- Preliminary analysis of data from an ongoing
investigator-initiated, single-center Phase 1 study supported by
BioNTech and Genentech and conducted at Memorial Sloan Kettering
Cancer Center, New York, United States
- Autogene Cevumeran, a fully individualized mRNA cancer
immunotherapy (iNeST) demonstrated that vaccine-induced immunity
significantly correlates with delayed tumor recurrence in patients
with resected pancreatic ductal adenocarcinoma
- Initial results suggest sequential combination of anti-PD-L1
checkpoint inhibitor atezolizumab with individualized cancer
therapy autogene cevumeran, and chemotherapy showed a favorable
safety profile, while the product candidate was feasibly
manufactured in a clinically relevant timeframe
- BioNTech and Genentech plan to jointly initiate a randomized
study of autogene cevumeran in adjuvant pancreatic
cancer
MAINZ, Germany and CHICAGO, June 5, 2022
(GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech”) today
announced initial data from an ongoing investigator-initiated
first-in-human Phase 1 study evaluating the safety and
tolerability of the mRNA-based individualized neoantigen specific
immunotherapy (iNeST) autogene cevumeran (also known as BNT122,
RO7198457) in combination with anti-PD-L1 immune checkpoint
inhibitor atezolizumab and chemotherapy in patients with resected
pancreatic ductal adenocarcinoma (PDAC). Feasibility of the process
of profiling each patient’s tumor to inform individualized vaccine
design and on-demand manufacturing of iNeST in a clinically
relevant timeframe was confirmed. The preliminary results showed a
favorable safety profile as well as encouraging signs of clinical
activity. The data have been presented at the American Society of
Clinical Oncology (“ASCO”) Annual Meeting 2022 by Vinod
Balachandran, M.D., at Memorial Sloan Kettering Cancer Center.
Autogene cevumeran is the lead candidate from BioNTech’s iNeST
platform, which is jointly developed together with Genentech, a
member of the Roche Group, in multiple solid tumor indications.
The data presented at the ASCO Annual Meeting
include a total of 19 patients who underwent surgery and received
atezolizumab. 16 out of these 19 patients (84%) received autogene
cevumeran at 9.4 weeks (median; 95% CI 9–10) after surgery. The
preliminary data readout from these 16 vaccinated patients revealed
that autogene cevumeran in combination with atezolizumab was
well-tolerated. Only 1 of 16 patients (6%) developed a
vaccine-related Grade 3 fever and hypertension, no other Grade 3 or
higher adverse events were observed. In addition, the treatment
induced de-novo, neoantigen-specific T cell response in half (8/16)
of these patients from undetectable levels to large fractions of
all blood T cells (median 2.9%). At an early median follow-up of 18
months, patients with de-novo immune response (n=8) had a
significantly longer recurrence-free survival (RFS) as compared to
those without vaccine-induced immune responses (n=8) (median not
reached vs. 13.4 months, HR 0.08, 95% CI 0.01-0.4, P = 0.003).
Based on these data, BioNTech and Genentech are planning a
randomized study to further evaluate the efficacy and safety of
autogene cevumeran in combination with atezolizumab and
chemotherapy in patients with resected PDAC.
“With only under 5 percent of patients
responding to current treatment options, PDAC is one of the highest
unmet medical need cancers. We are committed to take up this
challenge by leveraging our long-standing research in cancer
vaccinology and are trying to break new ground in the treatment of
such hard-to-treat tumors,” said Prof. Özlem Türeci, M.D.,
Co-Founder and Chief Medical Officer at BioNTech. “The results
of this Phase 1 study are encouraging. We look forward to further
evaluating these early results in a larger randomized study.”
The investigator-initiated, single-center, Phase
1 trial (NCT04161755) was designed to evaluate the treatment of the
companies’ individualized immunotherapy candidate autogene
cevumeran in combination with the anti-PDL-1 immune checkpoint
inhibitor atezolizumab as an add-on to the standard-of-care regimen
with adjuvant chemotherapy mFOLFIRINOX in patients with resected
PDACs. The primary objective of the study is to assess the safety.
Secondary objectives include the efficacy of the treatment measured
as the 18-month RFS, the immunogenicity as well as the feasibility
of the treatment regimen.
“Pancreatic cancer remains one of the deadliest
cancers as it is resistant to all treatments, including
immunotherapies. Conventional thinking has been that, as pancreatic
cancers have few mutations, the immune system is unlikely to
recognize mutation-derived neoantigens,” said Vinod
Balachandran, M.D., surgeon-scientist at Memorial Sloan
Kettering Cancer Center and Principal Investigator of the
study. “Our research, and now the results from this study show
that the immune system can recognize neoantigens in pancreatic
cancer, and that we can use mRNA vaccines to stimulate T cells to
recognize neoantigens in pancreatic cancer patients. We now look
forward to further investigating these results in a larger
randomized trial.”
BioNTech’s iNeST platform previously
demonstrated encouraging results with a tolerable safety profile of
autogene cevumeran as single agent and in combination with
atezolizumab in a heterogenous patient population with advanced and
heavily pretreated solid tumors. In a Phase1a/b trial autogene
cevumeran revealed robust CD8+ and CD4+ T cell responses and a
manageable safety profile (NCT03289962). In October 2021, BioNTech
announced that the first patient was dosed in a randomized Phase 2
trial (NCT04813627) of autogene cevumeran in the adjuvant treatment
of post-operative circulating tumor DNA (ctDNA) positive,
surgically resected colorectal cancer. BioNTech and Genentech are
also conducting a Phase II proof-of-concept study, which is
designed to evaluate autogene cevumeran plus pembrolizumab in the
first-line treatment of advanced melanoma (NCT03815058).
The abstract is available under the
following link: Title: Phase I Trial of
adjuvant autogene cevumeran, an Individualized mRNA Neoantigen
Vaccine, for Pancreatic Ductal Adenocarcinoma
- Poster: 172
- Abstract: 2516
About resected pancreatic ductal
adenocarcinoma (PDAC)PDAC is amongst the leading causes of
cancer-related deaths in the United States with ~90% of patients
dying within two years of their diagnosis. 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% in patients who undergo surgery followed by
adjuvant chemotherapy (ACT) and only 10% 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 (also known as 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 encapsuled 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 a first of its kind, 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 media
materials 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 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: 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.
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 AlatovicVP Corporate
Communications Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385
E-mail: Media@biontech.de
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