Treadwell Announces Initiation of Patient Dosing in TWT-101, a Phase 1/2 Study of HPK1 Inhibitor, CFI-402411, in Patients with Solid Tumors

- 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 25^th 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 T_reg), 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.