BERLIN--(BUSINESS WIRE)--Regulatory News:
NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today the latest clinical results from the Phase 1/2 study of NOX-A12 in combination with Keytruda® (pembrolizumab) in patients with microsatellite-stable, metastatic pancreatic and colorectal cancer in a poster presentation at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain.
The combination of NOX-A12 and pembrolizumab induced an immune response, stable disease in 25% of patients and prolonged time on treatment vs. prior therapy for 35% of patients. Continued follow-up of patients has now yielded near-final overall survival statistics of 42% at 6 months and 22% at 12 months. A third patient in the enrolled population of twenty passed the one-year survival mark and continues to be followed. The study confirmed that NOX-A12 is safe and well-tolerated in advanced cancer patients both as a monotherapy and in combination with pembrolizumab and further supports the role of CXCL12 in the resistance to immunotherapy.
“Both metastatic colorectal and pancreatic cancers are indications with very limited therapeutic options. These indications have thus far remained largely unaffected by the advent of immune checkpoint inhibitors. The finding that three heavily pre-treated patients survived for more than one year shows the potential of NOX-A12 to target the tumor microenvironment in a clinically meaningful way and to enable the intended mode of action of pembrolizumab. Larger scale randomized trials with less-advanced patient populations are warranted, an opportunity we intend to pursue with a partner,” said Aram Mangasarian, CEO of NOXXON.
“The encouraging survival data in this study suggests that the combination of NOX-A12 with pembrolizumab can impact the biology of the tumor in a clinically relevant manner. This is not what you would expect to see in patients at such an advanced stage of disease who had failed multiple prior lines of therapy,” commented Dr. Jarl Ulf Jungnelius, CMO of NOXXON.
The poster entitled, "Phase 1/2 study with CXCL12 inhibitor NOX-A12 and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer" was presented by Dr. Niels Halama, lead investigator of the trial, and the NOXXON team, on Sunday, September 29, from 12.00 - 01.00 p.m. CEST and is available on the NOXXON website.
Aram Mangasarian and Dr. Jarl Ulf Jungnelius will host a webcast poster presentation on September 30, 2019, at 09.00 a.m. CEST, to discuss significance of the latest data.
To participate: register for webcast.
NOXXON’s oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking the tumor protection barrier and blocking tumor repair. By neutralizing chemokines in the tumor microenvironment, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. Building on extensive clinical experience and safety data, the lead program NOX-A12 has delivered top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients in December 2018 and further studies are being planned in these indications. In September 2019 the company initiated an additional trial with NOX-A12 in brain cancer in combination with radiotherapy. The combination of NOX-A12 and radiotherapy has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. The company’s second clinical-stage asset NOX-E36 is a Phase 2 TME asset targeting the innate immune system. NOXXON plans to test NOX‑E36 in patients with solid tumors both as a monotherapy and in combination. Further information can be found at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp
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