NOXXON Presents Full Top-line Results From NOX-A12 Phase 1/2 GLORIA Trial in Glioblastoma at the 2022 ASCO Annual Meeting

• 90% of patients achieve tumor size reductions
• 40% of patients achieve partial response, i.e. tumor size reductions of more than 50%

BERLIN--(BUSINESS WIRE)--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), announced today the publication of the full top-line results from the NOX-A12 Phase 1/2 GLORIA trial in brain cancer (glioblastoma) in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, Illinois, US, from June 3 to June 7, 2022.

The poster presentation entitled “Radiotherapy and olaptesed pegol (NOX-A12) in partially resected or biopsy-only MGMT-unmethylated glioblastoma: Interim data from the German multicenter phase 1/2 GLORIA trial” was presented by Dr. Frank A. Giordano and highlighted that:

• 90% of patients who received NOX-A12 and radiotherapy achieved tumor size reductions vs. 25% of patients in a matched reference cohort receiving standard of care.
• 40% of patients who received NOX-A12 and radiotherapy achieved partial response (defined as tumor size reduction of more than 50%) vs. 10% in a matched reference cohort receiving standard of care.
• In 30% of patients who received NOX-A12 and radiotherapy, one or more non-target lesions (smaller secondary lesions) completely disappeared.
• Infiltration of the tumor with activated, cytotoxic T-cells and M1-like macrophages was seen in both patients who had repeat surgery during NOX-A12 therapy, consistent with NOX-A12 and radiotherapy overcoming immune cell exclusion and making the tumors immunologically hotter.
• The combination of NOX-A12 and radiotherapy was safe and well tolerated, with no dose limiting toxicities and no treatment-related deaths. Only 4% of the adverse events of Grade 2 or more were deemed solely NOX-A12-related.

Aram Mangasarian, CEO of NOXXON, commented: "We are excited about these impressive results, which demonstrate the potential of our lead asset NOX-A12 in brain cancer and further substantiate our innovative approach of targeting the tumor microenvironment. We will continue to report on maturing data from the dose-escalation part of the study and are looking forward to interim read-outs from the ongoing expansion study exploring additional combination therapies, which will help us design our planned pivotal trial. Brain cancer is a very difficult to treat condition and these results bring us a step closer to offering improved treatment options and hope for patients."

Dr. Frank A. Giordano, Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn and the lead investigator of the GLORIA trial, commented: "These encouraging results show a strong response to NOX-A12 and radiotherapy, with 90% of patients achieving tumor size reduction. In addition to this, the 40% of patients who have achieved more than 50% tumor size reduction under NOX‑A12 treatment is a considerable increase over the 22% disclosed in the previous interim data analysis, and a multi-fold increase over the 10% achieved by the reference cohort receiving standard of care. This suggests the promising clinical efficacy of this new approach to directly target CXCL12 in glioblastoma."

A copy of the poster presentation and a video describing the poster, is available on the NOXXON website. More information about the GLORIA study (NCT04121455) can be found at ClinicalTrials.gov.

Following the ASCO 2022 conference, NOXXON will host a Key Opinion Leader (KOL) webinar with Dr. Giordano, who will take the audience through the ASCO poster presentation and discuss the results of the GLORIA Phase 1/2 trial in more detail.

Details of the Key Opinion Leader webinar are as follows:
Title: KOL Webinar on GLORIA Top-Line Results of NOX-A12 & Radiotherapy Combination in First-Line Glioblastoma Presented at ASCO 2022
Presenter: Dr. Frank A. Giordano, Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany
Webinar time and date: June 10, 2022, at 02:00 p.m. CEST (08:00 a.m. EDT)
Registration: To register for the event, please click here

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 top-line data from all three dose-escalation 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.

Visit NOXXON on LinkedIn and Twitter.

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; and C. radiotherapy and pembrolizumab.

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.

Disclaimer

Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. Certain statements in this communication contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this communication regarding planned or future results of business segments, financial indicators, developments of the financial situation or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for updating such information, which only represents the state of affairs on the day of publication.

For more information, please contact:
NOXXON Pharma N.V.
Aram Mangasarian, Ph.D.
Chief Executive Officer
Tel. +49 (0) 30 726247 0
amangasarian@noxxon.com

Investor and Media Relations:
LifeSci Advisors
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31
gvanrenterghem@lifesciadvisors.com

NewCap
Arthur Rouillé
Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr