IO Biotech's Cancer Vaccine IO102-IO103 Shows Promise in Metastatic Lung Cancer Phase 2 Study

IO Biotech, a clinical-stage biopharmaceutical company focused on developing innovative, off-the-shelf immune-modulating cancer vaccines, has shared new data from its Phase 2 trial concerning patients with metastatic non-small cell lung cancer (NSCLC). The company’s lead investigational product, IO102-IO103, was administered along with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab). These findings, along with pre-clinical data from IO Biotech’s second vaccine candidate, IO112, were presented at the Society for Immunotherapy of Cancer’s Annual Meeting held in Houston from November 8-10, 2024.

The cohort of the trial comprised patients with previously untreated metastatic stage NSCLC and high PD-L1 expression (TPS ≥ 50). Among 31 evaluable patients, the data revealed a 55% overall response rate (unconfirmed) and a 48% confirmed response rate. Additionally, the disease control rate stood at 81%, with approximately 50% of patients exhibiting no disease progression at the 12-month mark. The median progression-free survival was noted to be 8.1 months, while the median duration of response remains undetermined. Importantly, no unexpected toxicities were reported, aligning with previous safety data from studies combining IO102-IO103 with anti-PD-1 therapy, with the most common adverse events being transient, low-grade injection site reactions.

Jonathan Riess, MD, principal investigator of the trial and Director of Thoracic Oncology at UC Davis Comprehensive Cancer Center, highlighted the significance of these results, underscoring the need for treatments that enhance the durability of response for lung cancer patients. The absence of disease progression in roughly half of the patients at 12 months signifies a positive outcome.

The company’s Chief Medical Officer, Qasim Ahmad, MD, emphasized the broader implications of the data, noting that positive results from the NSCLC cohort, when combined with prior promising data from studies on squamous cell carcinoma of the head and neck (SCCHN) and melanoma, reinforce the potential of IO102-IO103. This dual-targeting approach, which focuses on both tumor cells and immune-suppressive cells within the tumor microenvironment, shows meaningful clinical benefits across a spectrum of challenging cancer types.

In addition to the clinical data, pre-clinical findings from IO Biotech’s second vaccine candidate, IO112, were also presented. IO112 targets arginase 1, a protein associated with immune suppression found overexpressed in various cancers such as renal cell carcinoma, pancreatic cancer, and head and neck cancer. The mechanism of action involves the vaccine-induced modulation of tumor-associated macrophages (TAMs) within the tumor microenvironment, leading to a reprogramming from an immunosuppressive to a pro-inflammatory state. This reprogramming drives an immune-mediated attack on tumor cells, resulting in tumor growth inhibition.

Ayako Wakatsuki Pedersen, PhD, Senior Vice President of Translational Research at IO Biotech, elaborated on the pre-clinical data, noting that IO112 vaccination produces robust expansion of Arg1-specific T cells, which effectively reprogram TAMs, thereby altering the tumor microenvironment to support anti-tumor activity. This novel approach bolsters confidence in IO Biotech’s T-win® platform, which aims to induce a pro-inflammatory and anti-tumorigenic environment via targeted T cell activation.

Jonathan W. Riess, MD, and Evelina Martinenaite, PhD, presented detailed posters on the trial results and pre-clinical data at the conference, highlighting the promising potential of IO Biotech’s therapeutic strategies.

IO Biotech continues to advance its clinical development programs, with IO102-IO103 currently undergoing pivotal Phase 3 trials in combination with pembrolizumab for advanced melanoma. The company remains committed to addressing high unmet medical needs by developing innovative therapeutic cancer vaccines based on its T-win® platform, designed to activate T cells against immunosuppressive cells within the tumor microenvironment.