We develop and implement improved technologies and therapeutic candidates to lower cost and improve access to novel CAR-T cell and other advanced therapies.
Caring Cross is a 501(c)(3) non-profit organization headquartered in the USA with a mission to support the clinical development and implementation of affordable CAR-T cell and other advanced therapies around the world. The Caring Cross team has decades of experience in developing CAR-T cell and other advanced therapeutic products that provide revolutionary treatments for serious diseases, including hematologic malignancies such as acute lymphoblastic leukemia, non-Hodgkin lymphoma and Multiple Myeloma. CAR-T cells are a patient’s normal T cells that have been engineered to effect profound antitumor activity, resulting in complete remission of disease.
Current commercial strategies for development of CAR-T cell and other advanced therapies are focused upon developing highly risky break-through products that displace existing therapies, resulting in a very high rate of return for shareholders. However, this strategy invariably results in the pricing of advanced therapeutic products that are not affordable for underserved populations and not sustainable more generally over the longer term. Caring Cross has developed a wholly unique strategy using the decades of experience of its leadership in the field. Caring Cross’ approach is built upon successful development of affordable and improved versions of advanced therapeutic products that have already been proven to work clinically. With this strategy we create value for stakeholders and facilitate universal access of these products to the patients that need them. Our product development strategy ensures that initial commercial needs are met with therapeutics that are known to be safe and clinically effective, and simultaneously builds the infrastructure for more innovative products in the future at significantly decreased cost and risk.
Within Caring Cross’ strategy, there are significant opportunities to amplify its activities by partnering with like-minded inventors, hospitals, companies and institutions to create additional innovation and value. For example, Vector BioMed, Inc. a for-profit Benefit or B Corporation (https://vectorbiomed.com/) was founded on highly efficient Lentiviral vector manufacturing technology developed at Caring Cross. This immediately established Vector BioMed as a leading viral vector manufacturing organization, making high quality GMP Lentiviral vectors for use in CAR-T cell therapy and Stem Cell gene therapy. Technology transfer from Caring Cross to Vector BioMed ensured rapid establishment of commercial operations and services. Vector BioMed occupies world-class GMP manufacturing facilities located in Gaithersburg, Maryland, USA. Vector BioMed manufactures affordable GMP Lentiviral vectors for the gene therapy industry at about half the price of competitors and provides further discounted pricing for Caring Cross therapeutic products.
Caring Cross also partners directly with hospitals and global stakeholders to enable broad access of these therapies worldwide. For example, Caring Cross has recently executed an agreement with Fundação Oswaldo Cruz (Fiocruz), the leading manufacturer of vaccines and biologics in Latin America (https://portal.fiocruz.br/en). The collaboration is funded by the Ministry of Health of Brazil to develop, manufacture and commercialize CAR-T cell therapies for the Brazilian population and Latin America. The agreement transfers technology from Caring Cross to Fiocruz to enable the manufacture of innovative CAR-T cell therapies for Leukemia, Lymphoma, HIV and creates a platform to expand a pipeline of advanced therapies for the treatment of other diseases in the future.
Caring Cross has received several significant grants from the US Federal government (NIH, NIST, NIIMBL and NCATS ), supporting the development of Lentiviral vector and AAV vector technologies. These projects include the development of standards that support characterization of critical materials used to manufacture advanced therapeutic products. These awards position Caring Cross as a leader to develop manufacturing methods and standards that will be widely used by the global gene therapy community.
The continuing success of Caring Cross’s development of Lentiviral and AAV vector technology and creating efficient and cost-effective cell therapy manufacturing processes that utilize these gene vectors, has stimulated academic medical centers (AMCs) to form a network to initiate Caring Cross CAR-T clinical trials and to thereby provide point-of-care CAR-T cell manufacturing and clinical development for regulatory approval in the USA. Importantly, these centers demonstrate initial clinical safety and efficacy of Caring Cross therapeutic products before they are provided to other centers around the world for clinical development, regulatory approval, and subsequent commercial distribution to the patients that need them.
The AMC network shares a common point-of-care manufacturing platform using either existing hospital cleanrooms or newly-built mobile cleanrooms that are located on or close to the hospital campus. Such mobile cleanroom facilities are rapidly constructed and deployed to any hospital, anywhere. They are identical in construction and equipment, utilizing identical cell manufacturing processes and materials, and are networked through the internet to a reference facility to ensure consistent quality of the locally-manufactured product. Participation in this network creates a compelling value proposition for hospitals to manufacture these products locally and affordably for their patients. Success of the point-of-care model will have profound global implications for availability of affordable CAR-T cell and other advanced medicines for underserved patient populations in the US, and also for patients in low- or middle-income countries.
Caring Cross has focused its efforts on development and delivery of affordable manufacturing processes and improved therapeutic products to partners in this country, and then to translate these advances to other countries, particularly low- and middle-income countries where the need is greatest for certain diseases. The current staff is expert to meet current needs, but but further support is required to meet the increasing demand to deliver best-in-class technological solutions for each of these important disease classes. To further our global vision of universal affordable access to advanced therapies, support is sought to accelerate:
• Expanded research, production, clinical development and administration
• Operationalize logistical systems so to provide the materials for engineered cell therapy to clinical centers utilizing the point-of-care model
• Conduct clinical trials in partnership with leading hosptials to create the data set for regulatory approval, and subsequent self-sustainability of the products through reimbursement by Medicare/Medicaid/Private Payors/National Health Systems.
• Maintain a focused strategic plan independent of the trajectories of collaborators or market forces.
Caring Cross’ execution of our current and future strategic milestones will grow with additional investments in our operational infrastructure. In the last two years of its operation, Caring Cross has grown tremendously in the number of people and organizations we serve, and also in the innovation and reach of our programs. Yet demand continues to grow for our life-saving therapeutic products and manufacturing solutions. There is an urgent need to expand our product development and clinical trials to meet the growing domestic and global community’s need for our quality partnership programs. As we implement multiple clinical trials and expand our operations throughout the USA and overseas, additional funding for expanded operational growth is needed. This funding will facilitate implementation of our growing pipeline of therapeutic products and point-of-care manufacturing solutions to the increasing number of clinical centers and health providers around the world that want to provide access of these curative therapies to their patients in an affordably sustainable manner.
We have seen tremendous evidence of our impact, with significant demand for access to our technologies and products, given their superior affordability, point-of-care manufacturing and access. However, we have only begun to realize our potential in helping hospitals and health providers realize their potential – making the maximum possible therapeutic impact for the patients they serve.
