BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma
19 Novembro 2021 - 08:30AM
BioNTech Receives FDA Fast Track Designation for its FixVac
Candidate BNT111 in Advanced Melanoma
MAINZ, GERMANY, November 19,
2021 — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) today announced that the U.S. Food and Drug
Administration (FDA) granted Fast Track Designation for BNT111, an
investigational cancer immunotherapy for the potential treatment of
advanced melanoma. BNT111 is the lead product candidate from
BioNTech’s fully owned FixVac platform that utilizes a fixed
combination of mRNA-encoded, tumor-associated antigens aiming to
trigger a strong and precise immune response against cancer. The
vaccine candidate is currently being investigated in a Phase 2
trial (EudraCT No.: 2020-002195-12; NCT04526899) in patients
with anti-PD-1-refractory/relapsed unresectable Stage III or IV
melanoma.
“The Fast Track Designation underlines the
potential of our FixVac platform to address current treatment
challenges of pre-treated and immune checkpoint blocker experienced
melanoma with limited standard of care therapy options left. This
is an important step to pave the way for this versatile new
treatment approach in a high medical need setting,” said
Özlem Türeci, M.D., Co-founder and Chief Medical Officer of
BioNTech. “With the Fast Track status and support by the
FDA, we aim to expedite the further development of the BNT111
program to provide a new therapeutic option for patients with
life-threatening, hard-to-treat melanoma.”
Fast Track is a process designed to facilitate
the development, and expedite the review, of new drugs and vaccines
that are intended to treat or prevent serious conditions that have
the potential to address an unmet medical need. The FDA’s decision
is based on available preclinical and clinical data showing the
potential of BNT111 to overcome current limitations in the
treatment of inoperable therapy-resistant advanced-stage melanoma.
With the Fast Track Designation, the development of BNT111 can
benefit from more frequent engagement with the FDA, which will
support the collection of appropriate data needed to accelerate
BNT111’s development.
The ongoing randomized Phase 2 trial (BNT111-01)
in patients with anti-PD1-refractory/relapsed unresectable Stage
III or IV melanoma investigates BNT111 in combination with Libtayo®
(cemiplimab), an anti-PD-1 monoclonal antibody being co-developed
by Regeneron and Sanofi. The BNT111-01 trial which is conducted in
collaboration with Regeneron is enrolling a total of 180 patients
into three treatment arms in the United States, the United Kingdom,
Australia, Spain, Germany, Italy and Poland. This trial seeks to
support initial data reported from the ongoing Phase 1 Lipo-MERIT
monotherapy dose escalation trial (EudraCT No. 2013-001646-33;
NCT02410733; DOI: 10.1038/s41586-020-2537-9) that demonstrated a
favorable safety profile and anti-tumor responses of BNT111 alone
and in combination with immune checkpoint inhibitor therapy in
patients with advanced melanoma.
About BNT111BNT111 is an
intravenous therapeutic cancer immunotherapy candidate encoding a
fixed set of four cancer-specific antigens optimized for
immunogenicity and delivered as RNA-lipoplex formulation. Based on
current data from an exploratory interim analysis of the ongoing
Phase 1 Lipo-MERIT monotherapy dose escalation trial, published in
Nature, BNT111 induces novel antigen-specific anti-tumor immune
responses and enhances pre-existing immune responses against the
encoded melanoma-associated antigens (NY-ESO-1, MAGE-A3,
tyrosinase, and TPTE), which are expressed in more than 90% of
cutaneous melanomas. BNT111 is one of four clinical-stage FixVac
product candidates within BioNTech’s development pipeline.
BNT111 is not yet authorized by any regulatory
authority and the safety and efficacy has not yet been
established.
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 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 may not be
limited to statements concerning: BioNTech’s FixVac program
candidate BNT111; timing for any data readouts of the Phase 2
trial; 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; 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 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 RelationsSylke Maas,
Ph.D.+49 (0)6131 9084 1074Investors@biontech.de
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