BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody
Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO
- BNT316/ONC-392 is a next-generation
anti-CTLA-4 monoclonal antibody candidate jointly developed by
BioNTech and OncoC4 as monotherapy or combination therapy in a
range of solid tumor indications, including non-small cell lung
cancer (NSCLC)
- Interim data of BNT316/ONC-392 from
the ongoing Phase 1/2 trial to be presented at this year’s ASCO
Annual Meeting demonstrate encouraging signs of clinical anti-tumor
activity and a manageable safety profile in patients with
metastatic, PD-(L)1-resistant NSCLC
- Initiation of a pivotal Phase 3
trial with BNT316/ONC-392 as monotherapy in immunotherapy-resistant
NSCLC patients is planned in Q3 2023, following FDA’s Fast Track
designation in 2022
- Lung cancer remains one of the most
commonly diagnosed malignant cancer types and the leading cause of
cancer deaths worldwide, with NSCLC1 making up approximately 85% of
all lung cancers
MAINZ, Germany, and ROCKVILLE, Maryland,
USA, June 2, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq:
BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”), today announced
positive preliminary data from the ongoing Phase 1/2 trial with the
companies’ anti-CTLA-4 antibody candidate, BNT316/ONC-392
(gotistobart), in a patient cohort with metastatic,
PD-(L)1-resistant non-small cell lung cancer (“NSCLC”). The
preliminary results show encouraging clinical anti-tumor activity
for BNT316/ONC-392 as a monotherapy in a hard-to-treat patient
population, as well as a manageable safety profile. The data will
be presented in a poster discussion session at the 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting by Kai He, M.D.,
Ph.D., Pelotonia Institute for Immuno-Oncology, The Ohio State
University Comprehensive Cancer Center – Arthur G. James Cancer
Hospital and Richard J. Solove Research Institute, Columbus, Ohio,
USA.
The results featured at the ASCO Annual Meeting
include a total of 27 patients with metastatic, PD-(L)1-resistant
NSCLC, available for tumor response assessment who have received at
least two doses of 10 mg/kg of BNT316/ONC-392. At data cut-off, the
overall response rate (“ORR”) among evaluable patients was 29.6%,
with a disease control rate (“DCR”) of 70.4%, including 1 complete
response, 7 partial responses and 11 patients with stable disease.
BNT316/ONC-392 continues to be well tolerated with a manageable
safety profile. Immune-related adverse events (irAE) of Grade 3 and
4 were observed in 10 patients (30%), which is considered lower
than what was reported for similar drugs.
“Metastatic NSCLC has a very poor prognosis with
a 5-year survival rate of only 9%2. These new data highlight the
potential of BNT316/ONC-392 to provide a new approach to leveraging
CTLA-4 as an effective target to address advanced, hard-to-treat
tumors, further broadening our oncology toolkit,” said
Prof. Özlem Türeci, M.D., Chief Medical Officer and
Co-Founder at BioNTech. “Our goal is to accelerate the
development of this program in NSCLC towards pivotal Phase 3
evaluation in line with our mission of providing the optimal
therapeutic strategy for each cancer patient.”
“The clinical activity and safety profile
validate the improved therapeutic index of BNT316/ONC-392,” said
Pan Zheng, M.D., Ph.D. Chief Medical Officer and Co-Founder
at OncoC4. “We are especially encouraged by the readouts
from the PD-(L)1-resistant NSCLC. Responses were observed
regardless of PD-L1 status, and among those who failed multiple
lines of immunotherapy and chemotherapy, including PD-1 and CTLA-4
combination therapy.”
Lung cancer remains one of the most commonly
diagnosed malignant cancer types and the leading cause of cancer
deaths worldwide, with NSCLC1 making up approximately 85% of all
lung cancers. The new data further support the initiation of a
pivotal Phase 3 study with BNT316/ONC-392 as monotherapy for
immunotherapy-resistant NSCLC, for which the candidate received
Fast Track designation from the U.S. Food and Drug Administration
(“FDA”) in 2022. The Phase 3 trial, PRESERVE-003 (NCT05671510), is
planned to start in Q3 2023.
About
BNT316/ONC-392BNT316/ONC-392 (gotistobart) is a
next-generation anti-CTLA-4 antibody candidate jointly developed by
BioNTech and OncoC4. BNT316/ONC-392 is currently in late-stage
clinical development as monotherapy or combination therapy in
various cancer indications. The immune checkpoint receptor CTLA-4
inhibits T cell immune response and reduces the activity of T cells
in recognizing and eliminating cancer cells. Blocking CTLA-4
preserves T cell activity and enhances anti-tumor activity.
BNT316/ONC-392 was designed to preserve CTLA-4 recycling and thus
immunosuppressive T cells (regulatory T cells, or “Tregs”) function
in the peripheral tissues. This aims to give rise to fewer
immune-related adverse effects and a more favorable safety profile.
BNT316/ONC-392 is currently being evaluated in an ongoing Phase 1/2
trial (NCT04140526) in patients with advanced solid tumors as
single agent or in combination with pembrolizumab. In addition, the
candidate is also being evaluated in an additional Phase 2 trial as
a combination therapy with pembrolizumab in platinum-resistant
ovarian cancer (NCT05446298).
About NSCLCNon-small cell lung
cancer (NSCLC) covers all epithelial lung cancers other than small
cell lung cancer and includes squamous cell carcinoma, large cell
carcinoma, and adenocarcinoma. It is the most common type of lung
cancer, accounting for up to 85% of cases1, with risk factors
ranging from smoking to asbestos exposure and pulmonary fibrosis3.
With a 5-year relative survival rate of 23% in the United States
(2012-2018), NSCLC is a devastating disease with limited treatment
options depending on the stage and location of the tumor.3 Current
standard of care includes surgery and radiotherapy in combination
with chemotherapy.3
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 immune checkpoint 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.
About OncoC4
Based in Rockville, Maryland, OncoC4 is a
privately held, late clinical-stage biopharmaceutical company that
is actively engaged in the discovery and development of novel
biologicals for cancer treatment. Its lead clinical candidate is
ONC-392, a next generation anti-CTLA-4 antibody that allows CTLA-4
to recycle and maintain its protective function against autoimmune
diseases while enhancing anti-tumor activity at the same time. In
addition, OncoC4 has a pipeline of first-in-class preclinical
product candidates focusing on the CD24-Siglecs cancer immune
evasion pathway.
More information: www.oncoc4.com.
BioNTech Forward-Looking
StatementsThis press release contains “forward-looking
statements” of BioNTech 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 collaboration with OncoC4, Inc., the
ability of the anti-CTLA-4 monoclonal antibody candidate
BNT316/ONC-392 to eliminate immunosuppressive regulatory T cells
and enhance anti-tumor activity in various cancer indications; the
development of BNT316/ONC-392 as a monotherapy or combination
therapy in various cancer indications; the timing and success of a
Phase 3 study evaluating BNT316/ONC-392 as a monotherapy against
the current standard of care in PD-1-resistant NSCLC; and the
timing and success of a Phase 2 trial of BNT316/ONC-392 as a
combination therapy with pembrolizumab in platinum-resistant
ovarian cancer. 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: the ability of BioNTech to develop and, if
approved, commercialize these potential immunotherapies.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Quarterly Report on Form 6-K for the
quarter ended March 31, 2023, filed with the U.S. Securities and
Exchange Commission (“SEC”) on May 8, 2023, 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
BioNTechInvestor
RelationsVictoria Meissner, M.D.+1 617 528
8293Investors@biontech.de
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
OncoC4Investor RelationsMartin
Devenportmdevenport@oncoc4.com
Media RelationsHelen
Schiltzhschiltz@oncoc4.com
1 CA Cancer J Clin. 2021 May;71(3):209-2492
https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html
3
https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_37_toc
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