BioNTech's solid tumor CAR-T hits prime time with EU regulatory tag

Just a couple months after showcasing a small data set, BioNTech’s solid tumor CAR-T cell therapy is ready for prime time.

BNT211 has been granted a priority medicines, or PRIME, designation from the European Medicines Agency, giving the famed German biotech extra help during the regulatory process. The designation specifically targets third- or later-line treatment of testicular germ cell tumors, which BioNTech Chief Medical Officer and co-founder Özlem Türeci, M.D., said is a population that is associated with poor prognosis and few remaining treatment options.

In April, BioNTech showcased phase 1/2 data from 16 patients with solid tumors that associated BNT211 with a disease control rate of 86% and an overall response rate of 43%. These data, out at the American Association for Cancer Research meeting in New Orleans, were used to support the PRIME designation.

The therapy is an autologous CAR-T cell therapy targeting oncofetal antigen Claudin-6 that is being tested in the phase 1/2 solid tumor trial with or without a CLDN6-encoding CAR-T cell amplifying RNA vaccine called CARVac.

“We believe that a combination of engineered T cells and mRNA vaccines in one treatment regimen can stimulate and expand T cells. This could enable us to develop truly powerful precision immunotherapies,” Türeci said.

With the PRIME status in hand, BioNTech can step on the gas to move BNT211 through the clinic. Companies granted this tag are eligible for early support from regulators to speed development of promising medicines and get them to patients faster.