TME Pharma N.V.: Safety Confirmed of NOX-A12 and Pembrolizumab Combination in GLORIA Phase 1/2 Brain Cancer Study

Data Safety Monitoring Board deems combination of CXCL12 inhibitor NOX-A12, radiotherapy and anti-PD1 pembrolizumab safe and validates recruitment of remaining patients

BERLIN–(BUSINESS WIRE)–Regulatory News:

TME Pharma N.V., (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), announced today that the Data Safety Monitoring Board (DSMB) validated safety data from the initial four weeks of treatment of the first patient enrolled in the GLORIA Phase 1/2 clinical trial expansion arm with NOX A12 combined with radiotherapy and the PD-1 immune checkpoint inhibitor pembrolizumab, and concluded it is appropriate to continue with recruitment of the remaining 5 patients according to the study protocol.

Aram Mangasarian, CEO of TME Pharma, commented: “After the compelling results seen with NOX‑A12 in glioblastoma patients in the GLORIA study so far, we look forward to seeing the results in additional combination with immune checkpoint inhibition as well as maturing data from the combination of NOX-A12 and bevacizumab.”

GLORIA is a Phase 1/2 dose-escalation study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). The pembrolizumab expansion arm is the second triple-combination arm of the GLORIA clinical trial. The company also evaluates NOX-A12 combined with radiotherapy and bevacizumab. The company reported promising initial data from the bevacizumab expansion arm on June 23, 2022, and plans to disclose more detailed data from the study at a scientific conference later this year.

About TME Pharma

TME Pharma is a clinical-stage company focused on developing novel therapies for treatment of the most aggressive cancers. The company’s oncology-focused pipeline is designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. By neutralizing chemokines in the TME, TME Pharma’s approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. In the GLORIA clinical trial, TME Pharma is studying its lead drug candidate NOX-A12 in newly diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. TME Pharma has delivered top-line data from the NOX-A12 three dose-escalation cohorts combined with radiotherapy of the GLORIA clinical trial, observing consistent tumor reductions and objective tumor responses. Additionally, GLORIA expansion arms evaluate safety and efficacy of NOX-A12 in other combinations where the interim results from the triple combination of NOX-A12, radiotherapy and bevacizumab suggest even deeper and more durable responses. NOX-A12 in combination with radiotherapy has received orphan drug designation for glioblastoma in the United States and glioma in Europe. TME Pharma has delivered final top-line data with encouraging overall survival and safety profile from its NOX-A12 combination trial with Keytruda^® in metastatic colorectal and pancreatic cancer patients, which was published in the Journal for ImmunoTherapy of Cancer in October 2021. The company has entered in its second collaboration with MSD/Merck for its Phase 2 study, OPTIMUS, to further evaluate safety and efficacy of NOX-A12 in combination with Merck’s Keytruda^® and two different chemotherapy regimens as second-line therapy in patients with metastatic pancreatic cancer. The design of the trial is in discussion with regulatory authorities in the United States and Europe. The company’s second clinical-stage drug candidate, NOX-E36, is designed to target the innate immune system. TME Pharma is considering several solid tumors for further clinical development. Further information can be found at: www.tmepharma.com.

Keytruda^® is a registered trademark of Merck Sharp & Dohme Corp.

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About the GLORIA Study

GLORIA (NCT04121455) is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 three additional arms combining NOX-A12 with: A. radiotherapy in patients with complete tumor resection; B. radiotherapy and bevacizumab; and C. radiotherapy and pembrolizumab.

About the OPTIMUS Study

OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.

Disclaimer

Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain “forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.

Contacts

For more information, please contact:


TME Pharma N.V.
Aram Mangasarian, Ph.D., CEO

Bryan Jennings, CFO

Tel. +49 (0) 30 726247 0

[email protected]

Investor and Media Relations:


LifeSci Advisors
Guillaume van Renterghem

Tel. +41 (0) 76 735 01 31

[email protected]

NewCap
Arthur Rouillé

Tel. +33 (0) 1 44 71 00 15

[email protected]