IDO-derived peptide vaccine/PD-L1-derived peptide vaccine(Herlev Hospital)

-- 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. For further information, please visit www.iobiotech.com. Follow us on our social media channels on LinkedIn and X (@IOBiotech). 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. Contact: InvestorsMaryann Cimino, Director of Investor Relations IO Biotech, Inc.617-710-7305mci@iobiotech.com MediaJulie FunestiSalutem917-498-1967Julie.Funesti@salutemcomms.com

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 近日，一家丹麦生物制药公司IO Biotech 宣布已从欧洲投资银行获得高达 5750 万欧元的贷款，用于推进其治疗性癌症疫苗，包括 IO102-IO103，预计于 2025 年提交生物制品许可申请 (BLA)。 这笔贷款包括三笔承诺贷款，总额为 3750 万欧元，以及一笔非承诺贷款，总额为 2000 万欧元。预计将使该公司的现金流延长至 2026 年第二季度。 IO Biotech 首席财务官 Amy Sullivan 表示：“欧洲投资银行的支持将促进其癌症疫苗候选物的开发和商业化。该笔贷款是无担保的，没有最低现金要求，每笔贷款期限为六年期，并计算计息。” IO Biotech成立于2014年，总部位于丹麦，公司专注于开发免疫肿瘤学疗法，利用独特的T细胞疫苗技术来激活患者的免疫系统，以针对并摧毁癌细胞。基于对肿瘤微环境（TME）以及肿瘤逃避免疫系统监视和攻击能力的深入理解，该公司开发了专有的T-win技术平台，旨在激活天然存在的T细胞，靶向并直接杀伤免疫抑制细胞和肿瘤细胞。IO Biotech于2021年11月5日上市，目前，市值为5995万美元。 研发管线 IO Biotech主要候选产品 IO102-IO103 是一种现成的治疗性癌症疫苗，分别靶向IDO和PD-L1，适应症包括: 晚期黑色素瘤和非小细胞肺癌（NSCLC）。除此之外，IO102-IO103还有多项临床试验中正在测试中。最新的III期试验中期报告显示PFS有显著优势，但是OS尚未达到统计学差异。公司计划于2025年完成试验。 此次融资举措凸显了欧洲投资银行对欧盟创新生物技术企业的支持，也反映了 IO Biotech 在生物制药领域的进步。 参考资料： https://iobiotech.com/press-releases/?workflow=8842c69a-1a06-4b0b-a34f-e4c021f4c8d9