Core Insights - IO Biotech is preparing to present an update on the development and launch of its investigational cancer vaccine, Cylembio™, at the 45th Annual Cowen Health Care Conference scheduled for March 3-5, 2025 [1][2] - The company is conducting pivotal Phase 3 and Phase 2 clinical trials for Cylembio™, which targets advanced melanoma and other solid tumors in combination with Merck's KEYTRUDA [3][4][5] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines using its T-win platform [5] - The lead candidate, Cylembio™, is designed to activate T cells against tumor cells and immune-suppressive cells in the tumor microenvironment [3][5] - The company has received Breakthrough Therapy Designation from the US FDA for Cylembio™ in combination with KEYTRUDA for advanced melanoma treatment [5] Clinical Trials - Ongoing clinical trials include a pivotal Phase 3 trial (IOB-013/KN-D18) and two Phase 2 basket trials (IOB-022/KN-D38 and IOB-032/PN-E40) [3][4] - Enrollment for all three trials has been completed, with the trials sponsored by IO Biotech in collaboration with Merck [4]

– 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 ...

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 ...

"This completed cohort data marks a significant step forward in our efforts to explore the potential of IO102- IO103 as a therapeutic cancer vaccine across a range of solid tumors where there is a high need for new, accessible treatments," said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech. "We look forward to the presentation of this data at the upcoming ESMO Congress and the continued development of our novel immune-modulating cancer vaccine that could potentially improve outcomes for people liv ...

Core Insights - IO Biotech announced that an abstract related to its lead investigational therapeutic cancer vaccine candidate, IO102-IO103, has been accepted for poster presentation at the ESMO Congress 2024 [1][3] - The presentation will include data from a Phase 2 basket trial of IO102-IO103 in combination with pembrolizumab for treating advanced squamous cell carcinoma of the head and neck [1][3] - The ESMO Congress will take place in Barcelona from September 13-17, 2024, with the specific presentation scheduled for September 14, 2024 [3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulating therapeutic cancer vaccines using its Twin® platform [1][7] - The company is advancing IO102-IO103 through clinical trials and has received breakthrough therapy designation from the FDA for treating advanced melanoma [7][8] - IO102-IO103 is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment by activating T cells [11] Clinical Trials - The ongoing clinical trials include a pivotal Phase 3 trial investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma [11] - A Phase 2 basket trial is also being conducted to evaluate IO102-IO103 in combination with pembrolizumab as a first-line treatment for solid tumors [13] - The trials are sponsored by IO Biotech in collaboration with Merck, which supplies pembrolizumab [12][13]