On September 2, 2020 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel small molecule therapeutics for highly aggressive cancers, reported 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 (Press release, Treadwell Therapeutics, SEP 2, 2020, View Source [SID1234564330]). 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.

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"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.