TME Pharma Announces Further Improvement in Median Overall Survival at 19 Months Follow-up in GLORIA Brain Cancer Trial

• Median overall survival surpasses 19 months and continues to improve in glioblastoma patients receiving NOX-A12 combination with radiotherapy and bevacizumab
• Survival rate in this cohort at 19 months is 10-fold greater than a reference cohort of matched patients receiving standard of care (50% vs. 5%)

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), announces that with median overall survival (mOS) has now passed 19 months and will improve further in the GLORIA expansion arm for newly diagnosed glioblastoma patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy.

“The survival data in the cohort receiving the combination of NOX-A12, bevacizumab and radiotherapy has continued to improve with treatment or follow-up of enrolled brain cancer patients. Passing 19 months suggests a large survival benefit for patients on NOX-A12-based therapy since we are seeing more than an 80% increase in survival over the 10.5 months in the matched standard of care reference cohort of patients with the same profile as those we recruited into the study of NOX-A12: newly-diagnosed aggressive brain cancer (glioblastoma) with chemotherapy refractory tumors not amenable to complete surgical resection," said Aram Mangasarian, CEO of TME Pharma. "With further perspective on the data we can now say with certainty that median overall survival will be between 19.0 and 19.9 months and plan to provide an update before the end of February 2024.”

The NOX-A12-based combination with bevacizumab and radiotherapy has now further surpassed the median overall survival figures achieved in what TME Pharma believes to be all the relevant competitor studies conducted in the US or EU involving newly diagnosed, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients which ranged from 13.4 to 16.5 months mOS for therapies in clinical development and 16.9 months demonstrated by the Tumor Treating Fields device that was approved by the US Food and Drug Administration (FDA) for newly-diagnosed glioblastoma in 2015¹. In addition, the NOX-A12-based therapy achieved this result despite having a more difficult population to treat since only patients with residual detectable tumor after surgery were included the NOX-A12 trial, while competing trials included patients with complete removal of detectable tumor.

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, and improved survival. 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 has been approved in France, Spain and the United States. 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.

TME Pharma^® and the TME Pharma logo are registered trademarks.

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.

¹ See annex to the TME Pharma press release published on 13 September 2023

For more information, please contact:

TME Pharma N.V.
Aram Mangasarian, Ph.D., CEO
Tel. +49 (0) 30 726247 0
investors@tmepharma.com

Investor and Media Relations:

LifeSci Advisors
Guillaume van Renterghem
Tel. +41 (0) 76 735 01 31
gvanrenterghem@lifesciadvisors.com

NewCap
Arthur Rouillé
Tel. +33 (0) 1 44 71 00 15
arouille@newcap.fr