IO Biotech Announces First Patient Dosed in Phase 2 Neoadjuvant/Adjuvant Solid Tumor Basket Trial
21 Décembre 2023 - 2:30PM
IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical
company developing novel, immune modulating therapeutic cancer
vaccines based on its T-win® platform, announced today that the
first patient has been dosed in its Phase 2 trial (NCT05280314)
studying treatment with IO102-IO103 in combination with Merck’s
anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in neoadjuvant and
adjuvant patients with resectable melanoma or squamous cell
carcinoma of the head and neck (SCCHN) before and after surgery
with curative intent.
“We continue to see promising data and a
favorable safety profile supporting use of our lead investigational
therapeutic cancer vaccine candidate, IO102-IO103, combined with
PD-1 inhibitors to treat various types of cancer, including
melanoma, lung cancer and head and neck cancer,” said Mai-Britt
Zocca, PhD, President and CEO of IO Biotech. “In patients with
advanced melanoma, the activity and tolerability profile of
IO102-IO103 and a PD-1 inhibitor has been demonstrated in the Phase
1/2 trial and we are now conducting a pivotal Phase 3 trial in
patients with advanced melanoma, with enrollment completed in that
study and an interim analysis planned in 2024. We are embarking on
this neoadjuvant/adjuvant trial with the goal of also helping
patients in earlier disease settings.”
Qasim Ahmad, MD, Chief Medical Officer of IO
Biotech, added, “The importance of systemic immunotherapy before
surgery is becoming a critical area of research, with the potential
to change early treatment paradigms. In this perioperative disease
setting, the IOB-032 study will provide clinical and translational
data on the activity of IO102-IO103 in combination with
pembrolizumab in patients with resectable melanoma and squamous
cell carcinoma of the head and neck. Dosing the first patient in
this trial demonstrates our commitment to further explore the
potential our therapeutic cancer vaccine may offer to a broader
group of patients with cancer. Leading global experts from centers
of excellence in this field in the US, Australia and Europe are
involved in this clinical trial. We look forward to following the
progress of this study.”
About IOB-032/PN-E40
IOB-032/PN-E40 (NCT05280314) is a Phase 2 basket
trial investigating the IO102-IO103 therapeutic cancer vaccine in
combination with pembrolizumab as neo-adjuvant/adjuvant treatment
of patients with solid tumors. The study will enroll up to 15
patients with melanoma, and 15 patients with SCCHN. Patients
entering the study will be scheduled for surgery and begin
neoadjuvant treatment 6 weeks prior. During the neoadjuvant period,
patients will receive IO102-IO103 weekly (6 doses) in combination
with pembrolizumab every 3 weeks (Q3W) (2 doses). After patients
recover from surgery (for up to 13 weeks) they will receive
adjuvant treatment with IO102-IO103 in combination with
pembrolizumab for 12 months. The primary endpoint will be the
percentage of patients with major pathologic response (MPR) in the
resected tumor tissue after neoadjuvant treatment.
About IO102-IO103
IO102-IO103 is an off-the-shelf, investigational
therapeutic cancer vaccine designed to kill both tumor cells and
immune-suppressive cells in the tumor microenvironment (TME), by
stimulating the activation and expansion of T cells against IDO+
and/or PD-L1+ cells. This results in the modulation of the TME,
creates a more pro-inflammatory environment, and potentiates
anti-tumor activity via unleashing the tumor killing by effector T
cells. The company is currently conducting a pivotal Phase 3 trial
(IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination
with pembrolizumab in first-line advanced melanoma patients, a
Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating
IO102-IO103 in combination with pembrolizumab as first-line
treatment in patients with advanced non-small cell lung cancer or
squamous cell cancer of the head and neck (SCCHN), and a Phase 2
basket trial (IOB-032/PN-E40; NCT05280314) evaluating IO102-IO103
plus pembrolizumab as a perioperative treatment in patients with
solid tumors, including melanoma and SCCHN.
The clinical trials are sponsored by IO Biotech,
conducted in collaboration with Merck and Merck is supplying
pembrolizumab. IO Biotech maintains global commercial rights to
IO102-IO103.
KEYTRUDA® is a registered trademark of Merck
Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.
About IO Biotech
IO Biotech is a clinical-stage biopharmaceutical
company developing therapeutic cancer vaccines based on its T-win®
cancer vaccine platform. The T-win platform is a novel approach to
cancer vaccines designed to activate T cells to target tumor cells
and immune-suppressive cells in the tumor microenvironment. IO
Biotech is advancing its lead cancer vaccine candidate,
IO102-IO103, in clinical trials, and additional pipeline candidates
through preclinical development. Based on positive Phase 1/2 first
line advanced melanoma data, IO102-IO103, in combination with
pembrolizumab, has been granted a breakthrough therapy designation
for the treatment of unresectable / metastatic melanoma by the US
Food and Drug Administration. IO Biotech is headquartered in
Copenhagen, Denmark and has US headquarters in New York, New
York.
For further information, please visit
www.iobiotech.com. Follow us on our social media channels on
LinkedIn and X (@IOBiotech).
Forward-Looking Statement
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Forward-looking statements, including
regarding the timing of the interim analysis of our Phase 3 trial,
the timing of our Phase 2 basket trials and other current and
future clinical trials, their progress, enrollment or results, or
the company’s financial position or cash runway, are based on IO
Biotech’s current assumptions and expectations of future events and
trends, which affect or may affect its business, strategy,
operations or financial performance, and actual results and other
events may differ materially from those expressed or implied in
such statements due to numerous risks and uncertainties.
Forward-looking statements are inherently subject to risks and
uncertainties, some of which cannot be predicted or quantified.
Because forward-looking statements are inherently subject to risks
and uncertainties, you should not rely on these forward-looking
statements as predictions of future events. These forward-looking
statements speak only as of the date hereof and should not be
unduly relied upon. Except to the extent required by law, IO
Biotech undertakes no obligation to update these statements,
whether as a result of any new information, future developments or
otherwise.
Company Contact:Maryann Cimino, Director of
Investor RelationsIO Biotech, Inc.617-710-7305mci@iobiotech.com
IO Biotech (NASDAQ:IOBT)
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