Cantargia and GEICAM Share Updated Phase 1 Data and New Results on Nadunolimab for Advanced Triple Negative Breast Cancer

Cantargia AB, a Swedish biotechnology company listed on Nasdaq Stockholm, provided an update on the outcomes of its phase 1b study involving 15 patients with advanced triple-negative breast cancer (aTNBC). These patients were treated with nadunolimab in combination with platinum-based chemotherapy. The promising results, which mirror previous findings, confirm the safety and potential antitumor activity of the treatment regimen. These findings are set to be showcased during a poster session at the San Antonio Breast Cancer Symposium (SABCS) in December 2024.

Dr. Göran Forsberg, CEO of Cantargia, expressed enthusiasm about the data, highlighting its potential to bolster the immune system's response against cancer progression. This presentation will also discuss the broader implications of nadunolimab in combating not only breast cancer but also pancreatic and lung cancers.

The phase 1b segment of the study, known as TRIFOUR, assessed the impact of nadunolimab at doses of 1 mg/kg and 2.5 mg/kg combined with gemcitabine and carboplatin on previously treated aTNBC patients. Initial outcomes released in 2023 were promising, and the updated results corroborate these findings, demonstrating a 60% response rate, a median progression-free survival (PFS) of 6.2 months, and a median overall survival (OS) of 12.8 months.

In addition to clinical results, analyses of patient samples revealed a notable reduction in the neutrophil to lymphocyte ratio (NLR) and C-reactive protein (CRP), which are associated with nadunolimab’s mechanisms. A decrease in IL-8 levels was linked with a trend towards prolonged OS, indicating the potential of nadunolimab to positively influence immune cells involved in inflammation that promotes tumor growth.

Further exploration involved a larger set of pre-treatment tumor biopsies and blood samples to characterize IL1RAP expression. The analysis confirmed IL1RAP's presence on tumor cells, stromal cells, and tumor-infiltrating immune cells. The expression was also observed on myeloid cells, including myeloid-derived suppressor cells, underscoring IL1RAP's relevance as a viable target in aTNBC.

The ongoing phase 2 of the trial is currently enrolling patients to compare the effects of the 2.5 mg/kg dose of nadunolimab combined with GC versus GC alone. Preliminary results from this phase are expected in the latter half of 2025. The trial is conducted in collaboration with GEICAM, the Spanish Breast Cancer Research Group, and findings will be shared at the 47th San Antonio Breast Cancer Symposium.

Cantargia is committed to further exploring nadunolimab, an antibody targeting IL1RAP, which is a significant element in both cancer and inflammatory diseases. This antibody works by inducing antibody-dependent cellular cytotoxicity (ADCC) and blocking IL-1α and IL-1β signaling, thereby countering the immune-suppressive environment that often leads to chemotherapy resistance. The TRIFOUR study's initial promising results show a 60% response rate in aTNBC patients when nadunolimab is used alongside standard chemotherapy agents gemcitabine and carboplatin.

GEICAM, recognized globally for its breast cancer research, has played a pivotal role in this study. Since its inception in 1995, GEICAM has involved over 68,000 participants across more than a hundred studies. The organization's collaboration with Cantargia represents a significant stride towards advancing treatment options for breast cancer, emphasizing the importance of integrated clinical research efforts on a global scale.