NOXXON Initiates Patient Recruitment for Phase 1/2 Clinical Trial Combining NOX-A12 & Radiotherapy for the Treatment of Brain Cancer Patients

WEBINAR SCHEDULED FOR MONDAY, SEPTEMBER 23 AT 3.00 PM CEST

BERLIN--()--Regulatory News:

NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today the start of recruitment of newly diagnosed brain cancer patients in a Phase 1/2 clinical trial combining the CXCL12 inhibitor NOX-A12 with radiotherapy. NOX-A12 is thought to inhibit the influx of “repair cells” from the bone marrow to the tumor, an unwanted consequence of radiotherapy that leads to a replacement of the destroyed blood vessels within the tumor which ultimately results in a recurrence of the disease.

The safety and first efficacy data obtained in this study will support the definition of a Recommended Phase 2 Dose (RP2D) for this new treatment approach to guide further clinical developments. The non-invasive assessment of the changes in tumor vascularization by MRI is expected to confirm the predicted mechanism mode of action for the inhibition of CXCL12 in combination with radiotherapy.

NOX-A12 combined with radiotherapy is a novel and promising approach with the potential to effectively treat brain cancer patients for which there are currently no optimal therapies. The demand from the clinical community to test this combination has been very strong and we are pleased to initiate this trial. We expect data from the first cohort of patients to be available in mid-2020,” said Jarl-Ulf Jungnelius, Chief Medical Officer of NOXXON.

The trial will be conducted at three hospitals in Germany. Up to three escalating doses of NOX-A12 will be administered in combination with standard radiotherapy to newly diagnosed patients with brain tumors who would not benefit from the current standard of care of chemoradiotherapy and whose tumors cannot be fully resected by surgery. The main objective of the study is to assess the safety and tolerability of this combination. Secondary endpoints include activity of the therapy, assessed through the monitoring of tumor vascularization by MRI scans, progression-free survival, overall survival and rates of response.

CEO of NOXXON, Aram Mangasarian, will host a webinar on September 23, 2019 at 03.00 p.m. CEST, and will be joined by Dr. Frank Giordano, Vice Chairman of Radiation Oncology Department at University Medical Centre Mannheim for the presentation and Q&A session. To join the webinar, please send an email to BrainCancerEvent@noxxon.com.

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 tumor microenvironment, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. Building on extensive clinical experience and safety data, the lead program NOX-A12 has delivered top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients in December 2018 and further studies are being planned in these indications. The company initiated preparations for an additional trial with NOX-A12 in brain cancer in combination with radiotherapy. The combination of NOX-A12 and radiotherapy has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. 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 both as a monotherapy and in combination. Further information can be found at: www.noxxon.com

Keytruda® is a registered trademark of Merck Sharp & Dohme Corp

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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.

Contacts

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

Trophic Communications
Gretchen Schweitzer or Joanne Tudorica
Tel. +49 (0) 89 2388 7730 or +49 (0) 176 2103 7191
schweitzer@trophic.eu

NewCap
Alexia Faure
Tel. +33 (0) 1 44 71 98 51
afaure@newcap.fr

Contacts

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

Trophic Communications
Gretchen Schweitzer or Joanne Tudorica
Tel. +49 (0) 89 2388 7730 or +49 (0) 176 2103 7191
schweitzer@trophic.eu

NewCap
Alexia Faure
Tel. +33 (0) 1 44 71 98 51
afaure@newcap.fr