{"id":51870,"date":"2022-12-12T18:02:22","date_gmt":"2022-12-12T17:02:22","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/orca-bio-presents-encouraging-interim-clinical-data-on-orca-q-in-haploidentical-allogeneic-hematopoietic-stem-cell-transplants-at-64th-ash-annual-meeting\/"},"modified":"2022-12-12T18:02:22","modified_gmt":"2022-12-12T17:02:22","slug":"orca-bio-presents-encouraging-interim-clinical-data-on-orca-q-in-haploidentical-allogeneic-hematopoietic-stem-cell-transplants-at-64th-ash-annual-meeting","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/orca-bio-presents-encouraging-interim-clinical-data-on-orca-q-in-haploidentical-allogeneic-hematopoietic-stem-cell-transplants-at-64th-ash-annual-meeting\/","title":{"rendered":"Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th ASH Annual Meeting"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n<i>\u2013 Orca-Q is Orca Bio\u2019s investigational high-precision cell therapy designed to overcome the challenges of haploidentical allogeneic hematopoietic stem cell transplant (alloHSCT) \u2013<\/i>\n<\/p>\n<p class=\"bwalignc\">\n<b>\u2013 <\/b><i>Interim multi-center Phase 1 clinical trial results show that Orca-Q improved graft-versus-host disease-free, relapse-free survival in haploidentical alloHSCT compared to standard of care, without use of post-transplant cyclophosphamide \u2013<\/i>\n<\/p>\n<p>MENLO PARK, Calif.&#8211;(BUSINESS WIRE)&#8211;Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced that interim clinical data from its Phase 1 multi-center trial of its second investigational cell therapy, Orca-Q, were unveiled in an oral presentation at the 64<sup>th<\/sup> American Society of Hematology (ASH) Annual Meeting.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221212005018\/en\/1658660\/5\/Logo_Horizontal_Outlined_16x9_500px_%281%29_copy.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221212005018\/en\/1658660\/21\/Logo_Horizontal_Outlined_16x9_500px_%281%29_copy.jpg\"><\/a><\/p>\n<p>\nThe data from the ongoing clinical trial show that Orca-Q reduced the incidence and severity of graft versus host disease (GvHD) and improved graft-versus-host disease-free, relapse-free survival (GRFS) rates in 26 patients matched to haploidentical allogeneic hematopoietic stem cell donors. Unlike standard of care haploidentical allogeneic hematopoietic stem transplant (alloHSCT), Orca-Q does not require post-transplant cyclophosphamide (PTCy).\n<\/p>\n<p>\n\u201cPatients and transplant physicians are in urgent need of a novel treatment option that improves the chances of survival and the quality of that survival. This is the key limitation of haploidentical transplant, which is currently the only treatment option for the vast majority of blood cancer patients in need of a transplant,\u201d said Amandeep Salhotra, M.D., associate professor, Division of Leukemia, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope. \u201cThese results suggest Orca-Q\u2019s promise to overcome this serious challenge by offering a novel investigational high-precision cell therapy with the potential to significantly improve patient outcomes and reduce serious transplant-related risks.\u201d\n<\/p>\n<p>\nOrca-Q is an investigational high-precision cell therapy that is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets. The findings presented at ASH are from patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS) and chronic myeloid leukemia (CML) who were matched to haploidentical allogeneic donors, defined as matched across at least 4\/8 but fewer than 7\/8 human leukocyte antigen (HLA) loci. Historical controls from the literature of patients who received standard of care haploidentical alloHSCT with PTCy GvHD prophylaxis were used for comparison purposes<sup>1,2,3,4<\/sup>.\n<\/p>\n<p>\nInterim results from the Phase 1 single-arm, open-label trial showed:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nA reduction of grade 2-4 acute GvHD (aGvHD) at 6 months as compared to literature controls (13% vs 21-63%), with only one patient developing grade 3 aGvHD and no incidence of grade 4 aGvHD.\n<\/li>\n<li>\nNo patients experienced moderate-to-severe chronic GvHD (cGvHD), compared to 24%-33% in the literature control. There was only one case of mild cGvHD.\n<\/li>\n<li>\nGRFS was 75% at one year after Orca-Q, which compares favorably to a GRFS of 46% in patients in the literature control.\n<\/li>\n<\/ul>\n<p>\nPatients treated with Orca-Q also experienced a low adverse event profile, suggesting Orca-Q has the potential to offer a new treatment option for patients undergoing haploidentical alloHSCT.\n<\/p>\n<p>\nToday, approximately 70% of blood cancer patients do not have access to a fully matched related donor. Haploidentical transplant, which uses healthy, blood-forming cells from a partially matched donor to replace the unhealthy ones, is one of the few treatment options currently available to those without a fully matched donor. However, its use remains significantly limited because of the conditioning regimens that are required. Haploidentical transplant patients receiving higher intensity myeloablative conditioning treatments have a higher risk of cGvHD post-transplant, while patients receiving lower intensity pre-transplant conditioning have a greater risk of relapse.\n<\/p>\n<p>\n\u201cThese interim results from our second clinical program demonstrate Orca-Q\u2019s potential to overcome the challenges of haploidentical alloHSCT by providing a solution with which patients and physicians may no longer have to compromise between the risk of relapse and the risk of GvHD,\u201d said Scott McClellan, M.D., Ph.D., chief medical officer of Orca Bio. \u201cThis novel approach, along with our growing body of clinical evidence demonstrating Orca-T\u2019s improved GvHD and relapse-free survival rates in patients with HLA-matched donors, underscore the potential of our high-precision platforms to deliver cell therapies that can greatly expand the number of patients who receive life-saving treatment, whether their donor is a full or partial match.\u201d\n<\/p>\n<p>\nThe full presentation will be made available on <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Forcabio.com%2Fclinical-programs%2F&amp;esheet=53023437&amp;newsitemid=20221212005018&amp;lan=en-US&amp;anchor=www.orcabio.com&amp;index=1&amp;md5=daa81d24501a78ddf48bfd20a9babeb0\" rel=\"nofollow noopener\" shape=\"rect\">www.orcabio.com<\/a>.\n<\/p>\n<p>\n<b>About Orca-Q<br \/>\n<br \/><\/b>Orca-Q is Orca Bio\u2019s second investigational high-precision allogeneic cellular therapy to enter clinical development for hematological malignancies. Orca-Q is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets derived from haploidentical\u2014or partially matched\u2014donors that are purified through Orca Bio\u2019s high-precision platform. Orca-Q is a first-in-class therapy that has the potential to improve patient outcomes and reduce the risks of graft versus host disease, without the use of post-transplant cyclophosphamide (PTCy) in patients for whom a full human leukocyte antigen (HLA) match cannot be found.\n<\/p>\n<p>\n<b>About Orca-T<br \/>\n<br \/><\/b>Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.\n<\/p>\n<p>\n<b>About Orca Bio<br \/>\n<br \/><\/b>Orca Bio is a late-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than standard allogeneic stem cell transplants, like graft versus host disease and other debilitating transplant-related toxicities. At Orca Bio, we hope to not only replace patients&#8217; blood and immune systems with healthy ones, but restore their quality of life. For more information, visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.orcabio.com%2F&amp;esheet=53023437&amp;newsitemid=20221212005018&amp;lan=en-US&amp;anchor=www.orcabio.com&amp;index=2&amp;md5=d3e2743e48a0ce821c3445238884fb99\" rel=\"nofollow noopener\" shape=\"rect\">www.orcabio.com<\/a> and follow Orca Bio on Twitter: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Forcabio&amp;esheet=53023437&amp;newsitemid=20221212005018&amp;lan=en-US&amp;anchor=%40OrcaBio&amp;index=3&amp;md5=dfdf62d08da9275add6ed5e81472234c\" rel=\"nofollow noopener\" shape=\"rect\">@OrcaBio<\/a>.\n<\/p>\n<p>\n1 Gooptu, M, et al. Blood. 2021; 138 (3): 273\u2013282.<br \/>\n<br \/>2 Sanz, J, et al. J Hematol Oncol. 2020; 13:46.<br \/>\n<br \/>3 Baker, M, et al. Biol Blood Marrow Transplant. 2016; 22; 2047-2055.<br \/>\n<br \/>4 Sanz, J, et al. J Hematol Oncol. 2020; 13:46.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nCorporate Communications<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#x69;&#108;&#x74;&#x6f;:&#x6d;&#x65;d&#105;&#x61;&#64;&#111;&#x72;c&#97;&#x62;i&#111;&#x2e;c&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x6d;&#x65;&#x64;&#105;&#97;&#64;o&#x72;&#x63;&#x61;&#x62;&#105;&#111;&#46;c&#x6f;&#x6d;<\/a><\/p>\n<p>Investor Relations<br \/>\n<br \/>Joshua Murray<br \/>\n<br \/><a target=\"_blank\" href=\"ma&#105;&#108;&#x74;&#x6f;&#x3a;&#x69;r&#64;&#111;&#114;&#x63;&#x61;&#x62;&#x69;o&#46;&#99;&#111;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#105;&#x72;&#64;&#111;&#x72;c&#97;&#x62;i&#x6f;&#x2e;&#99;&#x6f;m<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u2013 Orca-Q is Orca Bio\u2019s investigational high-precision cell therapy designed to overcome the challenges of haploidentical allogeneic hematopoietic stem cell transplant (alloHSCT) \u2013 \u2013 Interim multi-center Phase 1 clinical trial results show that Orca-Q improved graft-versus-host disease-free, relapse-free survival in haploidentical alloHSCT compared to standard of care, without use of post-transplant cyclophosphamide \u2013 MENLO PARK, &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/orca-bio-presents-encouraging-interim-clinical-data-on-orca-q-in-haploidentical-allogeneic-hematopoietic-stem-cell-transplants-at-64th-ash-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-51870","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th ASH 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\/orca-bio-presents-encouraging-interim-clinical-data-on-orca-q-in-haploidentical-allogeneic-hematopoietic-stem-cell-transplants-at-64th-ash-annual-meeting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th ASH Annual Meeting - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"\u2013 Orca-Q is Orca Bio\u2019s investigational high-precision cell therapy designed to overcome the challenges of haploidentical allogeneic hematopoietic stem cell transplant (alloHSCT) \u2013 \u2013 Interim multi-center Phase 1 clinical trial results show that Orca-Q improved graft-versus-host disease-free, relapse-free survival in haploidentical alloHSCT compared to standard of care, without use of post-transplant cyclophosphamide \u2013 MENLO PARK, ... 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