BioNTech Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support of CAR-T Candidate BNT211 in Testicular Cancer
24 June 2022 - 01:00AM
- First BioNTech product candidate to receive priority medicines
(PRIME) designation by the European Medicines Agency for enhanced
regulatory support facilitating the clinical development of the
investigational cell therapy candidate BNT211 in the third- or
later-line setting in patients with heavily pretreated testicular
cancer
- Designation follows positive interim Phase 1/2 data for BNT211
demonstrating an encouraging safety profile and early signs of
anti-tumor activity in testicular cancer patients
- BNT211 combines two innovative approaches in one regimen, an
autologous chimeric antigen receptor (CAR) T cell therapy targeting
the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T
cell amplifying RNA vaccine (CARVac) to improve persistence and
functionality of the adoptively transferred cells
- The European Medicines Agency’s priority medicines status is
granted to drug candidates that may offer a major therapeutic
advantage over existing treatments, or benefit patients without
treatment options
MAINZ, Germany, June 23, 2022 (GLOBE
NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) today announced that that the European Medicines Agency
(EMA) has granted Priority Medicines (PRIME) designation to
BioNTech’s fully owned product candidate BNT211 for the third- or
later-line treatment of testicular germ cell tumors. BNT211 is a
potential first-in-class therapeutic approach which comprises a
synergistic combination of two of the Company’s proprietary drug
products, an autologous chimeric antigen receptor (CAR) T cell
therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a
CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac). The
product candidate is currently being investigated in an ongoing
Phase 1/2 study (NCT04503278; 2019-004323-20) that aims to evaluate
the safety and preliminary efficacy in heavily pretreated patients
with relapsed or refractory advanced solid tumors.
“Patients with relapsed or treatment refractory
testicular cancers have a poor prognosis with limited remaining
treatment options. The PRIME designation underlines the potential
of our approach in this high medical need setting. Our approach
brings together several new elements: Firstly, targeting CLDN6, a
pan-cancer cell surface marker, secondly, our CAR design, and
thirdly, “remote control” of CAR T cells by our uridine
RNA-lipoplex based vaccine. We believe that a combination of
engineered T cells and mRNA vaccines in one treatment regimen can
stimulate and expand T cells. This could enable us to develop truly
powerful precision immunotherapies,” said Prof. Özlem Türeci,
M.D., Co-Founder and Chief Medical Officer at BioNTech. “With
the PRIME status and support by the EMA, we aim to expedite the
further development of the BNT211 program to bring a novel
therapeutic option for patients with life-threatening testicular
cancer, and thus to extend the successes of CAR-T therapy also to
hard-to-treat solid tumors.”
The designation is based on positive preliminary
Phase 1/2 data from the ongoing study that was presented at the
AACR Annual Meeting in April 2022. The results demonstrated that
treatment with CLDN6 CAR-T alone or in combination with CARVac was
well tolerated and showed encouraging signs of anti-tumor activity
in testicular cancer patients at the first evaluated dose levels.
In the study all six patients with heavily pretreated testicular
cancer eligible for efficacy analysis showed clinical benefits
highlighting the potential of this novel approach. One patient
achieved a complete response 18 weeks after infusion. Three
patients achieved a partial response and showed deepening and
durability of responses (one of them in the lowest CAR-T dose level
cohort in combination with CARVac). One patient had stable disease
with shrinkage of target lesions.
The PRIME scheme is a regulatory mechanism
introduced by the EMA that provides early and proactive support to
developers of promising medicines, to optimize development plans
and speed up evaluations so these medicines can reach patients
faster. The goal is to help patients benefit as early as possible
from innovative new therapies that have demonstrated the potential
to significantly address an unmet medical need.
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. The 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, thus enabling and maintaining 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 (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 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, 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 Annual Report as Form 20-F for the
Year Ended December 31, 2021, filed with the SEC on March 30, 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
BioNTech
Investor RelationsSylke Maas, Ph.D. VP
Investor Relations & Strategy
Tel: +49 (0)6131 9084 1074
E-mail: Investors@biontech.de
Media RelationsJasmina Alatovic VP Corporate
Communications Tel: +49 (0)6131 9084 1513
E-mail: Media@biontech.de
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