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IO Biotech Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Piper Sandler 37th Annual Healthcare Conference summary3 Dec, 2025
Key clinical developments
Phase III trial of IO102-IO103 with pembrolizumab in metastatic melanoma showed clinically meaningful PFS improvement (19.4 vs. 11 months), though statistical significance was narrowly missed.
Subgroup analyses revealed consistent drug effect across all stratification markers, with a favorable safety profile and no added toxicity.
OS data is trending positively (hazard ratio 0.79), with more mature results expected next year.
First therapeutic cancer vaccine to show clear benefit in metastatic disease setting in a randomized Phase III trial.
Feedback from physicians and KOLs has been highly positive despite the primary endpoint miss.
Regulatory and trial strategy updates
FDA recommended against BLA submission due to lack of statistical significance, despite clear clinical benefit and safety.
New global adaptive Phase II/III trial planned, combining IO102-IO103 with Opdualag, reflecting updated standard of care and FDA input.
EU regulatory engagement ongoing, with potential for MAA submission in 2026, leveraging different guidelines and possible subgroup filings.
Phase II basket studies in neoadjuvant/adjuvant melanoma and SCCHN are underway, with initial data expected by year-end and presentations in 2026.
Pipeline and platform insights
IO102-IO103 demonstrates pan-tumor activity, with positive data in head and neck and encouraging results in lung cancer.
Early immune modulatory signatures may help identify responsive patient populations.
Pipeline assets IO112 (Arginase 1) and IO170 (TGF-beta) have generated strong interest, with IO112 nearing IND readiness.
Focus remains on melanoma, but broader indications and partnerships are being considered for the future.
How does new trial design mitigate FDA concerns?
What's the capital raise strategy for new trial?
How will pan-tumor potential be realized?
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Next IO Biotech earnings date
Q4 20256 Mar, 2026
Next IO Biotech earnings date
Q4 20256 Mar, 2026
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IO Biotech Inc. is a biotechnology company focused on developing immunotherapies for cancer. The company specializes in therapeutic cancer vaccines designed to stimulate the immune system to target and eliminate tumor cells. Its pipeline includes investigational treatments for various cancers, advancing through clinical trials and regulatory evaluations. The company is headquartered in Copenhagen, Denmark, and its shares are listed on the NASDAQ.
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