April 11, 2022 - BioNTch's CLDN6-encoding CAR-T cell amplifying RNA vaccine called CARVac is based on BioNTech’s mRNA-lipoplex technology, and is meant to boost CAR-T therapy and prolong the treatment effect at low doses.
BNT211 is an autologous CAR-T cell therapy that targets oncofetal antigen Claudin-6 that is being tested in the phase 1/2 solid tumor trial BioNTech found robust CAR-T cell expansion 10 to 17 days after infusion in all 16 patients, who had testicular, ovarian, endometrial, fallopian tube or gastric cancer or sarcoma. Six weeks after infusion, six out of 14 evaluable patients showed a partial response, and five had stable disease and evidence of tumor shrinkage, BioNTech said. One patient showed no change at that time, while two were continuing to progress. Responses were seen in four patients with testicular cancer and two with ovarian cancer.
As of 12 weeks, four of the six patients who had achieved a partial response showed what BioNTech called a “deepening and durability” of response. One patient had a complete response after 18 weeks. All four patients with testicular cancer in the higher dose group of the trial had disease control, including three who had objective responses. One patient in this group who received the lowest infusion dose with CARVac had a partial response.
BioNTech concluded that a higher CAR-T dose combined with CARVac seemed to spur the most antitumor activity. Four out of five patients in the CARVac group had a partial response.
Safety data was limited, but BioNTech did report instances of grade 1 and 2 cytokine release syndrome and one occurrence of neurotoxicity grade 1. The “adverse events and dose-limiting toxicities were manageable,” the company said.
https://www.fiercebiotech.com/biotech/aacr-biontech-showcases-post-comirnaty-future-early-cancer-vaccine-efficacy-data