NOXXON Pharma: Data Safety Monitoring Board Confirms Safety & Validates Recruitment of Last Patients in Final High-Dose Cohor...
12 Março 2021 - 4:00AM
Business Wire
First brain cancer patient from third-dose
cohort reaches 4 weeks of treatment with NOX-A12 combined with
radiotherapy
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 that
the Data Safety Monitoring Board (DSMB) analyzed safety data from
the initial four weeks of treatment of the first patient enrolled
in the third and final dose cohort of the NOX-A12 plus radiotherapy
brain cancer study. The DSMB concluded that it is safe and
appropriate to continue patient recruitment according to the study
protocol. The DSMB’s decision marks an important milestone in this
trial as it enables the advancement and analysis of the final dose
regimen, placing NOXXON on the path toward valuable data readouts
anticipated later this year.
The Phase 1/2 clinical study is testing three dose regimens of
NOX-A12 (200, 400 and 600 mg/week), each combined with
external-beam radiotherapy, in newly diagnosed brain cancer
patients. Based on the DSMB’s confirmation, participating clinical
centers have now initiated final patient recruitment for the last
and highest dose group. After all patients in the third cohort have
received four weeks of treatment with NOX-A12 and radiotherapy, the
DSMB will reconvene for a final meeting to assess safety and
tolerability. The outcome of this meeting will inform the
recommended dose for the next randomized, controlled brain cancer
trial which will lead to the registration of NOX-A12.
“We are pleased by the safety data confirmation of the DSMB, as
it will allow our study to progress and the last patients to
receive treatment at the highest planned dose of NOX-A12. This
achievement brings us one step closer to a topline data readout for
this cohort sometime around the end of Q3 2021,” commented Aram
Mangasarian, CEO of NOXXON. “As the study advances, we will be
analyzing data which will be used to define the recommended dose
and guide preparations for a potentially registrational Phase 2
study. The recent capital raise plus available financing vehicles
secure NOXXON’s financial runway well into 2022, thereby allowing
us to address operational matters crucial for the future of the
company.”
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 based on the trial results, including overall
survival and safety profile, further studies are being planned in
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.
A trial of NOX-A12 in combination with radiotherapy in newly
diagnosed brain cancer patients who will not benefit from standard
chemotherapy has delivered preliminary data from the first cohort
showing consistent tumor reductions. 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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Disclaimer
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.
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NOXXON Pharma N.V. Aram Mangasarian, Ph.D., Chief
Executive Officer Tel. +49 (0) 30 726247 0
amangasarian@noxxon.com
Trophic Communications Gretchen Schweitzer and Valeria
Fisher Tel. +49 (0) 172 861 8540 and +49 (0) 175 804 1816
noxxon@trophic.eu
NewCap Arthur Rouillé Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr