– Initial Phase 1 data expected in 2021
NEW YORK–(BUSINESS WIRE)–Treadwell Therapeutics, a clinical-stage biotechnology company developing novel small molecule therapeutics for highly aggressive cancers, today 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 dosing of the first patient with our first-in-class, highly-potent, oral HPK1 inhibitor is an important milestone for Treadwell as HPK1 represents a novel, orally-targetable node of therapeutic intervention in the immune-oncology space,” said Dr. Mark Bray, Treadwell Chief Scientific Officer and Co-Founder. “Preclinical studies have demonstrated CFI-402411’s promise as a potential monotherapy and in combination with existing checkpoint inhibitors in a wide array of solid and haematological cancer models. We look forward to continuing to explore the possibility of this novel agent as a treatment option in patients with solid and haematological cancers.”
This Phase 1/2 clinical trial of CFI-402411, an oral immunomodulatory kinase inhibitor with potent activity toward HPK1, 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 20 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.
CFI-402411 is a highly potent inhibitor of HPK1, which in preclinical studies has been shown to have an immune-activing 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.
About Treadwell Therapeutics
Treadwell Therapeutics is a clinical-stage oncology company exploiting cancer cells’ vulnerabilities to develop first-in-class and best-in-class small molecules 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 potentially best in class TTK inhibitor, CFI-402257 ready for Phase 2, and CFI-402411, an oral immunomodulatory kinase inhibitor with activity toward HPK1 in Phase 1/2 studies. For more information, please visit www.treadwelltx.com.
Stern Investor Relations, Inc.