regressions at clinically relevant doses and outperforms the current combination of pomalidomide with dexamethasone.In conclusion, we demonstrate in vitro and in vivo activity in an expanded set of MM models using the clinical oral BRD9 degrader CFT8634 as a single agent and show in vivo synergy between CFT8634 and SoC agents pomalidomide and dexamethasone at clinically relevant doses."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • CRBN • IKZF1 • SMARCB1

C4 Therapeutics to Present New Preclinical Data on Highly Selective Orally Bioavailable BiDAC Degraders at the American Association for Cancer Research Annual Meeting 2024 (GlobeNewswire) - "C4 Therapeutics, Inc...today announced the acceptance of two preclinical poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10, 2024 in San Diego, California."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CFT8634-1101: A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors (clinicaltrials.gov) - P1/2 | N=50 | Terminated | Sponsor: C4 Therapeutics, Inc. | Active, not recruiting ➔ Terminated; High levels of BRD9 degradation did not result in sufficient efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null solid tumor patients treated with CFT8634 as a single agent.

Metastases • Trial termination • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • SMARCB1

CFT8634-1101: A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors (clinicaltrials.gov) - P1/2 | N=50 | Active, not recruiting | Sponsor: C4 Therapeutics, Inc.

Metastases • Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • SMARCB1

CFT8634, a Clinical Stage BRD9 Bi DAC™ Degrader, Is Active in a Subset of Multiple Myeloma Cell Line Models and Synergistic When Combined with Pomalidomide (ASH 2023) - P1/2 | "Additionally, in vitro synergy in MM proliferation assays was observed when a tool BRD9 degrader was combined with the standard of care (SoC) agents, dexamethasone or pomalidomide. In conclusion, we demonstrate in vitro and in vivo activity in an expanded set of MM models using the clinical oral BRD9 degrader CFT8634 as a single agent and show in vivo synergy between CFT8634 and pomalidomide at clinically relevant doses. Our findings suggest that combining CFT8634 with pomalidomide may be a viable therapeutic strategy in treating MM patients."

Preclinical • Hematological Malignancies • Multiple Myeloma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • Targeted Protein Degradation • CRBN • IKZF1 • SMARCB1

A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors (clinicaltrials.gov) - P1/2 | N=50 | Active, not recruiting | Sponsor: C4 Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=110 ➔ 50

Enrollment change • Enrollment closed • Metastases • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • SMARCB1

A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: C4 Therapeutics, Inc.

New P1/2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • SMARCB1

INITIAL RESULTS FROM A PHASE 1 STUDY OF CFT8634, A NOVEL BIFUCTIONAL DEGRADATION ACTIVATING COMPOUND (BIDAC) DEGRADER OF BRD9, IN SYNOVIAL SARCOMA AND SMARCB1-NULL TUMORS (CTOS 2023) - P1/2 | "Preliminary findings from CFT8634-1101 indicate that CFT8634 demonstrated favorable tolerability and safety at early dose levels. Updated data to be presented at the conference."

P1 data • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • SMARCB1 • SS18

C4 Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights (GlobeNewswire) - P1/2 | N=110 | NCT05355753 | Sponsor: C4 Therapeutics, Inc. | "The median duration of treatment across all cohorts was 1.8 months (range of 0-11 months). CFT8634 was generally well-tolerated. As of the cutoff date, the majority of adverse events (AEs) reported were considered mild to moderate in severity....Dose proportional increases in plasma exposure were achieved and maintained after single and repeat oral administration, respectively. The calculated half-life is 10 to14 hours after oral administration. Additionally, high levels of BRD9 degradation in tumor tissue obtained at day 15 were noted across all dose levels studied....C4T has made the portfolio decision not to advance CFT8634 clinical development beyond the Phase 1 trial....No additional patients will be enrolled in the CFT8634 Phase 1 trial and wind down activities are expected to be complete by the end of Q1 2024."

Discontinued • P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Announces Upcoming Data Presentations for CFT8634, an Orally Bioavailable BiDAC Degrader in Development for Synovial Sarcoma and SMARCB1-Null Tumors, and CFT7455, an Orally Bioavailable MonoDAC Degrader in Development for Multiple Myeloma and Non-Hodgkin’s Lymphoma (GlobeNewswire) - "C4 Therapeutics, Inc...announced plans to share data from the Phase 1 dose escalation portions of the ongoing Phase 1/2 trials of CFT7455 and CFT8634. The CFT8634 Phase 1 dose escalation data has been accepted as a poster presentation at the Connective Tissue Oncology Society (CTOS) Annual Meeting taking place from November 1 – 4, 2023 in Dublin, Ireland."

P1 data • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights (GlobeNewswire) - "CFT7455: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial of Arm B1, evaluating CFT7455 as a monotherapy in MM, in the second half of 2023; CFT8634: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial for synovial sarcoma and SMARCB1-null solid tumors in the second half of 2023."

P1 data • Hematological Malignancies • Multiple Myeloma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma

A PHASE 1/2 STUDY OF CFT8634, A NOVEL BIFUCTIONAL DEGRADATION ACTIVATING COMPOUND (BIDAC) DEGRADER OF BRD9, IN SYNOVIAL SARCOMA AND SMARCB1-NULL TUMORS (CTOS 2022) - P1/2 | "Approximately 110 patients at approximately 10 US sites will be enrolled. This trial is registered with clinicaltrials.gov as NCT05355753, and is open to enrollment."

P1/2 data • Chordoma • Oncology • Rhabdoid Tumor • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • Targeted Protein Degradation • CRBN • SMARCB1 • SS18

C4 Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Business Highlights (GlobeNewswire) - "KEY UPCOMING MILESTONES: CFT7455: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial of Arm B1, evaluating CFT7455 as a monotherapy in MM, in the second half of 2023. CFT8634: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial in the second half of 2023 in synovial sarcoma and SMARCB1-null solid tumors."

P1/2 data • Hematological Malignancies • Multiple Myeloma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Announces 2023 Strategic Priorities to Advance Portfolio of Targeted Protein Degradation Medicines (GlobeNewswire) - "RECENT ACHIEVEMENTS AND ANTICIPATED 2023 OBJECTIVES: CFT7455:...2023 Objectives: (i) Continue dose escalation in Arms B1, B2 and C of the Phase 1/2 trial, evaluating CFT7455 as a single agent in MM, in combination with dexamethasone in MM, and as a single agent in NHL, respectively; (ii) Present Phase 1 dose escalation data from the ongoing Phase 1/2 trial of CFT7455 in MM in the second half of 2023; CFT8634:...2023 Objectives: (i) Continue dose escalation of the CFT8634 Phase 1/2 trial in synovial sarcoma and SMARCB1-null solid tumors; (ii) Present Phase 1 dose escalation data from the ongoing CFT8634 Phase 1/2 trial in the second half of 2023."

P1 data • Trial status • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Reports Third Quarter 2022 Financial Results and Recent Business Highlights (GlobeNewswire) - "Accepted to Present at the 2022 Connective Tissue Oncology Society (CTOS) Annual Meeting: Brian A. Van Tine, MD, PhD, Professor of Medicine, Division of Oncology, Section of Medical Oncology, the Washington University School of Medicine, Siteman Cancer Center, will present a trial-in-progress poster titled 'A Phase 1/2 Study of CFT8634, A Novel Bifunctional Degradation Activating Compound (BiDAC™) Degrader of BRD9, in Synovial Sarcoma and SMARCB1-Null Tumors' at the 2022 CTOS Annual Meeting on November 17, 2022 at 5 pm PT...CFT1946: Initiate a Phase 1/2 clinical trial of CFT1946 for the treatment of BRAF V600-mutant solid tumors by year-end 2022. CFT8919: Complete IND-enabling activities for CFT8919, a potent and selective degrader of EGFR L858R, for the treatment of non-small cell lung cancer, by year-end 2022."

IND • New P1/2 trial • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Reports Second Quarter 2022 Financial Results and Recent Business Highlights (GlobeNewswire) - "R&D expense for the second quarter of 2022 was $31.3 million, compared to $23.3 million for the second quarter of 2021. The increase in R&D expense was primarily attributable to increased personnel expenses including increases in stock compensation expenses, facility costs from additional leased space, and clinical expenses as a result of the ongoing Phase 1/2 clinical trial of CFT7455 and commencement of the CFT8634 Phase 1/2 trial."

Commercial • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Reports Second Quarter 2022 Financial Results and Recent Business Highlights (GlobeNewswire) - "The company anticipates the following milestones...Continue to enroll Cohorts B1 and C; data from these efforts will inform the identification of a recommended Phase 2 dose(s) and schedule(s) for single agent CFT7455 in MM and NHL; CFT8634: Continue to enroll patients in the Phase 1/2 trial throughout 2022. Data from these efforts will inform the identification of a recommended Phase 2 dose for synovial sarcoma and SMARCB1-null solid tumors; Submit an IND application and initiate a Phase 1 trial of CFT1946 in BRAF V600X-driven cancers including melanoma, colorectal and non-small cell lung cancer in 2H 2022; Complete IND-enabling activities for CFT8919, a potent and selective degrader of EGFR L858R for the treatment of non-small cell lung cancer, by year-end 2022."

Clinical • Enrollment status • IND • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Reports Second Quarter 2022 Financial Results and Recent Business Highlights (GlobeNewswire) - "SECOND QUARTER 2022 AND RECENT HIGHLIGHTS...C4T progressed the Phase 1/2 clinical trial of CFT7455 by enrolling patients in Cohort B1, exploring CFT7455 as a monotherapy for relapsed or refractory MM, and Cohort C, exploring CFT7455 as a monotherapy for NHL; C4T dosed the first patient in the Phase 1/2 clinical trial of CFT8634. The trial continues to progress, with sites open and enrolling patients in Cohort A, the Phase 1 dose escalation arm, to evaluate CFT8634 as an oral, single-agent therapy for patients with synovial sarcoma or SMARCB1-null solid tumors."

Trial status • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating CFT8634, an Orally Bioavailable BiDAC Degrader for the Treatment of Synovial Sarcoma and SMARCB1-null Tumors (GlobeNewswire) - "C4 Therapeutics...announced that the first patient has been dosed in its Phase 1/2 clinical trial of CFT8634, an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of SMARCB1-perturbed cancers, including synovial sarcoma and SMARCB1-null tumors....The Phase 1/2 trial will primarily investigate safety, tolerability and anti-tumor activity with secondary and exploratory objectives to characterize the pharmacokinetic and pharmacodynamic profile of CFT8634....Across the Phase 1/2 trial, C4T plans to enroll approximately 90 patients."

Trial status • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Reports First Quarter 2022 Financial Results and Recent Business Highlights (GlobeNewswire) - "The company anticipates the following milestones:...CFT7455: Continued enrollment of the Phase 1/2 trial throughout 2022; CFT8634: Dose the first patient in CFT8634 Phase 1/2 clinical trial in 1H 2022 and continue to enroll the trial throughout 2022; CFT1946: Submit an IND application and initiate a Phase 1 trial of CFT1946 in BRAF V600X-driven cancers including melanoma, colorectal and non-small cell lung cancer in 2H 2022; CFT8919: Complete IND-enabling activities for CFT8919 by year-end 2022."

Clinical • IND • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

The discovery and characterization of CFT8634: A potent and selective degrader of BRD9 for the treatment of SMARCB1-perturbed cancers (AACR 2022) - "The preclinical data presented herein support the clinical development of CFT8634 for the treatment of synovial sarcoma and SMARCB1-null tumors."

Chordoma • Oncology • Rhabdoid Tumor • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • SMARCB1 • SS18

C4 Therapeutics Announces FDA Orphan Drug Designation for CFT8634 for the Treatment of Soft Tissue Sarcoma (GlobeNewswire) - "C4 Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to CFT8634 for the treatment of soft tissue sarcoma....CFT8634 is a BiDAC™ degrader targeting BRD9 for the treatment of cancers that are dependent on BRD9, including synovial sarcoma and SMARCB1 deleted cancers."

Orphan drug • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

C4 Therapeutics Reports Full Year 2021 Financial Results and Recent Business Highlights (GlobeNewswire) - "KEY UPCOMING MILESTONES - The company plans to achieve the following milestones in 2022: CFT8634 - Present pre-clinical data on the discovery and characterization of CFT8634 in synovial sarcoma at the AACR Annual Meeting. Initiate a Phase 1 trial for CFT8634 in synovial sarcoma and SMARCB1-null solid tumors in 1H 2022; CFT1946 - Present pre-clinical data on the discovery and characterization of CFT1946 in BRAF V600X driven cancers at the AACR Annual Meeting. Submit an IND application and initiate a Phase 1 trial of CFT1946 in BRAF V600X-driven cancers including melanoma, colorectal and non-small cell lung cancer in 2H 2022; CFT8919: Complete IND-enabling activities for CFT8919 by year-end 2022."

IND • New P1 trial • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor

C4 Therapeutics Reports Recent Business Highlights and Second Quarter 2021 Financial Results (GlobeNewswire) - "UPCOMING KEY MILESTONES: Advance the CFT7455 Phase 1/2 program and share safety and efficacy data at a medical meeting in 2022. Submit an IND application for CFT8634 in 2H-2021. Advance IND-enabling activities for CFT8919 and submit an IND application by mid-2022."

IND • P1/2 data • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor