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), today announced entering into its second clinical collaboration agreement with MSD (Merck & Co., Inc., Kenilworth, N.J. USA), to collaborate in the upcoming Phase 2 clinical trial of NOXXON’s NOX-A12 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), as second-line therapy in pancreatic cancer.
This Phase 2 study will evaluate the safety and efficacy of NOX-A12, NOXXON’s anti-CXCL12 agent, in combination with KEYTRUDA and two different chemotherapy regimens in patients with microsatellite stable pancreatic cancer. The vast majority of pancreatic cancer patients have microsatellite stable tumors which are resistant to checkpoint inhibitor monotherapy. The study will enroll up to 70 patients and will contain an interim go/no-go in each arm in addition to usual safety and efficacy endpoints. MSD will provide pembrolizumab and expert advice for the study protocol, while NOXXON will sponsor the trial that will be conducted in clinical centers in the US and Europe.
The study will include two treatment arms to determine the most efficacious treatment combination to move forward into a registrational trial:
Arm 1: NOX-A12 + pembrolizumab + gemcitabine + nab-paclitaxel
Arm 2: NOX-A12 + pembrolizumab + nano-liposomal irinotecan + 5-fluorouracil + leucovorin
Dr. Jarl Ulf Jungnelius, Senior Medical Advisor at NOXXON, commented: “Checkpoint inhibitors have rapidly become first-line treatment options for many cancer types but have failed to demonstrate benefits in microsatellite stable pancreatic cancer as monotherapy or in combination with standard of care chemotherapy. We believe that tackling the microenvironment is a promising approach to deliver in pancreatic cancer the clinical benefits demonstrated by anti-PD-1 therapy in other tumor types.”
Aram Mangasarian, CEO of NOXXON commented: “We are excited to continue our successful collaboration with MSD, a key global player in the immuno-oncology space. We expect this upcoming Phase 2 to confirm the excellent safety and more clearly define the clinical benefits that NOX-A12 can provide in combination with KEYTRUDA to patients suffering from highly aggressive cancers, such as pancreatic cancer.”
NOXXON’s lead compound NOX-A12 is a highly selective inhibitor of CXCL12, a critical tumor microenvironment chemokine that shields the tumor from the immune system and promotes vasculogenesis, significantly reducing cancer treatment efficacy and promoting tumor growth. NOX-A12 acts by two potential mechanisms of action:
- Reducing the CXCL12 shield around the tumor, leading to an improved access of immune effector cells like T lymphocytes to the tumor;
- Blocking tumor blood vessel rebuilding by vasculogenesis post radiotherapy.
NOX-A12 is currently developed in second-line pancreatic cancer in combination with Keytruda® and in glioblastoma in combination with radiotherapy.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
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 clinically from standard chemotherapy has delivered interim data from the first two cohorts showing consistent tumor reductions and objective tumor responses. 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. Further information can be found at: www.noxxon.com
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp
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