BERLIN–(COMMERCIAL THREAD) – Regulatory news:
NOXXON Pharma SA (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), today provided an update on the clinical development and timelines of its core asset NOX-A12.
As NOX-A12 recently reported promising data from the second cohort of glioblastoma (brain cancer) patients, NOXXON is advancing and expanding clinical programs with the upcoming expansion of the ongoing GLORIA study in patients with brain cancer and the launch of a phase 2 study in pancreatic cancer patients over the next 12 months:
the ongoing Phase 1/2 GLORIA trial (NCT04121455), evaluating NOX-A12 in combination with radiotherapy in patients with first-line MGMT unmethylated brain cancer, has previously reported positive data from 2 first cohorts of 3 patients each treated with weekly doses of 200 and 400 mg of NOX-A12. The third cohort of 3 patients dosed at 600 mg per week was fully recruited with data expected in Q4 2021, but due to the discontinuation of one of the patients unrelated to NOX-A12, the recruitment of a patient from replacement has been initiated and data from this third cohort are now expected in the first quarter of 2022,
the extension of the Phase 1/2 GLORIA trial with NOX-A12 in patients with unmethylated MGMT brain cancer is expected to be launched in September 2021 at the 6 clinical sites in Germany already participating. The first patients are expected to be recruited in the fourth quarter of 2021. The trial (i) will expand the patient population to those with tumors completely resected for the combination of NOX-A12 with radiotherapy and (ii) will evaluate a new combination of treatment. NOX-A12 in patients. with incompletely resected tumors.
a new Phase 2 trial (OPTIMUS) with NOX-A12 in combination with anti-PD-1 therapy from MSD KEYTRUDA® (pembrolizumab), is now expected to start in Q2 2022, starting from the initial start-up scheduled for H2 2021. Although the collaboration with MSD was signed in July 2021, delays due to COVID-19 and other unrelated issues of NOXXON’s will in raw materials and assets Ingredient service providers mean that the batches of NOX-A12 needed to launch phase 2 will only be available in the first quarter of 2022, with the first patients to be dosed in the second quarter of 2022.
Aram Mangasarian, CEO of NOXXON said: “The unexpected manufacturing delay affecting the pancreatic cancer control program is understandably disappointing, but we have worked tirelessly to resolve the issues to ensure that batches of NOX-A12 are released as quickly as possible while maintaining the highest quality standards. We are very pleased that Merck has reiterated its confidence in our collaboration by entering into a second collaboration with NOXXON and we look forward to implementing our new expanded clinical program with NOX-A12. Recruitment of the expanding brain cancer cohort would not be affected by these drug manufacturing and supply issues. ”
NOXXON’s oncology-focused pipeline acts on the tumor microenvironment (TME) and the cancer immunity cycle by breaking down the tumor protective barrier and blocking tumor repair. By neutralizing the chemokines in TME, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and allow greater therapeutic impact. NOXXON’s main program, NOX-A12, provided the final revenue data of a Keytruda® combined trial in patients with metastatic colorectal and pancreatic cancer published at the ESMO conference in September 2020 and July 2021, the company announced its phase 2 study, OPTIMUS, to further assess safety and efficacy NOX-A12 in combination with Keytruda from Merck® and two different chemotherapy regimens as second-line treatment in patients with metastatic pancreatic cancer. NOXXON is also studying NOX-A12 in brain cancer in combination with radiation therapy, which has been granted orphan drug status in the US and the EU for the treatment of certain brain cancers. GLORIA, a trial of NOX-A12 in combination with radiation therapy in patients with newly diagnosed brain cancer who will not clinically benefit from standard chemotherapy, provided interim data from the first two cohorts showing consistent tumor reductions and objective tumor responses. The company’s second clinical-stage active, NOX-E36, is a phase 2 TME active targeting the innate immune system. NOXXON plans to test NOX-E36 in patients with solid tumors. Further information can be found at: www.noxxon.com.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp
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About the GLORIA study
GLORIA (NCT04121455) is the phase 1/2 dose escalation study of NOXXON on NOX-A12 in combination with irradiation in patients with first-line glioblastoma (brain cancer) with a non-MGMT promoter. methylated (resistant to standard chemotherapy).
About the OPTIMUS study
OPTIMUS (NCT04901741) is NOXXON’s open-label, two-arm phase 2 study of NOX-A12 in combination with pembrolizumab and nanoliposomal irinotecan / 5-FU / leucovorin or gemcitabine / nab-paclitaxel in patients with ‘stable microsatellite metastatic pancreatic cancer.
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