{"id":45078,"date":"2022-06-14T20:01:41","date_gmt":"2022-06-14T18:01:41","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/clovis-oncology-highlights-phase-1-data-from-ongoing-clinical-studies-of-targeted-radiotherapy-candidate-fap-2286-at-snmmi-annual-meeting\/"},"modified":"2022-06-14T20:01:41","modified_gmt":"2022-06-14T18:01:41","slug":"clovis-oncology-highlights-phase-1-data-from-ongoing-clinical-studies-of-targeted-radiotherapy-candidate-fap-2286-at-snmmi-annual-meeting","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/clovis-oncology-highlights-phase-1-data-from-ongoing-clinical-studies-of-targeted-radiotherapy-candidate-fap-2286-at-snmmi-annual-meeting\/","title":{"rendered":"Clovis Oncology Highlights Phase 1 Data from Ongoing Clinical Studies of Targeted Radiotherapy Candidate FAP-2286 at SNMMI Annual Meeting"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>First presentation of initial LuMIERE Phase 1 data demonstrated a manageable safety profile with preliminary evidence of activity<\/i><\/p>\n<ul class=\"bwlistcircle\">\n<li>\n<i>Nine patients treated to date with <sup>177<\/sup>Lu-FAP-2286 up to 5.5 GBq\/dose<\/i>\n<\/li>\n<li>\n<i>No serious adverse events, treatment discontinuations, deaths or dose-limiting toxicity events related to <sup>177<\/sup>Lu-FAP-2286 observed<\/i>\n<\/li>\n<li>\n<i>Confirmed partial response in one patient who completed six administrations of <sup>177<\/sup>Lu-FAP-2286 in the 3.7 GBq dose cohort<\/i>\n<\/li>\n<li>\n<i>Recruitment of the 7.4 GBq dose cohort is ongoing<\/i>\n<\/li>\n<\/ul>\n<\/li>\n<li>\n<i>FAP-2286 has shown high tumor uptake and prolonged retention across a range of solid tumors<\/i>\n<\/li>\n<li>\n<i>Data from a separate UCSF investigator-initiated Phase 1 imaging study of <sup>68<\/sup>Ga-FAP-2286 in solid tumors will also be presented during the meeting<\/i>\n<\/li>\n<\/ul>\n<p>\n\u00a0\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220614005817\/en\/305545\/5\/Clovis_Logo_Process_Color.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220614005817\/en\/305545\/21\/Clovis_Logo_Process_Color.jpg\"><\/a><\/p>\n<p>BOULDER, Colo.&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/search?q=%24CLVS&amp;src=ctag\" target=\"_blank\" rel=\"noopener\">$CLVS<\/a>&#8211;Clovis Oncology, Inc. (NASDAQ: CLVS) today announced an oral presentation detailing initial Phase 1 data from the Clovis Oncology-sponsored Phase 1\/2 LuMIERE clinical study <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT04939610%3Fterm%3Dlumiere%2BFAP%26draw%3D2%26rank%3D1&amp;esheet=52749553&amp;newsitemid=20220614005817&amp;lan=en-US&amp;anchor=%28NCT04939610%29&amp;index=1&amp;md5=3c25b5a45d5f33d06d3452a4bc1aa7cd\" rel=\"nofollow noopener\" shape=\"rect\">(NCT04939610)<\/a> investigating the safety, pharmacokinetics, dosimetry, and preliminary antitumor activity of its targeted radiotherapy candidate, FAP-2286 labelled with lutetium-177 (<sup>177<\/sup>Lu-FAP-2286). Overall, in nine patients treated in the first two dose cohorts,<sup>177<\/sup>Lu-FAP-2286 demonstrated a manageable safety profile and encouraging evidence of activity, including a confirmed RECIST partial response in one patient. In addition, updated data from an investigator-initiated Phase 1 study of FAP-2286 labelled with gallium-68 (<sup>68<\/sup>Ga-FAP-2286) as a novel imaging agent to identify metastatic cancer in patients with solid tumors are also being presented today <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT04621435%3Fterm%3DFAP-2286%26draw%3D2%26rank%3D1&amp;esheet=52749553&amp;newsitemid=20220614005817&amp;lan=en-US&amp;anchor=%28NCT04621435%29&amp;index=2&amp;md5=4fd4a7e949c81680eae8bbd4cd67e848\" rel=\"nofollow noopener\" shape=\"rect\">(NCT04621435)<\/a>. These datasets will be presented in oral presentations by Jonathan McConathy, M.D., Ph.D., Associate Professor and Director of the Division of Molecular Imaging and Therapeutics in the University of Alabama at Birmingham Department of Radiology in the Marnix E. Heersink School of Medicine, and Brad Kline, Clinical Research Coordinator at the University of California, San Francisco (UCSF), respectively, at the Society of Nuclear Medicine &amp; Molecular Imaging (SNMMI) Annual Meeting 2022 in Vancouver, British Columbia.\n<\/p>\n<p>\nFAP-2286 targets fibroblast activation protein (FAP), a promising theranostic target with expression across many tumor types. FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting FAP to enter clinical development and is the lead candidate in Clovis Oncology\u2019s targeted radionuclide therapy (TRT) development program. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent <sup>177<\/sup>Lu-FAP-2286 to identify the recommended Phase 2 dose and schedule. The safety and tumor uptake of the imaging agent <sup>68<\/sup>Ga-FAP-2286 is also being evaluated, with plans for Phase 2 expansion cohorts in multiple tumor types to initiate in Q4 2022.\n<\/p>\n<p>\n\u201cThese initial results demonstrate that FAP is a promising theranostic target with expression across many types of solid tumors,\u201d said Jonathan McConathy, M.D., Ph.D., Associate Professor and Director of the Division of Molecular Imaging and Therapeutics in the University of Alabama at Birmingham Department of Radiology in the Marnix E. Heersink School of Medicine. \u201cThese LuMIERE data from the first two dose cohorts demonstrated a manageable safety profile, with some preliminary evidence of activity, both of which are encouraging as we seek to better understand the potential of FAP-2286 as a treatment and imaging agent across a wide range of malignancies.\u201d\n<\/p>\n<p>\nInitial results from the Phase 1 portion of the ongoing Phase 1\/2 LuMIERE study found treatment-emergent adverse events (TEAEs) to be generally mild to moderate among the nine patients in the safety population receiving 3.7 or 5.55 GBq\/dose of the investigational therapeutic agent <sup>177<\/sup>Lu-FAP-2286. Three patients (33.3%) had a Grade \u22653 TEAE of back pain (11.1%), abdominal distension (11.1%), increased bilirubin (11.1%) and hyponatremia (11.1%); none were judged as related to <sup>177<\/sup>Lu-FAP-2286. There was one serious adverse event (SAE) of back pain not related to <sup>177<\/sup>Lu-FAP-2286. No dose-limiting toxicities were observed in the 3.7 or 5.55 GBq cohorts (n=3 evaluable in each cohort).\n<\/p>\n<p>\nAt the two dose levels evaluated to date, organ dosimetry revealed target organ exposure within the expected range to support administration of multiple doses. There was tumor uptake across a range of tumor types with prolonged tumor retention of <sup>177<\/sup>Lu-FAP-2286 after dosing.\n<\/p>\n<p>\nA confirmed RECIST partial response was reported in one heavily pre-treated patient in the 3.7 GBq dose cohort with pseudomyxoma peritonei of appendiceal origin who completed six administrations of <sup>177<\/sup>Lu-FAP-2286. A decrease in the level of the serum tumor marker carcinoembryonic antigen (CEA) was also observed in the patient over the course of <sup>177<\/sup>Lu-FAP-2286 administration.\n<\/p>\n<p>\nRecruitment for the third dose cohort (7.4 GBq) is ongoing.\n<\/p>\n<p>\n\u201cThis first presentation of data from the Phase 1\/2 LuMIERE study supports the hypothesis that FAP-2286 gets to the tumor, stays in the tumor, and avoids off-target tissue, and these initial Phase 1 data further support the potential clinical utility of FAP-2286 as a targeted radionuclide therapy to treat a variety of advanced solid tumors,\u201d said Patrick J. Mahaffy, President and CEO of Clovis Oncology. \u201cWe look forward to presenting additional clinical data from the LuMIERE study at another nuclear medical meeting and initiating Phase 2 expansion cohorts in multiple tumor types later in 2022.\u201d\n<\/p>\n<p>\nPresentation of the initial LuMIERE Phase 1 data, titled \u201c<sup>177<\/sup>Lu-FAP-2286 in Patients With Advanced or Metastatic Solid Tumors: Initial Data From a Phase 1\/2 Study Investigating Safety, Pharmacokinetics, Dosimetry, and Preliminary Antitumor Activity (LuMIERE)\u201d (Abstract #2271), is scheduled for Tuesday, June 14 at 11:00 am PT, as part of the Basic Oncology: Early Phase Human Studies I session from 10:00 \u2013 11:30 am PT.\n<\/p>\n<p>\nPresentation of the investigator-initiated imaging study, titled \u201cFirst-in-human evaluation of <sup>68<\/sup>Ga-FAP-2286, a fibroblast activation protein targeted radioligand\u201d (Abstract #2279), evaluating the ability of imaging agent <sup>68<\/sup>Ga-FAP-2286 to detect metastatic cancer in patients with solid tumors, is scheduled for Tuesday, June 14 at 1:50 pm PT, as part of the Basic Oncology: Early Phase Human Studies II session from 1:00 \u2013 2:30 pm PT.\n<\/p>\n<p>\nThese presentations can also be viewed at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclovisoncology.com%2Fpipeline%2Fscientific-presentations%2F&amp;esheet=52749553&amp;newsitemid=20220614005817&amp;lan=en-US&amp;anchor=https%3A%2F%2Fclovisoncology.com%2Fpipeline%2Fscientific-presentations%2F&amp;index=3&amp;md5=0fa1e1c65f166997d1e6e4a66745702f\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/clovisoncology.com\/pipeline\/scientific-presentations\/<\/a> following their presentations on June 14.\n<\/p>\n<p>\nFor more information about FAP-2286, targeted radionuclide therapy (TRT), or Clovis\u2019 TRT development program, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.targetedradiotherapy.com%2F&amp;esheet=52749553&amp;newsitemid=20220614005817&amp;lan=en-US&amp;anchor=targetedradiotherapy.com&amp;index=4&amp;md5=175f1e822912dc780ef398cbd5e96ab7\" rel=\"nofollow noopener\" shape=\"rect\">targetedradiotherapy.com<\/a>.\n<\/p>\n<p>\n<b>About the LuMIERE Clinical Study<\/b>\n<\/p>\n<p>\nLuMIERE is a Phase 1\/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors. The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (<sup>177<\/sup>Lu-FAP-2286). FAP-2286 labeled with gallium-68 (<sup>68<\/sup>Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.\n<\/p>\n<p>\n<b>About FAP-2286<\/b>\n<\/p>\n<p>\nFAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non\u2013small cell lung, and squamous head and neck cancers. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.\n<\/p>\n<p>\nFAP-2286 is an unlicensed medical product.\n<\/p>\n<p>\n<b>About Targeted Radionuclide Therapy<\/b>\n<\/p>\n<p>\nTargeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and\/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as \u201ctheranostics.\u201d Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.\n<\/p>\n<p>\n<b>About Clovis Oncology<\/b>\n<\/p>\n<p>\nClovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing innovative anti-cancer agents in the US, Europe, and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the US and Europe. Please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.clovisoncology.com&amp;esheet=52749553&amp;newsitemid=20220614005817&amp;lan=en-US&amp;anchor=www.clovisoncology.com&amp;index=5&amp;md5=08a65a5a6754851ca087de0de86ac329\" rel=\"nofollow noopener\" shape=\"rect\">www.clovisoncology.com<\/a> for more information.\n<\/p>\n<p>\n<i>To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements contained in this press release include, among others, statements of our intentions and expectations for our development and discovery programs, including the timing and pace of pre-clinical development, plans for clinical development, plans for additional applications of the FAP-2286 peptide, including potential indications, tumor types and combination trials, and regulatory plans with respect to FAP-2286. Such forward-looking statements involve substantial risks and uncertainties that could cause Clovis Oncology\u2019s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in drug discovery and pre-clinical and clinical development, including the outcome of pre-clinical studies and clinical trials, whether initial results, findings or research will support future studies or development, whether future study results will be consistent with previous study findings or other results, including pre-clinical studies, results in named-patient or similar programs or clinical trials, whether additional studies not originally contemplated are determined to be necessary, the timing of initiation, enrollment and completion of planned studies and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to approve drug applications. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology\u2019s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and its other reports filed with the Securities and Exchange Commission.<\/i>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Clovis Investor Contacts:<\/b><br \/>Anna Sussman, 303.625.5022<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;&#58;&#x61;&#115;&#x75;&#115;&#x73;&#109;&#x61;&#110;&#x40;&#99;&#x6c;&#111;&#x76;&#105;&#x73;&#111;&#x6e;&#99;&#x6f;l&#x6f;g&#x79;&#46;&#x63;o&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x61;&#115;u&#x73;&#115;m&#x61;&#110;&#64;&#x63;&#x6c;&#111;&#x76;&#x69;&#115;o&#x6e;&#99;o&#x6c;&#111;g&#x79;&#x2e;&#99;&#x6f;&#x6d;<\/a><span class=\"bwuline\"><br \/><\/span>or<br \/>\n<br \/>Breanna Burkart, 303.625.5023<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#116;&#111;&#58;&#98;bur&#x6b;&#x61;&#x72;&#x74;&#x40;&#99;&#108;&#111;vis&#x6f;&#x6e;&#x63;&#x6f;&#x6c;&#111;&#103;&#121;&#46;co&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#98;&#x62;u&#114;&#x6b;a&#114;&#x74;&#64;&#99;&#x6c;o&#118;&#x69;s&#111;&#x6e;c&#111;&#x6c;o&#103;&#x79;&#46;&#99;&#x6f;m<\/a>\n<\/p>\n<p>\n<b>Clovis Media Contacts:<\/b><br \/><b>US<\/b><br \/>Lisa Guiterman, 301.347.7964<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;a&#x69;&#108;t&#x6f;&#58;&#x63;&#x6c;o&#x76;&#105;s&#x6d;&#101;&#x64;&#105;a&#x40;&#99;l&#x6f;&#118;&#x69;&#115;o&#x6e;&#99;&#x6f;&#x6c;o&#x67;&#121;&#46;&#x63;&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#99;l&#x6f;v&#x69;s&#x6d;e&#x64;&#105;&#x61;&#64;&#x63;&#108;&#x6f;&#118;i&#115;o&#x6e;c&#x6f;l&#x6f;&#103;&#x79;&#46;&#x63;&#111;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>First presentation of initial LuMIERE Phase 1 data demonstrated a manageable safety profile with preliminary evidence of activity Nine patients treated to date with 177Lu-FAP-2286 up to 5.5 GBq\/dose No serious adverse events, treatment discontinuations, deaths or dose-limiting toxicity events related to 177Lu-FAP-2286 observed Confirmed partial response in one patient who completed six administrations of &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/clovis-oncology-highlights-phase-1-data-from-ongoing-clinical-studies-of-targeted-radiotherapy-candidate-fap-2286-at-snmmi-annual-meeting\/\">[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-45078","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clovis Oncology Highlights Phase 1 Data from Ongoing Clinical Studies of Targeted Radiotherapy Candidate FAP-2286 at SNMMI Annual Meeting - 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\/clovis-oncology-highlights-phase-1-data-from-ongoing-clinical-studies-of-targeted-radiotherapy-candidate-fap-2286-at-snmmi-annual-meeting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clovis Oncology Highlights Phase 1 Data from Ongoing Clinical Studies of Targeted Radiotherapy Candidate FAP-2286 at SNMMI Annual Meeting - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"First presentation of initial LuMIERE Phase 1 data demonstrated a manageable safety profile with preliminary evidence of activity Nine patients treated to date with 177Lu-FAP-2286 up to 5.5 GBq\/dose No serious adverse events, treatment discontinuations, deaths or dose-limiting toxicity events related to 177Lu-FAP-2286 observed Confirmed partial response in one patient who completed six administrations of ... 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