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ESMO 2023: BioNTech Unveils Groundbreaking Results for Solid Tumor Treatment

BioNTech presented positive results from its Phase 1/2 trial at the ESMO Congress 2023 for its CAR-T therapy, BNT211, targeting solid tumors. Combining a CAR-T cell therapy with a CARVac RNA vaccine, the treatment showed a 59% overall response rate in a specific dose group. The research signifies a promising advancement in cancer therapeutics.

In a presentation at the European Society for Medical Oncology (ESMO) Congress 2023, BioNTech unveiled encouraging results from its ongoing first-in-human Phase 1/2 trial concerning its innovative CAR-T therapy, BNT211, for solid tumors. This treatment combines two pioneering approaches: an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine, known as CARVac.

The data incorporated the findings from 44 patients with various types of solid tumors, including germ cell tumors, ovarian cancer, and other solid tumor types. These patients received CLDN6 CAR-T cells at multiple dose levels, either standalone or combined with CARVac.

Highlighting the company's commitment to advancing the treatment of solid tumors, Prof. Özlem Türeci, M.D. Chief Medical Officer at BioNTech, stated, 

“Our goal is to unlock the potential of CAR-T for solid tumors and to help improve outcomes for a broad range of hard-to-treat tumors. BNT211 aims to address two of the key limitations of CAR-T cell approaches in solid tumors, namely the lack of suitable cancer-specific cell surface targets and the limited persistence of CAR-T cells. To address this challenge, we have designed a CLDN6-specific autologous CAR-T cell therapy that we combine with our mRNA-based vaccine CARVac.”

Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech

Key findings from the trial include:

  • An overall response rate (ORR) of 45% was observed among 38 evaluated patients.
  • A more specific dose group, receiving 1x108 CAR-T cells with or without CARVac, showcased an impressive ORR of 59% and a disease control rate (DCR) of 95%.
  • Patients who were administered CARVac alongside CAR-T cells displayed prolonged persistence of these CAR-T cells, indicating the potential added benefit of this combination.

However, as the dosage increased, so did the observed adverse events. Specifically, 23 out of the 44 patients experienced cytokine release syndromes, primarily of grade 1 and 2, but with one grade 3 and one grade 4 event noted. A rare instance of acute respiratory distress syndrome was also reported but led to recovery. Two patients showed mild, self-resolving neurotoxicity.

The research abstract further explains that BNT211 harnesses the combined power of CAR-T and FixVac platform technologies. It emphasizes the use of a CAR-T Cell Amplifying RNA Vaccine (CARVac), grounded in BioNTech’s mRNA-lipoplex technology, which encodes the CAR-T target antigen. This mRNA vaccine is formulated to enhance CAR-T persistence and functionality. BNT211, in particular, targets the novel oncofetal antigen Claudin-6 (CLDN6), which is expressed in various solid tumors, including ovarian, testicular, endometrial, and gastric cancers.

While these results are promising, the durability of BNT211 remains an area of investigation, as CAR-T therapy can sometimes face relapse issues. Redosing studies offer potential solutions to this challenge. Regulatory discussions are in progress to refine trial designs and weigh curative methods against palliative care. BioNTech's plans to initiate the phase 2 segment of the trial, concentrating on germ cell cancers in the EU and US, is eagerly anticipated.

In summary, BioNTech’s innovative approach to CAR-T therapy marks a significant advancement in cancer therapeutics, providing hope for effective treatments for solid tumors. The data from their recent trials underline the potential of the BNT211 program, with further developments anticipated in the coming year.

BioNTech Presents Positive Phase 1/2 Data Update for CAR-T Cell Therapy Candidate BNT211

BNT211 combines two innovative approaches in one regimen with first-in-class potential: an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (“CARVac”). Data presented at ESMO Congress 2023 demonstrates that the application of CARVac increases the persistence of the adoptively transferred autologous CAR-T cells. BNT211 continues to show encouraging antitumor activity in patients with CLDN6-positive relapsed or refractory advanced solid tumors. Follow-up of efficacy data at 1x108 CAR-T cells with or without CARVac shows an overall response rate (“ORR”) of 59% and a disease control rate (“DCR”) of 95%, with the CARVac cohort demonstrating a prolonged persistence of CAR-T cells.


About Author: Hüseyin Kandemir

As a medical journalist with over 20 years of experience, I have served as an Editor and Reporter for various magazines, newspapers, and online broadcasting platforms, consistently demonstrating a strong commitment to excellence in journalism. My specialization includes medical science, digital health, AI for health, data science, and biotechnology.

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