BioNTech Presents Encouraging Phase 1/2 Follow-up Data for CAR-T Candidate BNT211 in Hard-To-Treat Solid Tumors at ESMO
September 09 2022 - 10:30AM
- Follow-up data further demonstrate encouraging signs of
clinical anti-tumor activity and a manageable safety and
tolerability profile, building on the positive interim data
presented at AACR in April
- Strongest responses seen in testicular cancer patients treated
at dose level 2 after lymphodepletion with overall response rate of
57% and a disease control rate of 85%; product candidate recently
received Priority Medicines designation by the European Medicines
Agency for this indication
MAINZ, Germany, September 9,
2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) today presented positive follow-up data from its ongoing
first-in-human Phase 1/2 trial evaluating the safety and efficacy
of the Company’s novel CAR-T cell therapy candidate, BNT211, in
patients with relapsed or refractory advanced solid tumors. The
results demonstrated encouraging signs of anti-tumor activity and
the safety profile remained manageable for the two tested dose
levels. The data were presented in the Investigational
Immunotherapy Proffered Paper Session at the European Society for
Medical Oncology (ESMO) Congress 2022 by Prof. Andreas Mackensen,
M.D., University Hospital Erlangen, Germany.
BNT211 is a novel therapeutic approach which
comprises a synergistic combination of two of BioNTech’s
proprietary platforms. The candidate combines an autologous
chimeric antigen receptor (CAR) T cell therapy targeting the
oncofetal antigen Claudin-6 (CLDN6) with a CLDN6-encoding CAR-T
cell amplifying RNA vaccine (CARVac). The product candidate
recently received Priority Medicines (PRIME) designation by the
European Medicines Agency (EMA) for the third- or later-line
treatment of testicular germ cell tumors. The designation was
granted based on the encouraging initial data particularly in
patients with testicular cancer which is the most common type of
germ cell tumors. BioNTech presented data from the ongoing Phase
1/2 trial (NCT04503278; 2019-004323-20) at the American Association
for Cancer Research (AACR) annual meeting in April 2022 and at the
annual meeting 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,” said
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 updated data read-out presented at ESMO
(data cut-offs: June 15, 2022 for safety and August 16, 2022 for
efficacy) included data from 22 patients (21 evaluable for
efficacy) who received CLDN6 CAR-T cells at dose levels 1 (1x107
CAR-T cells, n=7, including one patient with CAR-T dose below dose
level 1) and 2 (1x108 CAR-T cells, n=15) alone or combined with
CARVac. Tumor indications included testicular cancer (n=13),
ovarian cancer (n=4), endometrial cancer, fallopian tube cancer,
sarcoma, gastric cancer (one patient each) and one patient with a
tumor of unknown primary origin. Treatment with CLDN6 CAR-T alone
or in combination with CARVac up to dose level 2 showed encouraging
signs of clinical activity and was well tolerated. All 22 patients
showed robust, dose-dependent CAR-T cell expansion after infusion
with cell frequencies close to 109 total counts in dose level 2. At
the cut-off date, available data demonstrated the long-term
persistence of CAR-T cells observed in some patients for more than
100 days, and in one patient for 200 days. Two patients have been
treated without lymphodepletion as preconditioning and a strongly
reduced CAR-T expansion was observed. Adverse events, including
cytokine release syndromes (CRS) and dose limiting toxicities were
manageable. One transient occurrence of neurotoxicity grade 1 and
one grade 3 CRS were observed that quickly resolved.
Efficacy assessment of the 21 evaluable patients
showed a best overall response rate (ORR) of 33% and a disease
control rate (DCR) of 67% with one complete response, six partial
responses and seven patients with stable disease. In line with the
earlier data set initially presented at AACR this year,
particularly encouraging clinical responses were seen in patients
with testicular cancer treated with dose level 2 after
lymphodepletion (n=7), where one complete response, three partial
responses and two stable diseases were observed, representing an
ORR of 57% and a DCR of 85%. As previously reported, antitumor
activity tended to be higher at the higher dose of CAR-T cells and
when combined with the mRNA vaccine. 5 of 10 patients in the CARVac
combination group showed a partial response compared to 2 of 9
patients in the monotherapy cohort (CAR-T cell treatment only)
excluding two patients that have been treated without
lymphodepletion.
About BNT211Aiming to harness
the power of cell therapies for solid cancers and to overcoming
hurdles to date, BioNTech has combined their CAR-T and FixVac
platform technologies to develop a highly tumor-specific CAR-T cell
therapy product which is consecutively enhanced by a
CAR-T Cell Amplifying
RNA Vaccine (CARVac) that is
based on BioNTech’s mRNA-lipoplex technology and encodes for the
respective CAR-T target antigen. CARVac is based on BioNTech’s
backbone-optimized uridine mRNA (uRNA)-lipoplex technology which
through its inherent adjuvant function enables a potent T cell
stimulation to improve persistence and functionality of the
adoptively transferred CAR-T cells, thereby enabling the
investigation of a therapeutic effect even at low CAR-T doses.
BNT211 is an investigational CAR-T cell therapy directed against
the novel oncofetal antigen Claudin-6 (CLDN6), a target discovered
by BioNTech founders and expressed on multiple solid tumors such as
ovarian cancer, sarcoma, testicular cancer, endometrial cancer and
gastric cancer. The program is currently being evaluated in a
first-in-human Phase 1/2 trial as a monotherapy and in combination
with a CLDN6-encoding CARVac, aiming to boost persistence and
functionality of the CLDN6-CAR-T cells, in patients with
CLDN6-positive relapsed or refractory advanced solid tumors.
About BioNTechBiopharmaceutical
New Technologies is a next generation immunotherapy company
pioneering novel therapies for cancer and other serious diseases.
The Company exploits a wide array of computational discovery and
therapeutic drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product
candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor T cells, bispecific
immune checkpoint modulators, targeted cancer antibodies and small
molecules. Based on its deep expertise in mRNA vaccine development
and in-house manufacturing capabilities, BioNTech and its
collaborators are developing multiple mRNA vaccine candidates for a
range of infectious diseases alongside its diverse oncology
pipeline. BioNTech has established a broad set of relationships
with multiple global pharmaceutical collaborators, including
Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron,
Genevant, Fosun Pharma, and Pfizer. For more information, please
visit www.BioNTech.com.
BioNTech Forward-Looking
StatementsThis 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 may not be limited to statements concerning: BioNTech’s CAR-T
program candidate BNT211; timing for any data readouts of the Phase
1/2 trial; the registrational potential of any trial we may
initiate for BNT211; the nature and characterization of and timing
for release of clinical data across BioNTech’s platforms, which is
subject to peer review, regulatory review and market
interpretation; the planned next steps in BioNTech’s pipeline
programs and specifically including, but not limited to, statements
regarding timing or plans for initiation of clinical trials,
enrollment or submission for and receipt of product approvals with
respect to BioNTech’s product candidates; the ability of BioNTech’s
mRNA technology to demonstrate clinical efficacy outside of
BioNTech’s infectious disease platform; the potential safety and
efficacy of our other product candidates; and BioNTech’s
anticipated market opportunity and size for its product candidates,
the rate and degree of market acceptance of BioNTech’s
investigational medicines, if approved. Any forward-looking
statements in this press release are based on BioNTech’s current
expectations and beliefs of future events, and are subject to a
number of risks and uncertainties that could cause actual results
to differ materially and adversely from those set forth in or
implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to: discussions with
regulatory agencies regarding 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 BioNTech’s Quarterly Report as Form 6-K for the
quarter ended June 30, 2022, filed with the SEC on August 8, 2022,
which is available on the SEC’s website at www.sec.gov. All
information in this press release is as of the date of the release,
and BioNTech undertakes no duty to update this information unless
required by law.
CONTACTS
Investor RelationsSylke Maas, Ph.D. VP Investor
Relations & Strategy Tel: +49 (0)6131 9084 1074
E-mail: Investors@biontech.de
Media RelationsJasmina AlatovicVP Corporate
Communications Tel: +49 (0)6131 9084 1513
E-mail: Media@biontech.de
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