{"id":509897,"date":"2021-07-06T16:04:14","date_gmt":"2021-07-06T20:04:14","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/oncosec-enters-into-a-collaboration-agreement-with-merck-for-a-pivotal-global-phase-3-study-keynote-c87-of-tavo-combined-with-keytruda-for-late-stage-metastatic-melanoma\/"},"modified":"2021-07-06T16:04:14","modified_gmt":"2021-07-06T20:04:14","slug":"oncosec-enters-into-a-collaboration-agreement-with-merck-for-a-pivotal-global-phase-3-study-keynote-c87-of-tavo-combined-with-keytruda-for-late-stage-metastatic-melanoma","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/oncosec-enters-into-a-collaboration-agreement-with-merck-for-a-pivotal-global-phase-3-study-keynote-c87-of-tavo-combined-with-keytruda-for-late-stage-metastatic-melanoma\/","title":{"rendered":"OncoSec Enters into a Collaboration Agreement with Merck for a Pivotal Global Phase 3 Study, KEYNOTE-C87, of TAVO\u2122 Combined with KEYTRUDA\u00ae for Late-Stage Metastatic Melanoma"},"content":{"rendered":"
\n

– KEYNOTE-C87 is intended to support accelerated approval and\/or a full licensure<\/h2>\n

– Study addresses a high unmet medical need in certain patients with metastatic melanoma for whom there are no FDA approved treatment options<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n PENNINGTON, N.J.<\/span> and SAN DIEGO<\/span>, July 6, 2021<\/span> \/PRNewswire\/ — OncoSec Medical Incorporated (NASDAQ:ONCS) (the “Company” or “OncoSec”) today announced it has entered into a Clinical Trial Collaboration and Supply Agreement (“Agreement”) with Merck (known as MSD outside the United States<\/span> and Canada<\/span>) to evaluate the combination of OncoSec’s DNA-plasmid interleukin-12 (IL-12) TAVO\u2122 (tavokinogene telseplasmid) with Merck’s anti-PD-1 therapy, KEYTRUDA\u00ae<\/sup>\u00a0(pembrolizumab), in a global Phase 3 randomized clinical trial, KEYNOTE-C87. \u00a0The planned clinical trial will evaluate the overall survival of patients treated with the TAVO\u2122 in combination with KEYTRUDA\u00ae<\/sup> versus standard of care in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy.<\/p>\n

TAVO\u2122 has received Fast Track designation from the U.S. Food and Drug Administration (FDA), as a potentially first-in-class, intratumoral anti-cancer gene therapy that expresses IL-12 for the treatment of metastatic melanoma, following progression on KEYTRUDA\u00ae<\/sup> or OPDIVO\u00ae<\/sup> (nivolumab). \u00a0KEYNOTE-C87 is intended to support accelerated approval by the U.S. FDA and\/or serve as a pivotal study to support a full licensure. \u00a0Under the terms of the Agreement, Merck will provide KEYTRUDA\u00ae<\/sup> , while OncoSec will provide the investigational drug, TAVO\u2122.\u00a0 Each party will be responsible for its own internal costs, with OncoSec covering third party costs. \u00a0Eligible patients must have Stage III or IV unresectable, metastatic melanoma, and must be refractory to prior checkpoint therapy. \u00a0KEYNOTE-C87 intends to enroll approximately 400 patients and is planned to be conducted in the U.S., Canada<\/span>, EU, and Australia.\u00a0\u00a0\u00a0\u00a0\u00a0<\/p>\n

“We are thrilled to enter into this collaboration and supply agreement with Merck \u2013 one of the world’s leading immuno-oncology companies \u2013 to help bring TAVO\u2122 to patients with metastatic melanoma whose disease did not respond to initial checkpoint inhibitor therapy or who have developed progressive disease and therefore do not have additional treatment options available,” said Brian Leuthner<\/span>, Interim Chief Executive Officer of OncoSec.\u00a0 “This Phase 3 collaboration represents a crucial milestone for OncoSec as we advance TAVO\u2122 through the clinic and toward potential approval globally, and expands upon our initial 2017 clinical collaboration and supply agreement with Merck. \u00a0We look forward to our continued work and progress with Merck and its experienced team of immuno-oncology leaders as we continue to explore TAVO\u2122 in combination with KEYTRUDA\u00ae<\/sup> with the goal of helping more patients with cancer.”\u00a0\u00a0\u00a0\u00a0<\/p>\n

KEYTRUDA\u00ae<\/sup> is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J.<\/span>, U.S.A. \u00a0OPDIVO\u00ae<\/sup> is a registered trademark of Bristol Myers Squibb.<\/p>\n

\n About TAVO\u2122 <\/b>
\n
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body.\u00a0 TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b<\/span> trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC).\u00a0 TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.<\/p>\n

\n About OncoSec Medical Incorporated
<\/b>OncoSec Medical Incorporated (the “Company,” “OncoSec,” “we” or “our”) is a biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body’s immune system to target and attack cancer.\u00a0 OncoSec’s lead immunotherapy investigational product candidate \u2013 TAVO\u2122 (tavokinogene telseplasmid) \u2013 enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions.\u00a0 The technology, which employs electroporation, is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, enabling the immune system to target and attack tumors throughout the body.\u00a0 OncoSec has built a deep and diverse clinical pipeline utilizing TAVO\u2122 as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non-responders. \u00a0Results from recently completed clinical studies of TAVO\u2122 have demonstrated a local immune response, and subsequently, a systemic effect as either a monotherapy or combination treatment approach along with an acceptable safety profile, warranting further development. \u00a0In addition to TAVO\u2122, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions.\u00a0 For more information, please visit www.oncosec.com<\/a>. <\/p>\n

TAVO\u2122 is a trademark of OncoSec Medical Incorporated.\u00a0<\/p>\n

\n Risk Factors and Forward-Looking Statements
<\/b>This release, as well as other information provided from time to time by the Company or its employees, may contain forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements.\u00a0 Forward-looking statements provide the Company’s current beliefs, expectations and intentions regarding future events and involve risks, uncertainties (some of which are beyond the Company’s control) and assumptions.\u00a0 For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.\u00a0 You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts.\u00a0 These statements may include words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and “would” and similar expressions (including the negative of these terms).\u00a0 Although we believe that expectations reflected in the forward- looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.\u00a0 The Company intends these forward-looking statements to speak only at the time they are published on or as otherwise specified and does not undertake to update or revise these statements as more information becomes available, except as required under federal securities laws and the rules and regulations of the Securities Exchange Commission (“SEC”).\u00a0 In particular, you should be aware that the success and timing of our clinical trials, including safety and efficacy of our product candidates, patient accrual, unexpected or expected safety events, the impact of COVID-19 on the supply of our candidates or the initiation or completion of clinical trials and the usability of data generated from our trials may differ and may not meet our estimated timelines.\u00a0 Please refer to the risk factors and other cautionary statements provided in the Company’s Annual Report on Form 10-K for the fiscal year ended July 31, 2020<\/span> and subsequent periodic and current reports filed with the SEC (each of which can be found at the SEC’s website www.sec.gov<\/a>), as well as other factors described from time to time in the Company’s filings with the SEC. <\/p>\n

\n Company Contact
<\/b>
\n Investor Contact
<\/b>
\n Mike Moyer<\/span>
\n
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com<\/a><\/p>\n

\n Media Contact
<\/b>
\n Patrick Bursey<\/span>
\n
LifeSci Communications
+1-646-970-4688
pbursey@lifescicomms.com<\/a>\u00a0<\/p>\n

\u00a0<\/p>\n

\n

\n
\n \"OncoSec
\n <\/a>\n <\/p>\n<\/p><\/div>\n

\u00a0<\/p>\n

<\/div>\n

\n \"Cision\" View original content to download multimedia:https:\/\/www.prnewswire.com\/news-releases\/oncosec-enters-into-a-collaboration-agreement-with-merck-for-a-pivotal-global-phase-3-study-keynote-c87-of-tavo-combined-with-keytruda-for-late-stage-metastatic-melanoma-301325841.html<\/a><\/p>\n

SOURCE OncoSec Medical Incorporated<\/p>\n<\/p><\/div>\n

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

– KEYNOTE-C87 is intended to support accelerated approval and\/or a full licensure – Study addresses a high unmet medical need in certain patients with metastatic melanoma for whom there are no FDA approved treatment options PR Newswire PENNINGTON, N.J. and SAN DIEGO, July 6, 2021 \/PRNewswire\/ — OncoSec Medical Incorporated (NASDAQ:ONCS) (the “Company” or “OncoSec”) today announced it has entered into a Clinical Trial Collaboration and Supply Agreement (“Agreement”) with Merck (known as MSD outside the United States and Canada) to evaluate the combination of OncoSec’s DNA-plasmid interleukin-12 (IL-12) TAVO\u2122 (tavokinogene telseplasmid) with Merck’s anti-PD-1 therapy, KEYTRUDA\u00ae\u00a0(pembrolizumab), in a global Phase 3 randomized clinical trial, KEYNOTE-C87. \u00a0The planned clinical trial will evaluate the overall survival of patients treated with the … <\/p>\n

Continue reading “OncoSec Enters into a Collaboration Agreement with Merck for a Pivotal Global Phase 3 Study, KEYNOTE-C87, of TAVO\u2122 Combined with KEYTRUDA\u00ae for Late-Stage Metastatic Melanoma”<\/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-509897","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nOncoSec Enters into a Collaboration Agreement with Merck for a Pivotal Global Phase 3 Study, KEYNOTE-C87, of TAVO\u2122 Combined with KEYTRUDA\u00ae for Late-Stage Metastatic Melanoma - 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\/oncosec-enters-into-a-collaboration-agreement-with-merck-for-a-pivotal-global-phase-3-study-keynote-c87-of-tavo-combined-with-keytruda-for-late-stage-metastatic-melanoma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"OncoSec Enters into a Collaboration Agreement with Merck for a Pivotal Global Phase 3 Study, KEYNOTE-C87, of TAVO\u2122 Combined with KEYTRUDA\u00ae for Late-Stage Metastatic Melanoma - 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