BioNTech presents positive preliminary data from phase 1/2 for the first-class CAR-T BNT211 program at AACR

BioNTech SE

  • BNT211 combines two innovative approaches in one regimen, autologous CAR-T cell therapy targeting Claudin-6 oncofetal antigen (CLDN6) and CLDN6 encoding CAR-T cell amplifying RNA vaccine (CARVac) to improve the persistence and functionality of the adoptively transferred cell.

  • Treatment with BNT211 alone or in combination with CARVac, which is currently being tested in a phase 1/2 study in patients with advanced solid tumors, was well tolerated in several tumor indications, according to preliminary data from 16 patients.

  • Preliminary efficacy data showed encouraging signs of clinical activity with a disease control rate of 86% and an overall response rate of 43%

MAINZ, Germany, April 11, 2022 (GLOBE NEWSWIRE)BioNTech SE (Nasdaq: BNTX, “BioNTech” or “Company”) provided data from its ongoing first phase 1/2 human study evaluating the safety and preliminary efficacy of the company’s new CAR-T cell therapy candidate, BNT211, in patients. with advanced solid tumors. Preliminary results demonstrated an enhancing safety profile and antitumor activity in testicular cancer patients at the first BNT211 dose levels evaluated. The data were presented at the plenary session of clinical trials at the annual meeting of AACR 2022 prof. John Haanen, MD, Ph.D., The Netherlands Cancer Institute (NKI), Amsterdam, The Netherlands.

BNT211 is a potential first-class therapeutic approach that includes two drug products, autologous CAR-T cell therapy for Claudin-6 oncofetal antigen (CLDN6) and CLDN6 encoding a CAR-T cell amplifying RNA vaccine (CARVac), which is based on BioNTech mRNA technology. -lipoplex to improve the persistence and functionality of adoptively transferred cells.

The presentation included data from 16 patients who received CLDN6 CAR-T cells at doses of 1 (1×107 CAR-T cells) and 2 (1×108 CAR-T cells) alone or in combination with CARVac. Tumor indications included testicular cancer (n = 8), ovarian cancer (n = 4), endometrial cancer, fallopian tube cancer, sarcoma, and gastric cancer (1 patient each). Treatment with CLDN6 CAR-T alone or in combination with CARVac up to dose level 2 was well tolerated and showed encouraging signs of clinical activity. All 16 patients showed a strong expansion of CAR-T cells 10-17 days after the infusion with a cell frequency close to 109 total counts at dose level 2. Adverse events and dose-limiting toxicities were manageable; grade 1 and 2 cytokine release syndromes and one transient occurrence of grade 1 neurotoxicity were observed.

At the first efficacy evaluation 6 weeks after the infusion, 6 of the 14 evaluable patients showed a partial response and 5 patients had stable disease with a reduction in target lesions. One patient showed no change from baseline and two patients progressed. Responses were observed in patients with testicular (n = 4) and ovarian (n = 2) cancer. After 12 weeks, 4 of 6 patients with a partial response showed a deepening and persistence of response, with one patient achieving a complete response 18 weeks after the infusion. All 4 patients with higher dose testicular cancer had control of the disease and 3 of these patients showed objective responses. In addition, 1 patient with testicular cancer showed a partial response after infusion of the lowest dose level of CAR-T in combination with CARVac. Antitumor activity tended to be higher with higher doses of CAR-T and in combination with the vaccine, with 4 of 5 patients in the CARVac combination group showing a partial response.

“Seeing the first antitumor effects even at the lowest dose of CAR-T cells in this intensely pretreated patient population is truly remarkable and highlights the potential of our CAR design and our CARVac approach,” he said. Özlem Türeci, MD, co-founder and chief physician at BioNTech. “The results support our hypothesis that Claudin-6 is a suitable new tumor target. Combining these innovations into one regimen may be beneficial for patients with difficult-to-treat solid tumors with an otherwise poor prognosis, such as advanced testicular cancer. Our preliminary data suggest that CAR-T’s success in hematological cancers may indeed translate to solid tumors.

“Claudin-6 has never focused on cell therapy before, but in this study, this approach already shows efficacy that may be better than data from other CAR-T studies in solid tumors,” he said. John Haanen, MD, Ph.D. Medical Oncologist from the Dutch Cancer Institute (NKI), Amsterdam, The Netherlands, and principal investigator. “Although the data are very early, it is noteworthy that all testicular cancer patients have shown clinical benefits at dose level 2 and the reactions we have observed may be profound, including one ongoing complete remission. I look forward to further evaluating this exciting new method for patients with solid tumors.

Ongoing phase 1/2 study (NCT04503278; 2019-004323-20) aims to evaluate the safety and preliminary efficacy of CLDN6 CAR-T therapy alone and in combination with CARVac in severely pretreated patients with CLDN6-positive recurrent or refractory advanced solid tumors and is performed in several locations in Germany and the Netherlands. Further data updates are expected later this year.

About BNT211
In order to harness the power of cell therapies for solid cancers and overcome obstacles to date, BioNTech has combined its CAR-T and FixVac platforms to develop a highly tumor-specific CAR-T cell therapy product that is gradually improved by CAR-T Cell Aamplifying RON THE Vaccine (CARVac), which is based on BioNTech’s mRNA-lipoplex technology and encodes the appropriate CAR-T target antigen. The vaccine has the potential to increase CAR-T activity, thus enabling and maintaining a therapeutic effect even at low doses of CAR-T. BNT211 is a CAR-T cell therapy directed against the new oncofetal antigen Claudin-6 (CLDN6), a target expressed on several solid tumors, such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. The program is currently being evaluated in the first human clinical phase 1/2 as monotherapy and in combination with CARVac encoding CLDN6 to enhance the persistence and function of CLDN6-CAR-T cells in patients with CLDN6 – positive recurrent or refractory advanced solid tumors.

About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a next-generation immunotherapeutic company that is a pioneer in new therapies for cancer, infectious diseases and other serious conditions. The company uses a wide range of computational drug research and therapeutic platforms to rapidly develop new biopharmaceuticals. Its broad portfolio of candidates for cancer products includes individualized and commonly available mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific control immunomodulators, targeted anti-cancer antibodies, and small molecule immunomodulators. Based on its deep expertise in mRNA vaccine development and in-house production capabilities, BioNTech is developing multiple candidates for mRNA vaccines for a variety of infectious diseases in addition to its diverse cancer chain. BioNTech has established a wide range of relationships with several global pharmaceutical associates, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.

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Outlook statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but are not limited to, statements regarding: candidate BNT211 of the BioNTech CAR-T program; timing of data reading 1/2 study; the registration potential of any attempt we may begin for BNT211; the nature and characterization and timing of the publication of clinical data on BioNTech platforms that are subject to peer review, regulatory assessment and market interpretation; planned next steps in BioNTech programs and, in particular, including, but not limited to, statements regarding the timing or plans for initiating clinical trials, registering or submitting and accepting product approvals with respect to BioNTech product candidates; the ability of BioNTech mRNA technology to demonstrate clinical efficacy outside the BioNTech Infectious Diseases Platform; the potential safety and effectiveness of our other product candidates; and BioNTech’s anticipated market opportunity and size for its candidate products, the degree and degree of acceptance of BioNTech investigational drugs on the market, if approved. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs about future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied therein. . forward-looking statements. These risks and uncertainties include, but are not limited to: discussions with regulatory agencies on the timing and requirements for additional clinical trials; and the ability to produce comparable clinical results in future clinical trials.

For a discussion of these and other risks and uncertainties, see the “Risk Factors” section of BioNTech’s Annual Report on Form 20-F for the year ended December 31, 2021, filed with the SEC on March 30, 2022, available at SEC website at All information in this press release is as of the date of publication and BioNTech assumes no obligation to update this information unless required by law.

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