IO Biotech Completes Enrollment in Phase 2 Trial of its Investigational, Off-the-shelf Therapeutic Cancer Vaccine, IO102-IO103, as Neoadjuvant/Adjuvant Treatment for Patients with Resectable Melanoma or Head and Neck Cancer

-- Enrollment Completed Ahead of Schedule --

      -- Initial Data Expected in 2025 --

NEW YORK, Jan. 09, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, completed enrollment in its neoadjuvant/adjuvant Phase 2 basket trial (IOB-032/PN-E40). The trial is studying IO102-IO103, the company’s lead investigational therapeutic cancer vaccine candidate, in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), given before (neoadjuvant) and after (adjuvant) surgery with curative intent in patients with resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN).

“We are pleased to have completed enrollment early in this study, as it signifies an important step in exploring the potential of our investigational therapeutic cancer vaccine, IO102-IO103, across a range of solid tumors at an earlier stage of disease progression,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. “Our off-the-shelf cancer vaccine is designed to be a readily available option for patients and has demonstrated encouraging clinical activity without significant systemic toxicity across three first line advanced cancer indications – melanoma, lung cancer and head and neck cancer. With data from our Phase 3 trial in patients with advanced melanoma expected in the first half of 2025 and initial data from this Phase 2 basket trial also expected in 2025, we hope to add to the accumulating evidence of potential benefit of this combination therapy across a range of difficult-to-treat cancers.”

IOB-032/PN-E40, a multicenter, multi-cohort clinical trial, has enrolled 93 patients at sites in the United States, Europe, and Australia to evaluate anti-tumor activity, safety, and biomarker data of IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment in patients with resectable tumors. The primary endpoint is major pathologic response (MPR), which refers to reduction in viable tumor cells after treatment, defined as pCR (0% residual viable tumor) or near pCR (≤10% residual viable tumor) in the resected tumor tissue after neoadjuvant treatment (by central assessment). Secondary endpoints include pathological complete response (pCR), ORR, disease-free survival (DFS), event-free survival (EFS), and safety.

Qasim Ahmad, MD, Chief Medical Officer of IO Biotech, added, “The importance of systemic immunotherapy in the perioperative setting and its potential to change early treatment paradigms for a variety of cancers cannot be understated. This approach is being recognized as a critical opportunity to improve outcomes for patients by reducing the risk of recurrence and improving long-term survival. The interest we received from physicians and the rapid enrollment rate for this trial signifies the need for effective treatment options for patients with resectable melanoma and SCCHN. We are grateful to patients, families and investigators for their participation in this trial and for advancing the body of research for the oncology community.”

About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial

IOB-032/PN-E40 (NCT05280314) is a multicenter Phase 2 basket trial investigating the IO102-IO103 immuno-modulatory therapeutic cancer vaccine 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 IO102-IO103 with pembrolizumab. In cohort C, 59 melanoma patients were randomized 1:1 to either the combination of IO102-IO103 with pembrolizumab or pembrolizumab alone, with some patients still in screening, who, if they pass the entry criteria, will be allowed to join the study. 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.   

About IO102-IO103

IO102-IO103 is an investigational, immune-modulatory, 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 (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 IO102-IO103 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 IO102-IO103 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 IO102-IO103 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 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-modulatory 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 and expand 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, 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 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 timing or outcome of initial data from the IOB-032/PN-E40 study, the primary analysis of the company’s Phase 3 trial, 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.

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