NOXXON Pharma N.V.: NOXXON Presents Final Clinical Data From Phase 1/2 NOX-A12 / Keytruda Combination Trial in Colorectal and Pancreatic Cancer at the ESMO Virtual Congress 2020

Trial results including overall survival and safety profile warrant further clinical development of NOX-A12 plus immunotherapy combinations

Regulatory News:

NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), presents today a poster with the final clinical results from the Phase 1/2 study with CXCL12 inhibitor, NOX-A12, and pembrolizumab in patients with microsatellite-stable, metastatic colorectal or pancreatic cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The enhanced immune response and long survival times for certain late-stage patients combined with the good overall safety profile confirmed in the final data support further development of the combinations containing NOX-A12 plus pembrolizumab and established standard of care regimens in earlier lines of therapy. The poster presentation is complemented by a video presentation with remarks highlighting the trial's most significant data provided by Dr. Niels Halama from the National Center for Tumor Diseases (NCT) in Heidelberg, Germany, the first author of the poster presentation and the principal investigator of the trial.

"In this trial, we observed a number of patients 25% of the total who experienced disease stabilization and many with prolonged survival also during the follow-up period, which is particularly noteworthy in patients at such a late-stage of disease progression. In fact, we saw multiple cases of 4^th line pancreatic cancer patients, who did not respond at all to their prior therapy, surviving for more than one year," commented Dr. Niels Halama.

"The patients in this study were, on average, receiving their 6^th line of therapy in colorectal cancer and their 4^th line of therapy in pancreatic cancer. In addition, all patients had liver metastases and, in 95% of cases, were completely non-responsive to their last therapy before entering this study. As such, the data from this study provide signals that support a beneficial impact of the combination of NOX-A12 with pembrolizumab for patients with extremely limited options. Thus, we are planning to advance NOX-A12 into the next stage of clinical development in at least one of these indications," added Dr. Jarl Ulf Jungnelius, Senior Medical Advisor of NOXXON.

The trial called for all patients to have a baseline biopsy of tumor tissue, two weeks of NOX-A12 monotherapy and then a second biopsy to assess changes induced in the tumor microenvironment by NOX-A12. After the second biopsy, it was planned to move all patients to a combination therapy of NOX-A12 plus pembrolizumab (MSD's anti-PD-1 antibody) and continue combination therapy until tumor progression or safety issues. CXCL12, the target of NOX-A12 which is thought to exclude immune cells from the tumor microenvironment, was found to be abundantly present in all tumor samples at baseline.

NOX-A12 penetrated cancer tissue in both pancreatic and colorectal cancer patients where it neutralized its target, CXCL12. NOX-A12 monotherapy resulted in induction of a Th1-like immune response in patients when baseline biopsies were compared to post-NOX-A12 monotherapy samples. The extent of CXCL12 neutralization in tumor tissue correlates with a Th1 immune response and disease stabilization and based on the obtained results, an optimized dosing strategy for NOX-A12 will be used for future studies. As would be expected if the immune system were better coordinating a response against the cancer, T cells in the cancer both moved together (aggregation) and moved towards the tumor cells in responding tissues.

The combination of NOX-A12 plus pembrolizumab resulted in stable disease in 25% of patients, and prolonged time on treatment vs. prior therapy for 35% of patients. Overall survival was 39% at 6 months and 20% at 12 months. Three of the stable disease patients (15% of the starting study population) survived for more than a year. In addition, the combination of NOX-A12 with pembrolizumab appears to be safe and this allows exploration of further combination approaches in earlier line patients combining an optimized dose with standard of care.

Taken together, these data thus support a role of CXCL12 in resistance to immunotherapy and suggest that NOX-A12 may be able to counter this effect by boosting the immune response in tumor tissue. Further studies of NOX-A12 in combination regimens are warranted and currently the company is exploring strategies with external experts to combine NOX-A12 with anti-PD1 agents and established standard of care regimens in earlier lines of therapy than those explored in this clinical trial.

The poster presentation #1537P is available for registered delegates to view on demand on the ESMO Virtual Congress 2020 program page starting today from 09.00 a.m. CEST until 08.00 p.m. CEST on September 21, 2020. Additionally, Dr. Halama's video presentation as well as the poster have been published on the NOXXON website. The poster abstract is openly available on the Congress platform.

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 and further studies are being planned in these indications. In September 2019 the company initiated 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

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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.

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