The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Tessa Therapeutics’ investigational CD30-targeted CAR T-cell therapy for treating relapsed or refractory classical Hodgkin’s lymphoma.
This status, given to regenerative medicines that show preliminary evidence of clinical efficacy in treating serious conditions, grants Tessa all the benefits of Fast Track and Breakthrough Therapy designations in developing its CAR T-cell therapy, designed for people whose tumors produce the CD30 marker.
The benefits include early interactions with sponsors and the FDA, which may be used to discuss intermediate or surrogate clinical trial endpoints. It also supports accelerated approval for the therapy.
Antibodies targeting the CD30 molecule — such as Adcetris (brentuximab vedotin), developed by Seattle Genetics — have been increasingly used for treating lymphoma. However, their therapeutic activity is often short-lived, with the cancer returning after treatment.
Autologous CAR T-cell therapy is another type of immunotherapy that involves collecting a patient’s own immune T-cells — immune cells with the ability to fight cancers — and genetically modifying them in the lab to produce a chimeric antigen receptor, or CAR, that targets a specific cancer protein.
The modified cells are expanded into millions and then infused back into the patient, where they will be able to identify and kill cancer cells more efficiently.
Tessa’s CAR T-cells were designed to target the CD30 protein, a protein marker expressed by many lymphoma cells. Its RMAT status was supported by clinical data from two Phase 1/2 studies in relapsed or refractory CD30-positive classical Hodgkin’s lymphoma.
The trials are being conducted at the Baylor College of Medicine (NCT02917083) in Texas and at the University of North Carolina Lineberger Comprehensive Cancer Center (NCT02690545). Both are testing a preconditioning chemotherapy regimen, which depletes patients of their white blood cells, creating room for the expansion of the CAR T-cells and reducing the number of immunosuppressive cells that would threaten that expansion.
The participants in these trials had received multiple lines of therapy, including Adcetris, immune checkpoint inhibitors, and stem cell transplants.
The results showed that, overall, more than 70% of the patients in each study responded to the treatment. Moreover, 18 of the 27 patients (67%) treated across the two trials attained a complete response.
“The RMAT designation speaks to the strength of the data in two independent Phase I/II trials, which show promising efficacy and a strong safety profile of the therapy in Hodgkin lymphoma patients whose disease had failed to respond to other available therapies,” Ivan D. Horak, MD, president of research and development at Tessa Therapeutics, said in a press release.
Tessa is now planning to launch a pivotal Phase 2 trial (NCT04268706) that will continue to evaluate its CD30-CAR T-cell therapy in adults and children with relapsing or refractory CD30-positive classical Hodgkin’s lymphoma. The trial, which will enroll an estimated 90 participants, is expected to start in late 2020.
“We look forward to working closely with the FDA as we advance our trial at multiple sites in North America and work to bring this potentially transformative treatment option to patients,” Horak said.
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