NOXXON Enters Into Collaboration With US National Cancer Institute to Characterize Effects of Lead Compounds on Brain Tumors

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), announced today it has entered into a material transfer agreement with the U.S. National Cancer Institute (NCI), of the National Institutes of Health (NIH), to further explore the effects of NOXXON’s lead compounds, the CXCL12 inhibitor NOX-A12 and the CCL2 inhibitor NOX-E36, individually and combined, on brain tumors.

The research program will be led by Mark R. Gilbert, M.D., Chief of the Neuro-Oncology Branch at the National Cancer Institute’s Center for Cancer Research (NCI/CCR), part of the NIH. Under the agreement, NOXXON will supply NOX-A12 and mNOX-E36¹ to the NCI, which will conduct preclinical testing in different combinations with immunomodulatory treatments, including immune checkpoint inhibitors. The various combinations will be tested in an array of experiments in three murine brain cancer models, with extensive and detailed characterization of the tumor microenvironment.

“We are proud and excited to be establishing this partnership with NCI to deepen our understanding of our lead compounds, NOX-A12 and NOX-E36, in brain tumors. By using three different brain cancer models with very distinct immunological characteristics, this research will greatly improve the understanding of the effect of our compounds on the tumor biology. The work is also expected to deliver insights into whether and how our CXCL12 and CCL2 antagonist can be synergistic with other approaches in altering the brain tumor microenvironment, with the aim of facilitating a relevant anti-tumor immune reaction,” said Aram Mangasarian, CEO of NOXXON.

NOX-A12 is being investigated in the Phase 1/2 GLORIA dose-escalation study in brain cancer (glioblastoma) patients, top-line data from which were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, Illinois, US, on June 5, 2022. NCI is not participating in this clinical study.

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.

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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 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.

¹ NOX-E36 being not active in rodents; the surrogate Spiegelmer mNOX-E36 which binds and inactivates mouse and rat CCL2 will be used for these experiments.

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