NOX-A12 appears to be effective – at least that is what the top-line data from a combination study of NOX-A12, Noxxon Pharma NV’s lead candidate, and the immune checkpoint inhibitor Keytruda suggest. Patients with metastatic pancreatic or colon cancer who had failed a number of alternative therapies were treated.
The Berlin-based drug developer Noxxon presented clinical data of its lead candidate NOX-A12 at the ESMO immuno-oncology congress in Geneva in mid-December. This is initial data from a combination study of NOX-A12 with Keytruda in patients with metastatic colorectal or pancreatic cancer with a median of 5 and 3 prior treatments, respectively.
Due to the poor health of the subjects, only those who were still alive three months after the start of treatment were included in the evaluation. This is the only way to assume that Noxxon’s therapeutic approach to be tested had enough time to take effect. If this hurdle were taken, 70% of the subjects were still alive after 24 weeks and 50% after 36 weeks.
But in this study we have seen again and again that patients whose disease was progressing rapidly continued the combination therapy NOX-A12 with Keytruda for a long time – up to ten times longer. This combination appears to slow tumor growth and could benefit patients even if they don’t achieve stable disease.”
Noxxon’s confidence is underpinned by the analysis of the biopsies taken before and after the therapy. According to Noxxon, the inhibition of the chemokine CXCL12 by NOX-A12 should lead to an accumulation of CXCL12 in the tumor tissue, which could also be proven. In addition, the changed cytokine profile indicates that the treatment made the tumor “hot” – that is, made it more visible to the immune system and thus vulnerable.
Keytruda is the trade name of the monoclonal therapeutic antibody pembrolizumab, which belongs to a new class of drugs called immune checkpoint inhibitors. While monotherapy with these drugs fails in many patients, the response rate for combination therapies could be significantly higher. Hundreds of clinical studies are currently underway with immune checkpoint inhibitors in combination with active ingredients with other modes of action such as chemotherapy or Noxxon’s NOX-A12. So far, however, there can be no talk of a breakthrough. The results of most of these studies have so far been well below expectations.
Aram Mangasarian, CEO of NOXXON, described NOX-A12 as an agent with best-in-class pharmacology: “We believe that further studies with NOX-A12 in these indications are required and are currently working on the design of the next studies.” In the run-up, Noxxon had flirted with plans to carry out further studies with NOX-A12 in combination with radiotherapy in brain tumors. Orphan drug status has already been granted for these in the USA and the EU.
The capital market will only react to the news with a delay, since trading in the Noxxon papers on the Euronext stock exchange in Paris was suspended around the time the poster was published.