Caring Cross, Inc.

Agreement allows ImmunoACT to develop and commercialize a novel TriCAR-T cell therapy for leukemia and lymphoma designed to decrease lapses seen in current single CAR-T cell therapies and improve outcomes GAITHERSBURG, Md. and MUMBAI, India, May 7, 2024 /PRNewswire/ -- Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, and ImmunoAdoptive Cell Therapy (ImmunoACT), a Mumbai, India-based pioneering research and cell and gene therapy development company, announced an agreement to develop and commercialize a multi-targeted chimeric antigen receptor T-cell immunotherapy for leukemia and lymphoma. The TriCAR-T immunotherapy is designed to address relapse that can occur when patients with Leukemia or Lymphoma are treated with a single targeting anti-CD19 CAR T-cell product. Under the terms of the agreement, Caring Cross will provide a TriCAR-T cell immunotherapy for clinical development, manufacturing, and commercialization at ImmunoACT's facilities in India. ImmunoACT is developing an array of CAR-T therapeutic assets at various stages of clinical maturity to address oncological indications and autoimmune disorders. Its lead candidate, NexCAR19 (Actalycabtagene autoleucel), was recently approved as India's first CAR-T cell therapy for the treatment of r/r B-cell lymphomas and leukemia by the Central Drugs Standard Control Organization (CDSCO). It is a first-of-its-kind product that has given patients in India access to this lifesaving, leading-edge therapy at an affordable price. "We are pleased to form this commercial partnership with ImmunoACT, which is committed to providing affordable and accessible CAR-T cell therapies for serious diseases like leukemia and lymphoma," said Caring Cross Co-Founder and Executive Director Boro Dropulić, Ph.D. "Our global partnership model aims to improve access for CAR-T cell therapies by developing CAR-T cell manufacturing technologies and providing therapeutic candidates that are affordable in countries like India. We are excited to work with ImmunoACT to commercialize a dedicated proprietary TriCAR-T cell therapy in India, which we anticipate will decrease the rate of relapse seen with current single targeted anti-CD19 CAR-T cell therapies. We look forward to working closely with ImmunoACT to expand access to a commercial TriCAR-T cell therapy in India as part of our mission to further universal access and affordability of CAR-T therapies worldwide." "We are delighted to work with Caring Cross to bring next generation CAR-T therapies to India, which will enable cost-effective local production and improved access to these advanced medicines " stated ImmunoACT's Founder and Professor at IIT Bombay, Rahul Puwar, Ph.D. "ImmunoACT's technical and commercial operations capabilities are well proven and with its network of partner hospitals across the country, this partnership has great potential to benefit thousands of patients in coming years." About Caring Cross Caring Cross is a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and ensuring access to cures for all patients, everywhere. To enable its mission, Caring Cross is developing technologies and therapeutic candidates to improve the accessibility, affordability, and applicability of cell and gene therapies (CGTs) like CAR-T technology and stem cell gene therapy. Caring Cross founded Vector BioMed, a for-profit vector contract development and manufacturing organization (CDMO), specializing in rapid lentiviral vector manufacturing solutions, to provide the industry a source of affordable high-quality GMP Lentiviral vectors. For more information on Caring Cross visit . For more information on Vector BioMed visit . About ImmunoACT ImmunoACT is a cell and gene therapy company that was incubated at IIT Bombay with a mission to provide affordable access to novel autologous CAR-T cell therapies for cancer treatment. It received Market Authorization from Central Drugs Standard Control Organization ("CDSCO") in October 2023 for its lead product, namely, Actalycabtagene autoleucel (hereinafter referred to as "NexCAR19"). With a rapidly expanding pipeline beginning with blood cancers, the Company is working to expand it portfolio in solid tumours and autoimmune disorders, enabling medical professionals to provide patients with effective cancer therapy as an alternative to traditional chemotherapy, biologics, and bone marrow transplants. CONTACT Tiberend Strategic Advisors, Inc. Investors Daniel Kontoh-Boateng 862-213-1398 dboateng@tiberend.com Media David Schemelia 609-468-9325 dschemelia@tiberend.com

Maryland non-profit Caring Cross and Brazil's Fundacao Oswaldo Cruz (Fiocruz) plan to develop and manufacture cell and gene therapies at one-tenth of their cost in the U.S. Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduce the cost of these treatments in the United States and Europe. Caring Cross and Fundacao Oswaldo Cruz (Fiocruz)—a foundation funded by the Brazilian Ministry of Health—plan to develop and manufacture the medicines at a fraction of their cost in the U.S. Co-founded by cell and gene therapy manufacturing trailblazers Boro Dropulic, Ph.D. and Rimas Orentas, Caring Cross’ mission is to organize and support a community of healthcare professionals, scientists, engineers, advocates and business leaders to accelerate the development of advanced medicines and make them available for all patients around the world. The program with Brazil is the first of its kind anywhere in the world, Dropulic and Orentas said in an interview with Fierce Pharma. “We’re pioneering something quite new in terms of teaching an organization, that is directly linked to the Ministry of Health, how to manufacture CAR-T cells and the vectors themselves,” said Dropulic, the executive director of Caring Cross. “We will start first in Rio de Janeiro at the Fiocruz campus—in collaboration with INCA, which is their equivalent of the NCI (National Cancer Institute)—to run clinical trials for leukemia and lymphoma.” Dropulic knows the drill. He founded Lentigen, which developed the lentiviral vector used by Novartis to produce the first FDA-approved cell therapy product, Kymriah, in 2017. Dropulic directed Lentigen’s CDMO business model before launching Caring Cross in 2021. The effort in Brazil will include the development of a product for HIV, which is currently in clinical trials in the U.S. A candidate to cure sickle cell disease and beta thalassemia could enter the clinic later this year.   Under the plan, the therapies will be available for free for patients, with an approximate cost of $35,000 per dose covered by the Brazilian public health system. Dropulic and Orentas believe an approved product could be available within three years. Caring Cross aims to slash production costs with its point-of-care manufacturing model. Development and manufacturing can be executed entirely in modular units which are 56 by 13 feet and can be set up anywhere.   “When you make these products at the point of care or close to a hospital, you significantly decrease these logistical costs,” Dropulic said. Orentas added that it’s already dawned on the managed care systems in countries such as Spain, Germany and Denmark that the way gene therapies are produced in the U.S. is “not sustainable.” Even with the high cost of doing business in the U.S., Caring Cross believes it could deliver CAR-T therapies for around $80,000, Orentas said. In the U.S., cell and gene therapy prices currently range from hundreds of thousands of dollars to millions of dollars.  Caring Cross's Brazilian partner has "biomanufacturing expertise" and "an experienced workforce," Orentas said. Fiocruz is the world’s largest producer of the yellow fever vaccine. It also served as Brazil’s home base for production of its AstraZeneca-partnered COVID vaccine. Meanwhile, through its for-profit CDMO spinout, Vector BioMed, Caring Cross is developing technologies to improve the accessibility of CAR-T and other therapies.

Pictured: Aerial panorama of Botafogo Bay and Suga Brazil’s Ministry of Health and nonprofit Caring Cross announced a collaboration Tuesday aimed at local manufacturing of CAR-T cell and stem cell gene therapies at a much lower cost than Europe and the U.S. Pictured: Aerial panorama of Botafogo Bay and Sugar Loaf Mountain, Rio De Janeiro, Brazil iStock/ marchello74 Caring Cross , a U.S.-based nonprofit has reached a collaboration agreement with Fundação Oswaldo Cruz (Fiocruz), a foundation from the Brazilian Ministry of Health, to develop local manufacturing of CAR-T cell and stem cell gene therapies in Brazil. Under the agreement, CAR-T therapies will be developed to treat leukemia, lymphoma, and HIV, as well as other treatments for oncology, infectious disease, and genetic diseases in Brazil. “With local production, the treatment will be available free of charge to the population, and the cost to the Brazilian public health system would be reduced to 10% of the amount currently charged in Europe and the USA, dropping to $35,000 per dose,” according to the announcement. The terms of the agreement will have Caring Cross provide the technology, training and materials to Fiocruz’s Institute of Technology on Immunobiologicals to manufacture the therapies and the lentiviral vectors that can be used for further clinical development and approval. According to Caring Cross, the early stages of the program will focus on CAR-T cell therapies for leukemia and lymphoma, as well as improved versions of products already treating patients. The collaboration will also look to advance a “therapeutic product” to treat HIV, which is currently in a clinical trial and is seen as a potential cure. “Our collaboration with Fiocruz marks a significant step forward in making CAR-T cell therapies more accessible in Brazil and Latin America,” Boro Dropulić, the executive director of Caring Cross, said in a statement. “By sharing our knowledge and expertise, this collaboration will establish local manufacturing capabilities for our innovative CAR-T cell manufacturing platform. When integrated with local point-of-care manufacturing, this approach enables us to drastically cut production expenditures and enable access to these therapies at a fraction of the cost compared to the U.S. and Europe.” The nonprofit said it has already developed manufacturing processes that have “significantly decreased” the material cost of manufacturing CAR-T cell therapy products. Caring Cross added that its deal with Fiocruz, which is exclusive to Brazil and Latin America, will allow for affordable access to these therapies to the Brazilian public health system and access to materials and training needed in the region. “We are confident to partner with Caring Cross, which possesses deep expertise in the technologies used for CAR-T cell therapy production,” Mario Moreira, president of Fiocruz, said in a statement. “This technology transfer empowers Fiocruz to produce these vital CAR-T cells and other therapies in a cost-effective manner and equips our organization with the necessary capabilities to become a central hub for developing and manufacturing advanced medicines, including CAR-T cell therapies, across Latin America.” Caring Cross started its first production initiative in 2021 , focusing on CAR-T cell therapies for HIV treatment using affordable manufacturing and distribution models. Tyler Patchen is a staff writer at BioSpace . You can reach him at tyler.patchen@biospace.com . Follow him on LinkedIn .