- New data from GLORIA Phase 1/2 study show impact of CXCL12 inhibition on tumor blood vessels, increased tumor infiltration of effector immune cells, and consequently tumor size reduction in 8 of 9 patients
- Key Opinion Leader (KOL) webinar with lead investigator of the GLORIA trial, Dr. Frank A. Giordano on November 23, 2021, at 8 a.m. EST 2 p.m. CET
Regulatory News:
NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), today announces that new data from the ongoing Phase 1/2 GLORIA trial with NOX-A12 and radiotherapy in brain cancer (glioblastoma multiforme, GBM) were presented at the Society for Neuro-Oncology (SNO) Annual Meeting. The presentation was held by Frank A. Giordano, M.D., Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany, and lead investigator of the ongoing GLORIA study.
The oral presentation, entitled "CXCL12 inhibition in MGMT unmethylated glioblastoma results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial", included results from 9 chemotherapy refractory (MGMT promoter unmethylated) patients participating in the proof-of-concept study on CXCL12 inhibition during and after radiotherapy of glioblastoma. Eight of 9 patients (89%) receiving NOX-A12 showed reductions in tumor size (2 patients with objective responses [>50% reduction] and 6 patients with stable disease [<50% reduction], while one patient progressed. These results compare favorably with historic patient outcomes from a matched cohort that received standard of care, where only 1 out of 13 patients (8%) showed a reduction in tumor size with an objective response and 12 patients' tumors progressed.
Also, data from tissue analysis of a patient on NOX-A12 therapy shows [1] a significant reduction of the NOX-A12 target, CXCL12, on tumor blood vessels, [2] a significant decrease in tumor cell proliferation and [3] an increase in tumor infiltration of activated killer immune cells. Interestingly and very importantly, such benefits were observed across all available tumor tissue and not only in small subsections.
These benefits are strongly supportive of the dual mechanism of action of NOX-A12:
- inhibiting repair of blood vessels damaged by radiotherapy
- promoting of immune-response
This dual mechanism of action could prove transformational since this is not consistently observed in historical samples including patients treated with immune checkpoint inhibitors.
"The data presented by Dr. Giordano at the SNO meeting are a significant step forward in bringing NOX-A12 to glioblastoma patients. While a diagnosis of chemotherapy-resistant glioblastoma leads almost inevitably to systematic rapid progression of the disease, NOX-A12 combined with radiotherapy managed to achieve stable disease or an objective response in 8 out of the 9 patients. We very much look forward to presenting and explaining the transformational nature of these new data at our upcoming KOL event on Tuesday, November 23, when Dr. Giordano will also be available to answer questions," commented Aram Mangasarian, CEO of NOXXON
Details of the Key Opinion Leader webinar are as follows:
Title: NOX-A12 and Radiotherapy combination: A Differentiated and Promising New Approach to Treating Brain Cancer
Presenter: Dr. Frank A. Giordano, Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany
Webinar time and date: November 23, 2021 at 02:00 p.m. CET (08:00 a.m. EST)
Registration: To register for the event, please click here
NOX-A12 acts via a unique mechanism of action, which was confirmed by the presented results: by removing the CXCL12 chemokine from the tumor blood vessels the revascularization of the irradiated tumor area is blocked and a significant increase in activated killer immune cell infiltration to the tumor can be seen.
More information about the GLORIA study can be found at ClinicalTrials.gov number NCT04121455.
Dr. Frank A. Giordano, is Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn, Germany. He is an expert in precision radiation therapy and intraoperative irradiation of malignant tumors and has received international recognition for his brain tumor research, including an award from the American Society of Radiation Oncology (ASTRO) and an honorary membership of the Spanish Society of Radiation Oncology (SEOR). Dr. Giordano received his medical degree from the University of Heidelberg, Germany, and did his post-doctoral training as a Peter Engelhorn fellow at the German Cancer Research Center (DKFZ). He received clinical training at the National Center for Tumor Diseases (NCT) Heidelberg and the University Medical Center Mannheim, where he served as acting chairman and director of the Department of Radiation Oncology before moving to Bonn. For many years, his research has focused on optimized radiation therapy of brain cancers to offer cancer patients personalized and even more effective treatment. As one of the few Else-Kröner-Fresenius Excellence Fellows, Dr. Giordano developed innovative therapy options that even found their way in clinical practice. He sees great potential in the combination of radiotherapy and immunomodulatory therapy.
About NOXXON
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. 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.
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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 glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy).
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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NOXXON Pharma N.V.
Aram Mangasarian, Ph.D.
Chief Executive Officer
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