{"id":54614,"date":"2023-03-08T04:05:43","date_gmt":"2023-03-08T03:05:43","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/akston-biosciences-ends-vaccine-partnership-with-stelis-continues-to-advance-covid-universal-booster-eua\/"},"modified":"2023-03-08T04:05:43","modified_gmt":"2023-03-08T03:05:43","slug":"akston-biosciences-ends-vaccine-partnership-with-stelis-continues-to-advance-covid-universal-booster-eua","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/akston-biosciences-ends-vaccine-partnership-with-stelis-continues-to-advance-covid-universal-booster-eua\/","title":{"rendered":"Akston Biosciences Ends Vaccine Partnership with Stelis, Continues to Advance COVID Universal Booster EUA"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<b>Akston has reclaimed all commercial rights to AKS-452, its room temperature stable COVID-19 vaccine<\/b>\n<\/li>\n<li>\n<b>Akston is continuing its progress to secure Emergency Use Authorization (EUA) in India and has begun working with a new CDMO to produce AKS-452<\/b>\n<\/li>\n<\/ul>\n<p>\n\u00a0\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230306005704\/en\/1014773\/4\/Akston_logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230306005704\/en\/1014773\/21\/Akston_logo.jpg\"><\/a><\/p>\n<p>BEVERLY, Mass. and BANGALORE, India&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/VIE?src=hash\" target=\"_blank\" rel=\"noopener\">#VIE<\/a>&#8211;Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today it has ended its AKS-452 licensing, manufacturing, and commercialization agreement with Stelis Biopharma Limited, an arm of Strides Pharma Science Ltd.\n<\/p>\n<p>\nAkston has reclaimed all rights to AKS-452, a room temperature stable, low-cost, protein subunit COVID-19 vaccine. AKS-452 has completed a Phase II\/III clinical trial in India, with data showing robust safety profile and a 91% seroconversion rate at Day 56. Volunteers in the study had antibody titers that persisted at statistically-significant high levels through six months, with serum showing protection against variants of concern, including Delta and Omicron.\n<\/p>\n<p>\nAkston is now working with a new CDMO in India to produce the promising AKS-452 COVID &#8220;universal&#8221; booster vaccine.\n<\/p>\n<p>\nThe results of a Phase I\/II randomized, open-labelled study in The Netherlands and published in <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.sciencedirect.com%2Fscience%2Farticle%2Fpii%2FS0264410X23002001&amp;esheet=53357008&amp;newsitemid=20230306005704&amp;lan=en-US&amp;anchor=Vaccine&amp;index=1&amp;md5=34d69aa6917f8eb2a96a70835cfa2070\" rel=\"nofollow noopener\" shape=\"rect\">Vaccine<\/a> showed that seroconversion rates reached 100% with enhanced potencies of SP\/RBD-ACE2 binding inhibition and live virus neutralization.\n<\/p>\n<p>\nIn a Phase II study in the Netherlands of AKS-452 as a \u201cuniversal\u201d booster vaccine, 93% of subjects previously vaccinated with Pfizer, Moderna, Johnson &amp; Johnson (Janssen), and AstraZeneca vaccines showed an increase in neutralizing antibody titers after receiving a single dose. The average neutralization titers across all subjects increased 4-fold against the Wuhan strain and 5-fold against the Omicron variants at Day 28. There were no safety issues reported.\n<\/p>\n<p>\n<b>Todd Zion, Ph.D., President &amp; CEO of Akston Biosciences<\/b>, said,<b> <\/b>\u201cI am confident that AKS-452 can attain Emergency Use Authorization (EUA) in India, especially as a \u2018universal\u2019 booster vaccine capable of increasing and broadening people\u2019s immune response as their previous immunity wanes and new variants arise. We concluded that Akston and a different CDMO were better placed to move ahead the AKS-452 development plan at a rapid pace, so we reclaimed the rights.\u201d\n<\/p>\n<p>\n<b><span class=\"bwuline\">About Akston Biosciences<\/span><\/b>\n<\/p>\n<p>\nAkston Biosciences Corporation leverages its Ambifect\u2122 Fc-fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. Founded by the team that developed the world\u2019s first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck &amp; Co.), Akston owns and operates a cGMP biologics cleanroom facility that manufactures kilogram-scale batches of drug substance. This, along with its research and process development laboratories, are located at its Beverly, Mass. location. Additional information is available at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.akstonbio.com&amp;esheet=53357008&amp;newsitemid=20230306005704&amp;lan=en-US&amp;anchor=www.akstonbio.com&amp;index=2&amp;md5=3d876ea95f3a3afcb8ef63a424036a85\" rel=\"nofollow noopener\" shape=\"rect\">www.akstonbio.com<\/a>.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Linda Pendergast-Savage<\/b><br \/>Birnbach Communications for Akston Biosciences<br \/>\n<br \/>1-508-224-7905 | <a target=\"_blank\" href=\"m&#97;&#x69;&#x6c;t&#111;&#x3a;&#x6c;p&#101;&#x6e;&#x64;e&#114;&#x67;&#x61;s&#116;&#x73;&#x61;v&#97;&#103;&#x65;&#x40;b&#105;&#x72;&#x6e;b&#97;&#x63;&#x68;c&#111;&#x6d;&#x2e;c&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6c;&#x70;&#101;nd&#x65;&#x72;&#103;&#97;s&#x74;&#x73;&#97;&#118;a&#x67;&#x65;&#x40;&#98;ir&#x6e;&#x62;&#97;&#99;h&#x63;&#x6f;&#109;&#46;c&#x6f;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Akston has reclaimed all commercial rights to AKS-452, its room temperature stable COVID-19 vaccine Akston is continuing its progress to secure Emergency Use Authorization (EUA) in India and has begun working with a new CDMO to produce AKS-452 \u00a0 BEVERLY, Mass. and BANGALORE, India&#8211;(BUSINESS WIRE)&#8211;#VIE&#8211;Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/akston-biosciences-ends-vaccine-partnership-with-stelis-continues-to-advance-covid-universal-booster-eua\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-54614","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Akston Biosciences Ends Vaccine Partnership with Stelis, Continues to Advance COVID Universal Booster EUA - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/akston-biosciences-ends-vaccine-partnership-with-stelis-continues-to-advance-covid-universal-booster-eua\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Akston Biosciences Ends Vaccine Partnership with Stelis, Continues to Advance COVID Universal Booster EUA - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Akston has reclaimed all commercial rights to AKS-452, its room temperature stable COVID-19 vaccine Akston is continuing its progress to secure Emergency Use Authorization (EUA) in India and has begun working with a new CDMO to produce AKS-452 \u00a0 BEVERLY, Mass. and BANGALORE, India&#8211;(BUSINESS WIRE)&#8211;#VIE&#8211;Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, ... 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