Three-year Phase 1 Follow-Up Data for mRNA-based Individualized
Immunotherapy Candidate Show Persistence of Immune Response and
Delayed Tumor Recurrence in Some Patients with Resected Pancreatic
Cancer
- Three-year follow-up data of an
investigator-initiated Phase 1 trial of the individualized mRNA
cancer vaccine candidate autogene cevumeran (BNT122, RO7198457)
continue to show polyspecific T cell responses up to three
years and delayed tumor recurrence in patients with resected
pancreatic ductal adenocarcinoma (“PDAC”)
- A randomized Phase 2 clinical
trial with autogene cevumeran in patients with resected PDAC is
currently enrolling patients at clinical trial sites in the United
States, with additional sites planned to open globally
- The medical need in PDAC is high
with a 5-year overall survival rate of only
8-10%1,2, high
recurrence rates after surgery at nearly 80%3
and limited treatment options
- Autogene cevumeran, jointly
developed by BioNTech and Genentech Inc. (“Genentech”),
a member of the Roche Group, is the lead candidate of BioNTech’s
mRNA-based individualized cancer vaccine platform iNeST and
currently being evaluated in three ongoing randomized Phase 2
clinical trials in adjuvant PDAC, first-line melanoma, and adjuvant
colorectal cancer
MAINZ, Germany, April 7, 2024
- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”)
today announced three-year follow-up data from a Phase 1 trial with
the mRNA-based individualized neoantigen-specific immunotherapy
(“iNeST”) candidate autogene cevumeran (also known as BNT122,
RO7198457) in patients with resected pancreatic ductal
adenocarcinoma (“PDAC”). The data show that in 8 out of 16 patients
autogene cevumeran elicited an immune response up to three years
post administration measured by activated T cells. The persistence
of T cels was associated with a longer median recurrence-free
survival in cancer vaccine responders.
“These new data are an early signal for the
potential of our individualized mRNA cancer vaccine approach in
this indication with an unmet medical need. The results indicate
that our uridine mRNA-LPX technology can promote activation of
cytotoxic T cells that may help to eliminate residual tumor foci at
early stages of the disease to delay or prevent recurrence,” said
Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical
Officer at BioNTech. “Our ongoing Phase 2 trial with Genentech
aims to confirm these findings on benefit for patients with PDAC
compared with the current standard of care treatment in the
post-surgical, adjuvant setting in a larger patient population. We
remain committed to our vision of personalized cancer medicine and
aim to help advance the standard of care for many patients.”
The results featured in an oral presentation at
the American Association for Cancer Research (“AACR”) Annual
Meeting 2024 show the following:
- In 8 of 16 patients, autogene cevumeran elicited high-magnitude
T cells specific to the encoded neoantigens.
- 98% of the T cells targeting individual neoantigens on the
tumor and induced by autogene cevumeran were de novo in that they
were not detected in blood, tumors, and adjacent tissues prior to
administration of the investigational treatment.
- Over 80% of the vaccine-induced neoantigen-specific T cells
could still be detected up to three years post administration in
patients with an immune response. These patients showed a prolonged
median recurrence-free survival compared to non-responders.
- 6 of 8 patients with an immune response to autogene cevumeran
remained disease free during the three-year follow-up period, while
7 of the 8 patients without an immune response to the treatment
during the trial showed tumor recurrence.
The investigator-initiated, single center Phase
1 trial (NCT04161755) evaluated the safety of autogene cevumeran in
sequential combination with the anti-PD-L1 immune checkpoint
inhibitor atezolizumab and standard-of-care chemotherapy in 16
patients with resected PDAC. Data from the 1.5-year median
follow-up were published in Nature in May 2023. The current data
update includes a three-year median follow-up and was presented in
a late-breaking oral presentation at the AACR Annual Meeting 2024
in San Diego, California, by principal investigator Vinod
Balachandran, M.D., surgeon-scientist at Memorial Sloan Kettering
Cancer Center and principal investigator of the study.
An ongoing open-label, multicenter, randomized
Phase 2 trial (NCT05968326), sponsored by Genentech in
collaboration with BioNTech, was started in October 2023. The trial
will investigate the efficacy and safety of adjuvant autogene
cevumeran in combination with the anti-PD-L1 immune checkpoint
inhibitor atezolizumab and chemotherapy compared with the current
standard of care chemotherapy (mFOLFIRINOX) in patients with PDAC.
The Phase 2 trial is currently enrolling patients at clinical trial
sites in the United States, with additional sites planned to open
globally. Autogene cevumeran is being jointly developed by BioNTech
and Genentech and is currently being evaluated in three ongoing
randomized Phase 2 clinical trials in adjuvant PDAC (as mentioned
above), first-line melanoma, and adjuvant colorectal cancer.
-----
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%i,ii in those who do not
receive ACT. Thus, there is an unmet medical need for novel
therapies for patients with resected PDAC.
About
iNeST (individualized Neoantigen Specificimmuno Therapy)
iNeST immunotherapies are investigational 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 of helping the immune system recognize
the cancer. For this purpose, BioNTech has developed an on-demand
manufacturing process, following Good Manufacturing Practice (GMP)
conditions. Autogene cevumeran is currently being evaluated in
various solid tumor indications, including three Phase 2 clinical
trials in first-line melanoma, adjuvant colorectal cancer, and
adjuvant pancreatic ductal adenocarcinoma.
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 BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next
generation immunotherapy company pioneering novel therapies for
cancer and other serious diseases. BioNTech 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 and specialized pharmaceutical collaborators,
including Biotheus, DualityBio, Fosun Pharma, Genentech, a member
of the Roche Group, Genevant, Genmab, OncoC4, Pfizer and
Regeneron.
For more information, please visit
www.BioNTech.com.
BioNTech Forward-Looking Statements
This 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 individualized neoantigen
specific immunotherapy (“iNeST”) program candidate autogene
cevumeran (BNT122, RO7198457); the initiation, timing, progress and
results of BioNTech’s research and development programs in
oncology, including the targeted timing and number of additional
potentially registrational trials; the registrational potential of
any trial BioNTech may initiate for BNT122; BioNTech’s current and
future preclinical studies and clinical trials in oncology,
including autogene cevumeran in patients with resected PDAC; the
nature and characterization of and timing for release of clinical
data; the planned next steps in BioNTech’s pipeline programs,
including, but not limited to, statements regarding timing or plans
for initiation or enrollment of clinical trials, 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; and the potential safety and efficacy of
BioNTech’s product candidates. 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 based on BioNTech’s current expectations and beliefs of
future events, and are neither promises nor guarantees. 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 and adversely
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 clinical data, which is
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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 Annual
Report on Form 20-F for the year ended December 31, 2023 and in
subsequent filings made by BioNTech with the SEC, which are
available on the SEC’s website at www.sec.gov. These
forward-looking statements speak only as of the date hereof. Except
as required by law, BioNTech disclaims any intention or
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statements contained in this press release in the event of new
information, future developments or otherwise.
CONTACTS
Investor Relations
Victoria Meissner, M.D.
+1 617 528 8293
Investors@biontech.de
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1 Oettle, H. et al. Adjuvant
chemotherapy with gemcitabine and long-term outcomes among patients
with resected pancreatic cancer: the CONKO-001 randomized trial.
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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.
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