- Initiation of Phase 2 builds on data from a Phase 1 clinical
trial evaluating the safety and tolerability of autogene cevumeran
(BNT122, RO7198457) in combination with the anti-PD-L1 immune
checkpoint inhibitor atezolizumab and standard of care chemotherapy
in patients with resected pancreatic ductal adenocarcinoma
(PDAC)
- The Phase 2 trial is expected to enroll approximately 260
patients with PDAC at clinical trial sites initially in the United
States, followed by Europe and Asia Pacific region
- This is the third later-stage trial with a product candidate
based on BioNTech’s individualized cancer vaccine platform iNeST
aimed at treating patients with solid tumors in a high unmet need
indication
MAINZ, Germany, October 19, 2023 (GLOBE
NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the
Company”) today announced that the first patient has been treated
in a Phase 2 clinical trial evaluating the mRNA-based
individualized neoantigen-specific immunotherapy (iNeST) candidate
autogene cevumeran (also known as BNT122, RO7198457) in resected
pancreatic ductal adenocarcinoma (PDAC). PDACs are solid tumors
with a poor prognosis reflected in a 5-year overall survival rate
of only 8-10%1,2, high recurrence rates3 and limited treatment
options.
Autogene cevumeran, which is being jointly
developed by BioNTech and Genentech, a member of the Roche Group,
is a therapeutic, individualized cancer vaccine candidate encoding
up to 20 patient-specific cancer mutations selected for their
proficiency to serve as neoantigens. Neoantigens are proteins that
are produced by cancer cells that differ from the proteins produced
by healthy cells. The investigational treatment aims to induce a
neoantigen-directed immune response against the patient’s
individual tumor.
The open-label, multicenter, randomized Phase 2
trial (NCT05968326), sponsored by Genentech, will evaluate the
efficacy and safety of autogene cevumeran in combination with
anti-PD-L1 immune checkpoint inhibitor atezolizumab and
chemotherapy compared to the current standard-of-care chemotherapy
(mFOLFIRINOX). The Phase 2 study is expected to enroll 260 patients
with resected PDAC, who have not received prior systemic
anti-cancer treatment and showed no evidence of disease after
surgery. The trial will be conducted at various sites in the United
States, followed by Europe and Asia Pacific region. The primary
endpoint is disease-free survival. Secondary endpoints include
disease-free survival rates, overall survival, overall survival
rate and safety profile.
The Phase 2 initiation is based on data from an
investigator-initiated, single-center Phase 1 trial (NCT04161755)
evaluating the combination of autogene cevumeran (BNT122,
RO7198457), atezolizumab, and chemotherapy (mFOLFIRINOX) in
patients with resected PDAC. Preliminary data of the Phase 1 trial
were presented at the American Society of Clinical Oncology
(“ASCO”) Annual Meeting in June 2022 and complete study results
were recently published in Nature, demonstrating a favorable safety
profile and substantial vaccine-induced T cell responses that may
correlate with delayed PDAC recurrence.
“PDAC is a tumor type for which the relapse rate
after surgery is extremely high at nearly 80%. The recent Phase 1
study has shown that individualized neoantigen vaccination is
feasible for this tumor type with low mutational burden and an
immunosuppressive microenvironment3. We have been evaluating cancer
mutations since the start of the first clinical trial based on our
mRNA technology in 2014 with the hypothesis that they could be
suitable targets for individualized cancer vaccines,” said Prof.
Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at
BioNTech. “The Phase 2 study will provide additional data
whether our approach with autogene cevumeran has the potential to
provide a benefit for patients in this high unmet medical need
setting. Our aim is to prevent relapses and thus ensure that the
disease is managed at the earliest possible stage.”
Autogene cevumeran (BNT122, RO7198457) is part
of BioNTech’s and Genentech’s worldwide strategic collaboration to
develop, manufacture and commercialize novel mRNA-based,
individualized cancer vaccines, which was initiated in 2016.
Autogene cevumeran is currently being evaluated in various solid
tumor indications, including a Phase 2 trial (NCT04486378) in the
adjuvant treatment of surgically resected colorectal cancer, a
Phase 2 proof-of-concept study (NCT03815058) of autogene cevumeran
in combination with pembrolizumab in the first-line treatment of
advanced melanoma and a Phase 1a/b trial in locally advanced or
metastatic tumors (NCT03289962). The Phase 2 trial of autogene
cevumeran in patients with PDAC is the third later-stage trial
based on BioNTech’s individualized cancer vaccine platform
iNeST.
About resected pancreatic ductal
adenocarcinoma (PDAC)PDAC is amongst the leading causes of
cancer-related deaths in the United States4 with approximately 90%
of patients dying within two years of their diagnosis5. A
combination of surgical removal and systemic cytotoxic chemotherapy
has shown to improve clinical outcomes, however, even with surgical
resection, the relapse rate remains high, and the 5-year overall
survival is only approximately 20%6 in patients who undergo surgery
followed by adjuvant chemotherapy (“ACT”) and only 8-10%1,2 in
those who do not receive ACT. Thus, there is a high unmet medical
need for novel therapies for patients with resected PDAC. The
individualized neoantigen specific immunotherapy (“iNeST”)
candidate autogene cevumeran (BNT122, RO7198457) provides a novel
treatment strategy aimed to induce de-novo immune responses against
cancer-specific neoantigens, recognize residual cancer cells and to
prevent relapse.
About iNeST (individualized Neoantigen
Specific immunoTherapy)iNeST immunotherapies are individualized
cancer therapies tailored to a specific patient’s tumor. They
contain unmodified, pharmacologically optimized mRNA encoding up to
20 patient-specific neoantigens, identified using real-time next
generation sequencing and bioinformatic neoantigen discovery.
Neoantigens are proteins that are produced by cancer cells that
differ from the proteins produced by healthy cells and are
recognized by immune cells. The mRNA is encapsulated in BioNTech’s
proprietary intravenous RNA-lipoplex delivery formulation which is
designed to enhance stability as well as enable targeted delivery
to dendritic cells. By analyzing each patient’s tumor, BioNTech is
able to identify the cancer mutations that may act as neoantigens.
Each individual cancer vaccine encodes for neoantigen candidates
with the highest likelihood to help the immune system to recognize
the cancer. For this purpose, BioNTech has developed an on-demand
manufacturing process, following Good Manufacturing Practice (GMP)
conditions.
An iNeST Fact Sheet and images from
the iNeST manufacturing process are available in the newsroom
section on BioNTech’s website at this link.
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.
BioNTech Forward-Looking StatementsThis
press release contains 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 collaboration between BioNTech and Genentech to jointly
clinical develop the iNeST program candidate autogene cevumeran
(BNT122); timing for commencement of a Phase 2 trial as well as any
subsequent data readouts; the registrational potential of any trial
we may initiate for BNT122; 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,
enrolment 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. 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. In some cases,
forward-looking statements can be identified by terminology such as
“will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,”
“anticipates,” “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, including the data discussed in this
release, and including the possibility of unfavorable new
preclinical, clinical or safety data and further analyses of
existing preclinical, clinical or safety data; the nature of the
clinical data, which is subject to ongoing peer review, regulatory
review and market interpretation; the timing of and BioNTech's
ability to obtain and maintain regulatory approval for BioNTech's
product candidates; BioNTech's and its counterparties’ ability to
manage and source necessary energy resources; 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 development
candidates and investigational medicines; unforeseen safety issues
and potential claims that are alleged to arise from the use of
products and product candidates developed or manufactured by
BioNTech; BioNTech's and its collaborators’ ability to
commercialize and market, if approved, its product candidates;
BioNTech's ability to manage its development and expansion;
regulatory developments in the United States and other countries;
BioNTech's ability to effectively scale BioNTech's production
capabilities and manufacture BioNTech's products and BioNTech's
product candidates; risks relating to the global financial system
and markets; 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
BioNTechInvestor RelationsVictoria
Meissner, M.D.+1 617 528 8293Investors@biontech.de
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
1 Oettle, H. et al. Adjuvant chemotherapy with gemcitabine and
long-term outcomes among patients with resected pancreatic cancer:
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(2013).
2 Neoptolemos, J. P. et al. A randomized trial of
chemoradiotherapy and chemotherapy after resection of pancreatic
cancer. N. Engl. J. Med. 350, 1200–1210 (2004).
3 Rojas, L.A., Sethna, Z., Soares, K.C. et al. Personalized RNA
neoantigen vaccines stimulate T cells in pancreatic cancer. Nature
618, 144–150 (2023).
4 Siegel R.L., Miller K.D., Jemal A. Cancer statistics 2017. CA
Cancer J. Clin. 2017;67:7–30.
5 Stott, MC et al. Recent advances in understanding pancreatic
cancer. Fac Rev. 2022; 11: 9.
6 Strobel, O., Neoptolemos, J., Jäger, D. & Büchler, M. W.
Optimizing the outcomes of pancreatic cancer surgery. Nat. Rev.
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