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Cell Therapy Company and TIO Bioventures Portfolio Company","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Treadwell Therapeutics","sponsor":"Sino Biopharmaceutical Limited","pharmaFlowCategory":"D","amount":"$91.0 million","upfrontCash":"Undisclosed","newsHeadline":"Treadwell Therapeutics Announces The Closing of a $91 Million Series B Financing","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Treadwell Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Treadwell Therapeutics Announces Fast Track Designation Granted by the FDA to CFI-400945 for the Treatment of Acute Myeloid Leukemia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Treadwell Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Treadwell Therapeutics Announces Fast Track Designation Granted by the FDA to CFI-402257 for the Treatment of ER+\/HER2- Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Treadwell Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Treadwell Announces Ocifisertib, a First-in-Class PLK4 Inhibitor, has Received Orphan Designation from U.S. FDA for the Treatment of Acute Myeloid Leukemia","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"}]
Find Clinical Drug Pipeline Developments & Deals by Treadwell Therapeutics
CFI-400945 (ocifisertib) is a first-in-class, investigational PLK4 inhibitor. It is being evaluated for the treatment of relapsed/refractory acute myeloid leukemia.
CFI-402257, a best in class inhibitor of Threonine Tyrosine Kinase (TTK, also known as Mps1), for the treatment of adult patients with ER+/HER2- advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy.
CFI-400945, a first in class inhibitor of Polo-like kinase 4 (PLK4), for the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia, has shown encouraging signs of monotherapy activity in AML patients with adverse cytogenetics.
Proceeds will fund the continued clinical development of CFI-400945, CFI-402257 and CFI-402411, the preclinical development of the Biologics and Cell Therapy platform, as well as general corporate purposes.
Currently available approaches of autologous TCR-based cell therapy focus on TCRs recognizing HLA-A2 restricted epitopes, alleles well represented in Caucasian populations.
Lead Product(s):
Autologous TCR-based Cell Therapy
The trial is built on the preclinical work demonstrating an association between loss of the tumor suppressor PTEN, a common alteration in this disease setting, and response to CFI-400945.
Treadwell has started patient dosing in TWT-101, its Phase 1/2 study to evaluate CFI-402411, an oral, first-in-class inhibitor of hematopoietic progenitor kinase 1 in patients with solid tumors as a monotherapy or in combination with PD1 pathway blockade.
The expansion cohorts include ER+/HER2 breast cancer patients in combination with fulvestrant post CDK4/6 inhibitor failure, triple negative breast cancer patients and an additional cohort in solid tumors.
This multi-center, single-arm, open-label phase 2 trial is designed to assess the efficacy of CFI-400945 given with durvalumab in patients with treatment-resistant TNBC.
Treadwell intends to initiate a Phase 1/2 clinical trial of CFI-402411, designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CFI-402411 and to determine optimal dosing as a monotherapy and in combination with PD1 pathway inhibitors.