BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of
BNT316/ONC-392 Program in Metastatic NSCLC
-
Initiation of pivotal Phase 3 trial in non-small cell lung
cancer (NSCLC) marks the first landmark in BioNTech’s and OncoC4’s
strategic collaboration initiated in March 2023 with the aim to
evaluate BNT316/ONC-392 in various solid tumor indications
- The randomized Phase 3 trial is expected to enroll
approximately 600 patients with metastatic, immunotherapy-resistant
NSCLC at clinical trial sites initially in the United States,
followed by Europe and other countries and regions
- The trial initiation follows the FDA Fast Track Designation
granted in 2022, based on Phase 1/2 safety and efficacy data for
the monotherapy in metastatic, immunotherapy-resistant NSCLC
- BNT316/ONC-392 is entering the pivotal clinical evaluation as
part of BioNTech’s strategy to initiate multiple trials with
registrational potential in 2023 and 2024
MAINZ, Germany, and ROCKVILLE, Maryland, USA,
June 29, 2023 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX,
“BioNTech”) and OncoC4, Inc. (“OncoC4”) today announced that the
first patient with non-small cell lung cancer (NSCLC) has been
treated in a pivotal Phase 3 trial evaluating the companies’
next-generation anti-CTLA-4 antibody candidate BNT316/ONC-392
(gotistobart). The trial is part of BioNTech’s strategy to initiate
multiple pivotal trials in 2023 and 2024.
The two-stage, open-label, randomized Phase 3
trial, PRESERVE-003 (NCT05671510), will assess the efficacy and
safety of BNT316/ONC-392 as monotherapy compared to the
standard-of-care chemotherapy (docetaxel) in patients with
metastatic NSCLC that progressed under previous PD-(L)1-inhibitor
treatment. Approximately 600 patients are planned to be enrolled at
clinical sites in the United States, Europe and other countries and
regions, including Belgium, Germany, Italy, Spain, and Türkiye. The
primary endpoint measure will be overall survival. Secondary
endpoints include overall response rate, progression-free survival
and adverse event profile. The program received Fast Track
Designation from the U.S. Food and Drug Administration (FDA) in
2022 and represents an innovative approach which aims to leverage
the full potential of CTLA-4-targeting therapies.
“We believe this investigational treatment has
the potential to become a new option for patients with late-stage
NSCLC who have an otherwise poor prognosis. Given its specific mode
of action, this treatment approach may also be applicable in a
synergistic combination with other immunotherapeutic modalities to
provide benefit to further patient populations,” said Prof.
Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at
BioNTech. “We are committed to rapidly advancing our oncology
pipeline towards late-stage development for multiple product
candidates in cancer indications with high unmet medical need.”
“Today represents a significant landmark for the
differentiated program we developed with BNT316/ONC-392, aiming to
overcome current challenges of CTLA-4-targeting cancer therapeutics
and in particular the very narrow therapeutic window that restricts
them from delivering on their full potential,” said Pan Zheng,
M.D., Ph.D., Chief Medical Officer and Co-Founder at OncoC4.
“With less than three years from first-in-human dosing to Phase 3
initiation, we are hopeful these results will build on the
responses we have seen so far.”
The initiation of the Phase 3 trial is based on
positive safety and efficacy data from an ongoing Phase 1/2 study
(NCT04140526) with BNT316/ONC-392 alone and in combination with
pembrolizumab in patients with advanced solid tumors. Follow-up
data recently presented at the ASCO 2023 Annual Meeting demonstrate
an encouraging anti-tumor activity and a manageable safety profile
for BNT316/ONC-392 in a patient cohort with metastatic,
anti-PD-(L)1-resistant NSCLC.
The Phase 3 trial initiation marks the first
landmark of BioNTech’s and OncoC4’s strategic collaboration
initiated in March 2023. Under the terms of the collaboration
agreement, OncoC4 received a $200 million upfront payment and is
eligible to receive development, regulatory and commercial
milestone payments as well as double-digit tiered royalties.
BioNTech and OncoC4 will jointly develop BNT316/ONC-392 as
monotherapy and in combination with anti-PD-(L)-1 antibodies in a
range of solid tumor indications until regulatory authorization,
with the parties equally sharing development costs for such
studies. Combinations outside of PD-1 inhibition, in particular all
combinations with a compound in BioNTech’s pipeline, will be solely
developed by BioNTech. BioNTech will hold the exclusive worldwide
commercialization rights for any of these products with
participation of OncoC4 in certain markets to be negotiated in the
future.
About BNT316/ONC-392
(gotistobart)BNT316/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 cells1. This mechanism is also exploited by
cancer cells to prevent them from being eliminated by T cells2.
Blocking CTLA-4 may help to preserve T cell activity and enhance
anti-tumor activity. BNT316/ONC-392 was designed with the aim to
address this mechanism while preserving CTLA-4 recycling and thus
the immunosuppressive T cell (regulatory T cells, or “Tregs”)
function in the peripheral tissues. This approach, which is
currently in clinical evaluation, 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, PRESERVE-001, (NCT04140526) in patients with advanced solid
tumors as single agent or in combination with pembrolizumab. An
ongoing registrational Phase 3 trial, PRESERVE-003 (NCT05671510)
evaluates the candidate as monotherapy in patients with metastatic,
immunotherapy-resistant non-small cell lung cancer (NSCLC). In
addition, the candidate is also being evaluated in a 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 of the lung. It is the most common
type of lung cancer, accounting for up to 85% of cases3, with risk
factors ranging from smoking to asbestos exposure and pulmonary
fibrosis4. 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 tumor4. Current standard of care includes surgery, radiotherapy
in combination with chemotherapy and immunotherapy5.
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
DualityBio, Fosun Pharma, Genentech, a member of the Roche Group,
Genevant, Genmab, OncoC4, Regeneron, Sanofi, 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
BNT316/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, size
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; the timing and success of a Phase 2 trial of BNT316/ONC-392
as a combination therapy with pembrolizumab in platinum-resistant
ovarian cancer; and the timing of BioNTech’s strategy to initiate
trials with registrational potential for multiple oncology
candidates in 2023 and 2024. 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 Front Oncol. 2018 Mar 28;8:86 published
online, doi: 10.3389/fonc.2018.00086.2 Front. Immunol., 2021 Aug.
31; Vol. 12 – 2021; https://doi.org/10.3389/fimmu.2021.651634
3 CA Cancer J Clin. 2021 May;71(3):209-2494
https://www.cancer.gov/types/lung/hp/non-small-cell-lung-treatment-pdq#_37_toc
5
https://www.cancer.org/cancer/types/lung-cancer/treating-non-small-cell/by-stage.html
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