'We have also significantly strengthened our Supervisory Board by adding three new board members with outstanding and highly relevant experience in business development, corporate law, and finance. On the business development front, I am delighted that MSD/
H1 2021 Business Highlights
Top US and EU pancreatic cancer experts joined NOXXON's
Dr.
Supervisory Board
Appointment of 3 highly distinguished new members to the Supervisory Board in
Dr.
H1 2021 Financial Highlights
For the reporting period, the Group -
In H1 2021, the Group generated KEUR142 in other operating income from the sale of raw materials and services as well as other income.
Operating costs increased by 213% in H1 2021 over the same period last year, most of this increase being driven by research and development (R&D) expenses, accounting for 81% of operating costs. The R&D expenses increased by 421% in H1 2021 over the same period last year as NOXXON continued to make progress with the clinical stage assets. General and administrative (G&A) expenses increased by 14% to support operational activities. These operating costs led to
The Group was successful in strengthening its balance sheet by raising a total of
These activities and fund raising in H1 2021 led the Group to report
H1 2021 and Year-to-Date Clinical Highlights
NOXXON had a busy and productive H1 2021 period on the R&D front with significant progress made on its lead asset, NOX-A12.
NOX-A12 + radiotherapy in glioblastoma (GBM) Phase 1/2 study (GLORIA) in patients newly diagnosed with aggressive brain cancer is ongoing. All patients have been recruited in the low, mid and high dose cohorts (200, 400 or 600 mg NOX-A12 per week), and will have completed 6 months of therapy in Q1 2022. Data from two dose cohorts (low and medium) showed that:
Five out of six patients showed reductions in tumor size with maximal reductions baseline ranging from 2% to 71%, including two objective responses (reduction larger than 50%);
Five of six patients achieved reduced blood flow to the tumor compared with baseline;
Comparison of pre-treatment to on-therapy tumor tissue from one patient in the low dose cohort revealed that NOX-A12 effectively suppresses the target.
Based on the data obtained from the initial dose cohorts, an expansion of the study with patients who would not benefit from standard of care chemotherapy is planned. NOXXON believes that the next step in development should be a pivotal trial following the current Phase 1/2 study and targets first market approval in 2025.
NOX-A12 + immunotherapy.
Outlook for the Remainder of 2021 and 2022
NOXXON continues to progress its ongoing Phase 1/2 clinical trial of NOX-A12 plus radiotherapy in first-line brain cancer (glioblastoma) patients who are shown by biomarker analysis of their tumor tissue to be resistant to the current standard of care chemotherapy. The clinical trial remains on track to report data from the third cohort (highest dose) in Q1 2022. The Company also continues to advance the regulatory filings for the expansion cohorts to explore additional patient populations and combination therapies in brain cancer.
The operational environment continues to be uncertain due to the COVID pandemic and its consequences and NOXXON remains dependent upon its service providers for drug manufacturing and conducting clinical trials.
NOXXON's long-term strategic plans now include the following trials by indication:
NOX-A12 + radiotherapy in
Completion of the ongoing Phase 1/2 dose escalation trial is planned for Q1 2022. Thereafter, additional data are expected from expansion arms testing NOX-A12 in another population of brain cancer patients or in combination with other agents.
Anticipating that the ongoing Phase 1/2 trial data supports further development, NOXXON plans to initiate in 2022 a pivotal trial of NOX-A12 combined with radiotherapy in first-line MGMT promoter-unmethylated glioblastoma patients vs. standard of care, with first market authorization application and approval targeted for 2025.
NOX-A12 + immunotherapy in Pancreatic Cancer:
Following the promising results from the OPERA trial, NOXXON has decided to pursue the NOX-A12 + immunotherapy combination in second-line pancreatic cancer with a dosing regimen of NOX-A12 optimized to induce anti-tumor immune responses.
A two-step approach is planned with a Phase 2 study (OPTIMUS) comparing two NOX-A12 combinations with anti-PD-1 antibody and two different standard of care chemotherapy regimens in second-line patients followed by a pivotal trial comparing the best combination to the standard of care.
To conduct the OPTIMUS study, NOXXON and MSD (
As previously announced, first patients are expected to be dosed in Q2 2022. The study completion is expected in early 2024.
This strategic approach will enable NOXXON to choose the optimal regimen to move forward into a randomized, controlled pivotal study targeting marketing authorization application and approval in 2027.
NOX-E36 in Oncology:
The second clinical stage asset, NOX-E36, is also being readied for the first clinical trial of NOX-E36 in oncology. Manufacturing of clinical supply has been contracted and clinical trial supply is projected to be available in Q1 2022, and trial initiation is targeted for mid-2022.
The Half-Year Financial Report 2021 can be downloaded from the NOXXON website.
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
Keytruda is a registered trademark of
Visit NOXXON on LinkedIn and Twitter.
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 glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy).
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
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.
Contact:
Chief Executive Officer
Tel: +49 (0) 30 726247 0
E: amangasarian@noxxon.com
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