BioNTech Announces First Patient Dosed in Phase 2 Clinical Trial of mRNA-based BNT111 in Patients with Advanced Melanoma
June 18 2021 - 5:00AM
- First program from BioNTech’s fully-owned mRNA cancer vaccine
platform FixVac treats patients in a randomized clinical Phase 2
clinical trial
- Phase 2 trial is based on positive results from Phase 1
Lipo-MERIT trial that demonstrated a favorable safety profile for
BNT111 as well as durable objective responses observed in patients
with melanoma who had progressed following prior checkpoint
blockade
- Trial is enrolling a total of 120 patients at clinical trial
sites in the European Union, the United Kingdom, the United States
and Australia
MAINZ, Germany, June 18, 2021
(GLOBE NEWSWIRE) – BioNTech SE (NASDAQ: BNTX,
“BioNTech” or “the Company”), announced today that the first
patient has been treated in its BNT111 Phase 2 cancer vaccine
trial (2020-002195-12; NCT04526899). The study is evaluating the
Company’s therapeutic cancer vaccine candidate BNT111 in
combination with Libtayo® (cemiplimab) in patients with
anti-PD1-refractory/relapsed unresectable Stage III or IV melanoma.
BNT111 is the lead product candidate from BioNTech’s FixVac
platform that targets a fixed combination of mRNA-encoded,
tumor-associated antigens with the objective of triggering a strong
and precise immune response against cancer and is fully owned by
BioNTech.
The BNT111-01 trial which is being conducted in
collaboration with Regeneron, was reviewed and approved by the
regulatory authorities in Spain, Germany, Italy and Poland as well
as in the United Kingdom, the United States and Australia. The
open-label randomized trial evaluates the efficacy, tolerability,
and safety of BNT111 in combination with Libtayo, an anti-PD-1
monoclonal antibody, being co-developed by Regeneron and Sanofi.
The trial is enrolling a total of 120 patients and will evaluate
the effects of the combination as well as single agents alone. The
primary endpoint is the overall response rate of BNT111 in
combination with Libtayo. Secondary endpoints include overall
response rate in the single agent arms, duration of response, and
safety. The first patient has been dosed in the EU. BioNTech
retains global commercial rights to BNT111.
“Our vision is to harness the power of the
immune system against cancer and infectious diseases. We were able
to demonstrate the potential of mRNA vaccines in addressing
COVID-19. We must not forget, that cancer is also a global health
threat, even worse than the current pandemic,“ said Özlem
Türeci, M.D., Co-founder and Chief Medical Officer of
BioNTech. “BNT111 has already shown a favorable safety
profile and encouraging preliminary results in early clinical
evaluation. With the start of patient treatment in our Phase 2
trial, we are encouraged to continue on our initial path to realize
the potential of mRNA vaccines for cancer patients.”
BNT111 is an intravenous therapeutic cancer
vaccine candidate encoding for a fixed set of four cancer-specific
antigens optimized for immunogenicity and delivered as RNA-lipoplex
formulation. More than 90% of melanomas in patients express at
least one of the four tumor-associated antigens encoded in BNT111
(NY-ESO-1, MAGE-A3, tyrosinase, and TPTE). BNT111 is one of the
most advanced of five clinical-stage FixVac product candidates
within BioNTech’s development pipeline.
This Phase 2 clinical trial is based on previous
results from the Phase 1 Lipo-MERIT dose escalation trial
(NCT02410733) that demonstrated a favorable safety profile in 89
patients with advanced melanoma. In addition, efficacy analysis of
the Lipo-MERIT study in a subset of 42 metastatic melanoma patients
previously treated with a checkpoint-inhibitor (CPI) showed that
BNT111 mediated durable responses both as a single agent and in
combination with anti-PD-1 antibodies and that durable objective
responses by BNT111 were associated with activation and strong
expansion of tumor-antigen-specific CD4+ and CD8+ T cells. These
results were published in Nature in July 2020.
The Company also plans to start randomized Phase
2 trials with mRNA vaccine product candidates in two additional
programs in 2021 (FixVac: BNT113 and iNeST: BNT122). As part of its
development strategy, BioNTech aims to rapidly advance its broad
oncology pipeline and expects to bring additional candidates into
late-stage clinical development and towards market entry within the
next five years.
About FixVacBioNTech’s FixVac
platform candidates consist of a fixed combination of mRNA-encoded
non-mutated antigens shared within specific cancer types. They
feature the Company’s proprietary RNA-lipoplex delivery formulation
which is designed to enhance stability and translation of the mRNA
cargo as well as specifically target dendritic cells. Thus, the
vaccine candidate aims to trigger a strong and precise innate and
adaptive immune response against cancer cells overexpressing the
respective antigen.
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
checkpoint immuno-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, Bayer Animal Health, Genentech, a member of the
Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.
For more information, please
visit www.BioNTech.de
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 FixVac program
candidate BNT111; timing for commencement of a Phase 2 trial as
well as any data readouts; the registrational potential of any
Phase 2 trial we may initiate for BNT111; 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;
BioNTech’s anticipated market opportunity and size for its product
candidates the rate and degree of market acceptance of BioNTech and
Pfizer’s COVID-19 vaccine and BioNTech’s investigational medicines,
if approved; and BioNTech’s efforts to combat COVID-19. Any
forward-looking statements in this press release are based on
BioNTech 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 Annual Report on Form 20-F for the
Year Ended December 31, 2020, filed with the SEC on March 30, 2021,
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.
Media RelationsJasmina
Alatovic+49 (0)6131 9084 1513Media@biontech.de
Investor Relations
Sylke Maas, Ph.D.+49 (0)6131 9084
1074Investors@biontech.de
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