Favourable safety profile is confirmed at highest dose of NOX-A12
Percentage of patients in trial with tumor size reductions improves from previously disclosed 89%
Percentage of patients in trial with >50% tumor size reductions improves considerably from previously disclosed 22%
BERLIN, March 24, 2022--(BUSINESS WIRE)--Regulatory News:
NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today positive top-line results from six months therapy of all patients in the NOX-A12 GLORIA Phase 1/2 dose-escalation study in ten brain cancer (glioblastoma) patients.
GLORIA (NCT04121455) is NOXXON’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line glioblastoma patients with unmethylated MGMT promoter (resistant to standard chemotherapy). Three patients had been recruited in the 200 mg/week cohort, three patients in the 400 mg/week cohort and four patients in the 600 mg/week cohort, one of which dropped out and was replaced in September 2021.
The safety data seen at the highest dose level was consistent with what is to be expected in patients with glioblastoma receiving radiotherapy and similar to that seen in the lower dose cohorts. The percentage of patients who have achieved a best response of tumor size reduction under NOX-A12 treatment increased vs. the 89% disclosed in the previous interim data analysis presented at the Annual Meeting of the Society of Neuro-Oncology in November 2021. Furthermore, the percentage of patients who have achieved more than 50% tumor size reduction under NOX-A12 treatment increased considerably over the 22.2% disclosed in the previous interim data analysis. Multiple patients in the high-dose cohort achieved >50% tumor size reductions, which is a multi-fold increase over the 7.7% achieved by the matched imaging reference cohort disclosed in November 2021.
The company plans to present the full data set at a scientific conference later this year.
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 TME, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. NOXXON’s lead program NOX-A12 has delivered final top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients published at the ESMO conference in September 2020 and in July 2021 the company announced its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. NOXXON is also studying NOX-A12 in brain cancer in combination with radiotherapy which has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. GLORIA, a trial of NOX-A12 in combination with radiotherapy in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy has delivered interim data from the first two cohorts showing consistent tumor reductions and objective tumor responses. Additionally, GLORIA has been expanded to assess the benefit of NOX-A12 with other treatment combinations, radiotherapy + bevacizumab and radiotherapy + pembrolizumab. 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. Further information can be found at: www.noxxon.com.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.
About the GLORIA Study
GLORIA (NCT04121455) is NOXXON’s dose-escalation, phase 1/2 study of NOX-A12 in combination with irradiation in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 three additional arms combining NOX-A12 with: A. radiotherapy in patients with complete tumor resection; B. radiotherapy and bevacizumab in patients with incomplete tumor resection; and C. radiotherapy and pembrolizumab in patients with incomplete tumor resection.
About the OPTIMUS Study
OPTIMUS (NCT04901741) is NOXXON’s open-label two-arm phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.
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For more information:
NOXXON Pharma N.V.
Aram Mangasarian, Ph.D.
Chief Executive Officer
Tel. +49 (0) 30 726247 0
Investor and Media Relations:
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31