{"id":494054,"date":"2021-05-17T08:01:10","date_gmt":"2021-05-17T12:01:10","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\/"},"modified":"2021-05-17T08:01:10","modified_gmt":"2021-05-17T12:01:10","slug":"kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\/","title":{"rendered":"Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor – Gamma Delta T-cell Therapy"},"content":{"rendered":"

<\/p>\n

Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor – Gamma Delta T-cell Therapy <\/b><\/p>\n

Kiromic achieves key milestone for this first in human phase 1 clinical trial<\/i><\/p>\n

HOUSTON–(BUSINESS WIRE<\/a>)–
\nKiromic Biopharma, Inc. (Nasdaq: KRBP)\n<\/p>\n

\nToday, Kiromic announces the submission of a novel Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial that has the potential to be a universal T-Cell therapy for any solid malignancy that expresses the biomarker PD-L1, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs.\n<\/p>\n

\nThe clinical trial title: ALEXIS-PRO-1:<\/b> A Phase 1, Open-label, Dose Escalation Study of KB-PD1, an Allogeneic Gamma Delta T-Cell Expressing a Chimeric PD1 Switch Receptor, in Subjects with PD\u2011L1 Positive Metastatic or Progressive Locally Advanced Solid Malignancies.\n<\/p>\n

\nThe FDA feedback is expected within 30 days from this IND submission.\n<\/p>\n

Kiromic\u2019s preclinical studies show rapid and complete tumor elimination with no toxicity as per results presented at the American Association Cancer Research 2021 poster <\/i><\/b>LB148<\/a>.\n<\/p>\n

\nUnlike in the case of autologous CAR-T cell therapy products, which are derived from pretreated cancer patients, Kiromic\u2019s proprietary PD1 Gamma-delta switch receptor therapy is derived from healthy donors.\n<\/p>\n

Key features of the IND:<\/b><\/p>\n\n\n\n\n\n\n\n\n\n\n\n
\n

\nProduct Name\n<\/p>\n<\/td>\n

\n

\nKB-PD1\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nProduct Type\n<\/p>\n<\/td>\n

\n

\nChimeric PD1 T-Cell live cell therapy\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nCancer Type\n<\/p>\n<\/td>\n

\n

\nAll solid tumors\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nTargeting\n<\/p>\n<\/td>\n

\n

\nChimeric PD-L1\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPatient Type\n<\/p>\n<\/td>\n

\n

\nPatients with solid tumor positive for PD\u2011L1\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nProjected No. of Patients\n<\/p>\n<\/td>\n

\n

\n30\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nDosing\n<\/p>\n<\/td>\n

\n

\nDose escalation\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPrimary Completion of Trial\n<\/p>\n<\/td>\n

\n

\n18 months\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nFirst-in-human dosing\n<\/p>\n<\/td>\n

\n

\n3Q 2021 pending FDA authorization\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nFirst data from Trial\n<\/p>\n<\/td>\n

\n

\n4Q 2021\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

How Our KB-PD1 Live T-Cell Therapy Improves CAR-T Market:<\/b><\/p>\n\n\n\n\n\n\n
\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

Marketed and traditional CAR-T<\/b><\/p>\n<\/td>\n

\n

Kiromic KB-PD1<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nMalignancies
\n
(Cancer Type)\n<\/p>\n<\/td>\n

\n

\nHematologic\n<\/p>\n<\/td>\n

\n

\nSolid Tumors\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nLive Cell Origin\n<\/p>\n<\/td>\n

\n

\nAutologous
\n<\/p>\n

\nLive Cells from pre-treatment patients\n<\/p>\n<\/td>\n

\n

\nAllogeneic
\n<\/p>\n

\nLive Cells from healthy donors\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nLive Cell Cloning
\n
(Manufacturing)\n<\/p>\n<\/td>\n

\n

\nSingle batch
\n
Single dose\n<\/p>\n<\/td>\n

\n

\nSingle batch
\n
Multi dose
\n<\/p>\n

\n(aka. Off-The-Shelf)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nMass Manufacturing
\n<\/p>\n<\/td>\n

\n

\non-demand
\n
a single patient\n<\/p>\n<\/td>\n

\n

\n— Will be manufactured like a traditional drug
\n<\/p>\n

\n— Kiromic proprietary manufacturing
\n<\/p>\n

\n— Kiromic proprietary cryopreservation processing techniques\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nKiromic was able to respect the expectations and meet the timeline 45 days before the end of the second quarter. Kiromic now expects that it will be able to deliver a first in human patient dosing by the end of Q3 2021. Kiromic, an organization that is driven to achieve scientific breakthroughs, dedicated significant resources to the IND submission in an effort to achieve the optimal clinical trial design.\n<\/p>\n

\nHistorically, checkpoint inhibitors have been successful in solid malignancies, but KB-PD1 takes it one step further by not just blocking the PD1\/PD-L1 interaction (\u201ccutting the brakes\u201d) like a checkpoint inhibitor does, but rather, KB-PD1 rewires the brake into an accelerator.\n<\/p>\n

\nIn this way, Kiromic is optimistic that any cancer cell that expresses the PD-L1 marker will effectively activate and accelerate the ability of KB-PD1 to traffic through the tumor microenvironment (TME), which thus far has proven to be an imposing barrier to effective T-cell treatments in solid cancers.\n<\/p>\n

IQVIA (CRO, Clinical Research Organization)<\/b><\/p>\n

https:\/\/www.iqvia.com\/<\/a><\/p>\n

\nIQVIA is an industry driver in data technology and advanced analytics, designed to produce and develop optimal clinical trial outcomes.\n<\/p>\n

\nIQVIA will be managing our clinical trail sites CRO (Clinical Research Organization).\n<\/p>\n

\nLeading global sites are lining up to be the first to dose our KB-PD1 live cell therapies for solid tumors.\n<\/p>\n

\nSite announcements are coming within weeks.\n<\/p>\n

CEO of Kiromic, Dr. Maurizio Chiriva-Internati, DBSc, PhDs<\/b><\/p>\n

\n\u201cI\u2019m thrilled to see our technology go into the clinic, and it was due to the dedication of our team, and our strong preclinical results which helped propel Kiromic to be able to file this IND submission to the FDA on May 14, 2021,\u201d stated Dr. Maurizio Chiriva-Internati, DBSc, PhDs, CEO of Kiromic.\n<\/p>\n

\n“Our people and vendors have been working tirelessly. They are excited and ready to launch the first-in-human dosing by 3Q 2021 pending FDA authorization.\n<\/p>\n

\nOur KB-PD1 will be the first in the world to deliver this T-cell therapy to solid tumors with key features demanded by the T-cell therapy market. We aim to deliver KB-PD1 which will have:\n<\/p>\n

\n— Higher efficacy\n<\/p>\n

\n— Higher safety\n<\/p>\n

\n— Lower manufacturing costs\n<\/p>\n

\n— Lower distribution costs.\u201d\n<\/p>\n

CFO of Kiromic, Mr. Tony Tontat<\/b><\/p>\n

\n“This IND filing is an awaited news for the markets and will open up advantageous financing options to the company as we look to extend cash runway into 2022.”\n<\/p>\n

CSIO of Kiromic, Mr. Gianluca Rotino<\/b><\/p>\n

\n“This IND filing is supported by strong IP portfolio including new IP in areas such as:\n<\/p>\n

\n— Gene editing\n<\/p>\n

\n— Live cell harvesting\n<\/p>\n

\n— Live cell expansion (manufacturing clones from small batches)\n<\/p>\n

\n— Live cell logistics (manufacturing, tissue preservation, and transfers)\n<\/p>\n

\nAs we continue to grow our DIAMOND derived targets and our related clinical programs, our IP portfolio is continually being fortified in all major geographies, and we look forward to updating our investors in upcoming presentations and filings.\n<\/p>\n

\nThis is a key milestone, not only for Kiromic, positioning Kiromic as a pioneer in T-Cell therapy for solid tumors, but also for immunotherapy in general.\n<\/p>\n

\nWith the support of Kiromic\u2019s innovations in AI, the clinical trial R&D process will now be faster bringing cellular therapies to patients with more expediency than previously achievable.\u201d\n<\/p>\n

CMO of Kiromic, Dr. Scott Dalhbeck<\/b><\/p>\n

\n“Patients and clinicians alike have been waiting for a T-Cell therapy which could deliver a safe, effective, and lower cost solution for solid tumors. We are on the brink of making this vision a reality when we dose the first solid tumor patients.”\n<\/p>\n

About Metastatic Solid Malignancies<\/b><\/p>\n

\nThe ALEXIS-PRO-1 clinical trial will enroll patients with metastatic or progressive locally advanced solid malignancies that express the PD-L1 marker on their tumor.\n<\/p>\n

\nThese late-stage patients typically have a survival of only a few months, and so effective treatments that are non-toxic and rapidly effective, are desperately needed.\n<\/p>\n

\nSince most solid malignancies express PD-L1, the dose escalation phase of the trial will be open to a wide range of tumor types such as prostate, breast, pancreas, lung, colon, renal, bladder, ovarian, and others.\n<\/p>\n

\nOnce the optimal biologic dose (OBD) has been determined, the OBD will then be given to an expanded number of patients for the most promising indications.\n<\/p>\n

\nSince Kiromic\u2019s preclinical animal studies have shown a fast and brisk anti-tumor response, expectations are high that this product will be able to achieve what has thus far proven to be elusive with late-stage cancer patients \u2013 a significant and long-lasting improvement in the quality and quantity of life.\n<\/p>\n

About Kiromic <\/b><\/p>\n

\nKiromic Biopharma, Inc. (Nasdaq: KRBP) is a target discovery and gene-editing company utilizing a state-of-the-art artificial intelligence (AI) platform focused on unleashing the power of the patient\u2019s own immune system to fight cancer.\n<\/p>\n

\nKiromic\u2019s pipeline development is leveraged through the Company\u2019s proprietary target discovery Artificial Intelligence engine called “DIAMOND.” Kiromic’s DIAMOND is big data science meeting target identification, dramatically compressing the man-years and the millions of drug development dollars needed to develop a live drug.\n<\/p>\n

\nThe Company maintains its HQ offices in the world\u2019s largest medical center in Houston, Texas adjacent to MDAnderson Cancer Center and the Baylor College of Medicine where Kiromic has ongoing collaboration with these Institutions.\n<\/p>\n

\nKiromic\u2019s scientific achievements related to this endeavor can be seen in the six poster nominations awarded by the prestigious AACR at its annual meeting in April, 2021 (https:\/\/ir.kiromic.com\/news-releases\/news-release-details\/kiromic-announces-6-posters-presented-american-association<\/a>).\n<\/p>\n

\nFor more information, please visit the company\u2019s website at www.kiromic.com<\/a>.\n<\/p>\n

Forward-Looking Statements<\/b><\/p>\n

\nThis press release contains \u201cforward-looking statements\u201d that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontemplate,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cseek,\u201d \u201cmay,\u201d \u201cmight,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201ctarget,\u201d \u201caim,\u201d \u201cshould,\u201d “will\u201d \u201cwould,\u201d or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our company\u2019s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled \u201cRisk Factors\u201d in the Company\u2019s annual report on Form 10-K for the most recently completed fiscal year and subsequent reports filed after the date of the annual report with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and our company undertakes no duty to update such information except as required under applicable law.\n<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210517005496\/en\/<\/a><\/span><\/p>\n

\nTony Tontat – CFO
\n
(844) 539 – 2873
\n
inv.rel@kiromic.com<\/a><\/p>\n

KEYWORDS:<\/b> Texas United States North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> Research FDA Genetics Clinical Trials Stem Cells Biotechnology Pharmaceutical Health Science Oncology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor – Gamma Delta T-cell Therapy Kiromic achieves key milestone for this first in human phase 1 clinical trial HOUSTON–(BUSINESS WIRE)– Kiromic Biopharma, Inc. (Nasdaq: KRBP) Today, Kiromic announces the submission of a novel Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial that has the potential to be a universal T-Cell therapy for any solid malignancy that expresses the biomarker PD-L1, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs. The clinical trial title: ALEXIS-PRO-1: A Phase 1, Open-label, Dose Escalation Study of KB-PD1, an Allogeneic Gamma … <\/p>\n

Continue reading “Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor – Gamma Delta T-cell Therapy”<\/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-494054","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nKiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor - Gamma Delta T-cell Therapy - 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\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor - Gamma Delta T-cell Therapy - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor – Gamma Delta T-cell Therapy Kiromic achieves key milestone for this first in human phase 1 clinical trial HOUSTON–(BUSINESS WIRE)– Kiromic Biopharma, Inc. (Nasdaq: KRBP) Today, Kiromic announces the submission of a novel Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial that has the potential to be a universal T-Cell therapy for any solid malignancy that expresses the biomarker PD-L1, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs. The clinical trial title: ALEXIS-PRO-1: A Phase 1, Open-label, Dose Escalation Study of KB-PD1, an Allogeneic Gamma … Continue reading "Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor – Gamma Delta T-cell Therapy"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-05-17T12:01:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210517005496r1&sid=flmnd&distro=nx&lang=en\" \/>\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=\"7 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\\\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor – Gamma Delta T-cell Therapy\",\"datePublished\":\"2021-05-17T12:01:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\\\/\"},\"wordCount\":1517,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20210517005496r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/kiromic-announces-fda-ind-submission-forty-five-days-before-the-end-of-the-second-quarter-first-in-human-off-the-shelf-chimeric-pd1-switch-receptor-gamma-delta-t-cell-therapy\\\/\",\"name\":\"Kiromic Announces FDA IND Submission Forty-Five Days before the end of the Second Quarter: First-In-Human, Off-The-Shelf Chimeric PD1 Switch Receptor - 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(Nasdaq: KRBP) Today, Kiromic announces the submission of a novel Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial that has the potential to be a universal T-Cell therapy for any solid malignancy that expresses the biomarker PD-L1, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs. 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