BERLIN--(BUSINESS WIRE)--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 enrollment and first week of treatment of the first patient in the third, high 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 who would not benefit clinically from treatment with standard chemotherapy.
Once the newly enrolled patient in the third 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.
“As we enter the last cohort of the dose escalation trial and obtain sufficient data, we will soon be in a position to determine the recommended dose for our next randomized, controlled brain cancer trial which will compare NOX-A12 combined with radiotherapy to standard of care. We then plan to recruit additional patients to broaden the safety and efficacy data-set. The additional data will provide a comprehensive basis for discussions with EU and US regulators concerning plans for our next trial, which is planned to be registrational,” commented Aram Mangasarian, CEO of NOXXON. “Recruitment into the current trial continues in our six study centers, three of which were added in October 2020 in order to mitigate the challenges faced by hospital staff as a result of the COVID-19 pandemic. Six months of data from the second and third cohorts of patients should be available at end-Q2 2021 and end-Q3 2021, respectively,” he concluded.
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. Further information can be found at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp
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