BioNTech Presents Encouraging Phase 1/2 Follow-up Data for

• Follow-up information additional reveal encouraging indicators of scientific anti-tumor exercise and a manageable security and tolerability profile, constructing on the optimistic interim information offered at AACR in April
• Strongest responses seen in testicular most cancers sufferers handled at dose degree 2 after lymphodepletion with general response price of 57% and a illness management price of 85%; product candidate not too long ago acquired Priority Medicines designation by the European Medicines Agency for this indication

MAINZ, Germany, September 9, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) at present offered optimistic follow-up information from its ongoing first-in-human Phase 1/2 trial evaluating the protection and efficacy of the Company’s novel CAR-T cell remedy candidate, BNT211, in sufferers with relapsed or refractory superior stable tumors. The outcomes demonstrated encouraging indicators of anti-tumor exercise and the protection profile remained manageable for the 2 examined dose ranges. The information had been offered within the Investigational Immunotherapy Proffered Paper Session on the European Society for Medical Oncology (ESMO) Congress 2022 by Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany.

BNT211 is a novel therapeutic method which contains a synergistic mixture of two of BioNTech’s proprietary platforms. The candidate combines an autologous chimeric antigen receptor (CAR) T cell remedy concentrating on the oncofetal antigen Claudin-6 (CLDN6) with a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The product candidate not too long ago acquired Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) for the third- or later-line remedy of testicular germ cell tumors. The designation was granted primarily based on the encouraging preliminary information notably in sufferers with testicular most cancers which is the commonest sort of germ cell tumors. BioNTech offered information from the continued Phase 1/2 trial (NCT04503278; 2019-004323-20) on the American Association for Cancer Research (AACR) annual assembly in April 2022 and on the annual assembly of the Association for Cancer Immunotherapy (CIMT) in May 2022.

“This new dataset further supports the encouraging results we have seen for BNT211 to date. Together with the recently granted PRIME designation for BNT211 in testicular cancer it also reinforces our strategy to combine two of our key technology platforms in hard-to-treat tumor indications,” mentioned Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. “We are grateful for the continued support from both clinicians and regulators that enables us to rapidly advance the clinical evaluation of BNT211 as a novel treatment option for cancer patients with an otherwise very poor prognosis.”

The up to date information read-out offered at ESMO (information cut-offs: June 15, 2022 for security and August 16, 2022 for efficacy) included information from 22 sufferers (21 evaluable for efficacy) who acquired CLDN6 CAR-T cells at dose ranges 1 (1×10⁷ CAR-T cells, n=7, together with one affected person with CAR-T dose under dose degree 1) and a pair of (1×10⁸ CAR-T cells, n=15) alone or mixed with CARVac. Tumor indications included testicular most cancers (n=13), ovarian most cancers (n=4), endometrial most cancers, fallopian tube most cancers, sarcoma, gastric most cancers (one affected person every) and one affected person with a tumor of unknown major origin. Treatment with CLDN6 CAR-T alone or together with CARVac as much as dose degree 2 confirmed encouraging indicators of scientific exercise and was nicely tolerated. All 22 sufferers confirmed sturdy, dose-dependent CAR-T cell enlargement after infusion with cell frequencies near 10⁹ whole counts in dose degree 2. At the closing date, out there information demonstrated the long-term persistence of CAR-T cells noticed in some sufferers for greater than 100 days, and in a single affected person for 200 days. Two sufferers have been handled with out lymphodepletion as preconditioning and a strongly diminished CAR-T enlargement was noticed. Adverse occasions, together with cytokine launch syndromes (CRS) and dose limiting toxicities had been manageable. One transient prevalence of neurotoxicity grade 1 and one grade 3 CRS had been noticed that rapidly resolved.

Efficacy evaluation of the 21 evaluable sufferers confirmed a finest general response price (ORR) of 33% and a illness management price (DCR) of 67% with one full response, six partial responses and 7 sufferers with steady illness. In line with the sooner information set initially offered at AACR this yr, notably encouraging scientific responses had been seen in sufferers with testicular most cancers handled with dose degree 2 after lymphodepletion (n=7), the place one full response, three partial responses and two steady illnesses had been noticed, representing an ORR of 57% and a DCR of 85%. As beforehand reported, antitumor exercise tended to be increased on the increased dose of CAR-T cells and when mixed with the mRNA vaccine. 5 of 10 sufferers within the CARVac mixture group confirmed a partial response in comparison with 2 of 9 sufferers within the monotherapy cohort (CAR-T cell remedy solely) excluding two sufferers which were handled with out lymphodepletion.

About BNT211
Aiming to harness the ability of cell therapies for stable cancers and to overcoming hurdles so far, BioNTech has mixed their CAR-T and RepairVac platform applied sciences to develop a extremely tumor-specific CAR-T cell remedy product which is consecutively enhanced by a CAR-T Cell Amplifying RNA Vaccine (CARVac) that’s primarily based on BioNTech’s mRNA-lipoplex know-how and encodes for the respective CAR-T goal antigen. CARVac is predicated on BioNTech’s backbone-optimized uridine mRNA (uRNA)-lipoplex know-how which by way of its inherent adjuvant perform allows a potent T cell stimulation to enhance persistence and performance of the adoptively transferred CAR-T cells, thereby enabling the investigation of a therapeutic impact even at low CAR-T doses. BNT211 is an investigational CAR-T cell remedy directed towards the novel oncofetal antigen Claudin-6 (CLDN6), a goal found by BioNTech founders and expressed on a number of stable tumors comparable to ovarian most cancers, sarcoma, testicular most cancers, endometrial most cancers and gastric most cancers. The program is at the moment being evaluated in a first-in-human Phase 1/2 trial as a monotherapy and together with a CLDN6-encoding CARVac, aiming to spice up persistence and performance of the CLDN6-CAR-T cells, in sufferers with CLDN6-positive relapsed or refractory superior stable tumors.

About BioNTech
Biopharmaceutical New Technologies is a subsequent technology immunotherapy firm pioneering novel therapies for most cancers and different severe illnesses. The Company exploits a wide selection of computational discovery and therapeutic drug platforms for the speedy growth of novel biopharmaceuticals. Its broad portfolio of oncology product candidates contains individualized and off-the-shelf mRNA-based therapies, modern chimeric antigen receptor T cells, bispecific immune checkpoint modulators, focused most cancers antibodies and small molecules. Based on its deep experience in mRNA vaccine growth and in-house manufacturing capabilities, BioNTech and its collaborators are creating a number of mRNA vaccine candidates for a variety of infectious illnesses alongside its numerous oncology pipeline. BioNTech has established a broad set of relationships with a number of world pharmaceutical collaborators, together with Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For extra info, please go to www.BioNTech.com.

BioNTech Forward-Looking Statements
This press launch comprises forward-looking statements throughout the that means of the Private Securities Litigation Reform Act of 1995. These forward-looking statements could embody, however might not be restricted to statements regarding: BioNTech’s CAR-T program candidate BNT211; timing for any information readouts of the Phase 1/2 trial; the registrational potential of any trial we could provoke for BNT211; the character and characterization of and timing for launch of scientific information throughout BioNTech’s platforms, which is topic to look assessment, regulatory assessment and market interpretation; the deliberate subsequent steps in BioNTech’s pipeline applications and particularly together with, however not restricted to, statements relating to timing or plans for initiation of scientific trials, enrollment or submission for and receipt of product approvals with respect to BioNTech’s product candidates; the flexibility of BioNTech’s mRNA know-how to reveal scientific efficacy outdoors of BioNTech’s infectious illness platform; the potential security and efficacy of our different product candidates; and BioNTech’s anticipated market alternative and measurement for its product candidates, the speed and diploma of market acceptance of BioNTech’s investigational medicines, if accepted. Any forward-looking statements on this press launch are primarily based on BioNTech’s present expectations and beliefs of future occasions, and are topic to quite a few dangers and uncertainties that would trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements. These dangers and uncertainties embody, however are usually not restricted to: discussions with regulatory companies relating to timing and necessities for further scientific trials; and the flexibility to supply comparable scientific leads to future scientific trials.

For a dialogue of those and different dangers and uncertainties, see BioNTech’s Quarterly Report as Form 6-Okay for the quarter ended June 30, 2022, filed with the SEC on August 8, 2022, which is out there on the SEC’s web site at www.sec.gov. All info on this press launch is as of the date of the discharge, and BioNTech undertakes no obligation to replace this info except required by legislation.

CONTACTS

Investor Relations
Sylke Maas, Ph.D.
VP Investor Relations & Strategy
Tel: +49 (0)6131 9084 1074
E-mail: [email protected] 

Media Relations
Jasmina Alatovic
VP Corporate Communications
Tel: +49 (0)6131 9084 1513
E-mail: [email protected]