Exuma Biotechnology Advances Promising CAR-T Therapies for Metastatic Renal Cell Carcinoma with Plans to Expand Clinical Trials Across China

Artery New Medicine (WeChat Official Account: biobeat1) has learned that Exuma Biotechnology recently announced early treatment results of two CAR-T therapies for metastatic renal cell carcinoma (mRCC) at the Association for Cancer Immunotherapy's 2019 meeting in Germany. The trial is currently ongoing at the Shanghai Public Health Clinical Center, with the primary results as follows:

• To date, no dose-limiting toxicities have been observed, and there is no evidence of off-target, non-tumor toxicity for either product.

• At 1×10⁶At the /kg dose level, CAR-T product levels in blood were observed to be as high as 80,000 copies/g.

• Early radiological evidence of antitumor activity indicated that the best response was stable disease.

• CAR-T therapy was administered to seven patients with metastatic renal cell carcinoma; after approximately 140 days of follow-up, disease stabilization was observed in six patients.

• These interim results continue to support the potential of the company’s Conditionally Active Biologic (CAB)–CAR-T technology to enhance the safety of CAR-T therapy in metastatic renal cell carcinoma, a benefit that may also extend to other target-positive solid tumors.

AxiuMa Biologics has adopted two CAR-T therapies: CCT301-38 and CCT301-59. The core distinction between these two CAR-T therapies lies in their target antigens. CCT301-38 targets AXL, whereas CCT301-59 targets ROR2. Depending on the specific antigens present in tumor patients, either CAR-T therapy can be selected to bind specifically to the corresponding antigen, thereby treating cancer. Notably, the early clinical data released by the company represent the first-in-human trial results for both CAR-T therapies.

Exuma Biotechnology, established in April 2016, is a clinical-stage biotechnology company headquartered in the Cayman Islands, with its primary operations conducted in Shanghai and Shenzhen, China. Furthermore, Exuma Biotechnology is an affiliate of F1 Oncology, a renowned international biotechnology company. Since its inception, Exuma Biotechnology has received investment and exclusive technology licensing from F1 Oncology.

Currently, Axiomab Biologics primarily combines its Conditionally Active Biologic (CAB) protein therapeutic technology with CAR-T technology to develop novel cell therapies for the treatment of solid tumors (CAB-CAR-T therapy) and to achieve their commercialization. This novel CAB-CAR-T therapy helps reduce the incidence of off-target effects associated with CAR-T therapy.

It is reported that after releasing early clinical data on its CAR-T therapy for renal cell carcinoma, Exuoma Bio plans to expand the study to multiple other hospitals in China this summer and will decide whether to extend the research to the United States or Europe by the end of this year. However, Dr. Gregory Frost, founder of Exuoma Bio, stated that there are differences in the standard of care for metastatic renal cell carcinoma (mRCC) between China and Western countries, making it less feasible to adopt AXL- or ROR2-targeted trial designs outside China. If patients were brought to Europe and the United States, their treatment protocols would need to be altered.

Ensuring that matched CAR-T cells are correctly administered to patients is a critical step in the application of CAR-T therapy. According to a report by GlobalData, two clinical trial participants were mistakenly injected with each other’s CAR-T cells in 2016, rendering the CAR-T products unusable. A stringent chain of custody for CAR-T therapy ensures that patients’ own CAR-T cells are not mistakenly used by others. To address this chain-of-custody challenge, Axion Bio developed an Electronic Batch Record (EBR) system. This system utilizes QR codes to minimize delays and is designed to ensure accurate tracking and management of its products.

F1 Oncology, a biotechnology company headquartered in Delaware, was established in November 2015. The company maintains branches in West Palm Beach, San Diego (California), the Cayman Islands, Hong Kong (China), and Shanghai. Leveraging its global research and development teams, F1 Oncology accelerates the design, development, and screening of adoptive cell therapy (ACT) candidates. Currently, the company is developing a CAB-based ACT platform to advance CAR-T therapies for the treatment of solid tumors.

References:

https://medcitynews.com/2019/05/car-t-therapy-for-kidney-cancer-shows-early-signs-of-efficacy-in-chinese-trial/?rf=1

https://exumabio.com/wp-content/uploads/2019/05/EXUMA-CIMT-Interim-Results-Release_FINAL.pdf