BERLIN, Germany–(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 enrollment and first treatment of a patient with newly diagnosed brain cancer in the middle dose cohort of the phase 1/2 clinical trial. The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients.
Once the newly enrolled patient in the second cohort has received a four-week treatment of NOX-A12 and radiotherapy, the Data Safety Monitoring Board will convene to determine whether it is safe to recruit the remaining two patients into the cohort.
“Recruitment into this trial currently continues in our study centers, despite the challenges that hospital staff face as a result of the COVID-19 pandemic,” commented Aram Mangasarian, CEO of NOXXON. “Six months of data from the first cohort of patients should be available in October 2020, and from the second and third cohorts at the end of Q1 2021 and mid-2021, respectively. As a measure to ensure the timely completion of the study under the challenging conditions of the COVID-19 pandemic, we are currently preparing the inclusion of three additional clinical sites to increase recruitment capacity.”
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 and further studies are being planned in these indications. In September 2019 the company initiated 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. (Read more…) Further information can be found at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp
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NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Chief Executive Officer
Tel. +49 (0) 30 726247 0
Gretchen Schweitzer or Joanne Tudorica
Tel. +49 (0) 89 2388 7730 or +49 (0) 176 2103 7191
Tel. +33 (0) 1 44 71 00 15