IO Biotech Announces Topline Results of Pivotal Phase 3 Trial of Cylembio in Combination with KEYTRUDA for Advanced Melanoma

IO Biotech will announce topline results of its pivotal Phase 3 trial of Cylembio in combination with KEYTRUDA as a first-line treatment for advanced melanoma. The management team will host a webcast/conference call on August 11, 2025, to discuss the results. Cylembio is an immune-modulatory, off-the-shelf therapeutic cancer vaccine based on the T-win platform, and has received Breakthrough Therapy Designation for advanced melanoma.

IO Biotech (NASDAQ: IOBT), a clinical-stage biopharmaceutical company, has scheduled a conference call and webcast for August 11, 2025, at 8:30 AM ET to reveal topline results from its pivotal Phase 3 trial (IOB-013/KN-D18) of Cylembio, an investigational immune-modulatory cancer vaccine, in combination with KEYTRUDA® (pembrolizumab) versus KEYTRUDA® alone for first-line treatment of advanced melanoma [1].

The trial focuses on patients with unresectable or metastatic melanoma, with management hosting a live discussion of the results. A replay will be available on the company's website after the event. The webcast and conference call will provide investors and stakeholders with insights into the efficacy and safety of Cylembio in combination with KEYTRUDA, potentially offering a new treatment option for advanced melanoma patients [1].

Cylembio is based on IO Biotech's T-win platform, which aims to activate T cells to target both tumor cells and immune-suppressive cells in the tumor microenvironment. The company's lead therapeutic cancer vaccine candidate, Cylembio, has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of advanced melanoma [1].

Investors and financial professionals are closely monitoring the results of this pivotal trial, as it could significantly impact IO Biotech's stock performance and the broader cancer immunotherapy landscape. The company's stock price has been volatile, with a recent high of $2.47 and a low of $0.66 over the past year [2].

IO Biotech's management team, including CEO Mai-Britt Zocca, CFO Amy Sullivan, and CMO Qasim Ahmad, will participate in the webcast and conference call, providing detailed updates and answering questions from investors [1].

The company's participation in upcoming investor conferences, such as the Cowen 6th Annual Oncology Innovation Summit and the Jefferies Global Healthcare Conference, further underscores its commitment to transparency and engagement with stakeholders [1].

IO Biotech's financial performance has been steady, with a net loss of $22.4M in Q1 2025, driven by R&D expenses of $16.4M and G&A expenses of $6.2M. The company's cash position stood at $37.1M as of March 31, 2025, and it expects sufficient funding into Q2 2026 [1].

Investors are advised to stay tuned for the August 11, 2025, webcast and conference call to gain a comprehensive understanding of the topline results from IO Biotech's pivotal Phase 3 trial of Cylembio in combination with KEYTRUDA.

References:
[1] https://www.stocktitan.net/news/IOBT/io-biotech-to-announce-topline-results-of-pivotal-phase-3-trial-of-smndfr3pdv2n.html
[2] https://upstox.com/us-stocks/iobt-share-price/