IO Biotech Announces Achievement of Significant Phase 3 Clinical Trial Recruitment Milestone
June 14 2023 - 7:00AM
IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical
company developing novel, immune-modulating cancer vaccines based
on its T-win® technology platform, announced today that it has
randomized 225 patients in its global Phase 3 clinical trial for
IO102-IO103, in combination with KEYTRUDA® (pembrolizumab), Merck’s
anti-PD-1 therapy, in patients with advanced melanoma. This
clinical milestone is significant as the Phase 3 trial protocol
calls for an interim analysis of overall response rate one year
after 225 patients have been enrolled. Data obtained from this
interim analysis, if positive, could allow for submission of a
Biologics License Application for an accelerated approval in the
United States.
Additionally, the company announced that it is
increasing the number of patients to be enrolled in the Phase 3
trial to 380 patients, which could potentially accelerate the time
to reach the primary end point of progression free survival. If the
data are supportive, the PFS endpoint would serve as the basis for
submitting marketing applications on a global basis.
“I am very proud to announce today that we have
hit this critical enrollment milestone in our global Phase 3
clinical trial as planned,” said Mai-Britt Zocca, Ph.D., President
and CEO of IO Biotech. “The enthusiasm for this trial in cancer
care centers in Europe, Australia, South Africa, Israel, and the
United States is a testament to the need for improved outcomes for
patients with advanced melanoma. With the momentum of enrollment
building in this trial, we are taking the opportunity to increase
the target for full enrollment by 80 patients, which will
potentially accelerate the timeline to the primary endpoint of PFS.
Even with this increase in target enrollment to 380 patients, we
continue to expect to reach full enrollment in this trial by the
end of this year and we continue to expect our cash to support our
activities through the third quarter of 2024.”
Dr. Zocca continued, “Our full team continues to
work diligently to develop novel vaccines that have the potential
to significantly improve the current treatment paradigm for people
with cancer. Should the interim analysis for this Phase 3 trial be
positive, we have the potential to have our first vaccine candidate
approved and available for patients in 2025 – this is an exciting
time in the evolution of IO Biotech.”
About IO102-IO103
IO102-IO103 is an investigational
immune-modulating cancer vaccine designed to target the
immunosuppressive mechanisms mediated by the key immunosuppressive
proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1.
About the IOB-013/KN-D18 Phase 3 Clinical
Trial
IOB-013/KN-D18 (Clinical Trials.gov:
NCT05155254) is an open label, randomized Phase 3 clinical trial of
IO102-IO103 in combination with pembrolizumab versus pembrolizumab
alone in patients with previously untreated, unresectable or
metastatic (advanced) melanoma, being conducted in collaboration
with Merck. Target enrollment is 380 patients from centers spread
across the United States, Europe, Australia, Israel and South
Africa. Biomarker analyses will also be conducted. IO Biotech is
sponsoring the Phase 3 trial 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 novel, immune-modulating cancer vaccines based
on its T-win® vaccine platform. The T-win platform is a novel
approach to cancer vaccines designed to activate T cells to target
the most important immunosuppressive cells in the tumor
microenvironment. IO Biotech is advancing in clinical studies its
lead cancer vaccine candidate, IO102-IO103, targeting IDO and
PD-L1, and through preclinical development its other pipeline
candidates. IO Biotech is headquartered in Copenhagen, Denmark and
has US headquarters in New York, New York.
For further information, please visit
www.iobiotech.com.
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,
current or 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
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