Caring Cross Announces Publication in Nature Communications Demonstrating the Efficacy of In-Place Manufacturing of Anti-CD19 CAR T Cells for Treatment of B-Cell Malignant Tumors

GAITHERSBURG, MD., December 10, 2021 / PRNewswire / – Caring Cross, a 501 (c) (3) nonprofit dedicated to accelerating the development of advanced drugs and providing access to treatments for all patients, everywhere, announced today ‘what Nature Communication published a scientific manuscript highlighting research demonstrating the effectiveness of in-place manufacture of anti-CD19 CAR T cells for the treatment of malignant B-cell tumors. Point-of-care manufacturing is defined as near point treatment, allowing cell products to be produced and infused without the need for cryopreservation.

The manuscript, titled “Anti-CD19 CAR-T cells made at multiple sites of care induce high remission rates in patients with B-cell malignancies,” reported that novel CAR-T cells targeting CD19 (cells CAR19-T) similarly manufactured using automation at separate sites in Cleveland, United States and Moscow, Russia achieved complete response rates of 73% in adult B-cell lymphoma (NHL) and 89% in pediatric acute B-cell lymphoid leukemia (ALL), respectively. For complete responders of NHL, the one-year survival rate was 92.9%, with a median duration of response yet to be achieved. For ALL complete responders with a median follow-up of 17 months, the one-year survival rate was found to be 79.2% with a median duration of response of 10.2 months. Based on these results, it was concluded that the use of point-of-care-produced CAR-T cell products provides effective clinical results in the treatment of patients with B-cell malignancies.

Dr. Marcos de Lima, director of stem cell transplantation and cell therapy at The Ohio State University Medical Center, and a lead investigator in the clinical trial, commented, “Our studies show that manufacturing CAR-T cells at the point of care yields a consistent cellular product and produces effective clinical results, although ‘they are manufactured in two clinical centers located in the United States and Russia. We were able to make fresh CAR-T cells in as little as 8 days, which is very important for patients with rapidly progressing disease. We therefore conclude that the manufacture of CAR-T at the point of care T cells are a valid and valuable model for the manufacture and distribution of CAR-T cells among several clinical centers, and particularly important for patients with a symptomatic lymphoma with rapid progression and ALL. “

In addition to demonstrating that making CAR-T cells at the point of care yields a consistent cellular product and effective clinical results, the research team determined that fresh CAR19-T cells, which can only be made on point of care, reduce tumor burden faster in vivo in NSG mice that cryopreserved CAR19-T cells, immediately reducing tumor burden, while frozen CAR19-T cells first allowed tumor growth before controlling growth. Additionally, researchers found that point-of-care manufacturing of CAR19-T cells resulted in a highly comparable CAR-T cell product composition across multiple clinical centers and a low production failure rate, demonstrating the robustness of the manufacturing process.

Dr. Michael maschan, Director of the Department of Hematopoietic Stem Cell Transplantation at the Dmitriy Rogachev National Center for Pediatric Hematology and Oncology in Moscow, Russia, commented, “Point-of-care manufacturing of CAR-T cells offers several advantages over centralized manufacturing, including reduced vein-to-vein time due to lack of transportation to a centralized facility and the ability to infuse fresh, not necessarily cryopreserved products Simplified logistics increase flexibility to make decisions based on the patient’s disease state, such as a split dose for high tumor burden. The high response rates that we have seen in our clinical trials are remarkable given that we were able to treat essentially all -comers due to the short manufacturing times of the patient-derived CAR-T cell products, which are only possible when they are made at the point of care. treated as soon as possible. We are delighted with the clinical results to date and look forward to future innovations to further improve patient outcomes. “

Dr Boro Dropulić, Executive Director of Caring Cross, commented: “This is the first study to definitively demonstrate the feasibility of point-of-care manufacturing of genetically modified cellular products between multiple centers. We show that when the same device, materials, reagents and protocols are used to make CAR-T cells, even between two disparate clinical centers, the genetically modified cell products are very consistent with a low rate of product failure. . The clinical outcomes for patients were particularly remarkable given that almost all of the patients enrolled were treated, even patients who would otherwise not be eligible due to their advanced disease, demonstrating the enormous value of this approach. the point of care also offers the potential to dramatically reduce the cost of these transformational therapies at a fraction of their current cost due to the elimination of the need for transportation and the cost of multiple layers of quality and preservation assurance that ar e required for centrally manufactured CAR-T cellular products. The next step will be to expand the critical CAR-T cell trials to include more clinical centers and support the development of regulatory pathways for the approval of CAR-T and other genetically modified cellular products that are being produced on the premises. of care. “

The full article can be viewed through the Nature Communications website at http://www.nature.com/ncomms.

About Caring Cross

Caring Cross is a 501 (c) (3) nonprofit dedicated to accelerating the development of advanced drugs and ensuring access to treatment for all patients, everywhere. To enable its mission, Caring Cross mobilizes a growing community of healthcare professionals, scientists, engineers, community advocates, donors, investors and business leaders to support the development of technologies and drug candidates 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 the development and implementation of affordable solutions for the manufacture of CAR-T cells, the promotion of a decentralized point-of-care cell manufacturing model and the development of its first therapeutic candidate, a cell therapy. anti-HIV duoCAR-T designed to suppress HIV replication. and eliminate cells expressing HIV in people living with HIV. Stem cell gene therapy for sickle cell anemia and beta thalassemia is also in development. For more information on Caring Cross, visit https://caringcross.org/.

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