This agreement puts Immuneel as a front-runner in the pursuit of offering accessible and affordable CAR Ts to patients in India through registration clinical trials and its investments in further process optimization.
Speaking about this milestone collaboration:
Ms. Kiran Mazumdar Shaw (Co-founder, Immuneel) said, “This partnership with HCB & IDIBAPS is pathbreaking and heralds the advent of life saving CAR T therapy for patients in India. Immuneel is committed to providing affordable access to this cutting-edge therapy at state-of-the-art facilities housed at the Mazumdar Shaw Cancer Centre. I would particularly like to call out Dr. Campistol and Dr. Juan Uriach for their willingness to partner with us in our mission to give hope to cancer patients who can benefit from cell therapies.”
HCB/IDIBAPS are public institutions that collaborated with a vision to create ARI-0001 as a product that can be an affordable option to treat patients with B cell malignancies in Spain. Dr. JM. Campistol (CEO, HCB) said, “We are extremely proud about this collaboration with Immuneel. We are convinced about the benefits of our CAR T therapy on patients with ALL. This is the beginning of a fruitful and promising collaboration between our academic research efforts (HCB & IDIBAPS) and Immuneel to improve the treatment of hematological disorders.”
Dr. Elias Campo (Research Director, HCB-IDIBAPS) added, “CAR T based therapies have shown efficacy in the treatment of certain leukemias and lymphomas. With this partnership we will improve our knowledge on this kind of therapies and more patients will benefit from them”.
Dr. Juan Uriach Torello (Scientific Business Advisor, Immuneel-HCB-IDIBAPS Collaboration) who has played a key advisory role in the partnership added, “This a remarkable display of alignment on affordable cell therapy between an academic hospital and a start-up; and also, a demonstration of hope for Spain and India.”
ARI-0001 is a novel 2nd generation autologous CD19 CAR T, that has been extensively studied in-vitro and in-vivo. Clinical data from a recently concluded Phase 1-2 trial showed ARI-0001 to be a safe and efficacious product, with persistence of CAR T cells and response in patients who had failed previous therapies. ARI-0001 is currently under review for approval as a hospital exemption product by Spanish Drug Agency (AEMPS). “This collaboration and ARI-0001 licensing marks a strong foundation event on which Immuneel will bring its purpose to fruition - to enable really high quality and affordable cell therapy for patients in India. The collaboration seeks to align efforts to globalise affordable high-quality cell therapy strategies developed in India and Spain. We are really excited to be able to accelerate access to transformative therapies with ARI-0001 and build on the excellent data already generated in Spain” said Dr. Arun Anand, COO, Immuneel.
Dr. Siddhartha Mukherjee (Co-founder, Immuneel) further added, “Immuneel is extremely proud to bring this cutting-edge cell therapy to India. These "living drugs", created from genetically modified cells, have saved the lives of hundreds of cancer patients around the world but have been unavailable in India. Unlike standard medicines, these cell therapies have to be produced and delivered with immense care and technical finesse. A clinically tested target like CD 19 will enable Immuneel validate its clinical delivery for CAR T cells in India.”
According to Dr. Kush M Parmar (Co-founder, Immuneel) “As Immuneel sets out on its mission to enable access to cellular therapies in India, CD19 CAR T as a first product reflects the thoughtful and stepwise approach being taken. The manufacturing, regulatory, clinical and delivery experience in bringing this validated approach to patients in India will lay the foundation for Immuneel’s leadership role in cellular therapies in the region and positions us well to build a pipeline of next-generation products for many patients in need.”
“The agreement represents a first-rate opportunity to open the use of a product, that has been used only in our Hospital Clínic, for the patients of a continental-sized country like India, with a very different regulatory environment that can facilitate the validation of improvements that also could help our patients”, says Dr. Manel Juan, head of the Immunology Department of Hospital Clínic and head of the Immunogenetics of the autoinflammatory response group at IDIBAPS. Dr. Álvaro Urbano, director of the Clínic Institute of Hemato-oncological Diseases and head of the IDIBAPS group on Hematopoietic progenitor cell transplantation, points out that, “we are very proud because the effort of a large team of the Hospital Clinic/IDIBAPS has made it possible that thanks to the ARI001 many patients in India will have access to a CART, which they could not otherwise afford. At the same time, it is a great responsibility to maintain the demands of quality and efficacy, as it is highly complex gene therapy. This will be the focus of the agreement that we have signed with Immuneel”.
Additional terms were not disclosed.
About CD19 CAR T cell therapy
CD19 CAR T therapy is an adoptive autologous antitumor immunotherapy for patients with resistant or refractory CD19 + leukemia or lymphoma. This autologous product consists of a suspension of T-cells obtained from a patient, activated & genetically modified to express a chimeric antigen receptor (CAR) on its surface, in this case CD19. CAR Ts typically consist of a binding domain, a transmembrane domain & co- stimulatory molecules. Three CD19 CAR T products have been approved so far globally.