Full Press Release Details
IO Biotech Reports 2024 Business Highlights
New York, NY March 4, 2025: IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company
developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today reported business highlights for the fourth quarter of 2024.
We accomplished significant milestones in 2024 as we continue to rapidly advance our clinical programs investigating the benefits of Cylembio for the treatment of patients with advanced melanoma, metastatic head and neck cancer, and metastatic lung cancer, said Mai-Britt Zocca, PhD, President
and CEO of IO Biotech. With the primary endpoint readout of our pivotal Phase 3 trial investigating Cylembio in combination with pembrolizumab for patients with advanced melanoma now expected in the third quarter, we expect 2025 could be an
exciting year for IO Biotech. Pending positive data, we expect to submit a BLA to the US FDA by the end of the year and a potential launch in the US in 2026.
Dr. Zocca continued, There is still a significant unmet medical need for new treatment options for patients suffering from advanced melanoma,
metastatic head and neck cancer, and metastatic lung cancer. The full IO Biotech team is proud to be leading the next frontier of immune-oncology with the development of therapeutic cancer vaccines for these and other
difficult-to-treat cancers. Our investigational therapeutic cancer vaccines are designed with a unique mechanism of action capable of targeting both immune-suppressive
cells in the tumor microenvironment (TME) and cancer cells, which have demonstrated promising activity when combined with an anti-PD-1 therapy. We look forward to
potentially commercializing a first-in-class immune-modulatory, off-the-shelf therapeutic
cancer vaccine that could be delivered to cancer patients when treatment is needed.
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Fourth Quarter 2024 and other Recent Highlights
Cylembio (imsapepimut and
etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate 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 1 (IDO1) 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
Cylembio in combination with Merck s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab
alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line
treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the three ongoing company-sponsored clinical trials is now complete.
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 Cylembio.
Cylembio is a registered trademark of IO Biotech ApS, a
subsidiary of IO Biotech.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial
IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating
Cylembio in combination with Merck s anti-PD-1 therapy, KEYTRUDA (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. Top-line data readout is expected in the third quarter of
2025. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious
adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.
About IOB-022/KN-D38 Phase
2 Solid Tumor Basket Trial
IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of Cylembio in combination with Merck s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in the first-line treatment of metastatic non-small cell lung
cancer (NSCLC) or metastatic squamous cell carcinoma of the head and neck (SCCHN) at sites in the United States, Spain, and the United Kingdom. IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.
About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial
IOB-032/PN-E40 (NCT05280314) is a multicenter Phase 2 basket trial
investigating Cylembio in combination with Merck s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) as neo-adjuvant/adjuvant treatment of patients with solid tumors at sites in Australia, the United States, France, Germany, Spain, and
Denmark. The study completed enrollment in all cohorts: 18 patients with melanoma in cohort A and 16 patients with SCCHN in cohort B, both as single arm cohorts receiving combination of Cylembio with pembrolizumab. In cohort C, 61 melanoma patients
were randomized 1:1 to either the combination of Cylembio with pembrolizumab or pembrolizumab alone. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment
with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>10% residual viable tumor) may cross over to combination treatment
post-surgery. The primary endpoint is major pathological response at surgery ( 10% residual viable tumor; central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.
IO Biotech is a clinical-stage
biopharmaceutical company developing novel, immune-modulatory, off-the-shelf 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 both tumor cells and the
immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, Cylembio , 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 Merck s anti-PD-1 therapy, KEYTRUDA (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.
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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 expected timing of the top-line data from, or outcome of, the company s Phase 3 trial, the timing
regarding submission of a BLA, the timing regarding launch of Cylembio, the timing or outcome of other 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.
Maryann Cimino, Director of Investor Relations