NOXXON Pharma N.V. announced the latest update of clinical results from the Phase 1/2 study of NOX-A12 in combination with Keytruda® in patients with microsatellite-stable, metastatic pancreatic and colorectal cancer in a poster presentation at the American Association for Cancer Research Annual Meeting.
Berlin, Germany, April 1, 2019, 07.00 p.m. CEST - NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), announced today the latest update of clinical results from the Phase 1/2 study of NOX-A12 in combination with Keytruda® (pembrolizumab) in patients with microsatellite-stable, metastatic pancreatic and colorectal cancer in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting.
The study confirmed that NOX-A12 is safe and well-tolerated in advanced cancer patients both as monotherapy and in combination with pembrolizumab. The combination of NOX-A12 and pembrolizumab induced an immune response, stable disease in 25% of patients and prolonged time on treatment vs. prior therapy for 35% of patients. Overall survival was 48% at 6 months and 33% at 12 months. As indicated by these data, NOX-A12’s effect in patients with impaired immune systems, high tumor load and who have also failed multiple prior lines of therapy, supports additional investigation of the compound in these severe indications.
As initially announced in December 2018, the Phase 1/2 study in colorectal and pancreatic cancer patients investigated whether the inhibition of the chemokine CXCL12 by NOX-A12 could reverse the immune suppressive status of the tumor microenvironment, thereby broadening the applicability of checkpoint inhibitors to these indications. Biopsies were taken from liver metastases before and after a two-week monotherapy phase with NOX-A12. This was followed by the combination phase in which patients received cycles of NOX-A12 and pembrolizumab until progression or intolerable toxicity.
“Based on the fact that these indications have remained unaffected by checkpoint inhibitors, the outcome of this trial emphasizes the real potential NOX-A12 has on targeting the tumor microenvironment and enabling the intended mode of action of pembrolizumab,” said Aram Mangasarian, CEO of NOXXON. “These results provide a strong rationale for moving this program forward into a larger scale randomized trial with a less-advanced patient population, an opportunity we intend to pursue with a partner. In the meantime, we will continue to evaluate patients and monitor disease progression.”
“As a clinician who has worked with colorectal and pancreatic cancer patients, the data provide signals that support the potential impact of the combination of NOX-A12 with pembrolizumab, which is a significant step for these cancers with extremely limited options,” commented Dr. Jarl Ulf Jungnelius, CMO of NOXXON.
The poster titled, “Clinical outcome and safety in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer treated with the CXCL12 inhibitor NOX-A12 in combination with PD-1 checkpoint inhibitor pembrolizumab” was presented by NOXXON’s CMO, Jarl Ulf Jungnelius, on Monday, April 1 from 1.00 – 5.00 pm EDT and is available on NOXXON’s website.
For more information, please contact:
NOXXON Pharma N.V.
Aram Mangasarian, Ph.D., Chief Executive Officer
Tel. +49 (0) 30 726247 0
amangasarian@noxxon.com
MC Services AG
Raimund Gabriel, Managing Partner
Tel. +49 (0) 89 210228 0
noxxon@mc-services.eu
Trophic Communications
Gretchen Schweitzer or Joanne Tudorica
Tel. +49 (0) 89 2388 7730 or +49 (0) 176 2103 7191
schweitzer@trophic.eu
NewCap
Alexia Faure
Tel. +33 (0) 1 44 71 98 51
afaure@newcap.fr
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 tumor microenvironment, NOXXON’s approach works in combination with other forms of treatment to weaken tumor defenses against the immune system and enable greater therapeutic impact. Building on extensive clinical experience and safety data, the lead program NOX-A12 has delivered top-line data from a Keytruda® combination trial in metastatic colorectal and pancreatic cancer patients in December 2018 and further studies are being planned in these indications. The company initiated preparations for an additional trial with NOX-A12 in brain cancer in combination with radiotherapy. The combination of NOX-A12 and radiotherapy has been granted orphan drug status in the US and EU for the treatment of certain brain cancers. 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
