– Submission of Investigational New Drug Application (IND) to US FDA expected in 2025 – NEW YORK, Feb. 04, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, today announced the publication of results from a preclinical study of its second immune-modulatory therapeutic cancer vaccine candidate, IO112, targeting arginase 1 (Arg1), in the Journal for ImmunoTherapy of Cancer. These prec ...

Clinical Trial Progress - IO Biotech completed enrollment ahead of schedule for its Phase 2 basket trial (IOB-032/PN-E40) studying IO102-IO103 in combination with Merck's anti-PD-1 therapy, KEYTRUDA, for resectable melanoma and squamous cell carcinoma of the head and neck (SCCHN) [1] - The trial enrolled 93 patients across the United States, Europe, and Australia, with initial data expected in 2025 [2] - The primary endpoint is major pathologic response (MPR), defined as ≤10% residual viable tumor after neoadjuvant treatment [2] Trial Design and Cohorts - The Phase 2 trial includes three cohorts: Cohort A (18 melanoma patients), Cohort B (16 SCCHN patients), and Cohort C (59 melanoma patients randomized 1:1 to combination therapy or pembrolizumab alone) [4] - Neoadjuvant treatment is administered every 3 weeks for 2-3 cycles (SCCHN) or 3 cycles (melanoma), followed by surgery and 15 cycles of adjuvant treatment [4] - Cohort C patients with poor pathological response to pembrolizumab alone (>10% residual viable tumor) may cross over to combination treatment post-surgery [4] IO102-IO103 Overview - IO102-IO103 is an immune-modulatory, off-the-shelf therapeutic cancer vaccine designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment by stimulating T cells against IDO1 and PD-L1 positive cells [5] - The vaccine is being investigated in multiple clinical trials, including a pivotal Phase 3 trial for advanced melanoma and two Phase 2 basket trials for advanced solid tumors and neoadjuvant/adjuvant treatment of solid tumors [5] Company Background - IO Biotech is a clinical-stage biopharmaceutical company developing immune-modulatory therapeutic cancer vaccines based on its T-win platform, which targets tumor cells and immune-suppressive cells in the tumor microenvironment [7] - The company's lead candidate, IO102-IO103, has received Breakthrough Therapy Designation from the FDA for advanced melanoma in combination with pembrolizumab [7] Collaboration and Commercial Rights - The clinical trials are sponsored by IO Biotech in collaboration with Merck, which supplies pembrolizumab [6] - IO Biotech maintains global commercial rights to IO102-IO103 [6]

Funds expected to be used to advance IO Biotech’s immune-modulating therapeutic cancer vaccines, including potential BLA submission for IO102-IO103 in 2025Commitment is part of the European Investment Bank’s strategy to support biotech companies with cutting-edge expertise in therapeutic areas such as immuno-oncologyDebt facility expected to extend company’s cash runway into the second quarter of 2026 COPENHAGEN, Denmark and NEW YORK, Dec. 20, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-s ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Securities registered pursuant to Section 12(b) of the Act: FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-41008 IO Biotech, Inc. (Exa ...

Exhibit 99.1 IO Biotech Reports Third Quarter 2024 Financial Results and Provides Business Highlights • Pivotal Phase 3 trial (IOB-013/KN-D18) evaluating of -the-shelf therapeutic cancer vaccine IO102-IO103 in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced melanoma on track with primary endpoint of progression free survival (PFS) projected to be reached in first half of 2025 • Primary endpoint met in Phase 2 basket trial (IOB-022/KN-D38) cohort evaluating IO10 ...

Pivotal Phase 3 trial (IOB-013/KN-D18) evaluating off-the-shelf therapeutic cancer vaccine IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced melanoma on track with primary endpoint of progression free survival (PFS) projected to be reached in first half of 2025Primary endpoint met in Phase 2 basket trial (IOB-022/KN-D38) cohort evaluating IO102-IO103 in combination with pembrolizumab in the first-line treatment of advanced squamous cell carcinoma o ...

-- Metastatic non-small cell lung cancer (NSCLC) patients treated in the first line setting with IO102-IO103 in combination with Keytruda® demonstrated promising activity with an overall response rate of 55% unconfirmed/48% confirmed, disease control rate of 81%, and approximately 50% of patients without disease progression at 12 months; median duration of response not reached -- -- Safety profile consistent with prior studies with the combination, showing no unexpected toxicities compared to anti-PD1 monot ...

-- Study Meets Overall Response Rate Primary Endpoint, Encouraging Secondary Endpoint Progression-Free Survival Data in Squamous Cell Carcinoma of the Head and Neck Cohort -- -- No New Safety Signals or Added Systemic Safety Concerns Observed -- -- Data Presented at the European Society for Medical Oncology (ESMO) Congress -- NEW YORK, Sept. 14, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer ...

- Based on a per-protocol interim analysis of safety and efficacy data, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue without modifications - No new safety signals observed at interim analysis - Primary endpoint of progression free survival projected to be reached in the first half of 2025 NEW YORK, Aug. 30, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cance ...

NEW YORK, Aug. 26, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its Twin® platform, today announced that members of its senior management team will provide a corporate update and participate in one-on-one meetings at the following upcoming investor conferences: Event: Morgan Stanley 22nd Annual Global Healthcare Conference Location: New York, New York Fireside Chat Date & Time: Wednesda ...