BioNTech Presents Positive Phase 1/2 Data Update for CAR-T Cell
Therapy Candidate BNT211 in Advanced Solid Tumors at ESMO Congress
2023
- 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
MAINZ, Germany, October 23, 2023 (GLOBE
NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech”
or “the Company”) today announced follow-up data from its ongoing
first-in-human Phase 1/2 trial (NCT04503278; 2019-004323-20)
evaluating the safety and efficacy of the Company’s Claudin-6
(CLDN6)-directed CAR-T cell therapy candidate BNT211 in patients
with CLDN6-positive refractory/relapsed solid tumors. The data show
encouraging signs of clinical activity and an increased persistence
of cancer-specific CAR-T cells when combined with CARVac. At the
ESMO Congress 2023 in Madrid, Prof. John Haanen, M.D., Ph.D.,
Netherlands Cancer Institute (NKI), Amsterdam, Netherlands
presented the data in an oral late-breaking data session which
confirms the positive interim data presented at this year’s
American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, USA.
“Our goal is to unlock the potential of CAR-T
for solid tumors and to help improve the outcomes for a broad range
of hard-to-treat tumors,” said Prof. Özlem Türeci, M.D.,
Co-Founder and Chief Medical Officer at BioNTech. “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.”
The data update included 44 patients who
received CLDN6 CAR-T cells at four dose levels alone or in
combination with CARVac. Patients with germ cell tumors (n=16),
ovarian cancer (n=17) and other solid tumor types (n=11) were
treated. In course of the dose escalation, a dose-dependent
increase in adverse events was observed, with cytokine release
syndromes occurring in 23 of 44 safety evaluable patients. In most
cases, these were of grade 1 and 2, with one patient with a grade 3
and one with a grade 4 event. Neurotoxicity was mild and
self-limiting in two patients. Of the total 44 patients, 38 were
efficacy evaluable. The overall response rate (“ORR”) for these 38
patients was 45% and the disease control rate (“DCR”) 74%. Further,
27 patients were treated with CLDN6 CAR-T cells at dose level 2
(1x108 CAR-T cells) with or without CARVac. At this dose level, 13
patients showed partial responses resulting in an ORR of 59% and a
DCR of 95%. Additionally, in the same cohort, patients who received
CARVac showed a prolonged persistence of CAR-T cells.
These results further underline the potential of
BioNTech’s BNT211 program. One objective of the ongoing Phase 1/2
trial is to determine the recommended dose for the initiation of a
potential pivotal Phase 2 trial in patients with germ cell tumors
which is expected to be initiated in 2024.
About BNT211To harness the power of cell
therapies for solid cancers, BioNTech has combined their CAR-T and
FixVac platform technologies to develop a tumor-specific CAR-T cell
therapy which is enhanced by a CAR-T Cell Amplifying
RNA Vaccine (CARVac) that is based on BioNTech’s
mRNA-lipoplex technology and encodes for the CAR-T target antigen.
The mRNA vaccine is designed to boost CAR-T persistence and
functionality. BNT211 is a CAR-T cell therapy directed against the
novel oncofetal antigen Claudin-6 (CLDN6), a target 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 in
patients with CLDN6-positive relapsed or refractory advanced solid
tumors.
About BioNTechBiopharmaceutical New
Technologies (BioNTech) 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 (CAR) T cells,
several protein-based therapeutics, including bispecific immune
checkpoint modulators, targeted cancer antibodies and antibody-drug
conjugate (ADC) therapeutics, as well as 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 Duality Biologics,
Fosun Pharma, Genentech, a member of the Roche Group, Genevant,
Genmab, OncoC4, Regeneron, Sanofi and Pfizer.
For more information, please visit
www.BioNTech.com.
Forward-Looking StatementsThis press
release may contain forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, as
amended, including, but not be limited to, statements concerning:
the initiation, timing, progress and results of BioNTech’s research
and development programs in oncology; BioNTech’s current and future
preclinical studies and clinical trials in oncology, including
CAR-T cell therapy candidate BNT211, including statements regarding
the timing of initiation and completion of studies or trials, such
as the expected initiation of a pivotal Phase 2 trial of BNT211 in
germ cell tumors, related preparatory work and the availability of
results; timing for any data readouts; the registrational potential
of any trial we may initiate for our product candidates; the
potential safety and efficacy of our product candidates, including
qualitative assessments of available data and expectations of
potential benefits (including Phase 1/2 data for BNT211 in advanced
solid tumors); and BioNTech’s anticipated market opportunity and
size for its product candidates. In some cases, forward-looking
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“believes,” “estimates,” “predicts,” “potential,” “continue,” or
the negative of these terms or other comparable terminology,
although not all forward-looking statements contain these words.
The forward-looking statements in this press release are neither
promises nor guarantees, and you should not place undue reliance on
these forward-looking statements because they involve known and
unknown risks, uncertainties, and other factors, many of which are
beyond BioNTech’s control, and which could cause actual results to
differ materially from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited to: the uncertainties inherent in research and
development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for clinical
trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as risks associated with preclinical
and clinical data; the nature of the clinical data, which is
subject to ongoing peer review, regulatory review and market
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availability of raw materials; competition from other product
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different manufacturing and distribution constraints, on the basis
of, among other things, efficacy, cost, convenience of storage and
distribution, breadth of approved use, side-effect profile and
durability of immune response; BioNTech's ability to identify
research opportunities and discover and develop investigational
medicines; the ability and willingness of BioNTech's third-party
collaborators to continue research and development activities
relating to BioNTech's product candidates; the timing of and
BioNTech's ability to obtain and maintain regulatory approval for
its product candidates; and other factors not known to BioNTech at
this time.
You should review the risks and uncertainties
described under the heading “Risk Factors” in BioNTech’s Report on
Form 6-K for the period ended June 30, 2023, and in subsequent
filings made by BioNTech with the U.S. Securities and Exchange
Commission (“SEC”), which are available on the SEC’s website at
www.sec.gov. Except as required by law, BioNTech disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These
forward-looking statements are based on BioNTech’s current
expectations and speak only as of the date
hereof.
CONTACTS
Media Relations Jasmina Alatovic +49 (0)6131 9084 1513
Media@biontech.de
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8293Investors@biontech.de
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