Orgenesis Announces Positive Results From a Real-World Study of ORG-101 CAR-T Therapy in Patients with CD19+ Acute Lymphoblastic Leukemia
Orgenesis (NASDAQ: ORGS) announced positive results from a real-world study of its CD19 CAR-T therapy, ORG-101, in patients with CD19+ Acute Lymphoblastic Leukemia. The study showed complete response rates of 82% in adults and 93% in pediatric patients, with low incidence of severe Cytokine Release Syndrome (2% in adults, 6% in pediatrics).
ORG-101 utilizes a third-generation lentiviral vector with a proprietary CAR construct and decentralized onsite production, offering a potentially more affordable solution compared to traditional CAR-T therapies. Orgenesis is preparing to initiate a Phase 1/2 clinical multicenter study, starting in Greece.
Harley Street Healthcare Group plans to set up a Global Cancer Initiative through its joint venture with Orgenesis, aiming to democratize Advanced Therapies and support further clinical development.
Orgenesis (NASDAQ: ORGS) ha annunciato risultati positivi da uno studio del mondo reale sulla sua terapia CAR-T CD19, ORG-101, in pazienti con Leucemia Linfoblastica Acuta CD19+. Lo studio ha mostrato tassi di risposta completa dell'82% negli adulti e del 93% nei pazienti pediatrici, con una bassa incidenza di grave Sindrome da Rilascio di Citochine (2% negli adulti, 6% nei pediatrici).
ORG-101 utilizza un vettore lentivirale di terza generazione con un costrutto CAR proprietario e produzione decentralizzata in loco, offrendo una potenziale soluzione più accessibile rispetto alle terapie CAR-T tradizionali. Orgenesis si sta preparando a iniziare uno studio clinico multicentrico di Fase 1/2, che avrà inizio in Grecia.
Harley Street Healthcare Group prevede di avviare un Iniziativa Globale per il Cancro attraverso la sua joint venture con Orgenesis, con l'obiettivo di democratizzare le Terapie Avanzate e supportare ulteriori sviluppi clinici.
Orgenesis (NASDAQ: ORGS) anunció resultados positivos de un estudio en el mundo real sobre su terapia CAR-T CD19, ORG-101, en pacientes con Leucemia Linfoblástica Aguda CD19+. El estudio mostró tasas de respuesta completa del 82% en adultos y del 93% en pacientes pediátricos, con una baja incidencia de síndrome de liberación de citoquinas grave (2% en adultos, 6% en pediátricos).
ORG-101 utiliza un vector lentiviral de tercera generación con un constructo CAR propio y producción descentralizada en el lugar, ofreciendo una solución potencialmente más asequible en comparación con las terapias CAR-T tradicionales. Orgenesis se está preparando para iniciar un estudio clínico multicéntrico de Fase 1/2, comenzando en Grecia.
Harley Street Healthcare Group planea establecer una Iniciativa Global contra el Cáncer a través de su empresa conjunta con Orgenesis, con el objetivo de democratizar las Terapias Avanzadas y apoyar el desarrollo clínico adicional.
Orgenesis (NASDAQ: ORGS)는 CD19+ 급성 림프모구 백혈병 환자에서 자사의 CD19 CAR-T 치료제 ORG-101에 대한 실제 연구 결과를 발표했습니다. 이 연구는 성인에서 82%, 소아에서 93%의 완전 반응률을 보여주었으며, 중증 사이토카인 방출 증후군의 발생률은 낮았습니다(성인 2%, 소아 6%).
ORG-101은 3세대 렌티바이러스 벡터를 이용하며, 독자적인 CAR 구조와 분산된 현장 생산을 통해 전통적인 CAR-T 치료법에 비해 더 경제적인 솔루션을 제공합니다. Orgenesis는 그리스에서 시작하는 다국적 Phase 1/2 임상 연구를 시작할 준비를 하고 있습니다.
Harley Street Healthcare Group은 Orgenesis와의 합작 회사를 통해 글로벌 암 이니셔티브를 설립할 계획이며, 이는 고급 치료의 민주화와 추가 임상 개발 지지를 목표로 하고 있습니다.
Orgenesis (NASDAQ: ORGS) a annoncé des résultats positifs d'une étude dans le monde réel sur sa thérapie CAR-T CD19, ORG-101, chez des patients atteints de leucémie lymphoblastique aiguë CD19+. L'étude a montré des taux de réponse complète de 82 % chez les adultes et de 93 % chez les patients pédiatriques, avec une faible incidence de syndrome de libération de cytokines sévère (2 % chez les adultes, 6 % chez les pédiatriques).
ORG-101 utilise un vecteur lentiviral de troisième génération avec un construct CAR propriétaire et une production décentralisée sur site, offrant une solution potentiellement plus abordable par rapport aux thérapies CAR-T traditionnelles. Orgenesis se prépare à lancer une étude clinique multicentrique de Phase 1/2, débutant en Grèce.
Le Groupe de Santé Harley Street prévoit de mettre en place une Initiative Mondiale contre le Cancer à travers son partenariat avec Orgenesis, visant à démocratiser les thérapies avancées et à soutenir le développement clinique ultérieur.
Orgenesis (NASDAQ: ORGS) gab positive Ergebnisse einer realen Studie zu seiner CD19 CAR-T-Therapie, ORG-101, bei Patienten mit CD19+ akuter lymphoblastischer Leukämie bekannt. Die Studie zeigte eine vollständige Ansprechrate von 82 % bei Erwachsenen und 93 % bei pädiatrischen Patienten, mit einer niedrigen Inzidenz von schwerem Zytokinfreisetzungssyndrom (2 % bei Erwachsenen, 6 % bei Kindern).
ORG-101 verwendet einen dritten Generationen Lentivirenvektor mit einem proprietären CAR-Konstrukt und dezentraler vor Ort Produktion, was eine potenziell erschwinglicher Lösung im Vergleich zu traditionellen CAR-T-Therapien bietet. Orgenesis bereitet sich darauf vor, eine Phase 1/2 klinische Multizenterstudie in Griechenland zu beginnen.
Die Harley Street Healthcare Group plant die Einrichtung einer Globalen Krebsinitiative durch ihr Joint Venture mit Orgenesis, um fortschrittliche Therapien zu demokratisieren und die weitere klinische Entwicklung zu unterstützen.
- High complete response rates: 82% in adults and 93% in pediatric patients
- Low incidence of severe Cytokine Release Syndrome: 2% in adults and 6% in pediatric patients
- Potentially more affordable solution due to decentralized onsite production
- Preparation for Phase 1/2 clinical multicenter study
- Planned Global Cancer Initiative to democratize Advanced Therapies
- None.
Insights
The 82% complete response rate in adults and 93% in pediatric patients for ORG-101 CAR-T therapy is remarkably high, potentially positioning it as a leading treatment for CD19+ Acute Lymphoblastic Leukemia. The significantly lower incidence of severe Cytokine Release Syndrome (CRS) -
Orgenesis' ORG-101 results are impressive, but the real innovation lies in their decentralized production model. This approach could significantly reduce treatment costs and increase accessibility, addressing major hurdles in CAR-T therapy adoption. The GMP-Validated Platform for decentralized production could be a key differentiator in the competitive CAR-T market. The planned Phase 1/2 multicenter study, starting in Greece with potential expansion, will be important for validating these real-world results. Investors should watch for partnerships and expansion of the hospital network, as these could accelerate commercialization. The Global Cancer Initiative with Harley Street Healthcare Group could provide additional resources and market reach.
The potential cost reduction in CAR-T therapy production through Orgenesis' decentralized model could be transformative for healthcare systems and patients. Current CAR-T therapies often cost
Orgenesis’ CD19 CAR-T therapy, ORG-101, had a complete response (CR) of
Data indicate a potentially favorable safety profile with a lower incidence of Cytokine Release Syndrome
Encouraged by the positive data, Harley Street Healthcare Group along with its partners intends to commit resources to set up a Global Cancer Initiative with a focus to democratize Advanced Therapies and support further clinical development sharing the risks and rewards
GERMANTOWN, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) in order to improve access and outcomes in healthcare, today announced positive clinical trial results for a real-world study of CD19 CAR-T therapy, ORG-101, in patients with CD19+ Acute Lymphoblastic Leukemia (B-cell ALL). Harley Street Healthcare Group intends to set up a Global Cancer Initiative through its joint venture with Orgenesis, with a focus to democratize Advance Therapies and support further clinical development.
The top-line efficacy and safety data from the study had a complete response (CR )of
Orgenesis is leveraging its recently acquired GMP-Validated Platform to implement the CAR-T therapy, which has been adapted to a decentralized production model. This model is designed to expedite capacity setup, enhance production efficiency, and reduce treatment costs. The production data as well as the cost analysis provide additional confirmation that the Orgenesis decentralized approach is a potential alternative cost-efficient way to provide access to Advanced Therapies.
ORG-101 utilizes a third-generation lentiviral vector with a proprietary CAR construct, coupled with streamlined and decentralized onsite production and analytic testing. This approach offers a highly affordable solution compared to traditional CAR-T therapies that are produced in centralized facilities.
The Company has held meetings with the FDA in the U.S., the Israeli MOH and the Paul-Ehrlich-Institute in Germany in regard to ORG-101. The Company is now preparing to initiate its own Phase 1/2 clinical multicenter study with an initial clinical site at the General University Hospital of Patras in Greece, supported by its Enterprise Greece Grant, with the goal of expanding to additional locations of the Orgenesis network of hospital partnerships.
Vered Caplan, CEO of Orgenesis, commented, “We believe that these clinical results combined with our GMP-Validated Platform are a significant step forward for our strategy to combine our strong capabilities in decentralized cell therapy production with our regional partnerships. Not only has the product shown initial signs of positive clinical outcomes, but our production data also validated that Orgenesis’ cost-effective decentralized cell processing has the potential to improve access to this treatment and reduce costs. We remain committed to bringing this and other potentially life-saving treatments to patients in need worldwide.”
Sanjeev Kumar, Chief Visionary Officer at Harley Street Healthcare Group, discussed the plans for the Global Cancer Initiative: “Cancer is increasingly affecting younger populations. We expect that our Global Cancer Initiative will be based on contributions from varies partners fully committed in making cancer therapies more affordable globally with a focus to democratize Advance Therapies and will strategically support our biobanking partnership and Orgenesis’ decentralized solutions to lower the cost and increase access to these therapies.”
About Orgenesis
Orgenesis is a global biotech company that has been committed to unlocking the potential of cell and gene therapies (CGTs) since 2012 as well as a paradigm-shifting decentralized approach to processing since 2020. This new model allows Orgenesis to bring academia, hospitals, and industry together to make these essential therapies a reality sooner rather than later. Orgenesis is focusing on advancing its CGTs toward eventual commercialization, while partnering with key industry stakeholders to provide a rapid, globally harmonized pathway for these therapies to reach and treat a larger numbers of patients more cost effectively and with better outcomes through great science and decentralized production. Additional information about the Company is available at: www.orgenesis.com.
About Harley Street Healthcare Group
Harley Street Healthcare Group (HSHG), including its brands and subsidiaries, the Harley Club and HARLEY of LONDON, provides integrated health & wellness services to its global client base by bringing together the best of modern medicine, state-of-the-art technological innovations wrapped around the resourcefulness of ancient healing systems. Based in London with a growing global presence, HSHG is focused on being an invested partner in the health & wellness journey of its customers through a proactive, personalized and preventative approach to delivering healthcare, moving away from the current industrial sick care system.
More information on the group is available at:
www.theharleyclub.com, www.harleyoflondon.co.uk
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our clinical development plans and timelines and the initial safety and efficacy profiles of ORG-101 are forward-looking statements. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our point-of-care cell therapy platform, uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials, which may not be predictive of final results or the results of later-stage clinical trials, the timing of and our ability to initiate and successfully enroll future trials; our ability to obtain FDA clearance of our future IND submissions and commence and complete clinical trials on expected timelines, or at all, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products, risks relating to legal proceedings against us and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.
IR contact for Orgenesis:
Crescendo Communications, LLC
Tel: 212-671-1021
Orgs@crescendo-ir.com
Communications contact for Orgenesis
IB Communications
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
FAQ
What were the complete response rates for ORG-101 in the real-world study for ORGS?
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