BERLIN--(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), announces that interim data from the ongoing Phase 1/2 GLORIA trial in brain cancer will be presented by Dr. Frank Giordano in an oral presentation at the Society for Neuro-Oncology (SNO) Annual Meeting. The meeting will take place in Boston, Massachusetts, USA from November 18 to 21, 2021.
Dr. Frank Giordano, lead investigator of the GLORIA study, commented: “For many years, I have been focused on optimizing radiation therapy of brain cancers to offer patients more effective treatments that do not come at the costs of higher toxicity. The clinical data obtained to date from the combination of NOX-A12 with radiotherapy, that I will be presenting at the SNO, show a mild toxicity profile and at the same time encouraging efficacy. I am very much looking forward to seeing the results of six months of therapy of patients in the high-dose cohort in Q1 2022. To gather further data, we have also expanded the study to evaluate additional treatment combinations of NOX-A12 and radiotherapy.”
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” will present and discuss the results of the proof-of-concept study on CXCL12 inhibition during and after radiotherapy of brain cancer. Patients enrolled are all newly diagnosed with MGMT promoter unmethylated glioblastoma (GBM), that do not respond to standard of care chemotherapy (temozolomide). Advanced MRI and multiplexed immunofluorescence of treated patient samples suggest efficacy of combined radiotherapy and CXCL12 inhibition in unmethylated GBM. In addition, outcomes of patients treated with NOX-A12 and radiotherapy will be compared to a matched historical cohort of patients who received standard of care. More information about the GLORIA study (NCT04121455) can be found at ClinicalTrials.gov.
Details of the oral presentation are as follows:
Title: CXCL12 inhibition in MGMT unmethylated glioblastoma – results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial (NCT04121455)
Session Title: Abstract Session: Clinical Trials I
Session Date: Friday, November 19, 2021
Presentation Time: 05:00 p.m. EST // 11:00 p.m. CET
Presenter: Dr. Frank Giordano, Director and Chairman of the Department of Radiation Oncology at the University Hospital Bonn, Germany
Registration: To register to the event, please click here.
The NOXXON team will attend the conference in person. A copy of the presentation will be made available on the NOXXON website at the time of Dr. Giordano’s presentation.
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.
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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