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	<title>Sabine Possmann | CARAMBA</title>
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	<link>https://www.caramba-cart.eu</link>
	<description>CARAMBA</description>
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	<title>Sabine Possmann | CARAMBA</title>
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		<title>T-CURX GmbH announces the appointment of Thomas Loeser as CFO</title>
		<link>https://www.caramba-cart.eu/tcurx-announces-thomas-loeser-as-cfo/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=tcurx-announces-thomas-loeser-as-cfo</link>
		
		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Fri, 16 Dec 2022 13:29:37 +0000</pubDate>
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		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5763</guid>

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				<div class="et_pb_text_inner"><p>On 15th December, the SME T-CURX GmbH announced the appointment of Thomas Loeser as the new CFO of the company and the attendance of the JPM 41st Annual Healthcare Conference 2023 in San Francisco from Jan 9-12, 2023.<br />Tom has served for more than 20 years as CFO of several European and US biotech companies, where he directed growth and financial strategies with particular emphasis on transatlantic company building and outreach to US capital markets.<br />In his last CFO position at Origenis GmbH/IZB Martinsried, Germany, Tom focused on the commercialization of its IP portfolio by the foundation of US-based Neuron23, Inc., dedicated to precision medicines for neurodegenerative diseases. Since its launch in 2019, Neuron23 has raised a total of $213 million from Kleiner Perkins, Westlake Village BioPartners, Perceptive Advisors, Softbank Vision Fund 2 and other high-profile VC/cross-over funds.<br />Prior to Origenis, Tom directed the financing strategy of ESBATech AG, Zurich, Switzerland. ESBATech, now a Novartis company, was recognized for its pioneering role in developing single-chain antibody fragments for ophthalmic indications by the support of a strong US-led venture capital syndicate since 2006 and the trade sale of its ophthalmology franchise to Alcon, Inc. for $589 million in 2009.</p>
<p>Read the full <a href="https://www.caramba-cart.eu/wp-content/uploads/221215-Press-Release-CFO-appointment_and_JPM-final.pdf" target="_blank" rel="noopener">press release</a></p></div>
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			</div>The post <a href="https://www.caramba-cart.eu/tcurx-announces-thomas-loeser-as-cfo/">T-CURX GmbH announces the appointment of Thomas Loeser as CFO</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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		<title>Congratulations to Monica Casucci for receiving her ERC grant</title>
		<link>https://www.caramba-cart.eu/monica-caucci-receiving-erc-grant/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=monica-caucci-receiving-erc-grant</link>
		
		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Thu, 08 Dec 2022 08:18:17 +0000</pubDate>
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		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5755</guid>

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				<div class="et_pb_text_inner"><p>Monica Casucci, group leader of the innovative immunotherapies unit at IRCCS Ospedale San Raffaele, was awarded by the European Research Council, to refine her outstanding research work on a novel CAR specific for the CD44v6 antigen and strategies to improve CAR-T cell activity against solid tumors. <br />Congratulations from the whole CARAMBA team to Monica!</p>
<p>&nbsp;</p></div>
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			</div>The post <a href="https://www.caramba-cart.eu/monica-caucci-receiving-erc-grant/">Congratulations to Monica Casucci for receiving her ERC grant</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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		<title>Revolutionary Immune Cells: Michael Hudecek receives Schelling-Price for Innovative Cancer Research</title>
		<link>https://www.caramba-cart.eu/michael-hudecek-receives-schelling-price/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=michael-hudecek-receives-schelling-price</link>
		
		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Thu, 08 Dec 2022 07:40:10 +0000</pubDate>
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		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5739</guid>

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				<div class="et_pb_text_inner"><p>This year, the most important scientific price of the BAdW, endowed with 25.000 Euro, was awarded to Michael Hudecek, for his outstanding work on gen-modified CART-T cell therapy for cancer treatment. The Schelling price is awarded bi-annually, for outstanding scientific achievements.</p>
<p>Picture: President of the &#8220;Bayerische Akademie der Wissenschaften&#8221;, Prof. Dr. Dr. Thomas O. Höllmann (left), awarding Prof. Dr. Michael Hudecek (Uniklinikum Würzburg) on 3rd December. <span>(Bild: BAdW / Stefan Obermeier)</span></p>
<p>&nbsp;</p></div>
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			</div>The post <a href="https://www.caramba-cart.eu/michael-hudecek-receives-schelling-price/">Revolutionary Immune Cells: Michael Hudecek receives Schelling-Price for Innovative Cancer Research</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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		<title>VJHemOnc interviewing Hermann Einsele</title>
		<link>https://www.caramba-cart.eu/vjhemonc-interviewing-hermann-einsele/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=vjhemonc-interviewing-hermann-einsele</link>
		
		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Mon, 04 Apr 2022 06:45:16 +0000</pubDate>
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		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5692</guid>

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				<div class="et_pb_text_inner"><h5>VJHemOnc&#8217;s video series on CART cells interviewing HErmann Einsele</h5>
<p>During the EBMT-EHA 4th European CAR T-cell Meeting, VJHemOnc interviewed Hermann Einsele, MD, FRCP, University of Würzburg, Würzburg, Germany on CAR-T therapy for multiple myeloma patients and beyond. Watch the videos below, produced by the fantastic VJHemOnc team.</p></div>
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				<div class="et_pb_text_inner"><h5>Exciting developments in CAR-T therapies in and beyond hematological malignancies</h5>
<p>Hermann Einsele, MD, FRCP, University of Würzburg, Würzburg, Germany, discusses the latest advances in chimeric antigen receptor T-cell (CAR-T) therapies. CAR-Ts have changed the treatment landscape of hematological malignancies and are now being evaluated in earlier lines of therapy. There is a lot of ongoing work in developing CAR-Ts for solid tumors, as well as in other conditions including cardiac fibrosis, and autoimmune and infectious diseases. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting which was held virtually in 2022.</p></div>
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				<div class="et_pb_text_inner"><h5>Approved and emerging CAR-Ts in multiple myeloma</h5>
<p>Hermann Einsele, MD, FRCP, University of Würzburg, Würzburg, Germany, comments on the efficacy and safety of idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), two chimeric antigen receptor T-cell (CAR-T) therapies for multiple myeloma. Ide-cel has been approved by the FDA and EMA for patients with multiple myeloma who have received at least three lines of prior therapy and has shown impressive results in terms of overall response rate (ORR) and progression-free survival (PFS), with a low incidence of cytokine release syndrome (CRS) and neurotoxicity. Cilta-cel is another promising CAR-T therapy for multiple myeloma. Although it hasn’t been approved yet, studies are reporting very high response rates (RR) and remarkable PFS data, with limited toxicities. Clinical trials are also investigating these CAR-T therapies in earlier lines of therapy, which could ultimately allow achieving long-term control of the disease. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting which was held virtually in 2022.</p></div>
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				<div class="et_pb_text_inner"><h5>Safety considerations in CAR-T therapy: patient selection and side effects</h5>
<p>Hermann Einsele, MD, FRCP, University of Würzburg, Würzburg, Germany, shares guidelines on patient selection and patient follow-up after treatment with chimeric antigen receptor T-cell (CAR-T) therapy. Prof. Einsele explains that patients with comorbidities including cardiovascular and pulmonary diseases, as well as renal, liver or hematopoietic dysfunction should not receive CAR-T therapy. It is also important to avoid exposing patients to lymphodepleting treatments prior to leukapheresis. In addition, clinicians should be aware of side effects that can occur long after treatment with CAR-Ts. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting which was held virtually in 2022.</p></div>
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				<div class="et_pb_text_inner"><h5>Is CAR-T therapy going to replace high-dose chemotherapy with autoSCT in multiple myeloma?</h5>
<p>Hermann Einsele, MD, FRCP, University of Würzburg, Würzburg, Germany, talks on the role of high-dose chemotherapy with autologous stem cell transplantation (autoSCT) in the context of chimeric antigen receptor T-cell (CAR-T) therapies in multiple myeloma. CAR T-therapies are undeniably starting to challenge the current standard of care (SOC) due to their high efficacy and low toxicity, and they are currently being investigated in earlier lines of therapy where they are directly compared to chemotherapy and autoSCT. Prof. Einsele explains that CAR-T therapy may also be added to autoSCT as an additional consolidation strategy in high-risk and ultra-high risk disease. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting which was held virtually in 2022.</p></div>
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			</div>The post <a href="https://www.caramba-cart.eu/vjhemonc-interviewing-hermann-einsele/">VJHemOnc interviewing Hermann Einsele</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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		<title>VJHemOnc interviewing Michael Hudecek</title>
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		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Fri, 01 Apr 2022 10:57:59 +0000</pubDate>
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		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5679</guid>

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				<div class="et_pb_text_inner"><h5>VJHemOnc&#8217;s video series on CART cells interviewing Michael Hudecek</h5>
<p>During the EBMT-EHA 4th European CAR T-cell Meeting, VJHemOnc interviewed Michael Hudecek, MD, University of Würzburg, Würzburg, Germany on several exciting CAR-T topics. Watch the videos below, produced by the fantastic VJHemOnc team.</p></div>
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				<div class="et_pb_text_inner"><h5>CARAMBA-1: a Phase I/IIa trial of autologous SLAMF7 CAR-Ts in multiple myeloma</h5>
<p>Michael Hudecek, MD, University of Würzburg, Würzburg, Germany, outlines the rationale and preliminary results of CARAMBA-1, an ongoing Phase I/IIa clinical trial evaluating the feasibility, safety and anti-myeloma activity of autologous SLAMF7 chimeric antigen T-cells (CAR-T) in patients with multiple myeloma (NCT04499339). Recent pre-clinical studies have demonstrated that CAR-Ts targeting SLAMF7 have potent anti-myeloma efficacy. Early results from the dose-escalation part of the CARAMBA-1 study suggest that these CAR-Ts are safe and show indications of anti-tumor activity. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting in which was held virtually in 2022.</p></div>
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				<div class="et_pb_text_inner"><h5>Young EBMT &amp; EHA Ambassadors: the basic science behind CAR-Ts</h5>
<p>Michael Hudecek, MD, University of Würzburg, Würzburg, Germany, outlines the aims and key points of his talk in the Young EBMT &amp; EHA Ambassadors session. This session is dedicated to young clinicians and scientists and aims to explain the basic science behind chimeric antigen receptor T-cells (CAR-Ts), how they were transformed into a viable product, and how CAR-Ts are evaluated. The session will also highlight clinical data on CAR-Ts. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting which was held virtually in 2022.</p></div>
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				<div class="et_pb_text_inner"><h5>CAR-T trials and research at UKW</h5>
<p>Michael Hudecek, MD, University of Würzburg, Würzburg, Germany, gives an update of the chimeric antigen receptor T-cell (CAR-T) clinical trials and research conducted at the University Hospital of Würzburg (UKW). Dr Hudecek talks on the ongoing CARAMBA-1 trial evaluating autologous SLAMF7 CAR-Ts in multiple myeloma (NCT04499339), and comments on a novel promising target antigen for CAR-T therapy in acute myeloid leukemia (AML). He also explains that a clinical trial for a CAR-T product for breast cancer and lung cancer will be launched soon. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting which was held virtually in 2022.</p></div>
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				<div class="et_pb_text_inner"><h5>EBMT-EHA CAR T-cell meeting: all the latest in CAR-T</h5>
<p>Michael Hudecek, MD, University of Würzburg, Würzburg, Germany, gives an overview of the EBMT-EHA 4th European CAR T-cell Meeting program, highlighting the aims and importance of this meeting. Chimeric antigen receptor T-cell (CAR-T) therapy is one of the most rapidly evolving fields in translational research. The EBMT-EHA CAR T-cell meeting brings key opinion leaders (KOLs) and stakeholders from all over the world together to discuss the latest data in CAR-T therapies and exchange ideas to further improve this practice-changing technology. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting which was held virtually in 2022.</p></div>
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				<div class="et_pb_text_inner"><h5>Exploring the applications of CAR-Ts beyond hematology and oncology</h5>
<p>Michael Hudecek, MD, University of Würzburg, Würzburg, Germany, discusses the potential of engineered immune cell therapies such as chimeric antigen receptor T-cells (CAR-Ts) in fields other than hematology and oncology, namely infectious diseases, auto-immune diseases, and cardiovascular diseases. This interview took place at the EBMT-EHA 4th European CAR T-cell Meeting which was held virtually in 2022.</p></div>
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			</div>The post <a href="https://www.caramba-cart.eu/vjhemonc_interview/">VJHemOnc interviewing Michael Hudecek</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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		<title>REGULATORY WORKSHOP ON THE DEVELOPMENT OF CAR-T CELLS</title>
		<link>https://www.caramba-cart.eu/regulatory-workshop-on-the-development-of-car-t-cells/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=regulatory-workshop-on-the-development-of-car-t-cells</link>
		
		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Thu, 02 Apr 2020 16:53:35 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5335</guid>

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										<content:encoded><![CDATA[<p><div class="et_pb_section et_pb_section_5 et_section_regular" >
				
				
				
				
				
				
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				<div class="et_pb_text_inner"><p style="text-align: center;"><strong>Jointly organized by the H2020 projects</strong></p>
<h4 style="text-align: center;"><strong>EURE-CART</strong><br /> <strong> (European Endeavour for Chimeric Antigen Receptor Therapies)</strong></h4>
<p style="text-align: center;"><strong>&amp;</strong></p>
<h4 style="text-align: center;"><strong>CARAMBA</strong><br /> <strong> (SLAMF7-CAR T for Immunotherapy of Multiple Myeloma)</strong></h4>
<p style="text-align: center;"><strong>29 – 30 January 2020</strong></p>
<p style="text-align: center;"><strong>Meeting Report</strong></p></div>
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				<div class="et_pb_text_inner"><h3>EXECUTIVE SUMMARY</h3>
<p style="text-align: justify;">On 29th and 30th January 2020, the two EU-funded projects <strong><a href="http://www.eurecart.eu">EURE-CART</a></strong> (European Endeavour for Chimeric Antigen Receptor Therapies) and <strong><a href="http://www.caramba-cart.eu">CARAMBA</a></strong> (SLAMF7-CAR T for Immunotherapy of Multiple Myeloma) organized a joint regulatory workshop on the development of CAR-T cells, run-up to the 2nd European CAR T Cell Meeting in Sitges, Barcelona.<br /> The aim of the workshop was to share and discuss regulatory experiences gained during the development of CAR-T cells and the approval of clinical studies using CAR T cells. The first meeting day was held as a closed workshop, for project partners only, allowing open discussions on a very detailed level. For the second meeting day, the European CAR-T community was invited to join discussions with the project consortia and opinion leaders from national regulatory authorities.<br /> With 10 expert speakers, 73 meeting participants and 2 days of interactive sessions with valuable feedback, the successful regulatory workshop will serve as a basis for future common harmonization initiatives.</p></div>
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				<div class="et_pb_text_inner"><h3>MEETING DAY 1 – CLOSED REGULATORY WORKSHOP</h3></div>
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				<span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="1696" height="1066" src="https://www.caramba-cart.eu/wp-content/uploads/CART_WS_Hudecek_Galli.jpg" alt="" title="" srcset="https://www.caramba-cart.eu/wp-content/uploads/CART_WS_Hudecek_Galli.jpg 1696w, https://www.caramba-cart.eu/wp-content/uploads/CART_WS_Hudecek_Galli-1280x805.jpg 1280w, https://www.caramba-cart.eu/wp-content/uploads/CART_WS_Hudecek_Galli-980x616.jpg 980w, https://www.caramba-cart.eu/wp-content/uploads/CART_WS_Hudecek_Galli-480x302.jpg 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1696px, 100vw" class="wp-image-5373" /></span>
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				<div class="et_pb_text_inner"><h4><em>Cordial welcome by Michael Hudecek and Maria Cristina Galli</em></h4>
<p>&nbsp;</p>
<p style="text-align: justify;">After a warm welcome by the organizers, the two projects CARAMBA and EURE-CART shared detailed regulatory feedback on a confidential level and discussed common future initiatives.</p>
<p>&nbsp;</p></div>
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				<div class="et_pb_text_inner"><p>Find out more about CARAMBA and <strong>download</strong> the CARAMBA presentation.</p>
<p>Find out more about EURE-CART and <strong>download</strong> the EURE-CART presentation.</p></div>
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				<div class="et_pb_text_inner"><h4>CARAMBA and EURE-CART joining forces</h4></div>
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				<span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="2560" height="584" src="https://www.caramba-cart.eu/wp-content/uploads/CART_WS_CARAMBA_EURECART_consortium-scaled.jpg" alt="" title="" srcset="https://www.caramba-cart.eu/wp-content/uploads/CART_WS_CARAMBA_EURECART_consortium-scaled.jpg 2560w, https://www.caramba-cart.eu/wp-content/uploads/CART_WS_CARAMBA_EURECART_consortium-1280x292.jpg 1280w, https://www.caramba-cart.eu/wp-content/uploads/CART_WS_CARAMBA_EURECART_consortium-980x224.jpg 980w, https://www.caramba-cart.eu/wp-content/uploads/CART_WS_CARAMBA_EURECART_consortium-480x110.jpg 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 2560px, 100vw" class="wp-image-5372" /></span>
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				<div class="et_pb_text_inner"><p style="text-align: justify;">After a long day full of valuable contributions, both consortia were looking forward to the open day and the exciting discussions with the CAR-T community.</p></div>
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				<div class="et_pb_text_inner"><h3>MEETING DAY 2 – OPEN REGULATORY WORKSHOP</h3></div>
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				<div class="et_pb_text_inner"><h4>Welcome by Michael Hudecek and Maria Cristina Galli</h4>
<p>The EURE-CART regulatory expert Maria Cristina Galli (Istituto Superiore di Sanità) and the CARAMBA coordinator Michael Hudecek (University Hospital Wuerzburg) cordially welcome all participants and especially all speakers to the joint EURE-CART/CARAMBA regulatory workshop and highly acknowledge the EHA and EBMT for their support preparing the workshop.</p>
<p>The workshop was initiated to create a platform for knowledge and experience exchange, to share recent experiences of the two EU-funded projects EURE-CART and CARAMBA with the community, but also to receive and collect feedback from the audience.</p></div>
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				<span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="702" height="661" src="https://www.caramba-cart.eu/wp-content/uploads/CART_WS_MCGalli.jpg" alt="" title="" srcset="https://www.caramba-cart.eu/wp-content/uploads/CART_WS_MCGalli.jpg 702w, https://www.caramba-cart.eu/wp-content/uploads/CART_WS_MCGalli-480x452.jpg 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 702px, 100vw" class="wp-image-5374" /></span>
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				<div class="et_pb_text_inner"><h4>Applicant and assessor – communication is the key to success</h4>
<p>In her function as quality assessor for gene therapy and biotechnology medicines and as GMP and GLP inspector, <strong>Maria Cristina Galli</strong> (Istituto Superiore di Sanità Roma, Italy) provides an overview on key aspects crucial for a successful CAR-T product application. The principle of knowing the product and the disease is considered as fundamental prerequisite. In her presentation, Maria Cristina Galli elaborates the main risks for GTMP and CTMP, addresses CAR-T quality aspects and the role of bioactivity and potency of CAR-T cells.</p>
<p><a href="https://www.caramba-cart.eu/wp-content/uploads/CART_RegulatoryWorkshop_MCGalli.pdf" target="_blank" rel="noopener noreferrer"><strong>Find out more</strong></a></p></div>
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				<div class="et_pb_text_inner"><h4>It is never too early<br /> to contact your national regulatory authority</h4>
<p><strong>Martina Schüssler-Lenz</strong>, chair of EMA’s Committee for Advanced Therapies and deputy head of the Advanced Therapy Medicinal Products Section at the Paul-Ehrlich-Institute, provides a comprehensive overview on ATMP, the different responsibilities during the authorization process and the way towards clinical trial application. She highlights, that an EU portal for centralised applications is supposed to be set-up by 2021 allowing a very short time of approval. In addition, she stresses the importance of the EMA guidelines on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.</p>
<p><a href="https://www.caramba-cart.eu/wp-content/uploads/CART_RegulatoryWorkshop_PEI.pdf" target="_blank" rel="noopener noreferrer"><strong><span style="color: #ffffff;">Find out more</span></strong></a></p>
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				<span class="et_pb_image_wrap "><img loading="lazy" decoding="async" width="1253" height="1032" src="https://www.caramba-cart.eu/wp-content/uploads/CART_WS_MTimon.jpg" alt="" title="" srcset="https://www.caramba-cart.eu/wp-content/uploads/CART_WS_MTimon.jpg 1253w, https://www.caramba-cart.eu/wp-content/uploads/CART_WS_MTimon-980x807.jpg 980w, https://www.caramba-cart.eu/wp-content/uploads/CART_WS_MTimon-480x395.jpg 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1253px, 100vw" class="wp-image-5376" /></span>
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				<div class="et_pb_text_inner"><h4>Harmonization efforts on GMO issues for clinical trials with gene therapy products</h4>
<p><strong>Marcos Timón</strong>, head of service of the Unit for Advanced Therapies and Biotechnology at the Spanish Medicines Agency (AEMPS), describes how GMOs containing Medicinal Products are assessed throughout Europe with respect to compliance with GMO legislation and the efforts made to harmonise those procedures. He points out, that the requirements and the time of consultation can vary between the different member states and that several harmonization objectives have been achieved like country specific information sheets to provide an overview of national regulatory requirements for medical products containing GMOs, a simplified procedure for human cells, genetically modified by means of retro/lentiviral vectors (including a common application form), a simplified procedure for rAVVs clinical vectors and a Q&amp;A document on clinical trials with GMOs.</p>
<p><a href="https://www.caramba-cart.eu/wp-content/uploads/CART_RegulatoryWorkshop_MTimon.pdf" target="_blank" rel="noopener noreferrer"><strong>Find out more</strong></a></p></div>
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				<div class="et_pb_text_inner"><h4>Requirements for CAR-T cells to enter first-in-human studies:<br /> Views from a regulatory affairs consultant</h4>
<p style="text-align: justify;"><strong>Robert Doblhofer</strong>, regulatory affairs consultant at Granzer Regulatory Consulting &amp; Services, underlines the message to consult national regulators early in the process. He defines the major challenges from a CMC perspective, like the starting material or the manufacturing process validation and stresses the critical point of target liability. In his presentation, Robert Doblhofer also refers to an important new guidance document, not yet published, but already referenced by the Paul-Ehrlich-Institute.</p>
<p><span style="color: #ffffff;"><a href="https://www.caramba-cart.eu/wp-content/uploads/CART_RegulatoryWorkshop_Granzer.pdf" target="_blank" rel="noopener noreferrer" style="color: #ffffff;"><strong>Find out more</strong></a></span></p>
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				<div class="et_pb_text_inner"><h4>EATRIS: The European Infrastructure for Translational Medicine</h4>
<p style="text-align: justify;"><strong>Florence Beatrix</strong>, head of operations at EATRIS, introduces the European Strategy Forum on Research Infrastructures (ESFRI) and its member associations supporting researchers on their way from basic to clinical research. As the European infrastructure for translational research, EATRIS supports European researchers in the development of their biomedical innovation, thereby covering the five scientific platforms ATMPs, Biomarker, Imaging &amp;Tracing, Small Molecules and Vaccines.</p>
<p style="text-align: justify;"><a href="https://www.caramba-cart.eu/wp-content/uploads/CART_RegulatoryWorkshop_EATRIS.pdf" target="_blank" rel="noopener noreferrer"><strong>Find out more</strong></a></p></div>
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				<div class="et_pb_text_inner"><h4>Round table discussion: Harmonisation of first-in-human studies review in the EU</h4>
<p style="text-align: justify;">The experts <strong>Michael Hudecek, Martina Schüssler-Lenz, Daniele Alberti, Maria Cristina Galli, Marcos Timon, Yuan Zhao, Axel Stahlbom and Robert Doblhofer</strong> (ltr) discuss with the audience, whether a European-wide harmonization of regulation processes can influence the number of CAR-T clinical trials. The experts agree that a close interaction and knowledge exchange between the European member states and the training of applicants is important for the harmonization of processes. However, a central application process is discussed controversially. Maria Cristina Galli points out, that different guidelines should not hamper clinical trials but help and protect patients.</p>
<p style="text-align: justify;">Comments from the audiences emphasized the need for one harmonized process and for more transparent information.</p>
<p style="text-align: justify;">Kate Morgan, a representative from the patient organization Myeloma Patients Europe, comments on patient expectations. Patients worry most about safety. She points out that clinical trial protocols are difficult to understand. Therefore, collaborations and an involvement in the study design are highly acknowledged.</p></div>
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				<div class="et_pb_text_inner"><h3>CONCLUSION</h3>
<p style="text-align: justify;">The joint CARAMBA/EURE-CART regulatory workshop was a unique opportunity to connect European researchers with European regulators, to discuss and understand the mutual needs and to overcome communication barriers. All parties are highly committed to continue joining forces in the future, to harmonize and accelerate processes for the benefit, but also for the safety of patients.  </p></div>
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			</div></p>The post <a href="https://www.caramba-cart.eu/regulatory-workshop-on-the-development-of-car-t-cells/">REGULATORY WORKSHOP ON THE DEVELOPMENT OF CAR-T CELLS</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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		<title>Joint regulatory workshop of EURE-CART and CARAMBA</title>
		<link>https://www.caramba-cart.eu/joint-regulatory-workshop-of-eure-cart-and-caramba/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=joint-regulatory-workshop-of-eure-cart-and-caramba</link>
		
		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Tue, 07 Jan 2020 13:58:01 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5307</guid>

					<description><![CDATA[<p>With the first approvals of the CAR T cell treatments in Europe, a partial victory in the fight against hematological malignancies was achieved. However, the route from bench to bedside poses several challenges, demanding for a European-wide harmonization process. This is what the Regulatory Workshop on the Development of CAR-T cells aims for: Exchange of [&#8230;]</p>
The post <a href="https://www.caramba-cart.eu/joint-regulatory-workshop-of-eure-cart-and-caramba/">Joint regulatory workshop of EURE-CART and CARAMBA</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></description>
										<content:encoded><![CDATA[<p>With the first approvals of the CAR T cell treatments in Europe, a partial victory in the fight against hematological malignancies was achieved. However, the route from bench to bedside poses several challenges, demanding for a European-wide harmonization process. This is what the <strong>Regulatory Workshop on the Development of CAR-T cells</strong> aims for: Exchange of experiences and knowledge transfer will be the central aspects of the event on 29-30 January, 2020 in Sitges (Spain).</p>
<p>The two-day agenda comprises an overview on CAR-T development and regulatory aspects in the two H2020 projects EURE-CART (European Endeavour for Chimeric Antigen Receptor Therapies) and CARAMBA (SLAMF7-CAR T for Immunotherapy of Multiple Myeloma). The issues emerged from project experience will be discussed, and the requirements for CAR-T cells to enter first-in-human studies will be shown from different points of view.</p>
<p>All hematologists, oncologists, physicians, nurses, data managers and patient organization representatives are welcome to <a href="https://www.caramba-cart.eu/eure-cart-caramba-joint-open-regulatory-workshop/">register</a> until January 13th. Number of participants is limited to 100.</p>
<p><strong>Date: Wed 29 – Thur 30 January, 2020</strong><br />
Venue: Melia Sitges Hotel, Sitges (Spain)</p>The post <a href="https://www.caramba-cart.eu/joint-regulatory-workshop-of-eure-cart-and-caramba/">Joint regulatory workshop of EURE-CART and CARAMBA</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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		<title>Publication: Genomic Analyses of SLAMF7 CAR-T Cells</title>
		<link>https://www.caramba-cart.eu/publication-genomic-analyses-of-slamf7-car-t-cells/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=publication-genomic-analyses-of-slamf7-car-t-cells</link>
		
		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Mon, 24 Jun 2019 09:02:34 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5150</guid>

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				<div class="et_pb_text_inner"><p>In close collarboration between the CARAMBA partners Paul-Ehrlich-Insitiute, DRK-BSD and the University Hospital in Wuerzburg, first CARAMBA data were published on the bioRxiv platform.</p>
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<p id="page-title" class="highwire-cite-title"><strong>Genomic Analyses of SLAMF7 CAR-T Cells Manufactured by<br />
</strong><strong><em>Sleeping Beauty</em> Transposon Gene Transfer for Immunotherapy of Multiple Myeloma</strong></p>
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<p><strong>Abstract:</strong></p>
<p>Widespread treatment of human diseases with gene therapies necessitates the development of gene transfer vectors that integrate genetic information effectively, safely and economically. Accordingly, significant efforts have been devoted to engineer novel tools that i) achieve high-level stable gene transfer at low toxicity to the host cell; ii) induce low levels of genotoxicity and possess a ‘safe’ integration profile with a high proportion of integrations into safe genomic locations; and iii) are associated with acceptable cost per treatment and scalable/exportable vector production to serve large numbers of patients. The <em>Sleeping Beauty</em> (SB) transposon has been transformed into a vector system that is fulfilling these requirements.</p>
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<p id="p-3">In the CARAMBA project, we use SB transposition to genetically modify T cells with a chimeric antigen receptor (CAR) specific for the SLAMF7 antigen, that is uniformly and highly expressed on malignant plasma cells in multiple myeloma. We have demonstrated that SLAMF7 CAR-T cells confer specific and very potent anti-myeloma reactivity in pre-clinical models, and are therefore preparing a Phase I/IIa clinical trial of adoptive immunotherapy with autologous, patient-derived SLAMF7-CAR T cells in multiple myeloma (EudraCT Nr. 2019-001264-30/CARAMBA-1).</p>
<p id="p-4">Here we report on the characterization of genomic safety attributes in SLAMF7 CAR-T cells that we prepared in three clinical-grade manufacturing campaigns under good manufacturing practice (GMP), using T cells that we obtained from three healthy donor volunteers. In the SLAMF7 CAR-T cell product, we determined the average transposon copy number, the genomic insertion profile, and presence of residual SB100X transposase. The data show that the SLAMF7 CAR transposon had been inserted into the T cell genome with the close-to-random distribution pattern that is typical for SB, and with an average transposon copy number ranging between 6 and 12 per T cell. No residual SB100X transposase could be detected by Western blotting in the infusion products. With these attributes, the SLAMF7 CAR-T products satisfy criteria set forth by competent regulatory authorities in order to justify administration of SLAMF7 CAR-T cells to humans in the context of a clinical trial. These data set the stage for the CARAMBA clinical trial, that will be the first in the European Union to use virus-free SB transposition for CAR-T engineering.</p>
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<p><strong>Read more</strong></p></div>
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			</div>The post <a href="https://www.caramba-cart.eu/publication-genomic-analyses-of-slamf7-car-t-cells/">Publication: Genomic Analyses of SLAMF7 CAR-T Cells</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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		<title>Myeloma Patients Europe webinar on CAR-T cell treatment</title>
		<link>https://www.caramba-cart.eu/myeloma-patients-europe-webinar-on-car-t-cell-treatment/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=myeloma-patients-europe-webinar-on-car-t-cell-treatment</link>
		
		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Mon, 06 May 2019 09:32:47 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5135</guid>

					<description><![CDATA[<p>With the aim of providing an overview of CAR-T cell treatment in myeloma, healthcare professional expectations and an introduction to some of the advantages and challenges for patients and in bringing it to market, Myeloma Patients Europe (MPE) will held a webinar on Thursday 9 May from 18:00 to 19:00 CET. The webinar will be [&#8230;]</p>
The post <a href="https://www.caramba-cart.eu/myeloma-patients-europe-webinar-on-car-t-cell-treatment/">Myeloma Patients Europe webinar on CAR-T cell treatment</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></description>
										<content:encoded><![CDATA[<p>With the aim of providing an overview of CAR-T cell treatment in myeloma, healthcare professional expectations and an introduction to some of the advantages and challenges for patients and in bringing it to market, Myeloma Patients Europe (MPE) will held a webinar on <strong>Thursday 9 May from 18:00 to 19:00 CET</strong>.<br />
<span id="more-1916"></span>The webinar will be given by <strong>Dr Sara Mastaglio, Hematology and Bone Marrow Transplantation Unit, San Raffaele Scientific Institute, Milan (Italy).<br />
</strong>The webinar will last around 60-minutes, including a 40-minutes presentation by Dr Mastaglio followed by a 20-minute Q&amp;A session. The target audience is patient advocates, patients and caregivers but anyone with an interest in the topic is more than welcome to attend.<br />
Registration is free of charge. Please feel free to forward the registration link to colleagues who might be interested in attending the webinar.<br />
Should you be unable to attend the webinar, please feel free to send your questions in advance to <a href="&#x6d;&#x61;&#105;l&#x74;&#x6f;&#58;&#105;n&#x66;&#x6f;&#64;&#109;p&#x65;&#x75;&#114;op&#x65;&#x2e;&#111;r&#x67;">&#x69;n&#x66;&#111;&#x40;&#109;&#x70;&#x65;u&#x72;&#111;&#x70;&#101;&#x2e;&#111;r&#x67;</a> who will make sure they reach the speaker.<br />
A recording of the webinar will be available shortly after the session.<br />
Register <a href="https://www.mpeurope.org/2019/04/26/myeloma-patients-europe-webinar-on-car-t-cell-therapy/#more-1916">here</a>!</p>The post <a href="https://www.caramba-cart.eu/myeloma-patients-europe-webinar-on-car-t-cell-treatment/">Myeloma Patients Europe webinar on CAR-T cell treatment</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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		<title>Myeloma Patients Europe General Assembly</title>
		<link>https://www.caramba-cart.eu/myeloma-patients-europe-general-assembly/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=myeloma-patients-europe-general-assembly</link>
		
		<dc:creator><![CDATA[Sabine Possmann]]></dc:creator>
		<pubDate>Thu, 02 May 2019 09:16:21 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<guid isPermaLink="false">https://www.caramba-cart.eu/?p=5131</guid>

					<description><![CDATA[<p>Myeloma Patients Europe held its annual General Assembly on 15-17 March 2019 in Munich, Germany. Next to training, scientific and advocacy sessions, CARAMBA coordinator Dr. Michael Hudecek presented on CAR-T cells in multiple myeloma and AL amyloidosis. Watch here the video interview with Michael. &#160;</p>
The post <a href="https://www.caramba-cart.eu/myeloma-patients-europe-general-assembly/">Myeloma Patients Europe General Assembly</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></description>
										<content:encoded><![CDATA[<p>Myeloma Patients Europe held its annual General Assembly on 15-17 March 2019 in Munich, Germany. Next to training, scientific and advocacy sessions, CARAMBA coordinator Dr. Michael Hudecek presented on CAR-T cells in multiple myeloma and AL amyloidosis. Watch <a href="https://www.youtube.com/watch?v=jmpY5xrHPGI&amp;feature=youtu.be&amp;platform=hootsuite">here</a> the video interview with Michael.</p>
<p>&nbsp;</p>The post <a href="https://www.caramba-cart.eu/myeloma-patients-europe-general-assembly/">Myeloma Patients Europe General Assembly</a> first appeared on <a href="https://www.caramba-cart.eu">CARAMBA</a>.]]></content:encoded>
					
		
		
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