Core Insights - IO Biotech is advancing its lead investigational candidate, IO102-IO103, in a pivotal Phase 3 trial for advanced melanoma, with new non-clinical data supporting its efficacy in tumor growth control through T-cell activation [1][2] - The company is also presenting new preclinical data for IO170, which targets TGF-beta, further emphasizing the potential of immune-modulatory therapeutic cancer vaccines [1][2] - The American Association for Cancer Research (AACR) Annual Meeting 2025 will feature presentations on these candidates, highlighting their mechanisms of action and contributions to cancer immunotherapy [1][3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its proprietary T-win platform [6] - The T-win platform aims to activate T cells to target both tumor cells and immune-suppressive cells within the tumor microenvironment [6] - The company has received Breakthrough Therapy Designation from the US FDA for IO102-IO103 in combination with Merck's KEYTRUDA for treating advanced melanoma [6] Presentation Details - Two abstracts will be presented at the AACR Annual Meeting: one on IO102-IO103 and another on IO170, both scheduled for April 28, 2025 [3] - The educational session on cancer vaccines will be chaired by Dr. Mads Hald Andersen, focusing on advancements in cancer vaccine research [3][5]

Core Insights - IO Biotech has been recognized as the 9th most innovative company in the biotechnology category by Fast Company for its development of immune-modulatory therapeutic cancer vaccines [1][2][4] - The company is focused on creating off-the-shelf cancer vaccines that can be available at the time of patient diagnosis, aiming to change the oncology treatment paradigm [2][4] - IO Biotech's T-win® platform is designed to target both tumor cells and immune-suppressive cells in the tumor microenvironment, potentially leading to improved patient outcomes [2][4][6] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company headquartered in Copenhagen, Denmark, with a US office in New York [6] - The company is advancing its lead investigational cancer vaccine candidate, Cylembio® (imsapepimut and etimupepimut, adjuvanted), which is currently in a global Phase 3 clinical trial for advanced melanoma [4][6] - Cylembio® has received Breakthrough Therapy Designation from the US FDA for the treatment of advanced melanoma in combination with Merck's KEYTRUDA® (pembrolizumab) [6] Industry Recognition - Fast Company's list of the Most Innovative Companies is a highly anticipated feature that evaluates thousands of submissions to recognize organizations driving progress across various industries [3] - The recognition highlights companies that are leveraging innovative technologies and strategies to enhance customer experiences and introduce vital competition in their sectors [4][3]

Core Insights - IO Biotech has been recognized as the 9th most innovative company in the biotechnology category by Fast Company for its innovative approach to immune-modulatory cancer vaccines [1][2][4] - The company is focused on developing off-the-shelf cancer vaccines that can be available at the time of patient diagnosis, aiming to change the oncology treatment paradigm [2][4] - IO Biotech's lead investigational cancer vaccine candidate, Cylembio®, is currently in a global Phase 3 clinical trial for advanced melanoma, with primary endpoint readout expected in Q3 2025 [4][6] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company headquartered in Copenhagen, Denmark, with a US office in New York [6] - The company specializes in immune-modulatory therapeutic cancer vaccines based on its T-win® platform, which targets both tumor cells and immune-suppressive cells in the tumor microenvironment [6] - Cylembio® has received Breakthrough Therapy Designation from the US FDA for the treatment of advanced melanoma, based on positive Phase 1/2 data [6] Industry Recognition - Fast Company's list of the World's Most Innovative Companies includes 609 organizations across 58 sectors, highlighting companies that drive progress and innovation [3] - The recognition reflects IO Biotech's commitment to enhancing patient outcomes through innovative cancer treatment solutions [4][5]

Clinical Trials and Development - The primary endpoint readout of the pivotal Phase 3 trial for Cylembio is now expected in the third quarter of 2025, with a total enrollment of 407 patients completed ahead of schedule[4] - Initial data from the Phase 2 basket trial of Cylembio as neoadjuvant/adjuvant treatment for resectable melanoma or head and neck cancer is anticipated in the second half of 2025[4] - The Phase 2 basket trial IOB-022/KN-D38 showed promising activity in first-line treatment for metastatic non-small cell lung cancer, with approximately 50% of patients having no disease progression at 12 months[7] - The primary endpoint of overall response rate (ORR) was met in the Phase 2 basket trial investigating Cylembio in combination with pembrolizumab for squamous cell carcinoma of the head and neck[7] - The pivotal Phase 3 trial IOB-013/KN-D18 is evaluating Cylembio in combination with Merck's KEYTRUDA in patients with advanced melanoma, with top-line data readout expected in Q3 2025[11] Financial Position - Cash and cash equivalents at the end of Q4 2024 were approximately $60.0 million, with secured debt financing of up to €57.5 million from the European Investment Bank, extending the cash runway into Q2 2026[4] Regulatory Submissions - The company plans to submit a Biologics License Application (BLA) for Cylembio to the FDA by the end of 2025, with a potential launch in the US in 2026[3] - The company plans to submit an Investigational New Drug Application (IND) for its second candidate, IO112, targeting Arginase-1, to the FDA in 2025[7] Product Development - Cylembio has been adopted as the US brand name for the lead investigational therapeutic cancer vaccine, previously known as IO102-IO103[7] - The company is advancing its lead cancer vaccine candidate, Cylembio, in clinical trials while also developing additional pipeline candidates through preclinical development[15]

Core Insights - IO Biotech has made significant progress in 2024, particularly in advancing clinical programs for Cylembio, a therapeutic cancer vaccine targeting advanced melanoma, metastatic head and neck cancer, and metastatic lung cancer [2][5] - The company anticipates a pivotal Phase 3 trial readout for Cylembio in combination with pembrolizumab in Q3 2025, with plans to submit a Biologics License Application (BLA) to the FDA by the end of 2025 and a potential product launch in the US in 2026 [2][5][6] Company Developments - Cylembio's pivotal Phase 3 trial has completed enrollment with 407 patients, and the primary endpoint is progression-free survival (PFS), with a readout now expected in Q3 2025 [5][6][10] - The company has also completed enrollment ahead of schedule in a Phase 2 basket trial for Cylembio as neoadjuvant/adjuvant treatment for resectable melanoma and head and neck cancer, with initial data expected in the second half of 2025 [5][6][13] - Cash and cash equivalents at the end of Q4 2024 were approximately $60 million, and the company secured up to €57.5 million in debt financing from the European Investment Bank to extend its cash runway into Q2 2026 [5][12] Clinical Trials and Data - The ongoing Phase 3 trial (IOB-013/KN-D18) is evaluating Cylembio in combination with Merck's KEYTRUDA for advanced melanoma, with a total of 407 patients enrolled across multiple countries [10][14] - The Phase 2 basket trial (IOB-022/KN-D38) is investigating Cylembio in combination with KEYTRUDA for first-line treatment of metastatic non-small cell lung cancer and squamous cell carcinoma of the head and neck, with promising initial results [7][11] - The company has reported that the primary endpoint of overall response rate (ORR) was met in the Phase 2 trial, along with encouraging PFS data [6][7] Future Plans - IO Biotech plans to submit an Investigational New Drug Application (IND) for its second cancer vaccine candidate, IO112, in 2025 [12] - The company is focused on commercializing Cylembio as a first-in-class immune-modulatory, off-the-shelf therapeutic cancer vaccine, aiming to address significant unmet medical needs in oncology [2][14]

Core Insights - IO Biotech is developing a novel peptide vaccine targeting the immunosuppressive effects of Transforming Growth Factor Beta (TGF-β) in solid tumors, which may enhance treatment efficacy in cancer therapy [1][4] Presentation Details - The poster presentation titled "A TGF-β-directed peptide vaccine induces T cell activation & drives anti-tumor activity by modulating the architecture of the tumor microenvironment" will be presented by Dr. Matteo Bocci on February 25, 2025, at the AACR-IO conference [2] - The presentation will take place at JW Marriott Los Angeles, Platinum Ballroom A-E, from 1:45-4:00 PM PST [2] Research Findings - The TGF-β peptide vaccine, IO170, demonstrated significantly reduced tumor growth in models of pancreatic adenocarcinoma and prostate cancer, inducing robust immune responses without systemic toxicity [3] - The vaccine's mechanism involves reshaping the tumor microenvironment (TME) to enhance anti-tumor activity, contrasting with existing approaches that inhibit TGF-β signaling systemically [3][4] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company focused on immune-modulatory, off-the-shelf therapeutic cancer vaccines based on its proprietary T-win platform [5] - The company is advancing its lead investigational cancer vaccine candidate, Cylembio™, which has received Breakthrough Therapy Designation from the FDA for advanced melanoma treatment in combination with Merck's KEYTRUDA [5]

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 ...