ANYARA – unique substances for use in fighting cancer
ANYARA is a TTS (Tumor Targeting Superantigen), a protein drug that makes the treatment of cancer tumor-specific. The development of ANYARA has primarily been focused on renal cell cancer, but the compound has also demonstrated favorable results in connection with the treatment of, non-small cell lung cancer and pancreatic cancer. A Phase 2/3 trial encompassing just over 500 renal cell cancer patients was concluded in January 2013.
ANYARA mode of action and therapy concept
The development of ANYARA has primarily been focused on cancer indications with a high unmet medical need. Positive data was reported from clinical Phase 1 trials in lung cancer, renal cell cancer and pancreatic cancer, where ANYARA was studied both as a single agent (monotherapy) and in combination with an established tumor therapy - docetaxel (Taxotere®) - in patients with advanced cancer. The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel. The Phase 1 results also showed proof-of-concept in terms of increased tumor recognition and infiltration by T cells.
Initial results from the ANYARA Phase 2/3 clinical study in patients with advanced renal cell cancer were announced in January 2013. The study encompassed 513 patients and was designed to evaluate the effect of ANYARA in combination with interferon-alpha, compared with interferon-alpha alone. The Phase 2/3 study did not achieve its primary endpoint to show a prolonged overall survival (OS) in the ITT population. However, in a hypothesis generating subgroup analysis, the 25 % of patients with low/normal levels of baseline IL-6 and expected anti-superantigen antibody levels, showed a statistically significant treatment advantage on both OS (p=0.02, HR=0.59) and PFS. In North America and Western Europe, this subgroup account for 40-50% of the total number of advanced renal cell cancer patients.
The safety profile was good and in line with previous observations; the most common adverse events associated with ANYARA treatment were grade 1-2 fever, nausea or vomiting. No new and unexpected safety concerns were identified in the study.
Since October 2016, Active Biotech has an agreement with NeoTX therapeutics Ltd, an Israeli immuno-oncology company. NeoTX is responsible for the worldwide clinical development and commercialization of the ANYARA project.
Click here for a list of scientific publications related to ANYARA.