On June 2, 2020 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel therapeutics for highly aggressive cancers, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application 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, JUN 2, 2020, View Source [SID1234560766]). In addition, Treadwell also announced the receipt of a No Objection Letter (NOL) to a Clinical Trial Application (CTA) for CFI-402411 in solid tumors from Health Canada.
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"HPK1 represents a novel, orally targettable node of therapeutic intervention in the immune-oncology space. As a pleiotropic negative regulator of immune cell activation, inhibiting HPK1 may result in more potent anti-tumor responses in the treatment of cancer, simultaneously acting on multiple immune cell subsets to prevent tumor evasion. Therefore, we are excited to have received the FDA’s IND clearance to begin clinical trials for our first-in-class, highly-potent, oral HPK1 inhibitor," said Dr. Shane Burgess, Treadwell Co-Chief Executive Officer. "Our inhibitor program is the culmination of over two decades of pioneering work by Treadwell Founders and collaborators in HPK1 biology and immune regulation. Preclinical studies have demonstrated CFI-402411’s promise as a potential monotherapy and in combination with existing checkpoint inhibitors across both solid and hematological cancers, and we look forward to our Phase 1/2 trial later this year," added Dr. Mark Bray, Treadwell Chief Scientific Officer and Co-Founder.
Under this IND, Treadwell intends to initiate a Phase 1/2 clinical trial of CFI-402411, an oral immunomodulatory kinase inhibitor with activity toward HPK1, in the third quarter of 2020. This clinical trial 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 PD1 pathway inhibitors. Start-up activities are currently underway including clinical study site preparation and subject screening.
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 cytotoxic effects on specific subtypes of AML mouse models.