Cell Therapy
Clinical Trials

BioNTech Present Positive Data for First-in-Class CAR-T Program, BNT211, in Advanced Solid Tumours

Anna Osborne
12 April 2022
Next generation immunotherapy company, BioNTech, presented positive preliminary Phase I/II data for its CAR-T cell therapy – BNT211 – in patients with advanced solid tumours, at the American Association for Cancer Research this week.

BioNTech’s on-going Phase I/II trial in heavily pre-treated patients with advanced relapsed or refractory solid tumours, is evaluating preliminary efficacy and safety of BNT211 alone or in combination with CARVac in CLDN6-positive patients – the first-in-human trial for this therapy candidate.

Data showed BNT211 was well tolerated and led to promising clinical activity across the 16 patients evaluated in multiple solid tumour indications including: testicular, ovarian, endometrial, fallopian tube and gastric cancer and sarcoma. Results displayed an overall response rate of 43% and disease control rate of 86%.

In-particular promising anti-tumour activity and a positive safety-profile was observed in patients with testicular cancer at the first evaluated does levels 1 and 2.

“While the data are very early, it is remarkable that all patients with testicular cancer showed clinical benefits at dose level 2, and the responses we have observed can be deep, including one ongoing complete remission,” comments John Haanen, Medical Oncologist at the Netherlands Cancer Institute and Principal Investigator of the Study.

As a first-in-class therapeutic approach to target solid tumours, BNT211 is highly tumour specific, comprising of two drug products: an autologous, oncofetal antigen Claudin-6 (CLDN6) targeting CAR-T cell therapy, and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac), based on BioNTech’s mRNA-lipoplex technology.

CARVac works to enhance the CAR-T cell activity by encoding for the CAR-T’s CLDN6 target antigen expressed on multiple solid tumours. The combined CLDN6-CAR-T intends to increase CAR-T persistence and functionality.

Robust CAR-T cell expansion was observed in all 16 patients 10-17 days following infusion, with cell frequencies reaching near 109 in does level 2. The antitumor activity was shown to be higher at the higher CAR-T doses, and when in combination with CARVac. 4 out of 5 patients receiving the CLDN6-CAR-T therapy for testicular cancer demonstrated partial responses.

Does limiting toxicities and adverse events were reported as manageable, with only grade 1 and 2 cytokine release syndromes, and a single grade 1 neurotoxic event, observed.

“The results support our assumption that Claudin-6 is a well-suited new tumor target. Bringing these innovations together in one regimen may benefit patients with hard-to-treat solid tumors with an otherwise poor prognosis, such as advanced testicular cancer,” concludes Özlem Türeci, Co-Founder and CMO at BioNTech.

Source: BioNTech Press Release