On November 3, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that due to supply-chain issues affecting its drug-supply manufacturer, the start date of its two upcoming NOX-A12 clinical trials will be delayed by up to 3 months until Q3 2022 (Press release, NOXXON, NOV 3, 2021, View Source [SID1234594267]). The affected trials are the Phase 2 trial (OPTIMUS) with NOX-A12 in combination with MSD’s (Merck & Co., Inc., Kenilworth, N.J. USA) anti-PD-1 therapy Keytruda (pembrolizumab) as second-line therapy in pancreatic cancer, and the planned pivotal Phase 2/3 trial of NOX-A12 in combination with radiotherapy in first-line brain cancer (glioblastoma) patients.
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Due to a shortage in the US of dichloroacetic acid, a key chemical reagent necessary to synthesize NOX-A12, NOXXON has been informed by its contract active ingredient manufacturer that the NOX-A12 batches needed to initiate these two studies will only be available in Q2 2022 with first patients therefore expected to be dosed in early August 2022. These delays have impacted the overall approval timelines of NOX-A12 in glioblastoma, pushing it into early 2026, while market approval in pancreatic cancer remains unchanged and is planned in 2027.
Aram Mangasarian, CEO of NOXXON commented: "The effects of the COVID-19 pandemic continue to impact the healthcare industry in many areas, including the most essential ones like manufacturing supply chains. The NOX-A12 studies in pancreatic and brain cancer are our key clinical programs; the pancreas cancer trial is our second collaboration with MSD, a global leader in the immuno-oncology space, and the pivotal brain cancer trial is expected to deliver the data base for our first marketing authorization. We have worked with our contract manufacturer to overcome the unexpected shortages of what are usually easily sourced chemical reagents affecting these batches of NOX-A12 and are doing everything to ensure these batches will be released as soon as possible with the usual high standards of quality. We look forward to getting the trials underway and examining the potential clinical benefits of NOX-A12 in combination with Keytruda or radiotherapy for patients suffering from highly aggressive cancers."
With €13.7 million in cash and cash equivalents on June 30, 2021 and available secured financing of €10.45 million (nominal) drawable at the company’s discretion as reported on October 22, 2021 with the Half-Year Financial Report 2021, updated timing of commitments for manufacturing and clinical trials extends NOXXON’s financial visibility into July 2022.