IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical
company developing novel, off-the-shelf, immune-modulating
therapeutic cancer vaccines based on its T-win® platform, today
announced that an Independent Data Monitoring Committee (IDMC)
recommended continuation of the company’s pivotal Phase 3 trial
(IOB-013/KN-D18; NCT05155254) of its lead investigational
therapeutic vaccine, IO102-IO103, following a per-protocol interim
analysis. The trial is evaluating IO102-IO103 in combination with
KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, as a
first-line treatment for patients with unresectable or metastatic
(advanced) melanoma. Based on their review of the safety and
efficacy data, the IDMC recommended that the trial continue without
modifications and noted that no new safety signals were observed.
The primary endpoint of progression-free survival (PFS) is
projected to be reached in the first half of 2025.
The per-protocol interim analysis was performed
one year after 225 patients were randomized in the trial. The
interim efficacy analysis was intentionally set with a high
statistical bar (p≤0.005), and based on the analysis, the IDMC
determined that the data did not meet the criteria to declare
superiority of ORR. The trial was designed to preserve most of the
statistical alpha for the trial’s primary endpoint of PFS. The PFS
analysis is event-driven and will be conducted when 226 events
(disease progression or death) have been reported in the trial with
independent central review. With 407 patients randomized, the trial
is powered at 89% to detect a 35% reduction in the risk of an
event.
“To date, none of the approved immunotherapeutic
combinations for the treatment of advanced melanoma demonstrated
statistical significance in ORR in large Phase 3 trials;
nevertheless, these trials achieved statistical significance on
PFS,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech.
“Based on the 25.5 months median PFS we observed in the Phase 1/2
trial of IO102-IO103 in combination with a PD-1 inhibitor in
advanced melanoma, with no added significant systemic toxicity than
that typically seen with anti-PD-1 monotherapy, we remain
optimistic about meeting the primary endpoint of PFS, projected to
occur in the first half of 2025.”
Igor Puzanov, MD, MSCI, FACP, Director, Center
for Early Phase Clinical Trials, Chief, Division of Melanoma,
Department of Medicine and Investigator for the Phase 3 Study at
Roswell Park Comprehensive Cancer Center, Buffalo, New York
commented, “The incidence of melanoma is on the rise and new
treatments are needed. This is a novel investigational
immune-modulatory therapeutic cancer vaccine combined with an
anti-PD-1 therapy that has the potential to transform the treatment
paradigm with a new and better option for people battling advanced
melanoma. I am eagerly awaiting the PFS primary endpoint readout of
this Phase 3 trial that could further validate this novel cancer
vaccine’s ability to help patients with advanced melanoma who are
seeking more efficacious, low treatment-induced toxicity therapy
options.”
Jessica Hassel, MD, Head of the Section for
Dermato-Oncology at the University Hospital Heidelberg,
investigator and lead enroller for the Phase 3 trial added, “We
have been seeing promising results using combination
immunotherapeutic treatments and I remain confident that
IO102-IO103 in combination with pembrolizumab could offer new hope
for treating patients with advanced melanoma. I look forward to the
full readout of data at the end of this trial to further understand
the full potential of this investigational therapeutic cancer
vaccine combined with an anti-PD-1 agent.”
Dr. Zocca continued, “We continue to be
enthusiastic about the encouraging preliminary data from our Phase
2 basket trial evaluating IO102-IO103 in combination with
pembrolizumab for the treatment of metastatic non-small cell lung
cancer (NSCLC) or recurrent or metastatic squamous cell carcinoma
of the head and neck (SCCHN). Data from the SCCHN cohort has been
accepted for poster presentation at the ESMO congress, and data
from the NSCLC cohort has been accepted to another medical meeting
in the fall. We believe these data could provide further evidence
to support the broader potential of therapeutic cancer vaccines for
the benefit of patients in additional cancer indications.”
About the IOB-013/KN-D18 Clinical
Trial
IOB-013/KN-D18 (Clinical Trials.gov:
NCT05155254) is an open label, randomized Phase 3 pivotal clinical
trial of IO102-IO103 in combination with pembrolizumab versus
pembrolizumab alone in patients with previously untreated,
unresectable or metastatic (advanced) melanoma. A total of 407
patients have been enrolled from more than 100 centers across the
United States, Europe, Australia, Turkey, Israel and South Africa.
The primary endpoint of the study is progression-free survival, an
event-driven analysis conducted when 226 events, defined as disease
progression or death, have been reported in the study. Secondary
endpoints include overall response rate (ORR), overall survival
(OS), durable objective response (DRR), complete response rate
(CRR), duration of response (DoR), time to complete response
(TTCR), disease control rate (DCR), and incidence of AEs and SAEs
(safety and tolerability). Biomarkers in the blood and tumor tissue
will also be assessed. IO Biotech is sponsoring the Phase 3 trial
and Merck is supplying pembrolizumab.
About IO102-IO103
IO102-IO103 is an investigational off-the-shelf
therapeutic cancer vaccine designed to kill both tumor cells and
immune-suppressive cells in the tumor microenvironment (TME) by
stimulating activation and expansion of T cells against indoleamine
2,3-dioxygenase (IDO) positive and/or programmed death-ligand 1
(PD-L1) positive cells. The company is currently conducting a
pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating
IO102-IO103 in combination with pembrolizumab versus pembrolizumab
alone in patients with advanced melanoma, a Phase 2 basket trial
(IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in
combination with pembrolizumab as first line treatment in patients
with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40;
NCT05280314) investigating IO102-IO103 in combination with
pembrolizumab as neo-adjuvant/adjuvant treatment of patients with
solid tumors.
The clinical trials are sponsored by IO Biotech
and conducted in collaboration with Merck, which 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 novel, immune-modulating therapeutic cancer
vaccines based on its T-win® platform. The T-win platform is based
on a novel approach to cancer vaccines designed to activate T cells
to target the immunosuppressive 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 metastatic melanoma data, IO102-IO103, in
combination with pembrolizumab, has been granted a breakthrough
therapy designation for the treatment of advanced 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 completion of the company’s Phase 3
trial, current or future clinical trials, their progress,
enrollment or results, timing of submission of marketing
applications, 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.
Contact:InvestorsMaryann
Cimino, Director of Investor Relations IO Biotech,
Inc.617-710-7305mci@iobiotech.com
MediaJulie Funesti, National Health
MediaEdelman917-498-1967Julie.Funesti@salutemcomms.com
IO Biotech (NASDAQ:IOBT)
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