{"id":863424,"date":"2025-06-24T16:51:33","date_gmt":"2025-06-24T20:51:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/"},"modified":"2025-06-24T16:51:33","modified_gmt":"2025-06-24T20:51:33","slug":"cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/","title":{"rendered":"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease"},"content":{"rendered":"

\nCUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-\u03b2 and a modified variant of IL-2
\n<\/h2>\n
\n

BOSTON, June 24, 2025 (GLOBE NEWSWIRE) — Cue Biopharma, Inc.<\/a>\u00a0(Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA). The FDA reviewed the first-in-human trial design, including the Company\u2019s plan for dose escalation, proposed populations and safety monitoring plan. On the basis of the FDA feedback, the Company, intends to file an IND pending completion of final IND enabling studies. CUE-401 is the Company\u2019s lead autoimmune asset, a first-in-class bispecific fusion protein\/molecule designed to induce and expand regulatory T cells (Tregs) in vivo through the co-activity of transforming growth factor beta (TGF-\u03b2) and a modified variant of interleukin 2 (IL-2).<\/p>\n

\u201cWe are highly encouraged by the FDA\u2019s positive feedback on our proposed development plan for this important program. We believe CUE-401, with its first-in-class mechanism exploiting the combined activities of TGF-\u03b2 and IL-2 is a potentially disruptive approach differentiated from other Treg-directed therapies, and has the potential to provide durable, long-lasting immune rebalance and tolerance addressing multiple, significant disease indications,\u201d said Daniel Passeri, chief executive officer of Cue Biopharma.<\/p>\n

Dr. Dan Baker, chief development officer of Cue Biopharma commented, \u201cCUE-401\u2019s mechanistic design extends beyond nTreg proliferation by transforming effector\/autoreactive responses to an anti-inflammatory and\/or suppressive response,\u00a0with the prospects of establishing tolerance. The combination of interleukin 2 (IL-2) and transforming growth factor beta (TGF-\u00df) is considered the \u2018master switch\u2019 for conversion of activated T effector cells into T cells with a regulatory phenotype.\u201d<\/p>\n

\n About CUE-401<\/strong>
\n
CUE-401 is a preclinical, bispecific fusion protein designed to induce and expand regulatory T cells (Tregs) through the co-activity of modified variants of transforming growth factor beta (TGF-\u03b2) and interleukin 2 (IL-2) with therapeutic potential across a range of T-cell mediated autoimmune and inflammatory diseases.<\/p>\n

CUE-401 has been engineered to harness the Treg induction capacity of TGF-\u03b2 combined with IL-2 signaling to provide what Cue Biopharma believes to be superior quality and stability of Tregs. The design and specifications of CUE-401 have been guided by leading scientific publications demonstrating that both IL-2 and TGF-\u03b2 are required for stable and efficient production of active and durable Tregs.<\/p>\n

CUE-401 is designed to overcome multiple hurdles\u00a0required\u00a0to exploit the therapeutic potential of a master switch\u00a0with a first-in-class, bispecific molecule integrating\u00a0a masked TGF-\u00df,\u00a0with our\u00a0clinically validated, attenuated IL-2\u00a0with\u00a0an antibody Fc fragment. This novel\u00a0design\u00a0provides for \u201cconditional binding\u201d\u00a0and avoids off target activity, simplifies manufacturing and has highly differentiated findings in multiple pre-clinical models. \u00a0<\/p>\n

In these models, CUE-401 behaves as a master switch to convert\u00a0autoreactive effector T cells (inflammatory cells) into stable, induced T-regulatory cells (iTregs). These findings suggest that CUE-401 acts by establishing a \u2018tolerance positive feedback loop\u2019 that not only increases nonspecific Treg populations, but critically,\u00a0reduces\u00a0and converts specific autoreactive T cells into transdifferentiated iTregs that are\u00a0specific\u00a0for the disease-causing autoantigens.<\/p>\n

\n About\u00a0Cue Biopharma<\/strong>
\n
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient\u2019s body. The company\u2019s proprietary platform, Immuno-STAT\u2122 (Selective Targeting and Alteration of T cells)<\/em>, and biologics are designed to harness the curative potential of the body\u2019s intrinsic immune system without the adverse effects of broad systemic immune modulation.<\/p>\n

Headquartered in\u00a0Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.<\/p>\n

For more information please visit\u00a0www.cuebiopharma.com<\/a>\u00a0and follow us on\u00a0X<\/a>\u00a0and\u00a0LinkedIn<\/a>.<\/p>\n

\n Forward-Looking Statements<\/strong>
\n
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company\u2019s expectations regarding the planned IND filing for CUE-401; the Company\u2019 expectations regarding the potential characteristics and benefit of CUE-401; the company\u2019s belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective modulation of disease-relevant T cell and the applicability of the company\u2019s platform across many cancers and autoimmune diseases; and the company\u2019s business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company\u2019s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as \u201cbelieve,\u201d \u201cexpect,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201cwould,\u201d \u201ccould,\u201d \u201cseek,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201cgoal,\u201d \u201cproject,\u201d \u201cestimate,\u201d \u201canticipate,\u201d \u201cstrategy,\u201d \u201cfuture,\u201d \u201clikely\u201d or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company\u2019s pipeline of product candidates and platforms, and its strategies, prospects, plans and objectives are forward-looking statements. Important factors that could cause the company\u2019s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the Company\u2019s ability to successfully advance is development plan for CUE-401; potential setbacks in the company\u2019s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company\u2019s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (\u201cFDA\u201d) or other governmental approvals for its product candidates, including FDA clearance of any future IND submission for CUE-401, and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company\u2019s trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company\u2019s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company\u2019s ability to obtain adequate financing to fund its business operations in the near term; the company\u2019s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company\u2019s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.<\/p>\n

\n Investor Contact <\/strong>
\n
Marie Campinell\u00a0
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com<\/a><\/p>\n

\n Media Contact<\/strong>
\n
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-\u03b2 and a modified variant of IL-2 BOSTON, June 24, 2025 (GLOBE NEWSWIRE) — Cue Biopharma, Inc.\u00a0(Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA). The FDA reviewed the first-in-human trial design, including the Company\u2019s plan for dose escalation, proposed populations and safety monitoring plan. On the basis of the FDA feedback, the Company, intends to file an IND pending completion of final IND enabling studies. … <\/p>\n

Continue reading “Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-863424","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nCue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-\u03b2 and a modified variant of IL-2 BOSTON, June 24, 2025 (GLOBE NEWSWIRE) — Cue Biopharma, Inc.\u00a0(Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA). The FDA reviewed the first-in-human trial design, including the Company\u2019s plan for dose escalation, proposed populations and safety monitoring plan. On the basis of the FDA feedback, the Company, intends to file an IND pending completion of final IND enabling studies. … Continue reading "Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-24T20:51:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease\",\"datePublished\":\"2025-06-24T20:51:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/\"},\"wordCount\":1220,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/\",\"name\":\"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease - Market Newsdesk\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI=\",\"datePublished\":\"2025-06-24T20:51:33+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI=\",\"contentUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI=\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#website\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/\",\"name\":\"Market Newsdesk\",\"description\":\"Latest Business News in Real Time\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\",\"name\":\"Newsdesk\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g\",\"caption\":\"Newsdesk\"},\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/author\\\/newsdesk\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease - Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/","og_locale":"en_US","og_type":"article","og_title":"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease - Market Newsdesk","og_description":"CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-\u03b2 and a modified variant of IL-2 BOSTON, June 24, 2025 (GLOBE NEWSWIRE) — Cue Biopharma, Inc.\u00a0(Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA). The FDA reviewed the first-in-human trial design, including the Company\u2019s plan for dose escalation, proposed populations and safety monitoring plan. On the basis of the FDA feedback, the Company, intends to file an IND pending completion of final IND enabling studies. … Continue reading \"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/","og_site_name":"Market Newsdesk","article_published_time":"2025-06-24T20:51:33+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease","datePublished":"2025-06-24T20:51:33+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/"},"wordCount":1220,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/","name":"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease - Market Newsdesk","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/#primaryimage"},"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI=","datePublished":"2025-06-24T20:51:33+00:00","author":{"@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"breadcrumb":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/#primaryimage","url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI=","contentUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4MzkwNCM3MDE2NjU5IzIwOTI2OTI="},{"@type":"BreadcrumbList","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/cue-biopharma-receives-fda-feedback-on-pre-ind-briefing-document-reinforcing-companys-intention-to-advance-ind-submission-for-cue-401-to-address-unmet-need-in-the-treatment-of-autoimmune-dise\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.marketnewsdesk.com\/"},{"@type":"ListItem","position":2,"name":"Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company\u2019s Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease"}]},{"@type":"WebSite","@id":"https:\/\/www.marketnewsdesk.com\/#website","url":"https:\/\/www.marketnewsdesk.com\/","name":"Market Newsdesk","description":"Latest Business News in Real Time","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.marketnewsdesk.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979","name":"Newsdesk","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g","caption":"Newsdesk"},"url":"https:\/\/www.marketnewsdesk.com\/index.php\/author\/newsdesk\/"}]}},"_links":{"self":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/posts\/863424","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/comments?post=863424"}],"version-history":[{"count":0,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/posts\/863424\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/media?parent=863424"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/categories?post=863424"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/tags?post=863424"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}