Io Biotech, Inc. Stock Price, News & Analysis

IO Biotech (IOBT) announced the publication of preclinical study results for IO112, their second immune-modulatory therapeutic cancer vaccine candidate targeting arginase 1 (Arg1), in the Journal for ImmunoTherapy of Cancer. The study demonstrated that IO112 treatment inhibits tumor growth through changes in the tumor microenvironment (TME), showing how Arg1-specific T cells expanded by the vaccine enhance anti-tumor immunity by reprogramming tumor-associated macrophages (TAMs).

The research revealed that IO112 treatment directly impacts TAMs, completely changing their phenotype. This is particularly significant as Arg1-expressing TAMs are a major obstacle in cancer immunotherapy due to their role in creating an immunosuppressive TME. The company plans to submit an Investigational New Drug Application (IND) to the US FDA in 2025.

IO Biotech (IOBT) has completed enrollment ahead of schedule for its Phase 2 basket trial studying IO102-IO103, its lead therapeutic cancer vaccine candidate, in combination with Merck's KEYTRUDA®. The trial focuses on treating resectable melanoma or squamous cell carcinoma of the head and neck (SCCHN) before and after surgery.

The multicenter trial has enrolled 93 patients across sites in the United States, Europe, and Australia. The study's primary endpoint is major pathologic response (MPR), measuring the reduction in viable tumor cells after treatment. Secondary endpoints include pathological complete response, ORR, disease-free survival, event-free survival, and safety.

Initial data from this Phase 2 trial is expected in 2025, coinciding with anticipated results from the company's Phase 3 trial in advanced melanoma patients in the first half of 2025. The vaccine is designed as an off-the-shelf option and has shown encouraging clinical activity without significant systemic toxicity across three first-line advanced cancer indications.

IO Biotech (IOBT) has secured a loan facility of up to €57.5 million from the European Investment Bank (EIB) to advance its therapeutic cancer vaccines development. The facility includes three committed tranches totaling €37.5 million and an uncommitted accordion tranche of €20 million. The first two tranches are expected to be available in Q1 2025.

The unsecured loan has no minimum cash covenants and will extend the company's cash runway into Q2 2026. The facility includes warrants issuance to EIB for each tranche, with 6-year maturity terms and deferred payments. Tranche C requires raising an additional $50 million and submitting a marketing authorization application for IO102-IO103 in the U.S. or EU.

IO Biotech (IOBT) reported Q3 2024 financial results and business updates. The company's pivotal Phase 3 trial of IO102-IO103 cancer vaccine in combination with KEYTRUDA® for advanced melanoma is on track, with primary endpoint data expected in H1 2025. The company reported a net loss of $24.0 million for Q3 2024, compared to $21.7 million in Q3 2023. R&D expenses increased to $20.2 million, up from $17.7 million year-over-year. Cash position stands at $80.2 million, expected to support operations into Q4 2025.

IO Biotech (IOBT), a clinical-stage biopharmaceutical company focused on developing immune-modulating therapeutic cancer vaccines, has announced its participation in two major investor conferences. The company will attend the Jefferies London Healthcare Conference on November 20, 2024, with one-on-one meetings led by CEO Mai-Britt Zocca and CFO Amy Sullivan. Additionally, CEO Mai-Britt Zocca will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference in New York on December 3, 2024, at 11:00 am ET. A webcast replay of the Piper Sandler presentation will be available on IO Biotech's website for 90 days.

IO Biotech announced promising Phase 2 results for its cancer vaccine IO102-IO103 combined with KEYTRUDA® in first-line metastatic lung cancer treatment. The study showed a 55% unconfirmed/48% confirmed overall response rate and 81% disease control rate in NSCLC patients. About 50% of patients showed no disease progression at 12 months, with median progression-free survival of 8.1 months. The safety profile remained consistent with previous studies, mainly showing low-grade injection site reactions. The company also presented pre-clinical data for IO112, their second T-win vaccine candidate targeting arginase 1, demonstrating anti-tumor activity.

IO Biotech (Nasdaq: IOBT) announced two poster presentations at the Society for Immunotherapy of Cancer's 39th Annual Meeting (SITC 2024) in Houston, Texas on November 8-10, 2024. The first poster will present updated data from the complete cohort (n=31) of PD-L1 high metastatic non-small cell lung cancer (NSCLC) patients in the Phase 2 basket trial of IO102-IO103 combined with pembrolizumab. The second poster will showcase new pre-clinical data for IO112, targeting Arginase 1. Dr. Jonathan W. Riess from UC Davis will present the NSCLC data, while IO Biotech scientists will present the IO112 data. Both posters will be displayed on November 9, 2024, at the George R. Brown Convention Center and will be available on IO Biotech's website.

IO Biotech (Nasdaq: IOBT) announced positive results from its Phase 2 trial of IO102-IO103, a therapeutic cancer vaccine, in combination with Merck's KEYTRUDA® for advanced head and neck cancer. The study met its primary endpoint with a 44.4% overall response rate in PD-L1 high patients. Key findings include:

- 6.6-month median progression-free survival
- 66.7% disease control rate
- Safety profile consistent with previous data
- T-cell responses detected for both IO102 and IO103

The trial enrolled patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with PD-L1 CPS ≥ 20. These results support further investigation of the combination as a potential first-line treatment for metastatic and difficult-to-treat cancers.

IO Biotech (Nasdaq: IOBT) announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of its pivotal Phase 3 trial for IO102-IO103, a novel therapeutic cancer vaccine, in combination with KEYTRUDA® (pembrolizumab) for advanced melanoma. Key points:

1. No new safety signals observed
2. Primary endpoint of progression-free survival (PFS) projected for first half of 2025
3. Trial powered at 89% to detect a 35% reduction in event risk
4. 407 patients randomized
5. Interim analysis did not meet criteria for superiority in overall response rate (ORR)
6. Company remains optimistic based on Phase 1/2 results showing 25.5 months median PFS

IO Biotech also reported promising preliminary data from a Phase 2 basket trial in NSCLC and SCCHN, with upcoming presentations at medical conferences.