Caring Cross pursuing opportunities to de-centralize the manufacturing of CAR-T and develop a CAR-T cell therapeutic for HIV
Gaithersburg, MD, September 28, 2021 — 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, today announced its first initiative focused on CAR-T cell therapy for HIV utilizing manufacturing and distribution models that enable affordability and accessibility of these therapies to diverse patient populations and treatment indications.
“The high cost for CAR-T cell therapies provides an opportunity for innovators like Caring Cross to change the way these medicines are developed and how they are provided to the patients that need them,” said Caring Cross Co-founder and Executive Director Boro Dropulić, Ph.D., M.B.A. “Our highly experienced team members have developed CAR-T cell therapies and worked with more than 100 clinical sites around the world to enable affordable and sustainable place-of-care manufacturing of CAR-T cells, with outstanding clinical results observed thus far.”
Dr. Dropulić described Caring Cross as an educator, facilitator and accelerator of advanced medicinal candidates and technologies, working with non-profit and for-profit stakeholders to enable affordable access to these much-needed advanced medicines. “We collaborate with investigators at universities and hospitals to develop a pipeline of clinical candidates with support from our generous donors and foundations. We work with companies and add value to their pipelines in exchange for affordable access to underserved populations. We also create new companies. Caring Cross-founded companies use business models that ensure affordability and access, while providing excellent value for investors.”
CAR-T cell therapy is a groundbreaking innovation that has shown significant promise in certain cancer indications and could provide curative intervention for multiple cancers, genetic diseases, infectious diseases and other disorders. The vast potential of CAR-T cell therapy, however, is restricted by the high cost of treatment, which can exceed $400,000, excluding hospital fees. This price is unsustainable in developed countries and developing countries alike, which could leave many without access to new therapies that are significantly more effective than current standards of care.
Caring Cross is poised to reduce this cost burden by mobilizing a community of healthcare professionals, scientists, engineers, community advocates, donors, investors and business leaders to (1) enable the development of affordable solutions for current manufacturing methods of CAR-T cell and other advanced therapies; (2) improve access by supporting a decentralized manufacturing model where the final cell product is produced at a reduced cost at the hospital or place-of-care, rather than sent to a centralized corporate manufacturing hub, and (3) facilitate continual advanced technology development that reduces cost and improves access to these therapies.
The founders of Caring Cross were among the authors of a high-impact research paper recently published in the journal Science Translational Medicine, “Trispecific CD19-CD20-CD22–targeting duoCAR-T cells eliminate antigen-heterogeneous B cell tumors in preclinical models,” which found that trispecific duoCAR-T cells that they had engineered to target CD19, CD20, and CD22 simultaneously showed promise in preventing antigen loss-mediated relapse or the down-regulation of target antigens common in leukemia and lymphoma patients who are treated with monoCAR-T cell therapy.
In addition to improving access to CAR-T, Caring Cross is seeking to expand advanced cell therapy to a disease that impacts more than 37 million people worldwide – HIV. Currently, the only effective therapy for the treatment of HIV is lifelong adherence to drug cocktails which suppress the virus but are not curative. The founders of Caring Cross have developed an anti-HIV duoCAR-T cell therapeutic candidate that potently suppresses HIV and eliminates HIV-expressing cells in vitro and in animal models. This work was published in a 2019 paper in Science Translational Medicine, “Multispecific anti-HIV duoCAR-T cells display broad in vitro antiviral activity and potent in vivo elimination of HIV-infected cells in a humanized mouse model.” HIV-targeted CAR-both eliminated HIV-infected cells and protected CD4-T cells from infection in relevant animal models, outpacing other current approaches.
On this strong scientific foundation, a Phase 1/2a clinical trial has been cleared by the FDA to start enrolling patients at the University of California, San Francisco and a second site is planned at the University of California, Davis. The clinical trial is supported by a grant from the Californian Institute of Regenerative Medicine and a second grant from the Bill and Melinda Gates Foundation supports advanced technology developmental work.
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 mobilizing a growing community of healthcare professionals, scientists, engineers, community advocates, donors, investors and business leaders to support the development of technologies and candidate medicines and technologies. Currently, Caring Cross is advancing several initiatives that aim to improve the accessibility, affordability and applicability of CAR-T technology and stem cell gene therapy. These opportunities include developing and implementing affordable solutions for the manufacture of CAR-T cells, advancing a decentralized, place-of-care cell manufacturing model, and developing its first therapeutic candidate, an anti-HIV duoCAR-T cell therapy designed to suppress HIV replication and eliminate HIV-expressing cells in people with HIV. A stem cell gene therapy for Sickle Cell Disease and Beta-Thalassemia is also in development. For more information on Caring Cross visit https://caringcross.org/.