{"id":13470,"date":"2022-11-11T14:09:00","date_gmt":"2022-11-11T14:09:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3933878_AE33878_0"},"modified":"2022-11-11T14:09:00","modified_gmt":"2022-11-11T14:09:00","slug":"treadwell-therapeutics-announces-a-presentation-at-the-2022-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=13470","title":{"rendered":"Treadwell Therapeutics Announces A Presentation at the 2022 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. 11, 2022<\/span> \/PRNewswire\/ &#8212;&nbsp;Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines cancer, today announced a presentation for CFI-402411, an oral, first-in-class inhibitor of <u>H<\/u>ematopoietic <u>P<\/u>rogenitor <u>K<\/u>inase 1 (HPK1), a negative regulator of immune cell activation,&nbsp;at the 37<sup>th<\/sup>&nbsp;Society for Immunotherapy of Cancer (SITC) Annual Meeting being held virtually and in-person from&nbsp;November 8-12, 2022 at the Boston Convention and Exhibition Center in <span class=\"xn-location\">Boston<\/span>, MA.&nbsp; This presentation will provide an interim update from the ongoing 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;Inhibition of HPK1 with CFI-402411 could represent a safe and effective means to stimulate anti-tumor immunity. &nbsp;We continue to observe good tolerability and emerging signs of clinical activity, including in patients that have failed anti-PD1 therapy&#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;We are encouraged by the emerging clinical profile of CFI-402411,&#8221; said Dr. <span class=\"xn-person\">Michael Tusche<\/span>, co-Chief Executive Officer at Treadwell Therapeutics. &#8220;We hope to define the Recommended Phase 2 dose for the molecule in the near term, and are excited about the next stage of development for CFI-402411 both as a monotherapy and in combination with checkpoint blockade.&#8221;<\/p>\n<p><b><u>2022 SITC Poster Presentations and Details:<\/u><\/b><\/p>\n<p><b>TWT-101: A First-In-Clinic, Phase 1\/2 Study Of CFI-402411, a Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies<br \/><\/b>Publication Number: 750<br \/>Poster Hall<br \/>Date and Time: <span class=\"xn-chron\">November 11, 2022<\/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>&nbsp;CFI-402411 demonstrated a clinically manageable safety profile at doses up to 560 mg QD with exposures increasing proportionately with dose.&nbsp; In the efficacy evaluable population (N=31), 2 patients achieved partial response as best response.&nbsp; Both of responses were in Head and Neck Squamous Cell Carcinoma (HNSCC) patients previously treated with pembrolizumab. One patient was treated as a monotherapy (400 mg) and the other treated in combination (60 mg + pembrolizumab) with 36% and 81% reduction in target lesions, respectively.&nbsp; Nine patients had best response as stable disease and stayed on study for at least 4 cycles.&nbsp; The most common treatment emergent toxicities of any grade, which occurred in greater than 10% of patients, were diarrhea (61%), fatigue (39%), nausea (33%), decreased appetite (30%), vomiting (26%), dehydration (17%), ALT increase (15%). dyspepsia (15%) and back pain (11%). &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 effects 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 could enroll up to 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.&nbsp; The company is developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer.&nbsp; 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. <span class=\"xn-location\">Treadwell<\/span> also has a rapidly advancing pre-clinical pipeline with multiple biologic and next generation TCR based autologous cell therapy programs.&nbsp; For more information, please visit <a href=\"http:\/\/www.treadwelltx.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.treadwelltx.com<\/a>.<\/p>\n<p><b>Contact<br \/><\/b><u>Investors:<\/u>&nbsp;<br \/><span class=\"xn-person\">Jantzen Kwan<\/span><br \/>Investor Relations&nbsp;<br \/><a href=\"mailto:ir@treadwelltx.com\" target=\"_blank\" rel=\"nofollow noopener\">ir@treadwelltx.com<\/a><\/p>\n<p><u>General inquiries:<br \/><\/u><a href=\"mailto:info@treadwelltx.com%C2%A0\" rel=\"nofollow\">info@treadwelltx.com&nbsp;<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>NEW YORK, Nov. 11, 2022 \/PRNewswire\/ &#8212;&nbsp;Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines cancer, today announced a presentation for CFI-402411, an oral, first-in-class inhibitor of Hematopoietic Progenitor Kinase 1 (HPK1), a negative regulator of immune cell activation,&nbsp;at the 37th&nbsp;Society for Immunotherapy of Cancer (SITC) Annual Meeting being held virtually and in-person from&nbsp;November 8-12, [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-13470","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - 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