CFI-402411 / Treadwell Therap - LARVOL DELTA

TWT-101: Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies (clinicaltrials.gov) - P1/2 | N=170 | Recruiting | Sponsor: Treadwell Therapeutics, Inc | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Nov 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • MSI

Treadwell Announces Strategic Pipeline Prioritization and Leadership Transitions (GlobeNewswire) - "Treadwell Therapeutics...announced that it is realigning its pipeline, workforce and management structure to support its highest value program and extend its cash runway to prioritize the execution of key near term value drivers and clinical milestones. Treadwell has elected to focus on its first-in-class PLK4 inhibitor, CFI-400945, in relapsed/refractory AML by expanding the ongoing company sponsored TWT-202 study, building on exciting signals of efficacy seen at earlier phases, and advancing towards a potential pivotal study in 2025. The company will seek to capitalize on very promising proof-of-concept from sponsored clinical studies of CFI-402257 (TTK/Mps1 inhibitor) and CFI-402411 (HPK1 inhibitor) through further, innovative collaborative studies and work with potential partners to accelerate timelines."

New trial • Pipeline update • Trial status • Acute Myelogenous Leukemia • Solid Tumor

TWT-101: a first-in-clinic study of CFI-402411, a hematopoietic progenitor Kinase-1 (HPK1) inhibitor, as single agent or combined with pembrolizumab in subjects with advanced solid malignancies (SITC 2023) - "Responses as monotherapy and in combination with CPI in CPI exposed patients were seen. Monotherapy part A expansion at 560 mg is underway in HNSCC and RCC."

Clinical • Metastases • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

TWT-101: A First-In-Clinic, Phase 1/2 Study Of CFI-402411, a Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies (SITC 2022) - "Conclusions CFI-402411 is a well-tolerated, potent inhibitor of HPK1 with a manageable AE profile and initial evidence of activity. RP2D and additional safety and efficacy data will be reported at conference presentation."

Clinical • Combination therapy • P1/2 data • Head and Neck Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • LCP2

Treadwell Therapeutics Announces A Presentation at the 2022 SITC Annual Meeting Featuring a Clinical Trial Update on CFI-402411, a First-in-Class HPK1 inhibitor (PRNewswire) - "'Inhibition of HPK1 with CFI-402411 could represent a safe and effective means to stimulate anti-tumor immunity. We continue to observe good tolerability and emerging signs of clinical activity, including in patients that have failed anti-PD1 therapy' said Dr. Omid Hamid..."

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Treadwell Therapeutics Announces A Presentation at the 2022 SITC Annual Meeting Featuring a Clinical Trial Update on CFI-402411, a First-in-Class HPK1 inhibitor (PRNewswire) - P1/2 | N=170 | NCT04521413 | Sponsor: Treadwell Therapeutics, Inc | "In the presentation titled, 'TWT-101: A First In-human, Phase 1/2 Study of CFI-402411, Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as a single agent and in combination with pembrolizumab in subjects with advanced solid malignancies,' CFI-402411 demonstrated a clinically manageable safety profile at doses up to 560 mg QD with exposures increasing proportionately with dose. In the efficacy evaluable population (N=31), 2 patients achieved partial response as best response. Both of responses were in Head and Neck Squamous Cell Carcinoma (HNSCC) patients previously treated with pembrolizumab."

P1/2 data • Oncology • Solid Tumor

TWT-101: A Phase 1 Study of the Novel HPK1 Inhibitor CFI-402411 in Patients with Advanced Cancer (SITC 2021) - P1/2 | "Single agent dose daily oral escalation cohort (A1) in advanced tumors, then dose expansion (A3) with biomarker backfill (A2) in select advanced tumors; combination with PD-1 Inhibitor (pembrolizumab) (B1, pembrolizumab eligible tumors with no prior grade >=3 related to CPI)) and expansion (B2, PD-1/PD-L1 naïve pembrolizumab eligible tumors). Further safety and efficacy results will be presented at the meeting including additional cohorts if available. Trial Registration ClinicalTrials.gov Identifier: NCT04521413"

Clinical • IO biomarker • P1 data • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • LCP2 • PD-L1

TWT-101: Safety and Efficacy Study Of CFI-402411 in Subjects With Advanced Solid Malignancies (clinicaltrials.gov) - P1/2 | N=170 | Recruiting | Sponsor: Treadwell Therapeutics, Inc | Trial primary completion date: Dec 2021 ➔ Dec 2023

Combination therapy • Trial primary completion date • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • MSI

Treadwell Therapeutics Announces The Closing of a $91 Million Series B Financing (PRNewswire) - "The proceeds from this financing will allow Treadwell to continue the clinical and pre-clinical development of its broad, multi-modality pipeline. This includes TWT-101 study of CFI-402411 in advanced solid tumors as a monotherapy and in combination with pembrolizumab; TWT-202 study of CFI-400945 in leukemia as a monotherapy and in combination with decitabine or azacitidine, an IND filing in late 2021 and subsequent study of CFI-402257 in metastatic ER+ Breast cancer, as well as other opportunistic trials. It will also support Treadwell's continued development and validation of its preclinical pipeline of novel biologic and cell therapy approaches, the latter of which is expected to enter the clinic around early 2023."

Commercial • IND • New trial • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Leukemia • Oncology • Solid Tumor

Treadwell Therapeutics Announces a Presentation at the 2021 SITC Annual Meeting Featuring a Clinical Trial Update on CFI-402411, a First-in-Class HPK1 inhibitor (Businesswire) - '"CFI-402411 is a potent, orally available small molecule inhibitor of HPK1 (Hematopoietic progenitor kinase 1, also known as mitogen activated protein kinase kinase kinase kinase 1, MAP4K1). HPK1 is a negative regulator of both T and B cell responses. We have seen preliminary indications of tolerability and clinical benefit in patients with multiple solid tumors, including post PD1 progression' said Dr. Omid Hamid..."

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Treadwell Therapeutics Announces a Presentation at the 2021 SITC Annual Meeting Featuring a Clinical Trial Update on CFI-402411, a First-in-Class HPK1 inhibitor (Businesswire) - P1/2, N=170; NCT04521413; Sponsor: Treadwell Therapeutics, Inc; "'As the first HPK1 inhibitor in the clinic, we are excited by the promise of CFI-402411 and look forward to sharing additional results from TWT-101, including pembrolizumab combination and biomarker focused cohorts, throughout 2022 and beyond...'In the presentation titled, 'TWT-101: A First In-human, Phase 1/2 Study of CFI-402411, Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as a single agent and in combination with pembrolizumab in subjects with advanced solid malignancies,' CFI-402411 demonstrated a tolerable safety profile at doses up to 400 mg qd, linear pharmacokinetics, and biologically effective concentrations in patients, as assessed by an exploratory in vitro SLP-76 assay."

P1/2 data • Basal Cell Carcinoma • Oncology • Solid Tumor

[VIRTUAL] Novel clinical stage kinase inhibitors for cancer therapy and immuno-oncology: CFI-402257 (TTK), CFI-400945 (PLK4) and CFI-402411 (HPK1) (AACR 2021) - "There is no abstract associated with this presentation."

Clinical • Oncology • PLK4

Safety and Efficacy Study Of CFI-402411 in Subjects With Advanced Solid Malignancies (clinicaltrials.gov) - P1/2; N=170; Not yet recruiting; Sponsor: Treadwell Therapeutics, Inc

Clinical • Combination therapy • New P1/2 trial • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • MSI

Safety and Efficacy Study Of CFI-402411 in Subjects With Advanced Solid Malignancies (clinicaltrials.gov) - P1/2; N=170; Recruiting; Sponsor: Treadwell Therapeutics, Inc; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • MSI

Treadwell Announces Initiation of Patient Dosing in TWT-101, a Phase 1/2 Study of HPK1 Inhibitor, CFI-402411, in Patients with Solid Tumors (Businesswire) - "Initial Phase 1 data expected in 2021…Treadwell Therapeutics…announced the initiation of patient dosing in TWT-101, its Phase 1/2 study to evaluate its third therapeutic candidate, CFI-402411, an oral, first-in-class inhibitor of hematopoietic progenitor kinase 1 (HPK1) in patients with solid tumors as a monotherapy or in combination with PD1 pathway blockade. Dosing of the first patient in the trial commenced August 25th with Sarah Cannon Research Institute at Tennessee Oncology, Nashville TN, with Dr. Johanna C. Bendell, MD, as Investigator…The trial will enroll approximately 170 patients at up to 20 sites in North America and Asia."

Enrollment status • P1 data • Trial status • Oncology • Solid Tumor

Treadwell Therapeutics announces US FDA clearance of IND application for phase 1/2 study of HPK1 inhibitor, CFI-402411 (Businesswire) - "Treadwell Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its third therapeutic candidate, CFI-402411, an oral, first-in-class inhibitor of hematopoietic progenitor kinase 1 (HPK1) in patients with solid tumors as a monotherapy or in combination with PD1 pathway blockade. In addition, Treadwell also announced the receipt of a No Objection Letter (NOL) to a Clinical Trial Application (CTA) for CFI-402411 in solid tumors from Health Canada...Under this IND, Treadwell intends to initiate a Phase 1/2 clinical trial of CFI-402411...in the third quarter of 2020."

Canadian regulatory • IND • New P1/2 trial • Oncology • Solid Tumor