{"id":414141,"date":"2021-01-13T09:04:43","date_gmt":"2021-01-13T14:04:43","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=414141"},"modified":"2021-01-13T09:04:43","modified_gmt":"2021-01-13T14:04:43","slug":"genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/","title":{"rendered":"Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer"},"content":{"rendered":"

<\/p>\n

Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer<\/b><\/p>\n

Company passes final release tests of scaled-up clinical grade production to supply drug product for upcoming Acclaim-1 and Acclaim-2 clinical trials in lung cancer<\/i><\/p>\n

AUSTIN, Texas–(BUSINESS WIRE<\/a>)–Genprex, Inc.<\/a> (\u201cGenprex\u201d or the \u201cCompany\u201d) (Nasdaq: GNPX<\/a>), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced today that it has met all specifications and passed all of the final release tests for its first scaled-up clinical-grade manufacturing run of REQORSA\u2122 immunogene therapy, in advance of its upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small cell lung cancer (NSCLC).\n<\/p>\n

\n\u201cThe successful completion of this final step in our scaled-up clinical grade manufacturing of REQORSA marks a key manufacturing milestone for Genprex, and is credited to the hard work and commitment of both our internal manufacturing group and our manufacturing partners,\u201d said Rodney Varner, President and Chief Executive Officer of Genprex. \u201cThis production provides supply of REQORSA for our two upcoming Acclaim clinical trials and advances our mission to develop innovative new treatments for non-small cell lung cancer patients greatly in need of effective therapy options.\u201d\n<\/p>\n

\nGenprex recently announced the successful completion of the technology transfer<\/a> of its manufacturing process for the production of REQORSA from the major research institution where it was previously manufactured to experienced commercial Contract Development and Manufacturing Organizations (CDMOs). The Company also reported the completion of the manufacturing scale-up for the clinical-grade production of REQORSA<\/a>, subject to final testing that was underway. Passing all lot release specifications marks the successful completion of Genprex\u2019 manufacture of REQORSA in a scaled-up clinical production in accordance with the current Good Manufacturing Practices (cGMP) required by the U.S. Food and Drug Administration (FDA) in advance of commercial approval of a drug product.\n<\/p>\n

\nClinical-grade REQORSA has been shipped and delivered to its first cold storage depot. From there, REQORSA supply will be delivered to the clinical trial sites pending FDA clearance to commence the clinical trials. This production run will supply the Company\u2019s upcoming Acclaim-1 and Acclaim-2 clinical trials that combine REQORSA with Tagrisso\u00ae<\/sup> (marketed by AstraZeneca) and with Keytruda\u00ae<\/sup> (marketed by Merck & Co., Inc.), respectively, both of which are on track to be initiated in the first-half of 2021.\n<\/p>\n

About Genprex, Inc.<\/b><\/p>\n

\nGenprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex\u2019s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company\u2019s lead product candidate, REQORSA\u2122 (quaratusugene ozeplasmid<\/i>), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with osimertinib (AstraZeneca\u2019s Tagrisso\u00ae<\/sup>) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. <\/i><\/p>\n

\nFor more information, please visit the Company\u2019s web site at www.genprex.com<\/a> or follow Genprex on Twitter<\/a>, Facebook<\/a> and LinkedIn<\/a>.\n<\/p>\n

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

\nStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprex\u2019s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current, regarding the Company\u2019s future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of REQORSA\u2122 immunogene therapy drug, alone and in combination with targeted therapies and\/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining any FDA approvals of REQORSA and our other potential product candidates including whether we receive necessary approvals to commence clinical trials or benefit from fast track or similar regulatory designations; costs associated with developing our product candidates, whether we identify and succeed in acquiring other technologies and whether patents will ever be issued under patent applications that are the subject of our license agreements or otherwise. These and other risks and uncertainties are described more fully under the caption \u201cRisk Factors\u201d and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.\n<\/p>\n

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View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20210113005255\/en\/<\/a><\/span><\/p>\n

Genprex, Inc.
\n<\/b>
(877) 774-GNPX (4679)\n<\/p>\n

Investor Relations
\n<\/b>
GNPX Investor Relations
\n
(877) 774-GNPX (4679) ext. #2
\n
investors@genprex.com<\/a><\/p>\n

Media Contact
\n<\/b>
Genprex Media Relations
\n
Kalyn Dabbs
\n
(877) 774-GNPX (4679) ext. #3
\n
media@genprex.com<\/a><\/p>\n

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

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

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
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Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer Company passes final release tests of scaled-up clinical grade production to supply drug product for upcoming Acclaim-1 and Acclaim-2 clinical trials in lung cancer AUSTIN, Texas–(BUSINESS WIRE)–Genprex, Inc. (\u201cGenprex\u201d or the \u201cCompany\u201d) (Nasdaq: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced today that it has met all specifications and passed all of the final release tests for its first scaled-up clinical-grade manufacturing run of REQORSA\u2122 immunogene therapy, in advance of its upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small cell lung cancer (NSCLC). \u201cThe successful completion of this final … <\/p>\n

Continue reading “Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer”<\/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-414141","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nGenprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer - 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\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer Company passes final release tests of scaled-up clinical grade production to supply drug product for upcoming Acclaim-1 and Acclaim-2 clinical trials in lung cancer AUSTIN, Texas–(BUSINESS WIRE)–Genprex, Inc. (\u201cGenprex\u201d or the \u201cCompany\u201d) (Nasdaq: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced today that it has met all specifications and passed all of the final release tests for its first scaled-up clinical-grade manufacturing run of REQORSA\u2122 immunogene therapy, in advance of its upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small cell lung cancer (NSCLC). \u201cThe successful completion of this final … Continue reading "Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-01-13T14:04:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210113005255r1&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=\"5 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\\\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer\",\"datePublished\":\"2021-01-13T14:04:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\\\/\"},\"wordCount\":1018,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20210113005255r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\\\/\",\"name\":\"Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer - 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(\u201cGenprex\u201d or the \u201cCompany\u201d) (Nasdaq: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, announced today that it has met all specifications and passed all of the final release tests for its first scaled-up clinical-grade manufacturing run of REQORSA\u2122 immunogene therapy, in advance of its upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment of non-small cell lung cancer (NSCLC). \u201cThe successful completion of this final … Continue reading \"Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/","og_site_name":"Market Newsdesk","article_published_time":"2021-01-13T14:04:43+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210113005255r1&sid=flmnd&distro=nx&lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer","datePublished":"2021-01-13T14:04:43+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/"},"wordCount":1018,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20210113005255r1&sid=flmnd&distro=nx&lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/genprex-achieves-major-manufacturing-milestone-for-reqorsa-immunogene-therapy-for-upcoming-trials-to-treat-non-small-cell-lung-cancer\/","name":"Genprex Achieves Major Manufacturing Milestone for REQORSA\u2122 Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell Lung Cancer - 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