CFT8919 / C4 Therap, Betta Pharma - LARVOL DELTA

TY-2719, a potent and selective broad-spectrum mutation-effective EGFR-PROTAC molecule, attenuates acquired resistance to 3rd-generation EGFR TKIs (AACR 2025) - P1 | "These included CFT8919 (NCT06641609), HSK40118 (NCT06050980), and HJ-002-03 (CTR20241691). TY-2719 did not suppress the growth of normal cells, such as NHEK, and NSCLC cells, such as A549 and A431 cells harboring wild-type EGFR. However, TY-2719 has excellent in vitro antiproliferative activity against a number of EGFR mutants, including common mutations, post osimertinib-resistant mutations, and rare mutations. Our data suggest that TY-2719 has superior selective activity in cells containing EGFR mutants compared to wild-type EGFR-expressing cells."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CRBN • GSPT1 • IKZF1

C4 Therapeutics Announces 2025 Milestones Across Clinical Portfolio of Degrader Medicines Pursuing Targets of High Unmet Need in Oncology (GlobeNewswire) - "ANTICIPATED 2025 MILESTONES - CFT1946: Complete monotherapy Phase 1 dose escalation in BRAF V600 mutant solid tumors in the first half of 2025. Generate data from the Phase 1 cohorts exploring monotherapy CFT1946 in melanoma, CFT1946 in combination with cetuximab in CRC and CFT1946 in combination with trametinib in melanoma. Data from these cohorts will define and enable the next phase of development. Present Phase 1 data in the second half of 2025. These presentations will include: (1) monotherapy in BRAF V600 mutant solid tumors, (2) monotherapy expansion cohorts in melanoma, and (3) in combination with cetuximab in CRC. CFT8919: Evaluate data from the Phase 1 dose escalation study in Greater China, which is led by partner Betta Pharmaceuticals, in patients with locally or advanced metastatic NSCLC harboring an EGFR L858R mutation. These data will be used to determine the next phase of development."

P1 data • Trial status • Colorectal Cancer • Melanoma • Non Small Cell Lung Cancer • Solid Tumor

C4 Therapeutics Announces First Patient Dosed in CFT8919 Clinical Trial (GlobeNewswire) - "C4 Therapeutics...announced its partner Betta Pharmaceuticals has dosed the first patient in the Phase 1 clinical trial of CFT8919, an orally bioavailable allosteric degrader of EGFR L858R for non-small cell lung cancer (NSCLC), in Greater China."

Trial status • Non Small Cell Lung Cancer

A Phase I Study of CFT8919 in Patients With Advanced NSCLC (clinicaltrials.gov) - P1 | N=166 | Not yet recruiting | Sponsor: Betta Pharmaceuticals Co., Ltd.

Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

C4 Therapeutics Announces 2024 Priorities and Extended Cash Runway to Advance Portfolio of Targeted Protein Degradation Medicines (GlobeNewswire) - "2024 ANTICIPATED MILESTONES...CFT8919: Support study start-up activities related to the Phase 1 dose escalation trial in EGFR L858R mutated non-small cell lung cancer by partner Betta Pharmaceuticals....In December 2023, partner Betta Pharmaceuticals received approval from the Chinese National Medical Products Administration for the Investigational New Drug application for CFT8919."

New P1 trial • Non Small Cell Lung Cancer

C4 Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights (GlobeNewswire) - "Clinical Trial Application (CTA) Accepted for Review by China National Medical Products Administration (NMPA). Betta Pharmaceuticals announced that their CTA submission for CFT8919 has been accepted for review by China NMPA....CFT7455: Present data from the Phase 1 dose escalation portion of the ongoing Phase 1/2 clinical trial focusing on CFT7455 as a monotherapy in R/R MM on December 12 at 4:30 PM ET at a virtual company-sponsored event."

New trial • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

C4 Therapeutics Announces FDA Clearance of Investigational New Drug Application for CFT8919, an Orally Bioavailable BiDAC Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer (GlobeNewswire) - "C4 Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for CFT8919, an orally bioavailable BiDAC™ degrader designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC) patients....Betta Pharmaceuticals is responsible for preparing and submitting a Clinical Trial Application to the National Medical Products Administration in China and plans to commence a first-in-human clinical trial of CFT8919 in China. C4T expects to initiate clinical trial activities outside Greater China following the completion of Betta Pharmaceuticals’ Phase 1 dose escalation study in Greater China."

IND • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

C4 Therapeutics and Betta Pharmaceuticals Announce Exclusive Licensing Agreement for the Development and Commercialization in Greater China of CFT8919, an Orally Bioavailable BiDAC Degrader of EGFR L858R for NSCLC (GlobeNewswire) - "C4 Therapeutics, Inc...and Betta Pharmaceuticals Co. Ltd...announced an exclusive licensing agreement for the development and commercialization of CFT8919 in Greater China (including Hong Kong SAR, Macau SAR and Taiwan)....Under the terms of the agreement, C4T expects to receive $35 million, which includes $10 million in upfront cash as well as a $25 million one-time equity investment, to be completed following the receipt of required regulatory approvals and other customary closing conditions. Additionally, C4T is eligible for up to $357 million in potential milestones and low to mid-double-digit percent royalties on net sales in the licensed territories. Betta will be responsible for the development, manufacturing and commercialization of CFT8919 in the licensed territories and is eligible to receive low single-digit percent royalties on net sales outside of Greater China. C4T retains the right to develop and commercialize CFT8919 in all territories outside of Greater China."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

C4 Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Business Highlights (GlobeNewswire) - "KEY UPCOMING MILESTONES...CFT1946: Continue site activation and patient enrollment of the dose escalation portion of the CFT1946 Phase 1/2 clinical trial in BRAF V600 mutant solid tumors. Present new preclinical data on the discovery and characterization of CFT1946 at 2023 AACR Annual Meeting in April. CFT8919: Submit an Investigational New Drug (IND) application for CFT8919 for the treatment of NSCLC in the first half of 2023."

IND • Preclinical • Trial status • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma

C4 Therapeutics Announces 2023 Strategic Priorities to Advance Portfolio of Targeted Protein Degradation Medicines (GlobeNewswire) - "RECENT ACHIEVEMENTS AND ANTICIPATED 2023 OBJECTIVES:...CFT1946:...2023 Objectives: (i) Advance the dose escalation portion of the CFT1946 Phase 1/2 trial in BRAF-V600 mutant solid tumors; (ii) Present new preclinical data on the discovery and characterization of CFT1946 as a potent, selective, and orally bioavailable degrader for the treatment of BRAF-V600-driven cancers at a medical meeting in the first half of 2023; CFT8919:...2023 Objectives: Submit an IND application for CFT8919 for the treatment of NSCLC in the first half of 2023."

IND • Preclinical • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • BRAF

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) - "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 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

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

C4 Therapeutics Presents Pre-clinical Data on CFT8919, A Selective Degrader of EGFR L858R, at Keystone Symposium on Targeted Protein Degradation (GlobeNewswire) - "C4 Therapeutics...presented new pre-clinical data on CFT8919, a novel mutant-selective degrader of epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC) at the Keystone Symposium on Targeted Protein Degradation. The poster presentation shares pre-clinical data that suggests CFT8919 may be active as a single agent in patients with resistance to EGFR inhibitors due to secondary mutations in EGFR, including T790M and C797S, as well as in the front-line setting with the potential to avoid the emergence of resistance-causing secondary EGFR mutations seen with currently approved EGFR inhibitors."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology

C4 Therapeutics to Advance CFT8919, A Selective Degrader of EGFR L858R, Into IND-enabling Studies (GlobeNewswire) - “C4 Therapeutics…announced that it has decided to advance CFT8919, a novel degrader of epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC), into investigational new drug (IND)-enabling studies and anticipates filing an IND for this program by mid-2022, with the goal to initiate a Phase 1/2 clinical trial by year-end 2022…We are also looking forward to sharing the first preclinical data for CFT8919 at the upcoming Keystone Symposium for Targeted Protein Degradation in early June….Initiate patient dosing for CFT7455 in 1H 2021... June 18-22, 2021 – C4T will present preclinical data on CFT7455 in non-Hodgkin’s lymphoma (NHL) at the 16th Annual ICML meeting.”

IND • Preclinical • Trial status • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology