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
NEW YORK,Nov. 11,2022 --Treadwell Therapeutics,a clinical-stage biotechnology company developing novel medicines cancer,today announced a presentation for CFI-402411,an oral,first-in-class inhibitor of Hematopoietic Progenitor Kinase 1 (HPK1),a negative regulator of immune cell activation,at the 37thSociety for Immunotherapy of Cancer (SITC) Annual Meeting being held virtually and in-person fromNovember 8-12,2022 at the Boston Convention and Exhibition Center in Boston,MA. This presentation will provide an interim update from the ongoing TWT-101,a Treadwell-sponsored,first in human study of CFI-402411 in advanced solid tumors.
"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,Chief of Research/ Immuno-Oncology at The Angeles Clinic& Research Institute,a Cedars-Sinai affiliate,Los Angeles,California.
"We are encouraged by the emerging clinical profile of CFI-402411," said Dr. Michael Tusche,co-Chief Executive Officer at Treadwell Therapeutics. "We hope to define the Recommended Phase 2 dose for the molecule in the near term,and are excited about the next stage of development for CFI-402411 both as a monotherapy and in combination with checkpoint blockade."
2022 SITC Poster Presentations and Details:
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
Publication Number: 750
Poster Hall
Date and Time: November 11,2022,7:00 am - 8:30 pm
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. One patient was treated as a monotherapy (400 mg) and the other treated in combination (60 mg + pembrolizumab) with 36% and 81% reduction in target lesions,respectively. Nine patients had best response as stable disease and stayed on study for at least 4 cycles. The most common treatment emergent toxicities of any grade,which occurred in greater than 10% of patients,were diarrhea (61%),fatigue (39%),nausea (33%),decreased appetite (30%),vomiting (26%),dehydration (17%),ALT increase (15%). dyspepsia (15%) and back pain (11%).
AboutCFI-402411
CFI-402411 is a highly potent inhibitor of HPK1,which in preclinical studies has been shown to have an immune-activating effects 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 could enroll up to 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. The company is developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer. 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. Treadwell also has a rapidly advancing 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
