{"id":94178,"date":"2021-06-03T08:00:00","date_gmt":"2021-06-02T22:00:00","guid":{"rendered":"https:\/\/www.fnarena.com\/index.php\/2021\/06\/03\/first-patient-dosed-in-qbiotics-msd-clinical-trial-collaboration-for-unresectable-melanoma\/"},"modified":"2021-06-03T08:00:00","modified_gmt":"2021-06-02T22:00:00","slug":"first-patient-dosed-in-qbiotics-msd-clinical-trial-collaboration-for-unresectable-melanoma","status":"publish","type":"post","link":"https:\/\/staging.fnarena.com\/index.php\/2021\/06\/03\/first-patient-dosed-in-qbiotics-msd-clinical-trial-collaboration-for-unresectable-melanoma\/","title":{"rendered":"First Patient Dosed in QBiotics &amp; MSD Clinical Trial Collaboration for Unresectable Melanoma"},"content":{"rendered":"<table border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1524763\/QBiotics_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\" \/><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<ul type=\"disc\">\n<li>First patient dosed with QBiotics&#8217; lead oncology molecule tigilanol tiglate in combination with KEYTRUDA&#174; (pembrolizumab) in a clinical trial collaboration with MSD (tradename of Merck &#038; Co., Inc., <span class=\"xn-location\">Kenilworth, NJ<\/span>, USA) <\/li>\n<li>The Phase Ib\/IIa study will test the safety, optimal dose and tumour response of the combination in patients with late-stage unresectable melanoma and previous exposure to immune checkpoint inhibitors <\/li>\n<li>The multi-centre study will enrol approximately 22 patients across a number of Australian sites <\/li>\n<li>Melanoma is the most-deadly form of skin cancer, with more than 320,000 new cases diagnosed globally<sup>[1]<\/sup><\/li>\n<\/ul>\n<p><span class=\"xn-location\">BRISBANE, Australia<\/span>, <span class=\"xn-chron\">June 3, 2021<\/span> \/PRNewswire\/ &#8212; QBiotics Group Limited (QBiotics), a life sciences company developing novel small molecule anticancer and wound healing pharmaceuticals, is pleased to announce that it has dosed the first patient in the Phase Ib\/IIa clinical trial of the company&#8217;s lead oncology molecule, tigilanol tiglate in combination with MSD&#8217;s immune checkpoint inhibitor KEYTRUDA&#174;&#160;(pembrolizumab) for patients with unresectable melanoma, the deadliest form of skin cancer.&#160; <\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<\/p><\/div>\n<p>The QB46C-H06 multi-centre, open label study will enrol approximately 22 patients with Stage IIIB to IV M1c-melanoma across a number of Australian sites over 24 months. The study will test up to three intratumoural doses of tigilanol tiglate at three escalating dose levels, administered 3 weeks apart in combination with intravenous pembrolizumab administered every 3 weeks for up to 24 months. The study will evaluate the&#160;safety, optimal dose and tumour response of the tigilanol tiglate and pembrolizumab combination in patients with late-stage unresectable melanoma, who have been previously exposed to immune checkpoint inhibitors. <\/p>\n<p><b>Dr <span class=\"xn-person\">Victoria Gordon<\/span>, Managing Director and CEO of QBiotics, said &#034;We are very pleased to be collaborating with MSD in the fight against melanoma, a deadly form of skin cancer prevalent worldwide, but especially so here in <span class=\"xn-location\">Australia<\/span>. <\/b><\/p>\n<p>Dr Gordon continued &#034;Patients with unresectable melanoma who have received prior checkpoint inhibitors currently have limited effective treatment options. We hope to see that when combined, tigilanol tiglate and KEYTRUDA&#174; may produce additive anti-tumour immune responses, improving outcomes for patients.&#034;<\/p>\n<p>Over the last decade, the global cases of melanoma have increased by nearly 50 percent, with more than 320,000 people diagnosed annually. This translates to approximately 60,000 melanoma-related deaths per year<sup>[1]<\/sup>. <span class=\"xn-location\">Australia<\/span> has the highest <a target=\"_blank\" href=\"https:\/\/www.melanoma.org.au\/understanding-melanoma\/glossary\/#melanoma\" rel=\"nofollow\">melanoma<\/a> rates in the world, with <b>one person diagnosed every 30 minutes, and an estimated 1,300 deaths each year.<\/b><sup>[2]<\/sup><b>&#160;<\/b><\/p>\n<p>Tigilanol tiglate is a plant-derived small molecule, administered by injection directly into a solid tumour. Injected tumours are rapidly destroyed by tumour cell necrosis, vascular disruption, and immune-mediated mechanisms.<sup>[3]<\/sup> Pembrolizumab is a systemic immune checkpoint inhibitor, which reactivates the immune system by blocking the activity of PD-1, an immune checkpoint protein that prevents T cells from recognising and killing cancer cells.<sup>[4]<\/sup>&#160; <\/p>\n<p>&#034;The commencement of this trial with our first patient dosed is a significant milestone for QBiotics and is underpinned by positive outcomes from our Phase I QBC46-H01 Phase I study using tigilanol tiglate as a monotherapy in 22 patients with a broad range of refractory solid tumours.&#160; In this Phase I study a single injection of tigilanol tiglate showed an injected tumour response rate of 60% (CR of 20%, PR of 28%, SD of 12%).<sup>[5]<\/sup> Non-injected (abscopal) responses in distal tumours were observed in two patients with melanoma<sup>[6]<\/sup>,&#034; said Dr Gordon. <\/p>\n<div>\n<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" class=\"prntblns\">\n<tbody>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><b>FURTHER<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><b>DR VICTORIA GORDON, CEO &#038; MANAGING DIRECTOR, QBIOTICS GROUP<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><b>INFORMATION&#160;<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><a target=\"_blank\" href=\"mailto:victoria.gordon@qbiotics.com\" class=\"prnews_a\" rel=\"nofollow\"><b>victoria.gordon@qbiotics.com<\/b><\/a><b>&#160;or +61 418 453 737<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\"><\/td>\n<td class=\"prngen2\"><\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><b>MEDIA<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><b>JANE LOWE, IR DEPARTMENT<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><b>ENQUIRIES<\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><a target=\"_blank\" href=\"mailto:jane.lowe@irdepartment.com.au\" class=\"prnews_a\" rel=\"nofollow\"><b>jane.lowe@irdepartment.com.au<\/b><\/a>&#160;<b>or +61 411 117 774<\/b><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p><b>ABOUT TRIAL NCT04834973<\/b><\/p>\n<p>A Phase Ib\/IIa, multicentre, open label, dose-escalation study to evaluate the safety, tolerability, and preliminary effectiveness of intratumoural tigilanol tiglate in combination with intravenous pembrolizumab in adult patients with unresectable, Stage IIIB to IV M1c melanoma. <\/p>\n<p>The primary objectives are 1. &#160;To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) level of a single intratumoural injection of tigilanol tiglate administered in combination with intravenous pembrolizumab (200 mg), and 2. To assess the safety and tolerability of i) A single injection of tigilanol tiglate at escalating dose levels (dose-escalation) administered in combination with pembrolizumab; and ii) Repeat injections of tigilanol tiglate (maximum of 3) administered in combination with pembrolizumab.&#160; Secondary objectives include tumour responses according to RECIST 1.1 criteria, including loco-regional control of injected tumour(s) and non-injected tumour(s), and survival in patients. For more information, visit <a target=\"_blank\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04834973\" rel=\"nofollow\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04834973<\/a><\/p>\n<p><b>ABOUT QBIOTICS<\/b><\/p>\n<p>QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing pharmaceuticals for human and veterinary markets. Its lead molecule, tigilanol tiglate, is a small molecule anticancer pharmaceutical targeting a range of solid tumours across multiple species.&#160; QBiotics&#8217; business model is to develop products that have application in both veterinary and human markets. Success in the veterinary programs validates QBiotics technology and de-risks human development, while generating early, non-diluting revenues. <br \/><a target=\"_blank\" href=\"https:\/\/qbiotics.com\/\" rel=\"nofollow\">https:\/\/qbiotics.com<\/a><\/p>\n<p><b>ABOUT TIGILANOL TIGLATE <\/b><\/p>\n<p>Tigilanol tiglate is a small molecule being developed as an intratumoural treatment for solid tumours. It has a multimodal action that involves injected tumour responses as well as systemic responses in non-injected tumours. Complete destruction of the injected tumour is mediated via tumour vascular disruption, death of tumour cells by oncosis and immune-mediated mechanisms.<sup>3<\/sup> Following tumour destruction, rapid wound healing has been shown to ensue. <\/p>\n<p>A veterinary version of tigilanol tiglate (STELFONTA&#174;) is approved to treat canine mast cell tumours. STELFONTA&#174; is marketed in <span class=\"xn-location\">Europe<\/span>, the <span class=\"xn-location\">United Kingdom<\/span> and <span class=\"xn-location\">USA<\/span> by QBiotics partner Virbac, a global animal health company.&#160; STELFONTA&#174;&#160;is also under review by the Australian Pesticides and Veterinary Medicines Authority. In a pivotal US study, a single injection of STELFONTA&#174; induced a 75% complete response, and an 88% complete response with two injections. There was no tumour recurrence in 89% of evaluable cases 12 months post-treatment.<sup>[7]<\/sup><\/p>\n<div>\n<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" class=\"prntblns\">\n<tbody>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><sup>[1]<\/sup>&#160;Globocan, (2020) Melanoma of Skin, <a target=\"_blank\" href=\"https:\/\/gco.iarc.fr\/today\/data\/factsheets\/cancers\/16-Melanoma-of-skin-fact-sheet.pdf\" class=\"prnews_a\" rel=\"nofollow\">https:\/\/gco.iarc.fr\/today\/data\/factsheets\/cancers\/16-Melanoma-of-skin-fact-sheet.pdf<\/a><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><sup>[2]<\/sup>&#160;Global Coalition for Melanoma Patient Advocacy, (2020) Melanoma Skin Cancer Report, <a target=\"_blank\" href=\"https:\/\/melanomapatients.org.au\/wp-content\/uploads\/2020\/04\/2020-campaign-report-GC-version-MPA_1.pdf\" class=\"prnews_a\" rel=\"nofollow\">https:\/\/melanomapatients.org.au\/wp-content\/uploads\/2020\/04\/2020-campaign-report-GC-version-MPA_1.pdf<\/a><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><sup>[3]<\/sup>&#160;Boyle <i>et al.,<\/i> (2014) Intra-tumoural injection of the novel PKC activator EBC-46 rapidly ablates tumours in mouse models. <i>PLoS One<\/i> 9:e1068887.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><sup>[4]<\/sup>&#160;Hamid et al., (2019) Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. <i>Annals of Oncology<\/i> 30: 582\u2013588.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><sup>[5]<\/sup>&#160;CR, complete response; PR, partial response; SD, stable disease.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><sup>[6]<\/sup>&#160;Panizza <i>et al.,<\/i> (2019) Phase I dose-escalation study to determine the safety, tolerability, preliminary efficacy and pharmacokinetics of an intra tumoural injection of tigilanol tiglate (EBC-46). <i>EBioMedicine<\/i> 50: 433-441.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\">\n<p class=\"prnews_p\"><span class=\"prnews_span\"><sup>[7]<\/sup>&#160;De Ridder <i>et al<\/i>., (2020). Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cell tumors with tigilanol tiglate. <i>J. Vet. Inter. Med.<\/i> 1-15.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p>&#160;<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder2\">  <\/div>\n","protected":false},"excerpt":{"rendered":"<p>First patient dosed with QBiotics&#8217; lead oncology molecule tigilanol tiglate in combination with KEYTRUDA&#174; (pembrolizumab) in a clinical trial collaboration&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[105],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/staging.fnarena.com\/index.php\/wp-json\/wp\/v2\/posts\/94178"}],"collection":[{"href":"https:\/\/staging.fnarena.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/staging.fnarena.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/staging.fnarena.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/staging.fnarena.com\/index.php\/wp-json\/wp\/v2\/comments?post=94178"}],"version-history":[{"count":0,"href":"https:\/\/staging.fnarena.com\/index.php\/wp-json\/wp\/v2\/posts\/94178\/revisions"}],"wp:attachment":[{"href":"https:\/\/staging.fnarena.com\/index.php\/wp-json\/wp\/v2\/media?parent=94178"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/staging.fnarena.com\/index.php\/wp-json\/wp\/v2\/categories?post=94178"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/staging.fnarena.com\/index.php\/wp-json\/wp\/v2\/tags?post=94178"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}