{"id":2637,"date":"2021-11-12T18:56:00","date_gmt":"2021-11-12T18:56:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3574020_AE74020_0"},"modified":"2021-11-12T18:56:00","modified_gmt":"2021-11-12T18:56:00","slug":"treadwell-therapeutics-announces-a-presentation-at-the-2021-sitc-annual-meeting-featuring-a-clinical-trial-update-on-cfi-402411-a-first-in-class-hpk1-inhibitor","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=2637","title":{"rendered":"Treadwell Therapeutics Announces A Presentation at the 2021 SITC Annual Meeting Featuring a Clinical Trial Update on CFI-402411, a First-in-Class HPK1 inhibitor"},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/en.prnasia.com\/prnasia.com-PC\/images\/logo-en-blue-in.png\" class=\"ff-og-image-inserted\"><\/div>\n<p><span class=\"xn-location\">NEW YORK<\/span>, <span class=\"xn-chron\">Nov. 12, 2021<\/span> \/PRNewswire\/ &#8212; Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for highly aggressive cancers, today announced a presentation for the Company&#8217;s CFI-402411 program, an oral, first-in-class inhibitor of <u>H<\/u>ematopoietic <u>P<\/u>rogenitor <u>K<\/u>inase 1 (HPK1)&nbsp;a negative regulator of immune cell activation,&nbsp;at the 36<sup>th<\/sup>&nbsp;Society for Immunotherapy of Cancer (SITC) Annual Meeting being held virtually and in-person from&nbsp;November 10-14, 2021 at the Walter E. Washington Convention Center in <span class=\"xn-location\">Washington<\/span>, D.C.&nbsp; This presentation will describe preliminary dose escalation data from TWT-101, a <span class=\"xn-location\">Treadwell<\/span>-sponsored, first in human study of CFI-402411 in advanced solid tumors.<\/p>\n<p>&#8220;CFI-402411 is a potent, orally available small molecule inhibitor of HPK1 (Hematopoietic progenitor kinase 1, also known as mitogen activated protein kinase kinase kinase kinase 1, MAP4K1). HPK1 is a negative regulator of both T and B cell responses. We have seen preliminary indications of tolerability and clinical benefit in patients with multiple solid tumors, including post PD1 progression&#8221; said Dr. Omid Hamid,&nbsp;Chief of Research\/ Immuno-Oncology at The Angeles Clinic&nbsp;&amp; Research Institute, a Cedars-Sinai affiliate, <span class=\"xn-location\">Los Angeles, California<\/span>.<\/p>\n<p>&#8220;HPK1 inhibition with CFI-402411 represents a novel means to stimulate anti-tumor immunity, through an orally available therapy,&#8221; said Dr. <span class=\"xn-person\">Michael Tusche<\/span>, co-Chief Executive Officer at Treadwell Therapeutics. &#8220;As the first HPK1 inhibitor in the clinic, we are excited by the promise of CFI-402411 and look forward to sharing additional results from TWT-101, including pembrolizumab combination and biomarker focused cohorts, throughout 2022 and beyond.&#8221;<\/p>\n<p><b><u>2021 SITC Poster Presentations and Details:<\/u><\/b><\/p>\n<p><b>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<\/b><\/p>\n<p>Publication Number: 489<\/p>\n<p>Poster Hall<\/p>\n<p>Date and Time: <span class=\"xn-chron\">November 12, 2021<\/span>, <span class=\"xn-chron\">7:00 am &#8211; 8:30 pm<\/span><\/p>\n<p>In the presentation titled, &#8220;<i>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<\/i><i>,&#8221;<\/i><i>&nbsp;<\/i>CFI-402411 demonstrated a tolerable safety profile at doses up to 400 mg qd, linear pharmacokinetics, and biologically effective concentrations in patients, as assessed by an exploratory <i>in vitro<\/i> SLP-76 assay.&nbsp; In this heavily pre-treated, all-comer patient population (N=16), 5 patients achieved stable disease as best response for at least one tumor evaluation, with 2 of those patients (salivary gland and basal cell carcinoma) exhibiting stable disease through at least 3 tumor evaluations.&nbsp; The basal cell carcinoma patient had been previously treated with anti-PD1 antibodies.&nbsp; The most common drug related toxicities of any grade, which occurred in greater than 10% of patients, were diarrhea (62.5%), nausea (43.8%), decreased appetite (31.3%), dyspepsia (25%), blood creatinine increase (25%), and fatigue (25%).&nbsp;&nbsp;<\/p>\n<p><b>About<\/b>&nbsp;<b>CFI-402411<\/b><\/p>\n<p>CFI-402411 is a highly potent inhibitor of HPK1, which in preclinical studies has been shown to have an immune-activating 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.<\/p>\n<p><b>About<\/b>&nbsp;<b>TWT-101<\/b><\/p>\n<p>TWT-101 is a Phase 1\/2 clinical trial of CFI-402411 in advanced solid malignancies.&nbsp; 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 will enroll approximately 170 patients at up to 15 sites in <span class=\"xn-location\">North America<\/span> and <span class=\"xn-location\">Asia<\/span>. It will involve 5 arms including monotherapy and combination dose escalation and expansion in a variety of tumor types, as well as biomarker backfills<\/p>\n<p><b>About Treadwell Therapeutics<\/b><\/p>\n<p>Treadwell Therapeutics is a science driven, clinical-stage multi-modality oncology company, spun out of the University Health Network (UHN), in <span class=\"xn-location\">Toronto<\/span>, Canada.&nbsp; The company is developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer.&nbsp; Founded by a cadre of pre-eminent scientific luminaries, including Dr. <span class=\"xn-person\">Tak W. Mak<\/span>, the Company&#8217;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, an oral immunomodulatory kinase inhibitor with activity toward HPK1.&nbsp; <span class=\"xn-location\">Treadwell<\/span> also has a robust pre-clinical pipeline with multiple biologic and next generation TCR based autologous cell therapy programs.&nbsp; For more information, please visit <a target=\"_blank\" href=\"http:\/\/www.treadwelltx.com\/\" rel=\"nofollow noopener\">www.treadwelltx.com<\/a>.<\/p>\n<p><b>Contact<\/b><\/p>\n<p><u>Investors:<\/u><b>&nbsp;<\/b><br \/><span class=\"xn-person\">Jantzen Kwan<\/span><br \/>Investor Relations&nbsp;<br \/><a target=\"_blank\" href=\"mailto:ir@treadwelltx.com\" rel=\"nofollow noopener\">ir@treadwelltx.com<\/a><\/p>\n<p><u>General inquiries:<br \/><\/u><a target=\"_blank\" href=\"mailto:info@treadwelltx.com\" rel=\"nofollow noopener\">info@treadwelltx.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>NEW YORK, Nov. 12, 2021 \/PRNewswire\/ &#8212; Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for highly aggressive cancers, today announced a presentation for the Company&#8217;s CFI-402411 program, an oral, first-in-class inhibitor of Hematopoietic Progenitor Kinase 1 (HPK1)&nbsp;a negative regulator of immune cell activation,&nbsp;at the 36th&nbsp;Society for Immunotherapy of Cancer (SITC) Annual Meeting being [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":2638,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-2637","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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