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
NEW YORK,Nov. 12,2021 -- Treadwell Therapeutics,a clinical-stage biotechnology company developing novel medicines for highly aggressive cancers,today announced a presentation for the Company's CFI-402411 program,an oral,first-in-class inhibitor of Hematopoietic Progenitor Kinase 1 (HPK1)a negative regulator of immune cell activation,at the 36thSociety for Immunotherapy of Cancer (SITC) Annual Meeting being held virtually and in-person fromNovember 10-14,2021 at the Walter E. Washington Convention Center in Washington,D.C. This presentation will describe preliminary dose escalation data from TWT-101,a Treadwell-sponsored,first in human study of CFI-402411 in advanced solid tumors.
"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,Chief of Research/ Immuno-Oncology at The Angeles Clinic& Research Institute,a Cedars-Sinai affiliate,Los Angeles,California.
"HPK1 inhibition with CFI-402411 represents a novel means to stimulate anti-tumor immunity,through an orally available therapy," said Dr. Michael Tusche,co-Chief Executive Officer at Treadwell Therapeutics. "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."
2021 SITC Poster Presentations and Details:
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
Publication Number: 489
Poster Hall
Date and Time: November 12,2021,7:00 am - 8:30 pm
In the presentation titled,"TWT-101: A First In-human,Phase 1/2 Study of CFI-402411,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. In this heavily pre-treated,all-comer patient population (N=16),5 patients achieved stable disease as best response for at least one tumor evaluation,with 2 of those patients (salivary gland and basal cell carcinoma) exhibiting stable disease through at least 3 tumor evaluations. The basal cell carcinoma patient had been previously treated with anti-PD1 antibodies. The most common drug related toxicities of any grade,which occurred in greater than 10% of patients,were diarrhea (62.5%),nausea (43.8%),decreased appetite (31.3%),dyspepsia (25%),blood creatinine increase (25%),and fatigue (25%).
AboutCFI-402411
CFI-402411 is a highly potent inhibitor of HPK1,which in preclinical studies has been shown to have an immune-activating effect including the alleviation of inhibition of T cell receptors (TCR),disruption of abnormal cytokine expression,alteration of the tumor immunosuppressive environment through effector cells (i.e. Regulatory T cells or Treg),and potent anti-leukemic effects in several mouse models.
AboutTWT-101
TWT-101 is a Phase 1/2 clinical trial of CFI-402411 in advanced solid malignancies. The study is designed to assess the safety,tolerability,pharmacokinetics,pharmacodynamics and efficacy of CFI-402411,as well as to determine optimal dosing as a monotherapy and in combination with the anti-PD1 antibody,pembrolizumab. The trial will enroll approximately 170 patients at up to 15 sites in North America and Asia. It will involve 5 arms including monotherapy and combination dose escalation and expansion in a variety of tumor types,as well as biomarker backfills
About Treadwell Therapeutics
Treadwell Therapeutics is a science driven,clinical-stage multi-modality oncology company,spun out of the University Health Network (UHN),in Toronto,Canada. The company is developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. Founded by a cadre of pre-eminent scientific luminaries,including Dr. Tak W. Mak,the Company's robust,internally developed pipeline includes a first-in-class PLK4 kinase inhibitor,CFI-400945 and a best-in-class TTK inhibitor,CFI-402257,and CFI-402411,an oral immunomodulatory kinase inhibitor with activity toward HPK1. Treadwell also has a robust pre-clinical pipeline with multiple biologic and next generation TCR based autologous cell therapy programs. For more information,please visit www.treadwelltx.com.
Contact
Investors:
Jantzen Kwan
Investor Relations
ir@treadwelltx.com
General inquiries:
info@treadwelltx.com
